The document summarizes the internship report of Barath R at Piramal Pharmaceuticals. It describes some of the key responsibilities in the warehouse including receiving and storing raw materials, recording temperature and humidity, issuing materials to production, and handling expired goods. It also provides overviews of production, quality control, research and development, and the use of high-performance liquid chromatography in pharmaceutical analysis.
This document discusses parenteral products and water for injection (WFI). It provides details on:
1) What defines a parenteral product and reasons they are unique dosage forms.
2) The manufacturing process for parenteral products including procurement, processing, packaging, and quality control.
3) Key factors for WFI production including distillation units, storage and distribution, and validation to ensure quality standards.
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.
Good laboratory practices (GLP) are quality standards for conducting non-clinical health and environmental safety studies. GLP aims to ensure studies are properly planned, performed, monitored, recorded and reported. It was introduced after the FDA found issues like fraud, inadequate facilities and equipment, and inaccurate reports during inspections of toxicology labs in the 1970s. Key aspects of GLP include adequate resources, characterization of test items and systems, standard operating procedures, record keeping of raw data and reports, archiving, and quality assurance through audits and inspections. GLP promotes reliable, repeatable and auditable study results accepted worldwide.
A short presentation about good ware house practicing and GMP requiremnts regarding this .And other pros and cons related to it.Hope it would be helpful.
This internship report summarizes an internship in the warehouse department of a pharmaceutical company. The key responsibilities included maintaining clean and organized warehouse and finished goods areas, receiving and storing raw materials and packing materials according to status, dispensing materials to production as needed according to records, ensuring compliance with cGMP, and performing regular stock verifications and documentation. Safety was emphasized including following documentation practices, inspection and calibration procedures, and ensuring temperature and environmental conditions were properly monitored and recorded.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
This document discusses quality control procedures for raw materials, in-process controls, and finished drug products. It outlines various tests and checks done at different stages of production to ensure product quality and purity. These include sampling and testing of incoming raw materials, in-process checks of attributes like tablet weight and size, and final testing of finished products prior to release. The goals of quality control/assurance programs are to ensure consistent active ingredient amounts within limits, use of ingredients meeting specifications, minimized variability between doses, and high purity and stability of finished products.
GMP regulations are designed to minimize risks in pharmaceutical production. They provide a framework to assure safety, identity, strength, quality and potency of drug products. GMPs require controlled production and adherence to regulations under the Federal Food, Drug and Cosmetic Act. The US GMP regulations are divided into parts 210 and 211, addressing building and facilities, equipment, packaging, labeling, holding, returns, and more. GMPs help ensure drug products are manufactured and controlled using quality standards appropriate for their intended use and to prevent adulteration.
This document discusses parenteral products and water for injection (WFI). It provides details on:
1) What defines a parenteral product and reasons they are unique dosage forms.
2) The manufacturing process for parenteral products including procurement, processing, packaging, and quality control.
3) Key factors for WFI production including distillation units, storage and distribution, and validation to ensure quality standards.
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.
Good laboratory practices (GLP) are quality standards for conducting non-clinical health and environmental safety studies. GLP aims to ensure studies are properly planned, performed, monitored, recorded and reported. It was introduced after the FDA found issues like fraud, inadequate facilities and equipment, and inaccurate reports during inspections of toxicology labs in the 1970s. Key aspects of GLP include adequate resources, characterization of test items and systems, standard operating procedures, record keeping of raw data and reports, archiving, and quality assurance through audits and inspections. GLP promotes reliable, repeatable and auditable study results accepted worldwide.
A short presentation about good ware house practicing and GMP requiremnts regarding this .And other pros and cons related to it.Hope it would be helpful.
This internship report summarizes an internship in the warehouse department of a pharmaceutical company. The key responsibilities included maintaining clean and organized warehouse and finished goods areas, receiving and storing raw materials and packing materials according to status, dispensing materials to production as needed according to records, ensuring compliance with cGMP, and performing regular stock verifications and documentation. Safety was emphasized including following documentation practices, inspection and calibration procedures, and ensuring temperature and environmental conditions were properly monitored and recorded.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.
This document discusses quality control procedures for raw materials, in-process controls, and finished drug products. It outlines various tests and checks done at different stages of production to ensure product quality and purity. These include sampling and testing of incoming raw materials, in-process checks of attributes like tablet weight and size, and final testing of finished products prior to release. The goals of quality control/assurance programs are to ensure consistent active ingredient amounts within limits, use of ingredients meeting specifications, minimized variability between doses, and high purity and stability of finished products.
GMP regulations are designed to minimize risks in pharmaceutical production. They provide a framework to assure safety, identity, strength, quality and potency of drug products. GMPs require controlled production and adherence to regulations under the Federal Food, Drug and Cosmetic Act. The US GMP regulations are divided into parts 210 and 211, addressing building and facilities, equipment, packaging, labeling, holding, returns, and more. GMPs help ensure drug products are manufactured and controlled using quality standards appropriate for their intended use and to prevent adulteration.
cGMP aims to ensure consistent production and control of quality standards for intended drug use and legal requirements. The 5 P's of cGMP are People, Products, Processes, Procedures, and Premises. cGMP principles include designing and constructing facilities properly, following written procedures and instructions, documenting work, validating processes, monitoring equipment, and conducting audits. cGMP regulations cover organization and personnel, facilities, equipment, production controls, packaging and labeling, laboratory testing, and record keeping. Key requirements include personnel training, sanitary facilities and practices, adequate ventilation and utilities, and cleaning and maintenance of equipment.
The document outlines Good Laboratory Practices (GLP) which were introduced in response to cases of fraudulent activities and poor lab practices discovered by the FDA in the 1970s. GLP helps ensure data submitted is a true reflection of study results and can be relied upon for risk assessments. It establishes standards for laboratory facilities, equipment, personnel qualifications, organization, standard operating procedures, test and control articles, protocol for conducting studies, and maintenance of raw data. Adhering to GLP helps assure regulatory authorities that submitted safety data is of high quality and integrity.
Presentation on Good Clinical Practices (GCP) By Anubhav Singh m.pharm 1st yearAnubhav Singh
GCPs are generally accepted, international best practices for conducting clinical trials and device studies. They are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with GCPs provide public assurance that the rights and safety of participants in human subject research are protected and that the data that arises from the study is credible. GCPs aim to ensure that clinical studies are scientifically sound and that the clinical properties of investigational products are properly documented. They encompass the design, conduct, monitoring, termination, analyses, reporting and documentation of clinical studies.
This document defines key concepts related to pharmaceutical storage and provides guidance on best practices. It discusses proper storage conditions for materials, products and vaccines to preserve quality. Procedures for receiving, inspecting, storing, rotating and dispatching stock are outlined. The importance of record keeping, sanitation, security, and stability testing to ensure effective storage is emphasized.
This document defines key concepts related to pharmaceutical storage and provides guidelines for best practices. It discusses definitions of storage, materials, and quality control. It also outlines procedures for warehouse site selection, receipt of incoming materials, storage, stock rotation, and dispatch. Temperature requirements are provided for vaccine storage. Guidance is given for sanitation, housekeeping, fire prevention, security, and stability follow-up to ensure safe and effective storage of pharmaceutical products.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
This document summarizes key points about manufacturing operations and quality control from a seminar presentation. It discusses good manufacturing practices, identity, strength, safety and purity as important factors. It also covers sanitation, standard operating procedures, mix-ups and contamination prevention, in-process quality control, packaging operations, process deviations, drug product inspection, and expiration dating. Maintaining quality is essential at all stages of the manufacturing and packaging process.
This document discusses quality control of drugs and pharmaceuticals. It defines quality control as the inspection aspect of quality management that focuses on fulfilling quality requirements. Quality control ensures drugs are safe, effective, and consistent by testing raw materials, in-process materials, and finished products. It describes various analytical testing methods used in quality control like qualitative analysis, quantitative analysis, dissolution testing, disintegration testing, hardness testing, friability testing, and content uniformity testing. Sources of errors in pharmaceutical analysis and sources of impurities in drugs are also discussed.
The document discusses Good Laboratory Practice (GLP) which are quality standards for conducting non-clinical safety studies. It provides definitions and background information. Specifically:
1. GLP are principles defined by the OECD for organizing and conducting non-clinical safety studies of products in a quality, standardized manner.
2. The OECD published the GLP principles in 1981 to ensure safety studies are well-planned, performed, monitored and reported in accordance with best practices.
3. GLP principles apply primarily to safety studies on pharmaceuticals submitted for regulatory approval and cover many types of toxicity and safety pharmacology studies.
The document discusses several ethical issues in forensic pharmacy, including quality assurance and good manufacturing practices in pharmaceutical production. It outlines laws and regulations that manufacturers must follow to ensure drug quality, safety, and efficacy. It also discusses good storage and distribution practices, including maintaining cold chains for temperature-sensitive drugs. The document emphasizes that pharmacists must handle product complaints, recalls, and imports/exports of controlled substances ethically and according to documented procedures to protect patient safety.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
The document discusses good distribution practices for medical products. It emphasizes the importance of quality management systems and risk management throughout the supply chain. Key points include establishing a quality policy and procedures for facilities, storage, documentation, complaints, and receiving products. All entities must implement quality systems, standard operating procedures, and controls to ensure medical products are properly handled and distributed.
Good Manufacturing Practices (GMP) ensure consistency in the quality of pharmaceutical products. GMP guidelines cover quality control, documentation, personnel qualifications, premises, equipment, materials, production, and quality assurance. Adherence to GMP is important for pharmaceutical export and most regulatory agencies only approve imports of medicines made under GMP standards. Key aspects of GMP include qualification and validation of equipment and processes, complaint handling, recalls, and self-inspections. GMP guidelines also exist specifically for herbal medicines to ensure quality, safety and efficacy of these complex biological products.
Good storage and distribution practices may apply to all
organizations and individuals involved in any aspect of the
storage and distribution of all the drug products. Storage
and distribution may involve the complex movement of
products around the world, differences in documents and
handling requirements and communication among various
entities in the supply chain.
This document provides information about warehousing in the pharmaceutical industry. It defines warehousing and warehouses, and outlines the objectives, functions, purposes, types, and general guidelines of warehousing. It discusses finished product warehousing, warehouse layout, standard operating procedures, design and construction considerations, maintenance, sanitation, and good warehousing practices. The document emphasizes the importance of orderly storage, documentation, stock control, safety, and quality assurance in pharmaceutical warehousing.
1) The document outlines procedures for validating laboratory test results prior to reporting at Hilongos District Hospital.
2) It describes validation processes for specimens in the pre-analytical, analytical, and post-analytical phases to ensure accuracy of results.
3) Key steps include checking request forms, specimen handling, testing methods, result reporting, and notifying clinicians of critical results.
Good manufacturing practices (GMP) regulations ensure consistency and quality in pharmaceutical manufacturing. GMP covers facilities, equipment, personnel, production, packaging and quality control. Key requirements include designated clean areas for operations, qualified personnel, documented procedures, process validation, environmental monitoring, component testing and record keeping. GMP aims to prevent contamination and errors through strict quality standards at all stages of production.
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdfpoornima335163
This document provides an overview of Good Manufacturing Practices (GMP), Quality Assurance, and documentation as it relates to the pharmaceutical industry. It discusses the basic concepts of GMP including ensuring quality is built into every stage of manufacturing. It also covers the various aspects regulated by GMP such as personnel, facilities, equipment, materials, and waste disposal. Finally, it emphasizes the importance of documentation to ensure proper procedures are consistently followed.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
cGMP aims to ensure consistent production and control of quality standards for intended drug use and legal requirements. The 5 P's of cGMP are People, Products, Processes, Procedures, and Premises. cGMP principles include designing and constructing facilities properly, following written procedures and instructions, documenting work, validating processes, monitoring equipment, and conducting audits. cGMP regulations cover organization and personnel, facilities, equipment, production controls, packaging and labeling, laboratory testing, and record keeping. Key requirements include personnel training, sanitary facilities and practices, adequate ventilation and utilities, and cleaning and maintenance of equipment.
The document outlines Good Laboratory Practices (GLP) which were introduced in response to cases of fraudulent activities and poor lab practices discovered by the FDA in the 1970s. GLP helps ensure data submitted is a true reflection of study results and can be relied upon for risk assessments. It establishes standards for laboratory facilities, equipment, personnel qualifications, organization, standard operating procedures, test and control articles, protocol for conducting studies, and maintenance of raw data. Adhering to GLP helps assure regulatory authorities that submitted safety data is of high quality and integrity.
Presentation on Good Clinical Practices (GCP) By Anubhav Singh m.pharm 1st yearAnubhav Singh
GCPs are generally accepted, international best practices for conducting clinical trials and device studies. They are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with GCPs provide public assurance that the rights and safety of participants in human subject research are protected and that the data that arises from the study is credible. GCPs aim to ensure that clinical studies are scientifically sound and that the clinical properties of investigational products are properly documented. They encompass the design, conduct, monitoring, termination, analyses, reporting and documentation of clinical studies.
This document defines key concepts related to pharmaceutical storage and provides guidance on best practices. It discusses proper storage conditions for materials, products and vaccines to preserve quality. Procedures for receiving, inspecting, storing, rotating and dispatching stock are outlined. The importance of record keeping, sanitation, security, and stability testing to ensure effective storage is emphasized.
This document defines key concepts related to pharmaceutical storage and provides guidelines for best practices. It discusses definitions of storage, materials, and quality control. It also outlines procedures for warehouse site selection, receipt of incoming materials, storage, stock rotation, and dispatch. Temperature requirements are provided for vaccine storage. Guidance is given for sanitation, housekeeping, fire prevention, security, and stability follow-up to ensure safe and effective storage of pharmaceutical products.
gmp is the most important topic for the students of ayurveda specially for rasashstra.
so in my presentations knowledge of gmp given very elaborately and easy to understand manner.
please advise any suggestions. thank u
This document summarizes key points about manufacturing operations and quality control from a seminar presentation. It discusses good manufacturing practices, identity, strength, safety and purity as important factors. It also covers sanitation, standard operating procedures, mix-ups and contamination prevention, in-process quality control, packaging operations, process deviations, drug product inspection, and expiration dating. Maintaining quality is essential at all stages of the manufacturing and packaging process.
This document discusses quality control of drugs and pharmaceuticals. It defines quality control as the inspection aspect of quality management that focuses on fulfilling quality requirements. Quality control ensures drugs are safe, effective, and consistent by testing raw materials, in-process materials, and finished products. It describes various analytical testing methods used in quality control like qualitative analysis, quantitative analysis, dissolution testing, disintegration testing, hardness testing, friability testing, and content uniformity testing. Sources of errors in pharmaceutical analysis and sources of impurities in drugs are also discussed.
The document discusses Good Laboratory Practice (GLP) which are quality standards for conducting non-clinical safety studies. It provides definitions and background information. Specifically:
1. GLP are principles defined by the OECD for organizing and conducting non-clinical safety studies of products in a quality, standardized manner.
2. The OECD published the GLP principles in 1981 to ensure safety studies are well-planned, performed, monitored and reported in accordance with best practices.
3. GLP principles apply primarily to safety studies on pharmaceuticals submitted for regulatory approval and cover many types of toxicity and safety pharmacology studies.
The document discusses several ethical issues in forensic pharmacy, including quality assurance and good manufacturing practices in pharmaceutical production. It outlines laws and regulations that manufacturers must follow to ensure drug quality, safety, and efficacy. It also discusses good storage and distribution practices, including maintaining cold chains for temperature-sensitive drugs. The document emphasizes that pharmacists must handle product complaints, recalls, and imports/exports of controlled substances ethically and according to documented procedures to protect patient safety.
GOOD LABORATORY PRACTICES - A DETAILED STUDYTeny Thomas
A detailed study of the rules, regulations and guidelines of Good Laboratory Practices that should be practiced while conducting a Non Clinical Laboratory Study in Animals.
The document discusses good distribution practices for medical products. It emphasizes the importance of quality management systems and risk management throughout the supply chain. Key points include establishing a quality policy and procedures for facilities, storage, documentation, complaints, and receiving products. All entities must implement quality systems, standard operating procedures, and controls to ensure medical products are properly handled and distributed.
Good Manufacturing Practices (GMP) ensure consistency in the quality of pharmaceutical products. GMP guidelines cover quality control, documentation, personnel qualifications, premises, equipment, materials, production, and quality assurance. Adherence to GMP is important for pharmaceutical export and most regulatory agencies only approve imports of medicines made under GMP standards. Key aspects of GMP include qualification and validation of equipment and processes, complaint handling, recalls, and self-inspections. GMP guidelines also exist specifically for herbal medicines to ensure quality, safety and efficacy of these complex biological products.
Good storage and distribution practices may apply to all
organizations and individuals involved in any aspect of the
storage and distribution of all the drug products. Storage
and distribution may involve the complex movement of
products around the world, differences in documents and
handling requirements and communication among various
entities in the supply chain.
This document provides information about warehousing in the pharmaceutical industry. It defines warehousing and warehouses, and outlines the objectives, functions, purposes, types, and general guidelines of warehousing. It discusses finished product warehousing, warehouse layout, standard operating procedures, design and construction considerations, maintenance, sanitation, and good warehousing practices. The document emphasizes the importance of orderly storage, documentation, stock control, safety, and quality assurance in pharmaceutical warehousing.
1) The document outlines procedures for validating laboratory test results prior to reporting at Hilongos District Hospital.
2) It describes validation processes for specimens in the pre-analytical, analytical, and post-analytical phases to ensure accuracy of results.
3) Key steps include checking request forms, specimen handling, testing methods, result reporting, and notifying clinicians of critical results.
Good manufacturing practices (GMP) regulations ensure consistency and quality in pharmaceutical manufacturing. GMP covers facilities, equipment, personnel, production, packaging and quality control. Key requirements include designated clean areas for operations, qualified personnel, documented procedures, process validation, environmental monitoring, component testing and record keeping. GMP aims to prevent contamination and errors through strict quality standards at all stages of production.
GOOD MANUFACTURING PRACTICES AND QUALITY ASSURANCE.pdfpoornima335163
This document provides an overview of Good Manufacturing Practices (GMP), Quality Assurance, and documentation as it relates to the pharmaceutical industry. It discusses the basic concepts of GMP including ensuring quality is built into every stage of manufacturing. It also covers the various aspects regulated by GMP such as personnel, facilities, equipment, materials, and waste disposal. Finally, it emphasizes the importance of documentation to ensure proper procedures are consistently followed.
Leveraging Generative AI to Drive Nonprofit InnovationTechSoup
In this webinar, participants learned how to utilize Generative AI to streamline operations and elevate member engagement. Amazon Web Service experts provided a customer specific use cases and dived into low/no-code tools that are quick and easy to deploy through Amazon Web Service (AWS.)
This document provides an overview of wound healing, its functions, stages, mechanisms, factors affecting it, and complications.
A wound is a break in the integrity of the skin or tissues, which may be associated with disruption of the structure and function.
Healing is the body’s response to injury in an attempt to restore normal structure and functions.
Healing can occur in two ways: Regeneration and Repair
There are 4 phases of wound healing: hemostasis, inflammation, proliferation, and remodeling. This document also describes the mechanism of wound healing. Factors that affect healing include infection, uncontrolled diabetes, poor nutrition, age, anemia, the presence of foreign bodies, etc.
Complications of wound healing like infection, hyperpigmentation of scar, contractures, and keloid formation.
A Visual Guide to 1 Samuel | A Tale of Two HeartsSteve Thomason
These slides walk through the story of 1 Samuel. Samuel is the last judge of Israel. The people reject God and want a king. Saul is anointed as the first king, but he is not a good king. David, the shepherd boy is anointed and Saul is envious of him. David shows honor while Saul continues to self destruct.
How to Manage Reception Report in Odoo 17Celine George
A business may deal with both sales and purchases occasionally. They buy things from vendors and then sell them to their customers. Such dealings can be confusing at times. Because multiple clients may inquire about the same product at the same time, after purchasing those products, customers must be assigned to them. Odoo has a tool called Reception Report that can be used to complete this assignment. By enabling this, a reception report comes automatically after confirming a receipt, from which we can assign products to orders.
Level 3 NCEA - NZ: A Nation In the Making 1872 - 1900 SML.pptHenry Hollis
The History of NZ 1870-1900.
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From the NZ Wars to Liberals,
Richard Seddon, George Grey,
Social Laboratory, New Zealand,
Confiscations, Kotahitanga, Kingitanga, Parliament, Suffrage, Repudiation, Economic Change, Agriculture, Gold Mining, Timber, Flax, Sheep, Dairying,
Elevate Your Nonprofit's Online Presence_ A Guide to Effective SEO Strategies...TechSoup
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2. WAREHOUSE IN PHARMAECUTICAL INDUSTRY
• To maintained Warehouse and Finished Goods area clean
and presentable for audit.To follow Good Documentation
practices and safety instructions & ensure compliance
while working in warehouse. Receiving of Raw materials
and Packing materials and Prepare Goods receipt Note
(GRN).
• Recording of Temperature, Relative Humidity and
Differential Pressure in stores and Finished Goods area.
Arrangements of Raw material and Packing material in
stores according to the status i.e Under test Approved,
Rejected and Quarantine etc. Dispensing and issue of Raw
materials and Packing materials to production and Packing
department as per respective Batch manufacturing and
Packing record.
3. • Handling of Damaged, Rejected and Expired materials in
warehouse. To follow online documentation in Raw material,
Packing material and Finished Goods store. Follow up with
purchase and commercial department for disposal of non
moving, obsolete and rejected raw and packing materials.
Temperature mapping in Stores and Finished Goods area.
Posting and Transaction of materials in SAP or ERP system.
Follow up with Quality control department
for timely sampling and release of
materials. Preparation of Standard
Operating Procedure related to warehouse
department. To provide SOP Training to
juniors or new joining persons. Responsible
for Handling of Change control and
Deviations. Prepare packing list and
dispatch plan for Finished Goods and
dispatch of Finished Goods. Identify the
materials which are due for Retesting on
monthly basis and inform to respective
department for sampling of the same.
4. PRODUCTION IN PHARMACEUTICAL INDUSTRY
• Production should be performed and supervised by competent people.All
handling of materials and products, such as receipt and quarantine,
sampling, storage, labelling, dispensing, processing, packaging and
distribution should be done in accordance with written procedures or
instructions and, where necessary, recorded.
• All incoming materials should be checked to ensure that the consignment
corresponds to the order. Containers should be cleaned where necessary
and labelled with the prescribed data.
• Damage to containers and any other problem which might adversely affect
the quality of a material should be investigated, recorded and reported to
the Quality Control Department.
5. • Incoming materials and finished products should be physically or
administratively quarantined immediately after receipt or processing,
until they have been released for use or distribution.
• Intermediate and bulk products purchased as such should be handled
on receipt as though they were starting materials. Checks on yields,
and reconciliation of quantities, should be carried out as necessary to
ensure that there are no discrepancies outside acceptable
limits.Operations on different products should not be carried out
simultaneously or consecutively in the same room unless there is no
risk of mix-up or crosscontamination.
• At every stage of processing, products and materials should be
protected from microbial and other contamination.
6. When working with dry materials and
products, special precautions should be
taken to prevent the generation and
dissemination of dust. This applies
particularly to the handling of highly active
or sensitising materials.
At all times during processing, all materials,
bulk containers, major items of equipment
and where appropriate rooms used should
be labelled or otherwise identified with an
indication of the product or material being
processed, its strength (where applicable)
and batch number. Where applicable, this
indication should also mention the stage of
production.
7. R&D IN PHARMA INDUSTRY
• The pharma R&D process is simply the series of activities targeted to reach
the goal of discovering and delivering new medical drugs, devices, or
therapies to market.
• Very basically, R&D in the pharma industry involves:
• Pre-clinical research and discovery of innovative drugs
• Clinical testing of prescription drugs in trials
• Preparation and submission of applications for Food and Drug
Administration or FDA approval
8. Designing production processes for the new
product
Clinical testing of a new drug against an existing
drug to ultimately show the new product’s
superior benefits
Additional clinical trials after a new drug reaches
the market, for safety monitoring and detection
of additional side effects that may not have been
observed in earlier trials during development
Line extensions, or innovations and
improvements for existing prescription drugs,
which include developing new dosages and
delivery systems and testing for additional
potential uses
10. • Analyzes are performed according to what each drug requires and
depending on the phase this drug is in. In the physical-chemical laboratory,
controls of all types are carried out, from the simplest to the most
complex. We can mention as simple analyzes the product’s appearance,
hardness, density and pH. As more complex, we can mention the most
used method today in the largest pharmaceutical industries in the world,
the content of the product (dosage), carried out in a device called HPLC
(High Performance Liquid Chromatography).
• Each product goes through a production process and in a physico-chemical
laboratory it is analyzed from the raw material, passing through the initial
product, final product and stability study. Each phase requires special
attention in its tests, following the literature established by the countries of
dispatch and consumption of the drug. In Portugal, the European
Pharmacopoeia is used as the main literature.
11. HIGH PERFOMANCE LIQUID CHROMATOGRAPHY IN
PHARMACEUTICAL ANALYSES
• The purpose high perfomance liquid chromatography (HPLC) analysis of any drugs
is to confirm the identity of a drug and provide quantitative results and also to
monitor the progress of the therapy of a disease
• It may also be used to further our understanding of the normal and disease
process in the human body trough biomedical and therapeutically research
during investigation before of the drugs registration. The analyses of drugs and
metabolites in biological fluids, particularly plasma, serum or urine is one of the
most demanding but one of the most common uses of high performance of liquid
chromatography. Blood, plasma or serum contains numerous endogenous
compounds of ten present in concentrations much greater than those of analyte.
Analiyte concentrations are often low, and in the case of drugs, the endogenous
compounds are sometimes structurally very similar to the drug to be measured.
The binding of drugs to the plasma protein also may occur which decreases the
amount of free compound that is measured.
12.
13. • Liquid chromatography is an analytical technique that is used to
separate a certain sample into its individual components.1 The
separation occurs when the sample interacts with the mobile (liquid)
and stationary phases (column). The various parts of the sample are
separated out based on their polarities; they will have varying levels
of affinity for the mobile phase, resulting in migration through the
column at different speeds.
• The mixed components are placed at the top of the column of the
stationary phase, which is generally a fine adsorbent solid such as
silica. This must be distributed evenly to minimise the presence of air
bubbles that could influence the results of the test. The exit of the
column is stoppered with glass, wool or a porous plate. When the
mobile phase passes through, the mixture separates into bands.
These can then be collected and analysed via other methods.1