Health is a critical challenge for society on basis of economic asset of people. Pharmaceutical industries and it's manufacturing products have been impacting health related issues for social and community development in major issues of reducing child and maternal mortality, slowing the spread of HIV/AIDS, malaria, tuberculosis, malnutrition of children promoting gender equality and empowerment.Here in this poster presentation, the fascinating role with its different manufacturing process for different types of dosage form of the pharmaceutical industry have been presenting for development of social care.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
The Indian pharmaceutical industry is the third largest by volume and fourteenth largest by value. It supplies affordable drugs domestically while also exporting $10 billion in generic medicines annually. Key strengths include low production costs, a skilled workforce, and strong manufacturing capabilities. However, the industry also faces challenges like low R&D investment, regulatory issues, and international trade barriers that could hamper further growth.
ABBREVIATED NEW DRUG APPLICATION (ANDA),INVESTICATION OF MEDICINAL PRODUCTS D...GOKULAKRISHNAN S
Introduction to ANDA
Regulations applied to ANDA process
Format and content of ANDA
ANDA approval process
Exclusivity
Hatch-Waxman amendments & 180 days exclusivity
Introduction to IMPD
Contents of IMPD
Introduction to IB
Contents of IB
Drug Regulatory Authority of Pakistan (DRAP) Fee Structure (Updated))MUHAMMAD SOHAIL
The document outlines the revised fee structure for various regulatory functions of the Drug Regulatory Authority of Pakistan (DRAP). Key changes include a 50-100% increase in fees for granting and renewing drug manufacturing licenses, drug registration, variations to registered drugs, advertisements, and price fixation. Fees have also been introduced for late renewals of licenses/registration, contract manufacturing permission, price increases linked to inflation, and clearance of imported therapeutic goods. The goal of the changes is to align fees according to the cost of regulatory services and international standards.
This document discusses the different types of labels required for pharmaceutical products. It describes manufacturer labels, which contain drug information supplied by the manufacturer for medical professionals. Manufacturer labels must include the name, strength, dosage form, quantity, instructions, precautions, warnings, registration number, batch number, manufacturing and expiry dates, and manufacturer information. Dispensing labels contain additional information for patients, such as the patient's name, prescription number, directions for use, and pharmacy details. Proper labeling helps ensure drugs are used safely and effectively.
The Indian pharmaceutical industry has grown tremendously over the past few decades from being almost non-existent to meeting nearly 95% of the country's pharmaceutical needs. It is now self-reliant in terms of production capabilities across a wide range of medicines. The industry is highly fragmented with over 20,000 registered units and is characterized by intense price competition and government price controls. Exports have also increased significantly and are expected to surpass domestic sales in the coming years, driven primarily by growth in formulation exports. India also has the most FDA-approved manufacturing facilities outside of the US, positioning it as an important supplier for the global pharmaceutical market.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
FDA Regulation of Promotion & Advertising -- Part 6: First Amendment, Off-Lab...Michael Swit
Presentation to the Compliance Online 2-day course on Ensuring Compliance with FDA Requirements for the Promotion & Advertising of Drugs and Medical Devices, November 2, 2018, Boston.
The Indian pharmaceutical industry is the third largest by volume and fourteenth largest by value. It supplies affordable drugs domestically while also exporting $10 billion in generic medicines annually. Key strengths include low production costs, a skilled workforce, and strong manufacturing capabilities. However, the industry also faces challenges like low R&D investment, regulatory issues, and international trade barriers that could hamper further growth.
ABBREVIATED NEW DRUG APPLICATION (ANDA),INVESTICATION OF MEDICINAL PRODUCTS D...GOKULAKRISHNAN S
Introduction to ANDA
Regulations applied to ANDA process
Format and content of ANDA
ANDA approval process
Exclusivity
Hatch-Waxman amendments & 180 days exclusivity
Introduction to IMPD
Contents of IMPD
Introduction to IB
Contents of IB
Drug Regulatory Authority of Pakistan (DRAP) Fee Structure (Updated))MUHAMMAD SOHAIL
The document outlines the revised fee structure for various regulatory functions of the Drug Regulatory Authority of Pakistan (DRAP). Key changes include a 50-100% increase in fees for granting and renewing drug manufacturing licenses, drug registration, variations to registered drugs, advertisements, and price fixation. Fees have also been introduced for late renewals of licenses/registration, contract manufacturing permission, price increases linked to inflation, and clearance of imported therapeutic goods. The goal of the changes is to align fees according to the cost of regulatory services and international standards.
This document discusses the different types of labels required for pharmaceutical products. It describes manufacturer labels, which contain drug information supplied by the manufacturer for medical professionals. Manufacturer labels must include the name, strength, dosage form, quantity, instructions, precautions, warnings, registration number, batch number, manufacturing and expiry dates, and manufacturer information. Dispensing labels contain additional information for patients, such as the patient's name, prescription number, directions for use, and pharmacy details. Proper labeling helps ensure drugs are used safely and effectively.
The Indian pharmaceutical industry has grown tremendously over the past few decades from being almost non-existent to meeting nearly 95% of the country's pharmaceutical needs. It is now self-reliant in terms of production capabilities across a wide range of medicines. The industry is highly fragmented with over 20,000 registered units and is characterized by intense price competition and government price controls. Exports have also increased significantly and are expected to surpass domestic sales in the coming years, driven primarily by growth in formulation exports. India also has the most FDA-approved manufacturing facilities outside of the US, positioning it as an important supplier for the global pharmaceutical market.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
Access to customers is necessary for healthcare marketing and sales initiatives to succeed. Pharmaceutical and medical device manufacturers can optimally position, price and promote their products through strategic assessment of healthcare market segments!
www.healthcaremedicalpharmaceuticaldirectory.com
John G. Baresky
https://www.linkedin.com/in/johngbaresky
John Baresky Healthcare Marketing Leader, Pharmaceutical Marketing, Digital Marketing Strategy, Content Marketing Strategy, Market Access Strategy, Healthcare RPA Software Marketing Strategy
This document discusses out of specification (OOS) results and the processes for investigating them. It covers:
1) What OOS is and when investigations are conducted.
2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.
3) Full-scale investigations which include reviewing manufacturing, production, sampling, and initial lab results.
4) Supplementary laboratory testing like re-testing and re-sampling to identify the source of errors.
5) Analyzing the investigated results to determine the possible causes of OOS results.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Regulatory requirements of BIOAVAILABLITY & BIOEQUIVALENCE STUDIES Megha bhise
This document summarizes regulatory requirements for bioavailability and bioequivalence studies. It outlines key definitions of bioavailability and bioequivalence, requirements for studies submitted in INDs, NDAs, and ANDAs. Study designs should follow FDA guidelines and include pharmacokinetic studies using healthy volunteers. Documentation such as clinical reports and standard operating procedures must be maintained. Facilities conducting studies must be properly qualified and records retained for at least two years.
Clinical Data Quality Control and Assurance: Ensuring Reliable ResultsClinosolIndia
In clinical research, high-quality data is paramount to obtain reliable and meaningful results. Data quality control and assurance processes play a crucial role in ensuring the accuracy, integrity, and reliability of clinical data. In this blog post, we will delve into the importance of clinical data quality control and assurance, discuss key considerations and best practices, and explore how these processes contribute to generating robust and trustworthy results in clinical research.
Data Collection and Entry:
Data quality begins with proper collection and entry processes. Standardized data collection forms, clear instructions, and training for data collectors help minimize errors and inconsistencies. Implementing electronic data capture (EDC) systems can further enhance data accuracy by validating data during entry, reducing transcription errors, and ensuring adherence to predefined data ranges and formats.
Data Validation and Cleaning:
Data validation and cleaning are critical steps in data quality control. Validation checks, such as range checks, consistency checks, and logic checks, are performed to identify errors, discrepancies, or missing data points. These checks help identify and resolve data entry errors, ensuring data accuracy and integrity. Cleaning processes involve reviewing and resolving discrepancies, clarifying ambiguous entries, and addressing data outliers or inconsistencies.
India is the largest provider of generic drugs globally. Indian pharmaceutical sector industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medications in the UK.
India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level. Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) is supplied by Indian pharmaceutical firms.
Regulations in clinical research: obligations and responsibilities of investi...TrialJoin
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
This document provides an overview of the New Drug Application (NDA) process. It discusses what an NDA is, its goals, forms, contents, guidance documents, submission process, and review/approval. Key points include that an NDA is required for marketing approval of new drugs in the US and contains data from clinical trials demonstrating safety and effectiveness. The review process evaluates these factors and can result in approval or refusal. Guidance documents provide guidelines for preparing and submitting the various sections of an NDA to the FDA.
Thank you for the summary. Here are a few key points I noticed:
- GCP provides an international quality standard for clinical research to protect participants and ensure reliable data.
- It has evolved in response to past abuses and aims to harmonize standards across countries/regions.
- Key roles include sponsors to design/manage studies, principal investigators to oversee local research, and staff to conduct study procedures.
- Regulations like the Code of Federal Regulations codify GCP principles to facilitate compliance.
Overall this helps explain the purpose and scope of Good Clinical Practice as an important framework in clinical research. The summary effectively distills the main points from the lengthy document.
This document discusses the process for importing and registering drugs and cosmetics in India according to the Drugs and Cosmetics Act of 1945 and Rules of 1945. It outlines the following key points:
1. There are two phases - registration and import license. In Phase 1, an application is made using Form 40 to obtain a Registration Certificate for manufacturing premises and drugs. In Phase 2, Form 8/8A is used to apply for an Import License.
2. Schedules D(I) and D(II) require information about the manufacturer, manufacturing premises, and drugs. A fee of $1500 per manufacturing site and $1000 per drug is paid.
3. If registration is approved,
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
Pharmacoepidemiology is the study of the use and effects of drugs in large populations. It combines the fields of clinical pharmacology and epidemiology. Recent data shows that adverse drug reactions cause 100,000 deaths and 1.5 million hospitalizations in the US each year, yet 20-70% may be preventable. Pharmacoepidemiology aims to detect adverse drug reactions early through observational studies in order to educate healthcare providers and the public about safer medication use. Key study types include case series, case-control studies, cohort studies, cross-sectional studies, and experimental studies. Drug utilization studies also fall under pharmacoepidemiology and evaluate factors related to prescribing, dispensing, administering, and taking
This document defines and describes the role and responsibilities of an Institutional Review Board (IRB). The key points are:
1) An IRB is responsible for reviewing and approving research involving human subjects to ensure ethical standards are met and subjects' rights and safety are protected.
2) IRBs must have diverse and qualified membership, including scientific and non-scientific experts, to conduct in-depth reviews of research protocols.
3) The IRB review process involves evaluating research protocols, consent forms, recruitment procedures and investigators to ensure all applicable regulations and ethical guidelines are followed.
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRYSai Datri Arige
This document discusses procedures for exporting and importing pharmaceuticals in India. It provides an overview of India's pharmaceutical industry and regulations regarding export/import licenses, quality control inspections, labeling/packaging, and medical device imports. The general export process involves obtaining necessary licenses, procuring goods, packing/labeling, shipping, and completing documentation. Import regulations specify registration requirements and conditions for licenses, standards, and record keeping for imported pharmaceuticals. Certain medical devices are also regulated as drugs under Indian law.
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
SOLID WASTE MANAGEMENT IN THE PHARMACEUTICAL INDUSTRYTanvir Moin
Solid waste management (SWM) in the pharmaceutical industry in Bangladesh is a complex issue. The industry generates a wide range of solid waste, including:
Expired or unused pharmaceuticals: These wastes can contain hazardous active pharmaceutical ingredients (APIs) and other chemicals.
Packaging waste: This includes glass, plastic, and metal packaging.
Laboratory waste: This includes chemicals, glassware, and other materials used in research and development.
Manufacturing waste: This includes scrap materials, filter cakes, and other wastes generated from the manufacturing process.
This presentation introduces pharmaceutical quality assurance and quality control. It discusses that quality assurance covers all aspects of production from raw materials to finished products. Quality control ensures drugs are safe, effective and consistent. The presentation covers in-process quality control, production processes like blending and milling, and quality control of the storage facility. It also discusses technology transfer requirements for pharmaceutical production like manufacturing instructions, analytical methods and batch records.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
Access to customers is necessary for healthcare marketing and sales initiatives to succeed. Pharmaceutical and medical device manufacturers can optimally position, price and promote their products through strategic assessment of healthcare market segments!
www.healthcaremedicalpharmaceuticaldirectory.com
John G. Baresky
https://www.linkedin.com/in/johngbaresky
John Baresky Healthcare Marketing Leader, Pharmaceutical Marketing, Digital Marketing Strategy, Content Marketing Strategy, Market Access Strategy, Healthcare RPA Software Marketing Strategy
This document discusses out of specification (OOS) results and the processes for investigating them. It covers:
1) What OOS is and when investigations are conducted.
2) The initial laboratory investigation and the responsibilities of the analyst and supervisor.
3) Full-scale investigations which include reviewing manufacturing, production, sampling, and initial lab results.
4) Supplementary laboratory testing like re-testing and re-sampling to identify the source of errors.
5) Analyzing the investigated results to determine the possible causes of OOS results.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Regulatory requirements of BIOAVAILABLITY & BIOEQUIVALENCE STUDIES Megha bhise
This document summarizes regulatory requirements for bioavailability and bioequivalence studies. It outlines key definitions of bioavailability and bioequivalence, requirements for studies submitted in INDs, NDAs, and ANDAs. Study designs should follow FDA guidelines and include pharmacokinetic studies using healthy volunteers. Documentation such as clinical reports and standard operating procedures must be maintained. Facilities conducting studies must be properly qualified and records retained for at least two years.
Clinical Data Quality Control and Assurance: Ensuring Reliable ResultsClinosolIndia
In clinical research, high-quality data is paramount to obtain reliable and meaningful results. Data quality control and assurance processes play a crucial role in ensuring the accuracy, integrity, and reliability of clinical data. In this blog post, we will delve into the importance of clinical data quality control and assurance, discuss key considerations and best practices, and explore how these processes contribute to generating robust and trustworthy results in clinical research.
Data Collection and Entry:
Data quality begins with proper collection and entry processes. Standardized data collection forms, clear instructions, and training for data collectors help minimize errors and inconsistencies. Implementing electronic data capture (EDC) systems can further enhance data accuracy by validating data during entry, reducing transcription errors, and ensuring adherence to predefined data ranges and formats.
Data Validation and Cleaning:
Data validation and cleaning are critical steps in data quality control. Validation checks, such as range checks, consistency checks, and logic checks, are performed to identify errors, discrepancies, or missing data points. These checks help identify and resolve data entry errors, ensuring data accuracy and integrity. Cleaning processes involve reviewing and resolving discrepancies, clarifying ambiguous entries, and addressing data outliers or inconsistencies.
India is the largest provider of generic drugs globally. Indian pharmaceutical sector industry supplies over 50 per cent of global demand for various vaccines, 40 per cent of generic demand in the US and 25 per cent of all medications in the UK.
India enjoys an important position in the global pharmaceuticals sector. The country also has a large pool of scientists and engineers who have the potential to steer the industry ahead to an even higher level. Presently over 80 per cent of the antiretroviral drugs used globally to combat AIDS (Acquired Immune Deficiency Syndrome) is supplied by Indian pharmaceutical firms.
Regulations in clinical research: obligations and responsibilities of investi...TrialJoin
Two of the most important individuals in a clinical trial are investigators and sponsors. However, being such a crucial part of a trial also brings many obligations and responsibilities. Although the sponsor is the one who initiates and finances a trial, the investigator is the person who conducts it. For this reason, most of the obligations and responsibilities fall on the investigator as the person accountable for everything that goes wrong in a trial. Learning these obligations and knowing how to follow them is a crucial practice that will ensure compliance in a clinical trial.
For this reason, we’ve decided to compose this material that will give you a basic outline of all the rules and regulations that investigators and sponsors should follow.
This document provides an overview of the New Drug Application (NDA) process. It discusses what an NDA is, its goals, forms, contents, guidance documents, submission process, and review/approval. Key points include that an NDA is required for marketing approval of new drugs in the US and contains data from clinical trials demonstrating safety and effectiveness. The review process evaluates these factors and can result in approval or refusal. Guidance documents provide guidelines for preparing and submitting the various sections of an NDA to the FDA.
Thank you for the summary. Here are a few key points I noticed:
- GCP provides an international quality standard for clinical research to protect participants and ensure reliable data.
- It has evolved in response to past abuses and aims to harmonize standards across countries/regions.
- Key roles include sponsors to design/manage studies, principal investigators to oversee local research, and staff to conduct study procedures.
- Regulations like the Code of Federal Regulations codify GCP principles to facilitate compliance.
Overall this helps explain the purpose and scope of Good Clinical Practice as an important framework in clinical research. The summary effectively distills the main points from the lengthy document.
This document discusses the process for importing and registering drugs and cosmetics in India according to the Drugs and Cosmetics Act of 1945 and Rules of 1945. It outlines the following key points:
1. There are two phases - registration and import license. In Phase 1, an application is made using Form 40 to obtain a Registration Certificate for manufacturing premises and drugs. In Phase 2, Form 8/8A is used to apply for an Import License.
2. Schedules D(I) and D(II) require information about the manufacturer, manufacturing premises, and drugs. A fee of $1500 per manufacturing site and $1000 per drug is paid.
3. If registration is approved,
Ind (investigational new drug application) and ndaswati2084
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes for bringing new drugs to market. It describes how an IND must be submitted to the FDA to test an experimental drug in humans, and outlines the types of INDs, content requirements, and review process. An NDA contains extensive clinical trial data and is required for FDA approval to commercially market a new drug. The lengthy and costly process from initial research to marketing approval averages 15 years and $900 million per new drug.
Pharmacoepidemiology is the study of the use and effects of drugs in large populations. It combines the fields of clinical pharmacology and epidemiology. Recent data shows that adverse drug reactions cause 100,000 deaths and 1.5 million hospitalizations in the US each year, yet 20-70% may be preventable. Pharmacoepidemiology aims to detect adverse drug reactions early through observational studies in order to educate healthcare providers and the public about safer medication use. Key study types include case series, case-control studies, cohort studies, cross-sectional studies, and experimental studies. Drug utilization studies also fall under pharmacoepidemiology and evaluate factors related to prescribing, dispensing, administering, and taking
This document defines and describes the role and responsibilities of an Institutional Review Board (IRB). The key points are:
1) An IRB is responsible for reviewing and approving research involving human subjects to ensure ethical standards are met and subjects' rights and safety are protected.
2) IRBs must have diverse and qualified membership, including scientific and non-scientific experts, to conduct in-depth reviews of research protocols.
3) The IRB review process involves evaluating research protocols, consent forms, recruitment procedures and investigators to ensure all applicable regulations and ethical guidelines are followed.
EXPORTS AND IMPORTS OF INDIAN PHARMACEUTICAL INDUSTRYSai Datri Arige
This document discusses procedures for exporting and importing pharmaceuticals in India. It provides an overview of India's pharmaceutical industry and regulations regarding export/import licenses, quality control inspections, labeling/packaging, and medical device imports. The general export process involves obtaining necessary licenses, procuring goods, packing/labeling, shipping, and completing documentation. Import regulations specify registration requirements and conditions for licenses, standards, and record keeping for imported pharmaceuticals. Certain medical devices are also regulated as drugs under Indian law.
Drug Regulatory Affairs By Mr. Pankaj DhapadePankaj Dhapade
This presentation covers basic understandings of regulatory affairs profession. It contains,
1. Introduction of Regulatory Affairs
2. Why Drug Regulatory Affairs
3. Role of Regulatory Affairs Experts
4. Qualities of Regulatory Affairs Expert
5. Qualities for Submission Management
6. Regulatory Bodies
SOLID WASTE MANAGEMENT IN THE PHARMACEUTICAL INDUSTRYTanvir Moin
Solid waste management (SWM) in the pharmaceutical industry in Bangladesh is a complex issue. The industry generates a wide range of solid waste, including:
Expired or unused pharmaceuticals: These wastes can contain hazardous active pharmaceutical ingredients (APIs) and other chemicals.
Packaging waste: This includes glass, plastic, and metal packaging.
Laboratory waste: This includes chemicals, glassware, and other materials used in research and development.
Manufacturing waste: This includes scrap materials, filter cakes, and other wastes generated from the manufacturing process.
This presentation introduces pharmaceutical quality assurance and quality control. It discusses that quality assurance covers all aspects of production from raw materials to finished products. Quality control ensures drugs are safe, effective and consistent. The presentation covers in-process quality control, production processes like blending and milling, and quality control of the storage facility. It also discusses technology transfer requirements for pharmaceutical production like manufacturing instructions, analytical methods and batch records.
This document discusses quality and formulation of medicines. It covers several topics:
1) Quality use of medicines includes selecting management options wisely based on the individual, condition, risks/benefits, and costs. It also involves using medicines safely and effectively.
2) Manufacturing of pharmaceutical products must follow good manufacturing practices to ensure quality, including production and quality control procedures.
3) Non-clinical safety studies are conducted on active substances and formulations to explore safety and inform clinical trials. Safety testing assesses margins of safety.
Current scenario of pharmaceutical waste management in bangladeshMonirul Islam Shohag
The document discusses pharmaceutical waste management. It defines pharmaceutical waste and describes the types of waste generated from production, quality control labs, and microbiology labs in pharmaceutical industries. These include unused or expired raw materials, packaging waste, liquid waste, and biological/microbiological waste. The key methods for treating solid pharmaceutical waste are autoclaving, incineration, and landfilling. Liquid waste is treated using effluent treatment plants with primary, secondary, and tertiary treatments. Common tests conducted on treated wastewater include measuring pH, COD, BOD, TSS, and DO. Proper pharmaceutical waste management is important to reduce environmental pollution and health risks.
Current scenario of pharmaceutical waste management in bangladeshMonirul Islam Shohag
The document discusses pharmaceutical waste management. It defines pharmaceutical waste as unused or expired medications, personal care products, and accessories from medical facilities, pharmacies, and households. This waste poses environmental and health risks if not properly disposed of. The document outlines the different types of pharmaceutical waste, such as general waste, sharps, plastics, and hazardous materials. It also discusses the risks pharmaceutical waste can pose if released into the environment and the common treatment and disposal methods used, such as incineration and landfilling.
This document defines key terms related to phytopharmaceuticals and herbal medicine. It describes phytopharmaceuticals as plant-based drugs containing at least four bioactive compounds that are purified and standardized for human or animal use. Active ingredients are the therapeutic components of herbal medicines. Botanical drug substances, herbal preparations, and finished herbal products are other terms defined. The document also discusses regulatory affairs, traditional medicine, pharmacovigilance, and pharmacoeconomics as they relate to herbal products.
The document describes the internship experience of working on the development of three generic pharmaceutical products (Products A, B, and C) at Xylopia, including carrying out tasks across multiple departments such as formulation development, analytical testing, process development, and regulatory compliance. Key activities involved project management, material sourcing and evaluation, manufacturing process development including granulation, milling, blending and compression, and analytical method development and validation.
IPhVC recommendations & monitoring requirement of biosimilars, Worldwide & Iraq control of Bioproducts & biosimiliars, as well as references enlisted adverse reactions to common products used in our hospital
Lecture presented at the 31st Jan 2024 in our hospital
Biohazardous wastes are the most promising sections to manage in the present condition.There are many rules to be folowed in disposal,transportation and treatment of biohazardous waste.
Environmentalist & hospital waste managementRohina Tabassam
The document discusses the role of an environmentalist in hospital waste management. It begins by defining an environmentalist and their responsibilities, which include identifying environmental hazards, developing solutions to protect the environment, and providing guidance to mitigate issues. It then discusses hospital waste, sources, types including infectious, pathological, pharmaceutical, sharp, and radioactive waste. Improper hospital waste management can lead to health and environmental concerns like water, air and soil pollution. The key steps in hospital waste management are generation, segregation, collection, storage, transportation, treatment, and final disposal. An environmentalist's role in hospitals is to implement waste regulations and ensure proper management of waste.
Processing technology and value added food products of medicinal plantsDrSKGOYAL
Medicinal plants have many uses including in medicine, cosmetics, herbal drinks and foods. They contain important secondary metabolites. Processing of medicinal plants involves harvesting, drying, size reduction and extraction. Sun drying and mechanical dryers are common drying methods. Size is reduced using crushers, grinders and cutting machines. Important plants discussed include Ashwagandha, Stevia, Isabgol and Safed Musli. They provide chemicals like saponins, glycosides and menthol. Products include essential oils, extracts and drugs.
This document discusses biomedical waste (BMW) management in hospitals. It defines BMW and lists sources such as hospitals, clinics, and labs. It outlines the key steps in BMW management: collection and segregation, transportation and storage, treatment and disposal. Treatment and disposal methods include incineration, deep burial, and autoclaving. The document also covers safety measures, training of healthcare workers, and the roles and coordination of hospitals, municipal authorities, and pollution control boards in effective BMW management.
This document provides an introduction to pharmaceutics, which is concerned with the preparation and use of medicinal drugs. It discusses key topics including:
- The sources of drugs, pharmacology analysis, and active ingredients
- The design and manufacture of dosage forms, which combine active ingredients with excipients to facilitate drug delivery
- Quality assurance processes to ensure safe and effective drug production in a consistent manner
- The six main areas of pharmaceutics including physical chemistry principles, biopharmaceutics, dosage form design, manufacturing processes, sterilization, and product testing
- Factors considered in dosage form design like drug properties, administration route requirements, and therapeutic indications
This document discusses key aspects of product development for pharmaceutical products. It covers stages of product development including drug discovery, formulation development, process research and development, analytical research, toxicology testing, and clinical trials. It discusses important considerations for product design such as target product profiles, design specifications, commercial factors, technical risks, safety, intellectual property, and environmental impacts. Methods for testing drug-excipient compatibility like DSC, chromatography, and microscopy are also summarized. The importance of pilot plant scale up is discussed to help identify issues prior to full production.
The WHO guidelines provide technical guidance for monitoring the safety of herbal medicines within pharmacovigilance systems. They were developed to enhance monitoring of herbal medicine safety within current pharmacovigilance systems. The guidelines define key terms related to herbal medicines and contaminants. They provide guiding principles for assessing herbal medicine safety with regards to contaminants and residues, including determining levels of toxic metals, radioactive contaminants, aflatoxins, and microbiological contaminants. The objectives are to provide guidance on quality assessment criteria and methods to control herbal medicine quality relating to safety.
The document discusses new EPA regulations for hospital waste incinerators that require improved waste segregation and employee training. It defines various waste streams - municipal solid waste, recyclables, regulated medical waste, pharmaceutical waste, and hazardous waste - and proper disposal methods. Compliance with regulations helps protect health, safety and the environment while reducing disposal costs.
Strategic decision making in pharmacological companies.
Techno managerial aspects in pharmacological companies.
Regulations of biotechnological products
Drug pollution or pharmaceutical pollutionSmawi GH
Drug pollution, also known as pharmaceutical pollution, occurs when pharmaceutical drugs and their metabolites enter waterways through wastewater. Common sources include urine and feces from humans who have taken medications, as well as healthcare facilities and livestock farming. These drugs can have harmful effects on both humans and aquatic life. While their impacts on human health are still unclear, studies show they can feminize male fish and accumulate in fish brains. Solutions include safe disposal programs, limiting bulk purchases of unneeded drugs, and preventing drugs from entering wastewater through flushing or trash disposal.
In this video Quality assurance parameters has been discussed for herbal medicines in herbal drug industry. The Current Good Manufacturing of Herbal Products also covered. What kinds of area is suitable for herbal plant, water supply, Exhaust facility, storage requirements etc explained.
Video link :
https://youtu.be/9T82HALfpy8
Portion Disscussed :
1. Guidelines on Good Manufacturing Practices for the Manufacture of Herbal Medicines
2. Quality assurance in the manufacture of herbal medicines
3. Good manufacturing practice for herbal medicines
4. Sanitation and hygiene in herbal Drug Industry
5. Qualification and validation in herbal Drug Industry
6. Complaints in herbal Drug Industry
7. Product recalls in herbal Drug Industry
8. Contract production and analysis in herbal Drug Industry
9. Self-inspection in herbal Drug Industry
10. Personnel in herbal Drug Industry
11. Training in herbal Drug Industry
12. Personal hygiene in herbal Drug Industry
13. Premises for herbal Drug Industry
14. Storage areas in herbal Drug Industry
15. Production areas in herbal Drug Industry
16. Equipment in herbal Drug Industry
17. Materials in herbal Drug Industry
18. Reference samples and standards in herbal Drug Industry
19. Packaging materials and labeling in herbal Drug Industry
Similar to Social impact of pharmaceutical industry. (20)
The document provides an overview of syphilis, a sexually transmitted infection caused by the bacterium Treponema pallidum. It progresses through primary, secondary, latent, and tertiary stages characterized by distinct clinical manifestations. Syphilis can be diagnosed through blood tests or darkfield microscopy and treated with antibiotics like penicillin. Left untreated, it can cause severe complications and can also be transmitted from mother to child during pregnancy. Prevention involves safe sex practices and regular screening, especially for at-risk groups.
This document discusses Over-the-Counter (OTC) medicines. It begins by defining OTC medicines as drugs that can be purchased without a prescription and are used for self-treatment of common conditions. It then provides examples of common categories of OTC medicines, including pain relievers, antihistamines, decongestants, cough and cold medicines, and antacids. The document emphasizes that OTC medicines are generally safe when used as directed but that individuals should always read labels carefully and consult a healthcare provider if they have questions or symptoms persist.
Effective inventory control in a community setting involves regularly assessing needs, centralizing management, categorizing items, conducting audits, integrating technology, involving community members, forecasting planning, building supplier relationships, preparing for emergencies, educating about responsible use, reducing waste, and maintaining records. These principles help optimize resources and ensure well-being.
List of Application and community pharmacy management-WPS Office.pdfSudipta Roy
The document discusses the process for obtaining a license to sell drugs, which involves identifying the regulatory authority, researching the types of licenses available, submitting an application with required documentation, addressing any deficiencies, and maintaining compliance once a license is approved. Key steps include determining license requirements, preparing necessary documents, submitting applications, undergoing reviews, and renewing licenses periodically.
Community Pharmacy management-WPS Office.pdfSudipta Roy
Selecting the right site for a community pharmacy or clinic-attached facility requires considering factors like demographics, competition, accessibility, costs, zoning laws, and community support. Key aspects include proximity to customers and clinics, compliance with regulations, parking availability, infrastructure requirements, and ensuring the location can meet current and future needs. Comprehensively analyzing these criteria helps position the facility for viability and success in serving the community's healthcare needs.
This document discusses medication adherence and provides key information on the topic in several sections:
It defines medication adherence and outlines its importance for managing chronic conditions. Some factors that affect adherence are described, including the complexity of medication regimens and costs. Formulas for calculating medication possession ratio and proportion of days covered are also presented to quantify adherence. The document emphasizes the role of healthcare providers in promoting adherence through education, communication, and addressing individual patient needs and barriers.
Healthcare Screeninng services-WPS Office.pdfSudipta Roy
Health screening services aim to detect potential health issues before symptoms appear through various medical tests and examinations. Screenings are recommended based on factors like age, gender, family history, and individual risks. Common screenings include checking blood pressure, cholesterol levels, blood glucose, body mass index, and screening for cancers, vision/hearing, bone density, immunizations, genetic factors, infections, and other conditions. The objectives of screenings include early detection, prevention, risk assessment, and improving overall population health.
The document describes the Fry Readability Graph, a method developed by Dr. Edward Fry to assess the readability of written text. It involves taking a 100 word sample, counting the number of sentences and syllables, and plotting those values on a graph to determine the corresponding grade level - the level at which a typical student could understand the text. A lower grade level indicates an easier reading level. The Fry Readability Graph provides an estimate of readability, and other methods also exist to assess text complexity.
Patient Information leaflets-WPS Office.pdfSudipta Roy
The document discusses guidelines for creating effective patient information leaflets, focusing on readability and design. It recommends using clear language, short sentences and paragraphs, bullet points and lists, subheadings, consistent formatting and fonts, sufficient color contrast, visual aids, and defined medical terms to enhance readability. For design, it suggests a clear layout, hierarchy of information, branding, and contact information. User testing is also advised to gather feedback on usability. The goal is to empower patients with understandable health information.
The document discusses guidelines for creating effective patient information leaflets, focusing on readability and design. It recommends using clear language, short sentences and paragraphs, bullet points and lists, subheadings, consistent formatting, sufficient contrast, visual aids, and defined medical terms to enhance readability. For design, it suggests a clear layout, hierarchy of information, branding, and contact information. User testing is also advised to gather feedback on usability. The goal is to empower patients with understandable health information.
Patient counsel case study-WPS Office.pdfSudipta Roy
This document describes a case study of counseling sessions for a patient named Raj who was recently diagnosed with leprosy. Over 8 sessions, the counselor educated Raj about leprosy and its treatment, taught skin care and self-examination, addressed the social stigma associated with the disease, discussed strategies to prevent disability, involved Raj's family in the counseling process, and supported Raj's reintegration into his community post-treatment. Through this collaborative counseling approach, Raj gained an understanding of leprosy and strategies to manage challenges, engaged social support, and felt empowered to successfully complete treatment and return to his daily life.
The document discusses patient counseling, which involves providing patients with information, guidance, and support to help them make informed healthcare decisions. Effective patient counseling includes open communication, education on medical conditions and treatments, ensuring understanding of medication management, encouraging behavioral changes, and addressing emotional needs to promote informed decision-making and well-being. Regular counseling can benefit patients with chronic illnesses, undergoing surgery, taking complex medications, and more by improving health outcomes and adherence through ongoing support and monitoring of their care.
The document discusses prescriptions, including what they are, their components, how they are written and filled. A prescription is a written or electronic order from a healthcare professional to a pharmacist with instructions for dispensing medication to a patient. It includes details like the medication, dosage, directions for use, and refill information. The prescription filling process involves verifying the prescription, selecting the medication, labeling it, counseling the patient, and documenting the transaction. Standardized units and clear language are important for accurate interpretation of prescriptions.
This case study describes a pharmacist's role in optimizing medication therapy for Mr. Rodriguez, a patient diagnosed with epilepsy. The pharmacist conducts an assessment of Mr. Rodriguez's condition and medication history. They then provide education on his new anti-epileptic medication, lamotrigine, including dosage instructions and potential side effects. The pharmacist schedules follow-up appointments to monitor response to lamotrigine and collaborate with the healthcare team to ensure optimal seizure control through a comprehensive pharmaceutical care approach.
The document describes 4 case studies that illustrate how pharmacists can provide pharmaceutical care to optimize patient outcomes. For each case, the pharmacist conducts a medication review, assesses the patient's condition, provides education and counselling, collaborates with the physician to optimize treatment, monitors the patient, documents interventions, and provides follow-up care. The cases describe patients with hypertension, diabetes, osteoarthritis, and inflammation who benefit from the pharmacist's holistic and collaborative approach to medication management.
The document discusses pharmaceutical care and the pharmacist's role in optimizing patient medication therapy and outcomes. It describes key aspects of pharmaceutical care like patient-centered care, medication management, medication therapy management, collaborative healthcare, and monitoring. It also discusses common types of drug-related problems that can arise, including adverse drug reactions, drug-drug interactions, non-adherence, and inappropriate dosages. The goal of pharmaceutical care is to improve health outcomes, lower costs, and enhance patient satisfaction through safe and effective medication use.
The document discusses the role and scope of community pharmacy. It begins by defining community pharmacy as a place that dispenses medicines with or without a prescription and provides professional services. It outlines the roles of community pharmacists as dispensing medicines accurately, providing counseling, disseminating unbiased drug information, and promoting health. Globally, the role of pharmacists has shifted from product-focused to patient-focused, taking on roles like medication management and screenings. The document discusses pharmacy practice in various countries and the evolving role and responsibilities of community pharmacists in India.
This document discusses skin creams and their classification. It provides a brief history of skin care preparations dating back to antiquity. Modern creams are typically emulsion-based and can range in consistency from liquid to solid. Creams are classified by function, with some of the main types being cleansing/cold creams, foundation/vanishing creams, and hand/body creams. The document also provides several formulations for beeswax-borax cold creams and liquefying cleansing creams.
Pharmacoeconomics is important to various stakeholders in healthcare. It is relevant to pharmaceutical manufacturers for developing cost-effective drugs, to prescribers for making informed formulary and treatment decisions, to pharmacists for drug evaluation and resource allocation, and especially to Indian patients who bear most out-of-pocket drug costs. The field utilizes economic evaluations like cost-benefit, cost-effectiveness, cost-minimization and cost-utility analyses to compare treatment strategies and outcomes.
Role of Pharmacists in Eradication and prevention 1-WPS Office.pptxSudipta Roy
This document discusses the role of pharmacists in educating the public and preventing the spread of AIDS. It outlines four approaches to controlling AIDS: prevention through education about avoiding risky behaviors and using protection; preventing blood-borne transmission by screening donations; treating the disease with antiretroviral drugs; and providing preventive care like prophylaxis for opportunistic infections. The document also lists common antiretroviral drugs and their doses and discusses integrating primary health care for AIDS patients.
• For a full set of 530+ questions. Go to
https://skillcertpro.com/product/servicenow-cis-itsm-exam-questions/
• SkillCertPro offers detailed explanations to each question which helps to understand the concepts better.
• It is recommended to score above 85% in SkillCertPro exams before attempting a real exam.
• SkillCertPro updates exam questions every 2 weeks.
• You will get life time access and life time free updates
• SkillCertPro assures 100% pass guarantee in first attempt.
This presentation by OECD, OECD Secretariat, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
The importance of sustainable and efficient computational practices in artificial intelligence (AI) and deep learning has become increasingly critical. This webinar focuses on the intersection of sustainability and AI, highlighting the significance of energy-efficient deep learning, innovative randomization techniques in neural networks, the potential of reservoir computing, and the cutting-edge realm of neuromorphic computing. This webinar aims to connect theoretical knowledge with practical applications and provide insights into how these innovative approaches can lead to more robust, efficient, and environmentally conscious AI systems.
Webinar Speaker: Prof. Claudio Gallicchio, Assistant Professor, University of Pisa
Claudio Gallicchio is an Assistant Professor at the Department of Computer Science of the University of Pisa, Italy. His research involves merging concepts from Deep Learning, Dynamical Systems, and Randomized Neural Systems, and he has co-authored over 100 scientific publications on the subject. He is the founder of the IEEE CIS Task Force on Reservoir Computing, and the co-founder and chair of the IEEE Task Force on Randomization-based Neural Networks and Learning Systems. He is an associate editor of IEEE Transactions on Neural Networks and Learning Systems (TNNLS).
1.) Introduction
Our Movement is not new; it is the same as it was for Freedom, Justice, and Equality since we were labeled as slaves. However, this movement at its core must entail economics.
2.) Historical Context
This is the same movement because none of the previous movements, such as boycotts, were ever completed. For some, maybe, but for the most part, it’s just a place to keep your stable until you’re ready to assimilate them into your system. The rest of the crabs are left in the world’s worst parts, begging for scraps.
3.) Economic Empowerment
Our Movement aims to show that it is indeed possible for the less fortunate to establish their economic system. Everyone else – Caucasian, Asian, Mexican, Israeli, Jews, etc. – has their systems, and they all set up and usurp money from the less fortunate. So, the less fortunate buy from every one of them, yet none of them buy from the less fortunate. Moreover, the less fortunate really don’t have anything to sell.
4.) Collaboration with Organizations
Our Movement will demonstrate how organizations such as the National Association for the Advancement of Colored People, National Urban League, Black Lives Matter, and others can assist in creating a much more indestructible Black Wall Street.
5.) Vision for the Future
Our Movement will not settle for less than those who came before us and stopped before the rights were equal. The economy, jobs, healthcare, education, housing, incarceration – everything is unfair, and what isn’t is rigged for the less fortunate to fail, as evidenced in society.
6.) Call to Action
Our movement has started and implemented everything needed for the advancement of the economic system. There are positions for only those who understand the importance of this movement, as failure to address it will continue the degradation of the people deemed less fortunate.
No, this isn’t Noah’s Ark, nor am I a Prophet. I’m just a man who wrote a couple of books, created a magnificent website: http://www.thearkproject.llc, and who truly hopes to try and initiate a truly sustainable economic system for deprived people. We may not all have the same beliefs, but if our methods are tried, tested, and proven, we can come together and help others. My website: http://www.thearkproject.llc is very informative and considerably controversial. Please check it out, and if you are afraid, leave immediately; it’s no place for cowards. The last Prophet said: “Whoever among you sees an evil action, then let him change it with his hand [by taking action]; if he cannot, then with his tongue [by speaking out]; and if he cannot, then, with his heart – and that is the weakest of faith.” [Sahih Muslim] If we all, or even some of us, did this, there would be significant change. We are able to witness it on small and grand scales, for example, from climate control to business partnerships. I encourage, invite, and challenge you all to support me by visiting my website.
This presentation by Katharine Kemp, Associate Professor at the Faculty of Law & Justice at UNSW Sydney, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
This presentation by Juraj Čorba, Chair of OECD Working Party on Artificial Intelligence Governance (AIGO), was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
This presentation by Nathaniel Lane, Associate Professor in Economics at Oxford University, was made during the discussion “Pro-competitive Industrial Policy” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/pcip.
This presentation was uploaded with the author’s consent.
This presentation by Professor Giuseppe Colangelo, Jean Monnet Professor of European Innovation Policy, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
Gamify it until you make it Improving Agile Development and Operations with ...Ben Linders
So many challenges, so little time. While we’re busy developing software and keeping it operational, we also need to sharpen the saw, but how? Gamification can be a way to look at how you’re doing and find out where to improve. It’s a great way to have everyone involved and get the best out of people.
In this presentation, Ben Linders will show how playing games with the DevOps coaching cards can help to explore your current development and deployment (DevOps) practices and decide as a team what to improve or experiment with.
The games that we play are based on an engagement model. Instead of imposing change, the games enable people to pull in ideas for change and apply those in a way that best suits their collective needs.
By playing games, you can learn from each other. Teams can use games, exercises, and coaching cards to discuss values, principles, and practices, and share their experiences and learnings.
Different game formats can be used to share experiences on DevOps principles and practices and explore how they can be applied effectively. This presentation provides an overview of playing formats and will inspire you to come up with your own formats.
This presentation by OECD, OECD Secretariat, was made during the discussion “The Intersection between Competition and Data Privacy” held at the 143rd meeting of the OECD Competition Committee on 13 June 2024. More papers and presentations on the topic can be found at oe.cd/ibcdp.
This presentation was uploaded with the author’s consent.
This presentation by Yong Lim, Professor of Economic Law at Seoul National University School of Law, was made during the discussion “Artificial Intelligence, Data and Competition” held at the 143rd meeting of the OECD Competition Committee on 12 June 2024. More papers and presentations on the topic can be found at oe.cd/aicomp.
This presentation was uploaded with the author’s consent.
Why Psychological Safety Matters for Software Teams - ACE 2024 - Ben Linders.pdfBen Linders
Psychological safety in teams is important; team members must feel safe and able to communicate and collaborate effectively to deliver value. It’s also necessary to build long-lasting teams since things will happen and relationships will be strained.
But, how safe is a team? How can we determine if there are any factors that make the team unsafe or have an impact on the team’s culture?
In this mini-workshop, we’ll play games for psychological safety and team culture utilizing a deck of coaching cards, The Psychological Safety Cards. We will learn how to use gamification to gain a better understanding of what’s going on in teams. Individuals share what they have learned from working in teams, what has impacted the team’s safety and culture, and what has led to positive change.
Different game formats will be played in groups in parallel. Examples are an ice-breaker to get people talking about psychological safety, a constellation where people take positions about aspects of psychological safety in their team or organization, and collaborative card games where people work together to create an environment that fosters psychological safety.
Why Psychological Safety Matters for Software Teams - ACE 2024 - Ben Linders.pdf
Social impact of pharmaceutical industry.
1. Social impact of The
Pharmaceutical Industry
ensuring health in social and
community development.Presented by Miss Sudipta Roy
Designation: Assistant Professor
Email: sudiptaroy89@gmail.com
Place: Department of pharmaceutics
Northern Institute of Pharmacy and
2. Contents.
• Aim and objective.
• Abstract.
• Introduction
• Pharmaceutical products and it's role.
• Pharmaceutical agents.
• Pharmaceutical unit operation.
• Pharmaceutical manufacturing process for
bulk drug.
• Pharmaceutical manufacturing process for
3. Contents.
• Pharmaceutical safety hazards to workers.
• Role of Pharmaceutical industry collaboration
in implementing development of social and
community affairs.
• Conclusion.
• References.
4. Aim and objective.
• To ensure healthy human life as well as
environmental sustainability for social and
community development.
5. Abstract.
• Health is a critical challenge for society on
basis of economic asset of people.
Pharmaceutical industries and it's
manufacturing products have been impacting
health related issues for social and community
development in major issues of reducing child
and maternal mortality, slowing the spread of
HIV/AIDS, malaria, tuberculosis, malnutrition
of children promoting gender equality and
empowerment.
6. Abstract.
• Here in this poster presentation, the
fascinating role with its different
manufacturing process for different types of
dosage form of the pharmaceutical industry
have been presenting for development of
social care.
7. Introduction.
• There is important difference between
developed and developing countries according
to their needs for pharmaceutical substances.
Malnutrition and infectious diseases are major
cause of developing countries where
nutritional supplements, vitamins and anti-
infective drugs are most needed.
8. Introduction.
The diseases related to ageing are primary
health concerns in developed countries and
some specific diseases associated with
cardiovascular, central nervous system,
gastrointestinal, anti-infective, diabetes and
chemotherapy drugs are mostly required.
9. Introduction.
• Drugs used for health of human and animal
care is being prepared by same R&D activities
and manufacturing processes.
• Synthesized products having unique
therapeutic benefits and mechanisms have
been gone through their approval,
distribution, marketing and sales process.
10. Pharmaceutical products and it's
role.
• Biological products: Bacterial and viral
vaccines, antigens, antitoxin, analogous
products, serums, plasma and other blood
derivatives.
• Role: To protect therapeutically.
• To treat humans or animals.
Bulks: Active drug substance.
Role: To manufacture dosage form for animal
feeds, compound prescription medications.
11. Pharmaceutical products and it's
role.
• Diagnostic agents: These substances may be
inorganic chemicals, radioactive compounds.
• Role: To assist diagnosis of diseases, disorders
in human and animals.
• To examine human organs like G. I. tract,
circulatory system, liver etc.
12. Pharmaceutical products and it's
role.
• Drugs: These substances are
pharmacologically active and compounded
with others materials.
Role: To produce medicinal products.
Ethical pharmaceuticals: These substances are
biological, chemical agents.
Role: To prevent, diagnosis, treat diseases and
disorders in humans or animals.
13. Pharmaceutical products and it's
role.
• Excipients: These are inert ingredients.
• Role: To make combination with drug
substances to create a dosage form products.
• To help dosage form by affecting and
controlling rate of absorption, dissolution,
metabolism, distribution.
14. Pharmaceutical products and its
role.
• Over the counter pharmaceuticals: These
substances are drug products sold in retail
store/pharmacy.
Role: Without a prescription or the approval of a
medical, pharmacy or veterinary professional,
these drug products is being dispensed to a
patient.
15. Pharmaceutical agents.
• Biological agents: The pharmaceutical industry
uses biological agents, such as bacteria and
viruses in many special applications like
vaccine production, fermentation process,
derivation of blood based products and
biotechnology.
• Chemical agents: These are divided into
industrial chemicals and drug related
substances that may be raw materials,
intermediates or finished products.
16. Pharmaceutical agents.
• Industrial chemicals: These are used in
researching and developing active drug
substances and manufacturing bulk
substances, finished pharmaceutical products.
Organic and inorganic chemicals are raw
materials, serving as reactants, reagents,
catalyst and solvents.
• Drug related substances:
These are pharmacologically active products are
divided into natural products and synthetic
17. Pharmaceutical agents.
• Source of natural products are plant and
animal sources. Examples are antibiotics,
steroid, peptide hormones, vitamins,
enzymes, prostaglandins, pheromones.
• Source of synthetic products are from
microbiological and chemical technologies.
• Pharmaceutical inactive ingredients: These are
mixed with active drug substances providing
desired physical and pharmacological
properties in the dosage form products.
18. • Diluting agents, ointment bases,
pharmaceutical solvents and excipients.
19. Pharmaceutical unit operations.
• Weighing and dispensing: To weigh and
dispense of solids and liquid is a very common
activity through out pharma industry.
• This operation must be performed in a
partitioned work place area with good
dilution, ventilation.
• Weighing surfaces must be smooth and sealed
to give proper cleaning.
• To weigh and dispense highly toxic materials
may require additional control measures. Eg.
20. Pharmaceutical unit operation.
• Charging and discharging solids and liquids:
• These phenomenon are frequently happened
through charged and discharged containers
and process equipment in pharmaceutical
manufacturing operation.
• This operation may be performed manually by
workers or by other methods such as gravity,
mechanical/pneumatic transfer systems.
21. Pharmaceutical unit operation.
• Liquid separations: liquids are separated
based upon their physical properties.
• Eg. Density, solubility, miscibility.
• Liquid separations are commonly performed
during bulk chemical production,
pharmaceutical manufacturing operations.
• Hazardous liquids should be transferred,
processed, separated in closed vessel and
piping systems to reduce worker exposure to
liquid spills and airborne vapours.
22. Pharmaceutical unit operation.
• Transferring liquids:
• Liquids are frequently transferred between
storage vessels, containers and process
equipment during pharmaceutical
manufacturing operations.
• Sealed vessels and containers and piping
system are highly desirable when transferring
large volumes of liquids with precautions for
inert gases pressurizing transfer lines/process
equipment.
23. Pharmaceutical unit operation.
• Filtration:
• Solids and liquids are separated during
filtration operations. Filters have different
designs and features. When open filters are
used for hazardous materials, workers may be
exposed to liquids, wet solids, vapours and
aerosols during loading and unloading
operations. Closed process equipment can be
used to filter highly hazardous materials,
reducing vapour emissions and preventing
24. Pharmaceutical unit operation.
• Compunding.
• Solids and liquids are mixed in compounding
operations to produce solutions, suspensions,
syrups, ointments and pastes. Buffering
agents, detergents and germicides that are
neutralizing, cleaning and biocidal agents may
be hazardous to workers. Eyewashes and
safety showers reduce injuries, if workers
accidentally contact corrosive or irritating
substances.
25. Pharmaceutical unit operation.
• Granulation:
• Dry and wet solids are granulated to change
their physical properties.
• Granulators have different designs and
features with varying containment and control
of mechanical hazards.
• Enclosed granulators can be vented to air-
control devices, reducing emissions of solvent
vapours or dusts to the workplace and
atmosphere.
26. Pharmaceutical unit operation.
• Material-handling concerns arise when
loading and unloading granulators.
Mechanical equipment (e.g., elevated
platforms, lift tables and pallet jacks) assists
workers to perform heavy manual tasks.
Eyewashes and safety showers are needed, if
workers accidentally contact solvents or
irritating dusts.
27. Pharmaceutical unit operation.
• Drying:
• Water- or solvent-wet solids are dried during
many pharmaceutical manufacturing
operations. Dryers have different designs and
features with varying containment and control
of vapours and dusts . Flammable solvent
vapours and explosive airborne dusts may
create flammable or explosive atmosphere;
28. Pharmaceutical unit operation.
• Milling:
• Dry solids are milled to change their particle
characteristics and produce free-flowing
powders. Mills have different designs and
features with varying containment and control
of mechanical hazards and airborne dusts .
Prior to milling materials, their physical
properties and hazards should be reviewed or
tested.
29. Pharmaceutical unit operation.
• Blending:
• Dry solids are blended to produce
homogeneous mixtures. Blenders have
different designs and features with varying
containment and control of mechanical
hazards and airborne dusts . Worker
exposures to drug substances, excipients and
blends may occur when loading and unloading
blending equipment.
30. Pharmaceutical unit operation.
• Compression:
• Dry solids are compressed or slugged to
compact them, changing their particle
properties. Compression equipment has
different designs and features with varying
containment and control of mechanical
hazards and airborne dusts Compression
equipment may pose serious mechanical
hazards if inadequately guarded. High noise
levels may also be produced by compression
31. Pharmaceutical unit operation.
• Solid dosage form manufacturing:
• Tablets and capsules are the most common
oral dosage forms. Compressed or moulded
tablets contain mixtures of drug substances
and excipients. These tablets may be uncoated
or coated with solvent mixtures or aqueous
solutions. Capsules are soft or hard gelatin
shells. Tablet presses , tablet-coating
equipment and capsule-filling machines have
different designs and features with varying
32. Pharmaceutical unit operation.
• Sterile manufacturing:
• Sterile products are manufactured in
pharmaceutical manufacturing plants with
modular design , clean workplace and
equipment surfaces, and high efficiency
particulate air (HEPA) filtered ventilation
systems.
33. Pharmaceutical unit operation.
• Cleaning and maintenance activities:
• cleaning, repairing and maintaining
equipment, utilities and workplaces. Although
unique hazards may arise during non-routine
tasks, recurring health and safety concerns are
encountered. Workplace and equipment
surfaces may be contaminated by hazardous
materials and drug substances, requiring them
to be cleaned before unprotected workers
conduct servicing or maintenance work.
34. Pharmaceutical unit operation.
• Cleaning is performed by washing or wiping
liquids and sweeping or vacuuming dusts. Dry
sweeping and blowing solids with compressed
air are not recommended, since they create
high worker exposures to airborne dusts. Wet
mopping and vacuuming reduce worker
exposures to dusts during cleaning activities.
Vacuum cleaners with HEPA filters may be
needed when cleaning hazardous substances
and high-potency drugs. Explosion-proof
35. Pharmaceutical unit operation.
• Packaging:
• Finished dosage-form products may be
packaged in many different types of
containers (e.g., plastic or glass bottles, foil
blister packs, pouches or sachets, tubes and
sterile vials). The mechanical equipment fills,
caps, labels, cartons and packs the finished
products in shipping containers.
36. Pharmaceutical unit operation.
• Laboratory operations:
• Lab workers may conduct scientific research to
discover drug substances, develop
manufacturing processes for bulk chemical
and dosage-form products or analyze raw
materials, intermediates and finished
products. Clearly defined responsibilities,
training and information, safe work practices
and control measures and emergency
response plans are important means for
37. Pharmaceutical manufacturing
process for bulk drug.
• Pharmaceutical manufacturing process is
basically of three major types of processes:
fermentation, organic chemical synthesis, and
biological and natural extraction.
• Antibiotics, steroids and vitamins are
produced by fermentation, whereas many
new drug substances are produced by organic
synthesis. Historically, most drug substances
were derived from natural sources such as
plants, animals, fungi and other organisms.
39. Pharmaceutical manufacturing
process for bulk drug.
• Fermentation:
• Fermentation is a biochemical process
employing selected micro-organisms and
microbiological technologies to produce a
chemical product. Batch fermentation
processes involve three basic steps: inoculum
and seed preparation, fermentation, and
product recovery or isolation.
41. Pharmaceutical manufacturing
process for bulk drug.
• Chemical synthesis:
• Chemical synthesis processes use organic and
inorganic chemicals in batch operations to
produce drug substances with unique physical
and pharmacological properties. Typically, a
series of chemical reactions are performed in
multi-purpose reactors and the products are
isolated by extraction, crystallization and
filtration. The finished products are usually
dried, milled and blended. Organic synthesis
43. Pharmaceutical manufacturing
process for bulk drug.
• Biological and natural extraction:
• Large volumes of natural materials, such as
plant and animal matter, may be processed to
extract substances which are
pharmacologically active. In each step of the
process, the volumes of materials are reduced
by a series of batch processes, until the final
drug product is obtained.
44. Pharmaceutical manufacturing
process for dosage form.
• Drug substances are converted into dosage-
form products before they are dispensed or
administered to humans or animals. Active
drug substances are mixed with
pharmaceutical necessities, such as binders,
fillers, flavouring and bulking agents,
preservatives and antioxidants. These
ingredients may be dried, milled, blended,
compressed and granulated to achieve the
desired properties before they are
46. Pharmaceutical manufacturing
process for dosage form.
• Liquid suspensions and emulsions are
produced by colloid mills and homogenizers,
respectively. Creams and ointments are
prepared by blending or compounding active
ingredients with petrolatum, heavy greases or
emollients.
• Liquid solutions for oral or topical use do not
require sterilization, solutions to be
administered to the eyes (ophthalmic) must
be sterilized. Oral liquids are prepared by
47. Pharmaceutical manufacturing
process for dosage form.
• Parenteral liquids are injected by intradermal,
intramuscular or intravenous administration
into the body, sterilized by dry or moist heat
under high pressure with bacteria-retaining
filters.
• Blended and granulated materials are
produced in tablet, capsule form.
48. Pharmaceutical manufacturing
process for dosage form.
• Modern pharmaceutical manufacturing
facilities and process equipment are reducing
environmental, health and safety risks by
preventing pollution and improving the
containment of hazards. Worker health and
safety and quality control objectives are
achieved by improving the isolation,
containment and cleanliness of
pharmaceutical facilities and process
equipment.
49. Pharmaceutical safety hazards to
workers.
• To prevent worker exposures to hazardous
substances and pharmaceutical products is
highly compatible with the concurrent need to
prevent workers from accidentally
contaminating raw materials and finished
products. Safe work procedures and good
manufFire and explosion prevention and
protection; process containment of hazardous
substances, machine hazards and high noise
levels, dilution.
50. Pharmaceutical safety hazards to
workers.
and local exhaust ventilation (LEV); use of
respirators (e.g., dust and organic vapour masks
and, in some cases, powered air-purifying
respirators or air-supplied masks and suits) and
personal protective equipment (PPE);and worker
training on workplace hazards and safe work
practices are workplace control measures
applicable during all of the various
pharmaceutical manufacturing Operation.
51. Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• Regarding issue of noise: Engineering methods
reduce sound levels by modifying, enclosing
and dampening noise sources. Employee
rotation and use of hearing-protective devices
(e.g., ear muffs and plugs) reduce workers’
exposure to high noise levels. Comprehensive
hearing conservation programmes identify
noise sources, reduce workplace sound levels,
and train workers on the hazards of noise
exposure and proper use of hearing-protective
devices.
52. Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• Noise monitoring and medical surveillance
(i.e., audiometry) assess worker exposures to
noise and their resulting loss of hearing. This
helps to identify noise problems and evaluate
the adequacy of corrective measures.
53. Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• As with the strong position compared to
others industries, the pharmaceutical industry
has resources, networks and expertise and has
a responsibility driving positive social change .
Though many companies in the
pharmaceutical sector are already doing
amazing work in helping to tackle complicated
and difficult issues. There are three key ways
in which pharma businesses can lead in
driving social change.
54. Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• To increase access to healthcare, pharma has
an obvious advantage compared to other
industries for social changes , pharma
business outputs are all designed to improve
and save lives. Pharna research and the
prepared life saving developing medicines
creations are paramount to the well-being of
society, playing a critical role in health care
that prevent, alleviate and cure diseases.
55. Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• To acquire adequate medicine remains a
crucial issue for many people across the globe,
facing barriers to get the proper needy urgent
healthcare and the situation can mean those
in rural areas, who face extreme poverty, are
left without adequate healthcare facilities.In
such cases pharmaceutical industry is
producing pharma businesses that can offer
their insights and expertise to NGOs to help
tackle global healthcare challenges.
56. Role of Pharmaceutical industry collaboration in
implementing development of social and community
affairs.
• The industry has the potential to drive social
change in our society to review industrial
processes, utilise pharmaceutical industrial
networks and identify areas where industry
can contribute and give back to society.
Produced products are fundamental in the
treatment offered to patients.
57. Conclusion.
• Health is a universal right. To overcome
barriers for health facilities must be cured for
classes of people around the world. If the
most needy people have no access, then
vision of pharmaceutical companies to
improve global health will fall short by making
advanced progress to become part of a bigger
network sharing the same vision, and by
learning from each other's and foster
scientific advances.
58. Conclusion.
• Through charitable giving programmes
pharmaceutical industry can effectively tackle
complex issues and strengthen the support to
local communities in areas where
improvements are urgently needed.There is
necessity to use the power to take an active
role in improving the healthcare issues faced
by millions of people all over the world.
59. References.
• Hardman, JA Gilman and L Limbird. 1996.
Goodman and Gilman’s The Pharmacologic
Basis of Therapeutics. New York: McGraw Hill
Co.
• International Labour Organization (ILO). 1983.
Encyclopaedia of Occupational Health and
Safety, 3rd edition. Geneva. ILO.
• Spilker, B. 1994. Multinational Pharmaceutical
Companies: Principles and Practices, 2nd
edition. New York: Raven Press.
60. References.
• Reynolds, J. 1989. Martindale’s: The Extra
Pharmacopoeias, 29th Edition. London:
Pharmaceutical Press.
• National Research Council. 1981. Prudent
Practices for Handling Hazardous Chemicals in
Laboratories. Washington, DC: National
Academy Press.
• Gennaro, A. 1990. Remington’s
Pharmaceutical Sciences, 18th edition. Easton,
PA: Mack Publishing Company.