This document outlines the Drug Manufacturing Code 2041 (1984 AD) in Nepal. It details requirements for drug manufacturing facilities including their location, building requirements, necessary equipment, raw material storage and record keeping, manufacturing processes, quality control procedures, packaging and labeling, and staffing. The code aims to ensure drugs are manufactured following proper standards and quality control to comply with drug laws and protect public health. It provides regulations for good manufacturing practices that manufacturers must adhere to when producing pharmaceutical products in Nepal.
Premises - Part of Good Manufacturing PracticesTeny Thomas
This document discusses good manufacturing practices for pharmaceutical premises. It covers factors to consider for location, design, construction, sanitation, maintenance, utilities, and environmental control of premises to prevent contamination. The premises must have defined areas for receiving, sampling, storage, production, packaging, and quality control. Cleaning procedures and environmental monitoring programs are important to control contamination. Grade A or B areas for sterile products require additional controls like air quality standards and maintenance of sterile conditions.
This presentation contains legal requirements for labeling for pharmaceuticals, types of label, objective of label and recent advancement in labeling of pharmaceuticals.
Parenteral preparations must be sterile and free of pathogens to safely administer drugs through non-digestive routes like injection. Strict aseptic techniques are required during production to prevent contamination. Key aspects of aseptic processing include designated clean, compounding, and aseptic areas; laminar flow hoods with HEPA filters; and trained personnel following proper gowning procedures. Sources of contamination include airborne particles, fluids, and microbes from personnel that must all be controlled to ensure sterile and safe parenteral products.
Cold creams are oil-in-water emulsions used to smooth skin and remove makeup. They produce a cooling effect due to the slow evaporation of water. Common ingredients include beeswax, mineral oils, and scents. Cold creams were traditionally made from animal fats but now use vegetable and mineral oils. When applied, the emulsion inverts from oil-in-water to water-in-oil. Cleansing creams are similar but contain detergents to clean the skin by removing dirt, oil, and dead cells in addition to makeup. Vanishing creams are oil-in-water emulsions that leave a thin, almost invisible layer of stearic acid on the skin.
Schedule M outlines Good Manufacturing Practices (GMP) that must be followed by pharmaceutical manufacturing units in India. It contains requirements for factory premises, plants, equipment, and quality assurance to ensure products are consistently manufactured and controlled to quality standards. Schedule M has two parts - Part 1 covers GMP for premises and materials, and Part 2 covers specific plant and material requirements. It provides detailed guidelines for facilities, equipment, sanitation, personnel, documentation, manufacturing, quality control, distribution, and more to help ensure therapeutic goods produced meet the required quality standards.
Quality control tests for parenterals pptsuraj p rajan
This document discusses quality control tests that are performed on parenteral products. It describes 7 key tests: uniformity of content, volume of liquid, pyrogen, sterility, clarity of solution, uniformity of weight, and bacterial endotoxin. These tests ensure parenteral products meet standards for dosage uniformity, volume accuracy, freedom from fever-causing substances, freedom from microbes, visibility of solutions, weight consistency, and limits on bacterial contaminants. The tests are important for ensuring parenteral products are safe and effective for patients.
This document outlines general and special labeling requirements for drugs and cosmetics under the Drugs & Cosmetics Act of 1940 and its Rules of 1945 in India. It provides details on what information must be included on labels, such as the drug name, ingredients, manufacturer information, batch details, and expiry date. It also specifies additional labeling for certain drug schedules, like Schedule H which requires a prescription, as well as for external preparations, ophthalmic products, and veterinary medicines. Sample labels are given for various drug schedules and uses. The document also lists permitted colors that can be used in drugs.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
Premises - Part of Good Manufacturing PracticesTeny Thomas
This document discusses good manufacturing practices for pharmaceutical premises. It covers factors to consider for location, design, construction, sanitation, maintenance, utilities, and environmental control of premises to prevent contamination. The premises must have defined areas for receiving, sampling, storage, production, packaging, and quality control. Cleaning procedures and environmental monitoring programs are important to control contamination. Grade A or B areas for sterile products require additional controls like air quality standards and maintenance of sterile conditions.
This presentation contains legal requirements for labeling for pharmaceuticals, types of label, objective of label and recent advancement in labeling of pharmaceuticals.
Parenteral preparations must be sterile and free of pathogens to safely administer drugs through non-digestive routes like injection. Strict aseptic techniques are required during production to prevent contamination. Key aspects of aseptic processing include designated clean, compounding, and aseptic areas; laminar flow hoods with HEPA filters; and trained personnel following proper gowning procedures. Sources of contamination include airborne particles, fluids, and microbes from personnel that must all be controlled to ensure sterile and safe parenteral products.
Cold creams are oil-in-water emulsions used to smooth skin and remove makeup. They produce a cooling effect due to the slow evaporation of water. Common ingredients include beeswax, mineral oils, and scents. Cold creams were traditionally made from animal fats but now use vegetable and mineral oils. When applied, the emulsion inverts from oil-in-water to water-in-oil. Cleansing creams are similar but contain detergents to clean the skin by removing dirt, oil, and dead cells in addition to makeup. Vanishing creams are oil-in-water emulsions that leave a thin, almost invisible layer of stearic acid on the skin.
Schedule M outlines Good Manufacturing Practices (GMP) that must be followed by pharmaceutical manufacturing units in India. It contains requirements for factory premises, plants, equipment, and quality assurance to ensure products are consistently manufactured and controlled to quality standards. Schedule M has two parts - Part 1 covers GMP for premises and materials, and Part 2 covers specific plant and material requirements. It provides detailed guidelines for facilities, equipment, sanitation, personnel, documentation, manufacturing, quality control, distribution, and more to help ensure therapeutic goods produced meet the required quality standards.
Quality control tests for parenterals pptsuraj p rajan
This document discusses quality control tests that are performed on parenteral products. It describes 7 key tests: uniformity of content, volume of liquid, pyrogen, sterility, clarity of solution, uniformity of weight, and bacterial endotoxin. These tests ensure parenteral products meet standards for dosage uniformity, volume accuracy, freedom from fever-causing substances, freedom from microbes, visibility of solutions, weight consistency, and limits on bacterial contaminants. The tests are important for ensuring parenteral products are safe and effective for patients.
This document outlines general and special labeling requirements for drugs and cosmetics under the Drugs & Cosmetics Act of 1940 and its Rules of 1945 in India. It provides details on what information must be included on labels, such as the drug name, ingredients, manufacturer information, batch details, and expiry date. It also specifies additional labeling for certain drug schedules, like Schedule H which requires a prescription, as well as for external preparations, ophthalmic products, and veterinary medicines. Sample labels are given for various drug schedules and uses. The document also lists permitted colors that can be used in drugs.
A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.
Quality control test: Containers, Closures and Secondary packing materialsPranali Polshettiwar
This document summarizes quality control tests for containers, closures, and secondary packaging materials. It describes common materials used for each, such as glass, plastic, metal for containers and rubber, plastic, metal for closures. Key quality tests for containers include powdered glass test, water attack test, hydrolytic resistance test, and thermal shock test. Tests for closures include residue on evaporation, pH of extract, and sterility. Secondary packaging materials like paper and cardboard are also tested for quality.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the types of parenteral formulation including the types of parenteral route for administration along withcomponents of parenteral formulation.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
1. Pharmaceutical plant layout involves arranging departments and machinery to integrate machines, materials, and personnel for efficient production while following safety and regulatory requirements.
2. There are two main types of layouts - process layout which groups similar machines together and product layout which arranges machines in the order of operations.
3. Effective planning of production involves selecting the process, materials, and equipment; determining the layout; and creating routing sheets and schedules to optimize resource usage and meet production targets.
A study on waste disposal in the pharmaceutical areas. the chapter deals with types of waste, how the waste is disposed, the procedure of waste disposale and the regulatory guidelines.
This document summarizes parenterals and their quality control testing. Parenterals are sterile dosage forms intended for administration other than orally that enter systemic circulation. Their advantages include quick onset, suitability for non-oral drugs, and use in emergencies. Disadvantages are the need for trained personnel and risks of pain, sensitivity, and expense. Quality control tests described include content uniformity, leakers, pyrogens, sterility, and particulates. Specific test methods and acceptance criteria are provided to ensure parenterals meet quality standards.
Quality control for rubber closures & secondary materialkavita bahmani
This document outlines various tests that are conducted on rubber closures and secondary packaging materials like paper and board. It describes the preparation of a solution for rubber closures and then lists different tests like sterility testing, fragmentation testing, self-seal ability, pH testing, light absorption testing, and residue on evaporation. It also provides an overview of 20 different tests that are performed on secondary packaging materials to analyze properties like moisture content, density, tensile strength, tear strength, puncture resistance, stiffness, water absorbency, rub resistance, pH, roughness, brightness, wet burst strength, and more.
The document discusses drug scheduling systems in the United States and India. It describes the five schedules of controlled substances in the US based on abuse potential and accepted medical use. It then outlines the various schedules in India which classify drugs and regulate their manufacture, import, and sale. The schedules specify forms, fees, standards, labeling requirements, and exemptions for different classes of drugs, biological products, and poisons.
A Detailed Study on Pharmaceutical Drug RecallTeny Thomas
1. A drug recall is a process of removing a pharmaceutical product from distribution due to defects, adverse reactions, or counterfeiting concerns.
2. The objectives of a drug recall are to stop distribution and sale of the affected product, notify relevant parties, efficiently remove the product, and implement corrective actions to prevent future recalls.
3. Recalls are classified by the CDSCO as Class I, II, or III depending on the health risks posed by the defective product. A recall strategy and team must be in place to effectively execute any necessary recalls.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
The document discusses the Good Manufacturing Practices (GMP) guidelines for Ayurvedic, Siddha, and Unani medicines as specified in Schedule T of the Drugs and Cosmetics Rules. It covers various components of GMP including factory premises requirements, machinery and equipment, production areas, raw material and finished goods storage, worker hygiene, and documentation. The objective of GMP is to ensure quality control throughout the manufacturing process to produce medicines of acceptable standards.
The document discusses Good Manufacturing Practices (GMP) for herbal medicines in Indian systems of medicine. It outlines the key requirements for GMP compliance, including factory premises requirements, manufacturing processes, equipment, quality control, training, documentation, labeling and packing. The objectives of GMP are to ensure authentic and quality raw materials are used, manufacturing processes are standardized, and finished products meet predefined specifications to ensure consistent quality and minimize contamination and errors.
This document provides an overview of equipments and raw materials used in pharmaceutical manufacturing. It discusses the selection, purchase specifications, maintenance, and storage of both equipments and raw materials. Key points covered include cleaning and calibration of equipments, purchasing raw materials from approved vendors against specifications, and storing materials under proper conditions to prevent degradation.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
The document discusses the manufacturing process of parenteral preparations. It describes parenterals as sterile liquids or solids for injection or implantation. The manufacturing process involves planning, material management, production, quality control testing, filling, and packaging. Production areas are divided into strict zones based on cleanliness. Environmental controls and facility design aim to prevent contamination, with areas for filling, weighing, storage, and administration. Personnel flow and utility locations are also considered for efficiency.
This document discusses various ophthalmic products including eye drops, eye lotions, eye suspensions, eye ointments, and contact lens solutions. It describes the ideal characteristics of ophthalmic products such as being sterile, isotonic, and having the proper pH and viscosity. It also discusses the types of microorganisms that can cause eye infections and how sterility is achieved. The document provides details on the formulation, preparation, and labeling of different ophthalmic products.
The document summarizes procedures for evaluating ophthalmic drug preparations. It discusses that evaluation includes sterility testing, clarity testing, leak testing, and testing for metal particles in ointments. It also describes that drug product quality tests assess attributes like identification, potency, purity, sterility and particulate matter, while performance tests evaluate drug release. Key quality tests discussed are identification, assay, pH, osmolarity, bacterial endotoxins, and uniformity of dosage units. Specific tests covered include viscosity and drop size.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
The document outlines the Good Manufacturing Practices (GMP) as per Schedule M of the Drugs and Cosmetic Act of 1940 in India. It details the requirements for facilities, equipment, production, quality control, documentation, personnel and other aspects of pharmaceutical manufacturing. The key points covered include requirements for premises location, building design to prevent contamination, waste disposal procedures, manufacturing controls, quality control testing, documentation and record keeping, personnel qualifications, and compliance with other applicable regulations.
Quality control test: Containers, Closures and Secondary packing materialsPranali Polshettiwar
This document summarizes quality control tests for containers, closures, and secondary packaging materials. It describes common materials used for each, such as glass, plastic, metal for containers and rubber, plastic, metal for closures. Key quality tests for containers include powdered glass test, water attack test, hydrolytic resistance test, and thermal shock test. Tests for closures include residue on evaporation, pH of extract, and sterility. Secondary packaging materials like paper and cardboard are also tested for quality.
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the types of parenteral formulation including the types of parenteral route for administration along withcomponents of parenteral formulation.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
Unit 2 organization and personnel and permisies himanshuhimanshu kamboj
pharmaceutical quality assurance
b pharma 6th sem
Personnel objectives
Personnel qualifications
Personnel responsibilities
Key personnel
Responsibilities of the head of the production department
Responsibilities of the head of quality control department
Training
Personnel hygiene
Premises
Layout of pharmaceutical industry
Areas of premises
Environmental control in sterile areas
Equipment and raw materials
Stages of equipment
Cleaning and maintenance
Raw materials
Steps involved in purchase procedure
Maintenance of stores
Storage conditions
The document summarizes key aspects of the Drug and Cosmetic Act and Rules in India, including:
- The Acts and Rules regulate the import, manufacture, distribution and sale of drugs and cosmetics in India.
- Important definitions are provided for terms like "drug", "cosmetic", "manufacture" and others.
- Drugs and cosmetics can be deemed "misbranded", "adulterated" or "spurious" if they do not meet certain standards.
- The Rules contain 18 parts and 26 schedules providing detailed requirements and guidelines for drugs and cosmetics.
- Key agencies like the Drugs Technical Advisory Board help administer the Acts and
1. Pharmaceutical plant layout involves arranging departments and machinery to integrate machines, materials, and personnel for efficient production while following safety and regulatory requirements.
2. There are two main types of layouts - process layout which groups similar machines together and product layout which arranges machines in the order of operations.
3. Effective planning of production involves selecting the process, materials, and equipment; determining the layout; and creating routing sheets and schedules to optimize resource usage and meet production targets.
A study on waste disposal in the pharmaceutical areas. the chapter deals with types of waste, how the waste is disposed, the procedure of waste disposale and the regulatory guidelines.
This document summarizes parenterals and their quality control testing. Parenterals are sterile dosage forms intended for administration other than orally that enter systemic circulation. Their advantages include quick onset, suitability for non-oral drugs, and use in emergencies. Disadvantages are the need for trained personnel and risks of pain, sensitivity, and expense. Quality control tests described include content uniformity, leakers, pyrogens, sterility, and particulates. Specific test methods and acceptance criteria are provided to ensure parenterals meet quality standards.
Quality control for rubber closures & secondary materialkavita bahmani
This document outlines various tests that are conducted on rubber closures and secondary packaging materials like paper and board. It describes the preparation of a solution for rubber closures and then lists different tests like sterility testing, fragmentation testing, self-seal ability, pH testing, light absorption testing, and residue on evaporation. It also provides an overview of 20 different tests that are performed on secondary packaging materials to analyze properties like moisture content, density, tensile strength, tear strength, puncture resistance, stiffness, water absorbency, rub resistance, pH, roughness, brightness, wet burst strength, and more.
The document discusses drug scheduling systems in the United States and India. It describes the five schedules of controlled substances in the US based on abuse potential and accepted medical use. It then outlines the various schedules in India which classify drugs and regulate their manufacture, import, and sale. The schedules specify forms, fees, standards, labeling requirements, and exemptions for different classes of drugs, biological products, and poisons.
A Detailed Study on Pharmaceutical Drug RecallTeny Thomas
1. A drug recall is a process of removing a pharmaceutical product from distribution due to defects, adverse reactions, or counterfeiting concerns.
2. The objectives of a drug recall are to stop distribution and sale of the affected product, notify relevant parties, efficiently remove the product, and implement corrective actions to prevent future recalls.
3. Recalls are classified by the CDSCO as Class I, II, or III depending on the health risks posed by the defective product. A recall strategy and team must be in place to effectively execute any necessary recalls.
It is unique in bringing together the regulatory authorities and
pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines.
The document discusses the Good Manufacturing Practices (GMP) guidelines for Ayurvedic, Siddha, and Unani medicines as specified in Schedule T of the Drugs and Cosmetics Rules. It covers various components of GMP including factory premises requirements, machinery and equipment, production areas, raw material and finished goods storage, worker hygiene, and documentation. The objective of GMP is to ensure quality control throughout the manufacturing process to produce medicines of acceptable standards.
The document discusses Good Manufacturing Practices (GMP) for herbal medicines in Indian systems of medicine. It outlines the key requirements for GMP compliance, including factory premises requirements, manufacturing processes, equipment, quality control, training, documentation, labeling and packing. The objectives of GMP are to ensure authentic and quality raw materials are used, manufacturing processes are standardized, and finished products meet predefined specifications to ensure consistent quality and minimize contamination and errors.
This document provides an overview of equipments and raw materials used in pharmaceutical manufacturing. It discusses the selection, purchase specifications, maintenance, and storage of both equipments and raw materials. Key points covered include cleaning and calibration of equipments, purchasing raw materials from approved vendors against specifications, and storing materials under proper conditions to prevent degradation.
An innovator or branded drug is the first drugs created containing its specific active ingredient to receive approval for use.
A generic drug is made of the same active ingredient as its innovator drug.
The document discusses the manufacturing process of parenteral preparations. It describes parenterals as sterile liquids or solids for injection or implantation. The manufacturing process involves planning, material management, production, quality control testing, filling, and packaging. Production areas are divided into strict zones based on cleanliness. Environmental controls and facility design aim to prevent contamination, with areas for filling, weighing, storage, and administration. Personnel flow and utility locations are also considered for efficiency.
This document discusses various ophthalmic products including eye drops, eye lotions, eye suspensions, eye ointments, and contact lens solutions. It describes the ideal characteristics of ophthalmic products such as being sterile, isotonic, and having the proper pH and viscosity. It also discusses the types of microorganisms that can cause eye infections and how sterility is achieved. The document provides details on the formulation, preparation, and labeling of different ophthalmic products.
The document summarizes procedures for evaluating ophthalmic drug preparations. It discusses that evaluation includes sterility testing, clarity testing, leak testing, and testing for metal particles in ointments. It also describes that drug product quality tests assess attributes like identification, potency, purity, sterility and particulate matter, while performance tests evaluate drug release. Key quality tests discussed are identification, assay, pH, osmolarity, bacterial endotoxins, and uniformity of dosage units. Specific tests covered include viscosity and drop size.
This presentation consists of information related to Schedule M, a topic under #Drug_and_Cosmetics_Act. This presentation could be beneficial for the sake of the seminar in #Pharmaceutical_Jurisprudence for pharmacy students.
The document outlines the Good Manufacturing Practices (GMP) as per Schedule M of the Drugs and Cosmetic Act of 1940 in India. It details the requirements for facilities, equipment, production, quality control, documentation, personnel and other aspects of pharmaceutical manufacturing. The key points covered include requirements for premises location, building design to prevent contamination, waste disposal procedures, manufacturing controls, quality control testing, documentation and record keeping, personnel qualifications, and compliance with other applicable regulations.
This document outlines Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani medicines. It discusses requirements for factory premises, buildings, water supply, waste disposal, storage, and other facilities. Specific guidelines are provided for raw material storage, manufacturing areas, equipment, batch records, quality control, and more. Lists of recommended machinery and minimum space requirements are also included for producing different types of medicines in each system.
The document outlines Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani drugs. It discusses requirements for factory premises, general building requirements, water supply, waste disposal, raw material and finished goods storage, and quality control facilities. Key points include:
1) Factory areas must be adequately sized and separated for raw material receipt and storage, manufacturing, quality control, and finished goods storage.
2) Buildings must allow hygienic production and be free of pests. Interior surfaces must be cleanable.
3) Raw materials must be stored by type in labeled containers indicating source, batch, and receipt date.
4) Finished goods are
The GMP Operations Manager is responsible for overseeing the implementation and sustained operations of world-class technical cleaning and sanitization programs to include cGMP space, semi-conductor, clean rooms, laboratory, data and other critical environments.
cGMP as per shedule M outlines the Good Manufacturing Practices that must be followed for pharmaceutical manufacturing according to the Drugs and Cosmetics Act of India. It covers requirements for facilities, equipment, personnel, sanitation, documentation, quality control, packaging and labeling. All aspects of production from raw materials to finished products must meet GMP standards to ensure consistency and quality of manufactured drugs. Detailed written procedures and records are required for all manufacturing processes.
To compare GMP requirement of India, US and Europe for tablets.Aakashdeep Raval
The document discusses Good Manufacturing Practice (GMP) requirements for tablet manufacturing in India, the US, and Europe. It provides an in-depth overview of key GMP requirements for tablet production in India, covering general facility requirements, warehousing, production areas, ancillary areas, quality control, personnel, manufacturing operations, equipment, documentation, quality assurance, and validation. The guidelines outline aspects of production and testing that impact quality, including clearly defined and controlled manufacturing processes, change control, training, facilities, equipment, and documentation.
SCHEDULE M, Pharmaceutical Jurisprudence, 5th semnaikanu3813
The document outlines Good Manufacturing Practice (GMP) requirements for pharmaceutical manufacturing facilities, equipment, and processes according to Schedule M of the Drugs and Cosmetics Act in India. It covers 17 parts with specific requirements for premises, plant, equipment, production, packaging, quality control, documentation and other key aspects. Adherence to GMP helps ensure pharmaceutical products are consistently manufactured and controlled to the quality standards appropriate for their intended use.
The document outlines the Good Manufacturing Practice (GMP) requirements for pharmaceutical manufacturing facilities according to Schedule M. It discusses 14 parts that cover requirements for facility premises, equipment, sanitation, personnel, materials, production, quality control, documentation, and quality assurance. The goal of GMP is to ensure consistent production of quality pharmaceutical products by having standardized operating procedures, trained staff, suitable premises and equipment, and validated processes.
GMP is a set of principles and procedures that ensure products are consistently manufactured and controlled according to quality standards for their intended use. Key aspects of GMP include requirements for facilities, equipment, personnel, documentation, raw materials, production, packaging and labeling, quality control, self-inspection and product recalls. GMP regulations in India were introduced in 1988 and amended in 2001, embracing rules under the Drugs and Cosmetics Rules 1945. Facilities must be designed and maintained to allow production under hygienic conditions in order to prevent contamination and cross-contamination.
This document provides an overview of good manufacturing practices (GMP) in the pharmaceutical industry. It begins with definitions of GMP and discusses its early history starting in the 1900s with no regulations. Key events that led to increased regulation include Upton Sinclair's 1905 book The Jungle exposing unsanitary meat plants and the 1906 Pure Food and Drug Act. The document then outlines the timeline of major GMP regulations from 1902 to the present. It provides details on key areas covered by GMP including personnel, premises, equipment, process validation, and quality assurance.
This document provides an overview of Good Manufacturing Practices (GMP) regulations for manufacturing drug substances and products. It outlines 10 basic GMP principles, including maintaining clean facilities, validated manufacturing processes, thorough record keeping, and recalls of defective batches. Key GMP categories are also summarized, such as premises, equipment, personnel, sanitation, manufacturing controls, and quality control. Specific requirements are defined for areas like storage, sterile products, and stability testing.
The document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It outlines requirements for facilities, equipment, personnel, documentation, production processes, quality control, and other operational aspects to minimize risks and ensure consistent production of quality products. GMP covers all aspects of production and testing to maintain standards, prevent contamination and errors, and comply with regulatory guidelines.
The document discusses auditing of sterile production processes. It outlines several key areas that an auditor must evaluate, including building and facilities, HVAC systems, environmental monitoring, garments, sanitation, equipment, manufacturing processes, sterilization, and documentation. The auditor needs to ensure control measures are in place to prevent contamination and assess if critical environmental parameters and cleaning/sanitization procedures are properly followed. The manufacturing records also must contain all relevant processing details to ensure sterility of batches. Auditing is important to verify sterile production meets Good Manufacturing Practice standards.
Schedule M for Pharmacy Students, Here from Pharmaceutical Jurisprudence 5th Sem.
Make easy in Student language.
Both Pharmacy Students (B Pharm & D Pharmacy
Good Manufacturing Practices (GMP) regulations were introduced in 1988 and amended in 2001 to ensure pharmaceutical products are consistently produced and controlled according to quality standards. GMP covers all aspects of production from starting materials to training and hygiene of staff. Detailed written procedures and documented proof of following correct procedures are required at each step of manufacturing. The goal is to minimize risks that cannot be detected by final testing and ensure consumers receive products of the specified quality.
This document discusses Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It begins with an overview of why GMP is important for ensuring consistent quality and safety of medicines. It then outlines the key principles of GMP, including requirements for facilities, equipment, documentation, personnel, sanitation, and quality control. The document provides details on specific GMP requirements for premises, materials, production areas, equipment, packaging, batch records, and quality assurance systems. It also discusses self-inspection and quality auditing.
1. The document discusses Good Manufacturing Practices (GMP) regulations for Schedule M drugs and cosmetics in India.
2. It covers GMP requirements for premises, equipment, sanitation, personnel, production, quality control, documentation and other areas to ensure consistent high quality of pharmaceutical products.
3. Key aspects include requirements for manufacturing facilities, warehouses, equipment calibration, personnel training, hygiene, production supervision, validation of cleaning procedures, and maintenance of records to allow traceability of all manufacturing steps.
This document provides an overview of Schedule M, which outlines Good Manufacturing Practices (GMP) regulations in India for pharmaceutical manufacturing. It discusses the requirements for facilities, equipment, documentation, quality control, personnel, packaging and labeling. The key points covered include specifications for premises and equipment location, water systems, waste disposal, storage areas, production facilities, sanitation procedures, raw material control, calibration of instruments, documentation of records, self-inspection practices, quality control testing, batch processing, packaging and labeling, validation, recalls and adverse event reporting. The goal of Schedule M is to ensure consistent production and quality control of pharmaceuticals manufactured in India.
Similar to Code for Manufacture of Drugs (1).pdf (20)
Health services consist of medical professionals, organizations, and workers who provide care to those in need. They cover emergency, preventative, rehabilitative, long-term, hospital, diagnostic, primary, palliative, and home care centered around making healthcare accessible, high quality and patient-centered. There are four main types of health services: promotive, preventive, curative, and rehabilitative. Promotive services enable people to improve their health through education, environmental initiatives, and lifestyle changes. Preventive services aim to prevent disease through immunization, family planning, and controlling infectious diseases. Curative services detect and treat diseases, while rehabilitative services help restore functional ability through medical, vocational, economic and social
This document discusses complementary and alternative medicine systems, including Ayurveda, homeopathy, siddha, unani, and traditional Chinese medicine. It provides details on the key concepts and practices of each system. For Ayurveda, it describes the concepts of tridosha, saptdhatu, and the eight examination methods. It explains the principles of like cures like for homeopathy. For siddha and unani, it outlines their fundamental theories. And it notes the core concepts of yin and yang balance in traditional Chinese medicine. The document also lists several important herbal medicines used in each system and describes various Ayurvedic dosage forms.
This document summarizes key requirements for drug distribution service centers in Nepal based on the Drugs Sales and Distribution Code, 2071 (Codes on sales and Distribution of Drugs).
The key requirements include: having adequate infrastructure like a building with a minimum area of 120 sqm; proper storage facilities for drugs; necessary equipment for storage and distribution; maintaining proper documentation and quality control processes; having qualified human resources like a chief pharmacist and trained staff; and complying with good practices for procurement and inventory management of drugs.
2.The Drugs Registration Regulation, 2038(1981 and Medicine Registration Guid...Purbanchal University
The document summarizes the key rules and regulations regarding drug registration and pharmacy registration in Nepal as outlined in the Drugs Registration Regulation of 2038 and the Medicine Registration Guidance of 2073. Some of the main points covered include that one must obtain recommendation letters to establish a drug industry or for export/import of drugs. A product license must be obtained to manufacture drugs and drugs must be registered prior to sale, distribution, or importation. Pharmacies must also register and only certified individuals can operate pharmacies or sell/distribute medicines. Regulations further specify renewal fees, duplicate licenses, observance of codes, and the power of the government to alter schedules.
The document discusses WHO guidelines on rational medicine use and types of irrational medicine use. It notes that more than half of global medicine use is irrational, costing money and reducing treatment effectiveness. Irrational use includes polypharmacy, inappropriate antibiotic use, overuse of injections, and self-medication without prescriptions. The document lists several causes of irrational use, such as the natural history of illnesses, pseudo-logic, advertising influence on prescribers, and the perception that injections are always better than oral medications. Addressing irrational medicine use is important for improving health outcomes and efficient use of resources.
The National Drug Policy of 1995 aimed to ensure access to safe, effective and quality medicines at reasonable prices throughout Nepal. Its key objectives included making Nepal self-reliant in drug production, developing human resources, and promoting rational drug use. The policy outlined strategies for drug management, quality assurance, developing the domestic drug industry, and integrating traditional medicines. It sought to establish national and regional quality control laboratories, update drug registration processes, and disseminate drug information.
This document summarizes key aspects of the Nepal Health Services Act, 2053 BS. It outlines the objectives of establishing a competent, vigorous, service-oriented and responsible health service for the public. It establishes the Nepal Health Service and defines employee classifications. It specifies that certain posts will be filled through open competition or promotion, while other posts will be upgraded from lower levels. It restricts appointments on wages or contracts except under certain circumstances. It also outlines criteria for upgrading employees to higher post levels based on qualifications, performance, and years of service, especially in remote areas.
The document is the Consumer Protection Act of Nepal from 2054 BS (1997 AD). Some key points:
- It establishes the rights of consumers to obtain quality goods and services.
- It regulates the supply, price, quality, labeling and advertising of goods and services to protect consumer rights.
- It defines the liabilities and responsibilities of various parties in the production and distribution chain, including producers, importers, sellers, and service providers for defective or substandard goods that harm consumers.
- It establishes a Consumer Protection Council and various market monitoring committees to oversee the implementation of the Act. It also defines offenses and punishments for violations.
This document outlines the Black-marketing and Some Other Social Offenses and Punishment Act of 2032 (1975) in Nepal. The key points are:
1. The act aims to control black-marketing, profiteering, adulteration and other social offenses to protect public health, convenience and economics.
2. It defines various offenses like black-marketing, profiteering, deflection of goods, hoarding, artificial shortage, misrepresentation and adulteration of medicines.
3. Punishments for offenses include fines, imprisonment up to 10 years, or life imprisonment in some cases of medicine adulteration. The act also describes procedures for filing cases and adjudicating authorities.
This document outlines the Narcotic Drugs (Control) Act of 2033 (1976) in Nepal. Some key points:
1. It prohibits various acts related to narcotic drugs including cultivation, production, preparation, purchase, sale, distribution, export, import, trafficking, storage, consumption and addiction.
2. Exceptions are made for medical use of narcotic drugs with a valid prescription from a licensed medical practitioner. The government can also regulate and license the collection and sale of hashish from wild cannabis plants.
3. Penalties are established for violations, including confiscation of materials and property related to offenses. Rewards are also provided for informants. The government is empowered to investigate,
The document summarizes key provisions of the Drug Act 2035 and Rules made thereunder in Nepal. It outlines the objectives of controlling and regulating drugs to ensure they are safe, effective and of standard quality. It describes the various chapters that establish committees to advise on drugs, regulate research and production, and enforce standards. The act defines important terms, requires licenses and permits for manufacturing, import, sale and clinical trials of drugs, and prohibits misuse, adulteration and sale of expired drugs.
This document provides an overview of the history of pharmacy in Nepal. It discusses the evolution of the pharmacy profession in Nepal from ancient times using traditional Ayurvedic and herbal medicines, to the introduction of modern allopathic medicine in the 19th century. It then covers the development of pharmaceutical regulation, education, manufacturing, and hospital/retail pharmacy in Nepal over time. Key events discussed include the establishment of the first hospital in 1890, the introduction of pharmaceutical education programs in the 1970s, the formation of regulatory bodies like DDA in the late 1970s, and the growth of the pharmaceutical industry from the 1960s-1980s.
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Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Code for Manufacture of Drugs (1).pdf
1. Lecturer
Dinesh Kumar Yadav
BPharm , MPharm(P.U)
NPC No:G-1715
Department of Pharmacy
School of Health Science Purbanchal University
Goathgaun ,Morang
Drug Manufacturing Code 2041,(1984)
2. Drug Manufacturing Code 2041 (1984 AD)
Date of Publication in Nepal Gazette : 2041/04/11
As Government of Nepal has implemented the following code on Manufacturing of
Drugs for the purpose of rule 11 of the Drug Registration Regulation 2038 (1981) ,
the public has been informed by this notice.
3. Drug Manufacture Code 2041 (1984)
1.Short Title and Commencement
2.Definition
3.Obligation to follow the code
4.Location of the manufacture premises
5.Requirement for manufacture premises
6.Necessary Equipment for manufacture of drugs
7.Raw Materials and Record of Raw Materials
8.Manufacture
9.Quality Control
10.Equipment and Means required for quality control of drug
11.Process of Quality Control
12.Record of Test Analysis
13.Packing and Labeling
14.Manufacturer’s records for sale and Distribution
15.Other Records
16.Technical Manpower
17.Miscellaneous
4. 1.Short Title and Commencement
1. This code may be called the “ Code on Manufacture of Drugs”.
2. This code shall come into force immediately.
5. 2.Definitions
• Unless the subjects or the context otherwise specified ,in this codes” Persons”
means the manufacturer and the owner of the industry established in pursuant
to drug act 2035( 1978) and Drug Registration Regulation 2038 (1981).
6. 3.Obligation to follow the code
1. Every person is obliged to follow this code .
2. Behavior in contravention to the provision of this code ,shall be convicted as
failure to comply with this code.
7. 4.Location of the manufacturing Premises
• The factory of manufacturing should not be situated in a place:
a. Away from public toilet and dumping place
b. Free from odour , smoke and dirt.
8. 5.Requirement for Manufacturing Premises
1. General Arrangement :The building used for manufacture of drugs should have
at least the following facilities :
a. Sufficient quantity of water supply and good ventilation for fresh air
b. Sufficient electricity or other source of energy.
c. Necessary arrangement for disposal of contaminated air and gases.
d. Hygienic working environment.
e. Necessary arrangement to dispose ,bury , destroy or render the water or residing of
manufacture harmless.
f. Toilet ,enough water , provision for taking both.
g. Necessary arrangements and equipment to control possible fire hazard.
h. Separate facilities for storage of raw materials ,production of drug , packing materials for
drugs ,storage of finished products.
i. Necessary arrangement to maintain cleanliness in production areas.
9. 2. Special Arrangement: In addition to the general arrangement mentioned above , there
must be provision to prevent the entry of unrelated persons , and to keep necessary
precaution for freedom from dust ,insect and micro-organism in all areas specially in the area
used for the mentioned in the production rooms . Such rooms should have the following
provisions:
a. A facility with separate rooms for different activities such as storage of raw materials
,washing of containers , preparation of solution ,filling ,sealing ,sterilization of i.v fluids
,packing ,labeling and storage of finished products .
b. The production of parenteral requires the following additional arrangement in addition to
above.:
1. A clean room which should be easily washable smooth floor and walls and an in previous ceiling .
2. The room for preparation of solutions should be completely clean and with washable waterproof
floors, walls and ceilings.
3. The filling and sealing room should be washable with disinfectant and have a waterproof floor , walls
and ceiling .This room should be under positive pressure with air locks and a filters to prevent the entry
of a dusty air from the outside.
4. (a) The filling and sealing rooms, for parenteral products which are not subject to terminal sterilization
should have provision for very strict control of micro-organisms along with the provisions mentioned as
above (3).E.g. provision should for fumigation.
10. (b)For products subjects to terminal sterilization the provision should be as per mentioned under(3)
(C) Provision should be made to store raw materials and prepared drugs in such manner that quantity thereof is
not affected adversely.
6.Necessary equipment for manufacture of drugs :
The manufacturer should have the following equipment's for manufacturing of the
following dosage form.
a. Liquid (Elixir , Mixture, Syrup ,Lotion , Liniments drops, Spray and Galenicals )
b. For ointments and pastes
c. For tablets and capsules
d. For parenteral Products
7. (Materials ):
The Standard of each raw materials used for manufacture of drugs should accompany with the standards
mentioned in the pharmacopoeia or other treatise or related standards:
a. Identification test for materials
b. Test certificate by quality control
c. The raw materials under quality control or those declared as sub standard should be store separately
preventing their possible use during manufacture.
d. The raw materials under quality control should be exercised to prevent intermixing with other
substances.
11. 7(2) Record of Raw Materials :
Such records should indicate the name ,source (manufacture and batch no.)
quantity received an date , date of analysis , storage condition ,date of release from
quality control , quantity used in production ,quantity remaining in the store of the
raw materials.
8. Manufacture :
Production should be undertaken under the responsibility and supervision of an
expert as mentioned in section 13 of this code . Attention should be paid to the
following points during manufacture of drugs.
a. Related equipment's ,tools and the room should be thoroughly cleaned and if
required sterilized before using them in production.
b. All equipment , means machines and containers should be clearly labeled
regarding the purpose for which it is being used throughout production.
c. The person involved in production should wear proper clothes ,shoes,cap,mask
,gloves, and safety goggles ,all the exposed parts of the body.
12. d. Hands should be washed with disinfectant solution before entering the
production room where manufacture of parenteral is carried out.
e. The personnel should be free from contagious disease . Health checks of the
personnel should be undertaken from to time.
f. Written production chart: Instruction of the process and procedures related to
production should be prepared under the supervision of the responsible persons .
Such types of production charts should contain the following methods and
directions for each drugs.
1. Name of the drug manufactured ,dosage form , type and quantity of the active
ingredients and formula of the product.
2. Procedure of manufacture of the drugs.
3. Clearly labeled batch no. and name of the drug on each storage container used at various
stages of production.
4. Identification of raw materials used and for production , their standards and quantity
shall be identifiable at all stages during manufacture till finished products.
5. Quality control to be undertaken during production stages , the test or analytical methods
details of the branch responsibilities for it and the name of related persons should be
clearly mentioned.
6. Direction related to storages of finished and unfinished goods.
13. g. In any room where production will be carried out unrelated drugs and materials .if is
there any, should be kept separately in such a way that they are not taken.
h. Drugs which are sterilized ,should be produced continuously by required , methods in a
proper ways. Each materials used for that products should be labeled indicating whether
it is sterilized or not.
i. A separate room should be provided for weighing mixing ,pulverizing ,tabulating and
capsulation of poisonous drugs and antibiotics ,this room should have separated
ventilation.
J. Batch record of production : The production records should contain complete details of
each batch . They should contain full details of whether the production method had been
followed or not, whether analysis has been carried out or not, if carried out the name of
the analyst . A separate batch record should be maintained along with the production
records and such records should be kept securely for at least 5 years . The batch records
should contain the following particulars :
1. Name , dosage form and formula of the drug.
2. Date on which production was started.
3. Date on which production was completed
4. Batch no or its indication
5. Quantity and identification test used at each step , precautions taken and any note of unusual
happening or points of observed.
6. Theoretical and practical yield at each stage.
14. 7.Regularly signed records showing the production method used at each steps ,precaution taken
and any note of unusual happening or points of observed.
8.The procedures used to control production and its results.
9.Label specimen
10.Duration and machineries used in production and description of packing materials.
11.Signature of the incharge responsible for manufacture and the date.
12.Quality control report showing the attainment of standard to related batch of the drug.
13.Finished goods should be labeled as specified by law.
14.Date of manufactured and expiry date , if any must be mentioned on the label on the finished
goods.
15. 9. Quality Control:
Each industry involved in manufacture of drugs should have an autonomous
quality control laboratory . Its primary function should be to test the quality,
maintenance of standard and stability of each raw materials used for manufacture
of drugs ,products in process , and finished goods , and to provide requisite help in
the maintenance of quality during production . There should be sufficient staffs
and equipment in the laboratory for the purpose of testing and analysis of both in-
process and finished products .Under this management , the minimum quality
control determined by the department would be undertaken by the concerned
industry and other special quality analysis can be performed by other laboratories
approved by the department .
10.Equipment and means required for quality control of drugs:
The methodology and equipment's required for evaluation of drugs its quality and
standard as prescribed in the recognized pharmacopoeia or other treatise and
standards recognized by the department should be strictly followed .
16. 11.Process of quality of Control :
The following will be the duties required to be performed by an analyst responsible for
quality control :
a) Preparation of detailed method of analysis for each drug and information on testing.
b) Approval of raw materials used in each batch in manufacturing .
c) Test or analysis of semi-finished products for each batch and approval to go ahead in production.
d) Approval for storage ,distribution and sale after testing and analysis of the finished products.
e) To control the materials to be used to pack and label drugs and materials to be used in the final
packing and give approval to bring them in use.
f) To evaluate the situation of storage of any raw materials , semi processed materials or produced
drugs.
g) Evaluation of the quality and stability of raw materials ,semi finished products.
h) Determination of the expiry date and possible changes during storage of the drugs.
i) Fix internal method for quality control.
j) The quality controller should have a good sense of responsibility should draw sample properly ,
label it and should keep a portion of sample for the possible analysis in the future.
k) Marketed products should be also drawn sample from the market , time to time to access the
quality and stability studies should be performed then.
17. 12. Record of test of analysis :
a) Results of analysis of raw materials and production process made a various stages and decision as
to whether final evaluation of the produced drugs and test and analysis of the standards of the
drugs concerned have been performed or not.
b) Details of methods and standards used as per pharmacopeias or other approved methods of
analysis.
c) Signature of the analyst and the date when it is performed.
d) Signature of the expert responsible for rechecking and the date.
13. Packing and labeling :
Only related persons and some other related in his presence can enter the store where labels and
packing materials are stored. Only required quantities of label and packing materials should be
released from the store to prevent possible mistakes in packaging and labeling. Only concerned store
in charge should handle those materials .Approval for packaging and labeling should be obtained from
the quality controller before the packaging and labeling of each batch.
Only concern store in charge should take out packaging and labeling materials from the store after
carefully checking the demand sheet from the production in charge. The demand sheet should show
clearly the signature of the persons requesting materials and its quantity along with date of issue. The
person should taken calculate the labels and packing materials present in the store by deducting the
requested quantity with that of balance in the store. The labels and packaging materials unsuitable
for use undertaken if any labels or packaging materials are lost.
18. Label on finished good should contain the following particulars :
a. Name and quantity of the generic and Brand name of drugs
b. Product licensce No.
c. List of active ingedients used in the formula
d. Batch no.
e. Date of manufacture
f. Expiry date (if necessary)
g. Information on recommended storage conditions and precautions
h. Method of administration
i. Name and addresses of manufacturer
j. Category of drug
k. Name of the drug in ‘’Dev Nagari” script in.
14.Manufacturer’s records for sale and distribution
Clear records of each drug manufactured should be kept before release for sale and distribution . Such
records should be helpful if recall or any drug is deem necessary.
19. 15.Others records : Necessary records should be maintained if any drugs which are
recalled ,returned ,inward , expired ,destroyed or of sub-standard quality on
manufacture .The record of decision of the re-processing and date, the processing
methodology and resale should be kept ,if such drugs have been reprocessed for
the purpose of sale and distribution.
16.Technical Manpower:
1. Any person establishing a drug industry should engage at least one expert with the
following qualification for the purpose of supervision of the production process.
a. Holder of a degree in pharmacy or
b. Holder of a master degree in pharmaceutical chemistry or
c. Holder of a master degree in chemistry with three years if practical experience in manufacture of
drugs.
2. Any person establishing a drug industry should engage at least one expert with the
following qualifications for the purpose of supervision of quality control.
a. Holder of degree in pharmacy or
b. Holder of a Master degree in Pharmaceutics and Chemistry.
20. 17. Miscellaneous:
a) All record books should be maintained and stored securely.
b) Adequate manpower for production and quality control should be maintained.
c) If any report or information is obtained stating that a manufactured drug has caused
harm or adverse effects , the manufacture should at once review the manufacturing and
quality control process and take necessary steps as deem necessary.
d) Testing , analysis and evaluation of the returned or recalled drug should be performed
before reprocessing for the purpose of resale and distribution of such drugs.
21. Assignment
• List out the necessary equipment for manufacturing of drug of section 6 as per
Drug Manufacturing code 2041(1984 AD)