Good Manufacturing Practices (GMP) provide assurance that medicines are manufactured safely, effectively and with quality. GMP involves implementing quality management systems and following inspection guidelines to ensure compliance with standards during production. Inspections verify that manufacturing matches the authorized dossier and marketing approval. GMP guidelines cover APIs, finished pharmaceuticals, and other areas like personnel, facilities, equipment, materials, documentation, production, and quality control. Senior management plays a key role in continuously improving GMP implementation.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
This document discusses batch manufacturing records (BMRs), which are necessary quality and GMP documentation used to trace the complete manufacturing cycle of a batch or lot of a product. A BMR contains information about the batch including the batch number, size, composition, manufacturing record, weight of drug, shelf life, and storage conditions. It also includes general manufacturing instructions, a cleaning record of equipment used, a bill of materials listing raw materials, step-by-step manufacturing process details, yield calculations, a list of abbreviations, and a history of changes made to the document. A good BMR format contains all of this essential information.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
CTD AND ECTD IN QUALITY ASSURANCE BY INTHIYAZ RIPERInthiyazBegum
The document discusses the Common Technical Document (CTD) format and the Electronic Common Technical Document (ECTD) format for submitting documentation to regulatory agencies for drug approval.
The CTD format was agreed upon in 2000 and standardized the organization of documentation into five modules: quality, non-clinical studies, clinical studies, and regional administrative information. The ECTD format further standardized electronic submission in an internationally agreed upon format to facilitate review. Benefits of the CTD and ECTD formats include global harmonization, easier preparation and review of submissions, and reduced costs. Risks of electronic submissions include technical issues and ensuring documentation is properly formatted and validated.
The document provides an overview of current good manufacturing practices (cGMP) as defined by the World Health Organization (WHO). It discusses key aspects of cGMP including personnel, facilities, equipment, material management, quality management, manufacturing operations, validation, sterile products, security, documentation, and records. The goal of cGMP is to consistently produce pharmaceutical products that meet quality standards for their intended use and legal requirements.
This document discusses batch manufacturing records (BMRs), which are necessary quality and GMP documentation used to trace the complete manufacturing cycle of a batch or lot of a product. A BMR contains information about the batch including the batch number, size, composition, manufacturing record, weight of drug, shelf life, and storage conditions. It also includes general manufacturing instructions, a cleaning record of equipment used, a bill of materials listing raw materials, step-by-step manufacturing process details, yield calculations, a list of abbreviations, and a history of changes made to the document. A good BMR format contains all of this essential information.
A brief presentation on the current good manufacturing practices employed in the manufacture of pharmaceuticals in the US.
Comprises of all aspects of good manufacturing practices
CTD AND ECTD IN QUALITY ASSURANCE BY INTHIYAZ RIPERInthiyazBegum
The document discusses the Common Technical Document (CTD) format and the Electronic Common Technical Document (ECTD) format for submitting documentation to regulatory agencies for drug approval.
The CTD format was agreed upon in 2000 and standardized the organization of documentation into five modules: quality, non-clinical studies, clinical studies, and regional administrative information. The ECTD format further standardized electronic submission in an internationally agreed upon format to facilitate review. Benefits of the CTD and ECTD formats include global harmonization, easier preparation and review of submissions, and reduced costs. Risks of electronic submissions include technical issues and ensuring documentation is properly formatted and validated.
This document discusses good manufacturing practices for manufacturing operations and controls in the pharmaceutical industry. It covers several key topics:
1. Sanitation of manufacturing premises is important to ensure good hygiene of facilities, equipment, processes, and personnel. Cleaning and validation procedures should be established and records maintained.
2. Proper controls must be established to prevent mix-ups and cross-contamination during production. This includes separation of products, labeling, cleaning procedures, and qualified personnel.
3. Waste and scrap from manufacturing must be properly handled, collected, stored, and disposed of according to established guidelines. Hazardous and pharmaceutical wastes require special treatment and disposal.
This document discusses Good Manufacturing Practice (GMP) in the pharmaceutical industry. It provides the history and regulations around GMP, explains why following GMP is important, and outlines the key elements that make up a GMP system.
GMP guidelines were established in the 1960s after thousands of babies were born with birth defects due to the drug Thalidomide. Regulations were put in place to ensure drug safety and quality. Following GMP helps build quality into manufacturing processes and products to avoid mistakes that could harm patients. Key aspects of GMP include controlling quality, using well-trained staff, thorough documentation, and adequate premises and equipment. The overall goal is to establish a system that consistently produces high quality pharmaceutical products.
This document discusses the batch manufacturing record (BMR) process for pharmaceutical companies. It provides details on:
- The responsibilities of quality assurance, production, and quality control in preparing, processing, reviewing, and approving BMRs.
- The documentation required in a BMR including equipment used, process parameters, batch details, packaging information, and analytical testing results.
- The standard operating procedures for issuing a BMR, documenting the batch production process, reviewing the completed BMR, and retaining records.
The document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled according to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and evolve over time. The document outlines several key GMP considerations including organization and personnel qualifications, facility and equipment design, production and process control, packaging and labeling, handling and distribution, and documentation through records and reports.
Quality control in pharmaceutical laboratoriesSagar Kamble
This document discusses quality control practices for laboratories. It is divided into four parts. Part one covers management and infrastructure topics like organization, quality systems, documentation, and facilities. Part two discusses materials, equipment, and calibration procedures. Part three outlines working procedures for sample intake, testing, and results. Part four describes inspecting the laboratory and ensuring safety, including proper handling of chemicals, protective equipment, and waste disposal. The overall aim is to discuss quality control systems and inspecting laboratories to ensure correct, reliable testing.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
This document provides an overview of pharmaceutical documentation and quality control processes. It discusses the importance of documentation in areas like manufacturing, batch records, and quality control. The key points covered are:
- Pharmaceutical documentation includes master formulas, batch records, quality control records, and distribution records.
- Documents must be properly controlled and approved to ensure accurate information. Controlled documents are identified, dated, approved, and retained for a specified period.
- Batch records are built from approved master formulas and provide a history of each batch production for quality purposes. They include processing details, materials used, equipment, and lab results.
- Quality control documentation helps ensure compliance and that products meet specifications. Proper documentation is
GMP (good manufacturing practices) and cGMP (current good manufacturing practices) are quality standards for the manufacture of pharmaceutical products and medical devices. They help ensure that products are consistently produced and controlled according to quality standards for safety and efficacy. Key aspects of GMP include establishing processes and procedures for production, cleaning, maintenance, personnel training, and quality testing of products. Following GMP guidelines helps manufacturers produce pharmaceuticals that meet the necessary quality standards.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
This document provides an overview of FDA regulations 21 CFR Parts 210 and 211, which establish current Good Manufacturing Practices (cGMP) for manufacturing, processing, packing, or holding of drugs.
The summary includes definitions of key terms such as batch, component, drug product, and quality control. It also summarizes some of the major requirements for facilities, equipment, components, containers and closures, organization and personnel, and production and process controls to ensure identity, strength, quality and purity of drug products. The goal of Parts 210 and 211 is to provide minimum requirements and requirements for quality systems, not prescribe specific ways to meet those requirements.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
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 guidelines on Good Manufacturing Practices (GMP) for equipment used in the pharmaceutical industry. It discusses the selection criteria, design and construction, installation, cleaning and maintenance, documentation requirements for equipment. Automatic, mechanical and electronic equipment must be routinely calibrated and inspected according to a written program. Proper documentation and record keeping is essential to ensure equipment is functioning properly and producing quality products.
This document discusses good manufacturing practices for manufacturing operations and controls in the pharmaceutical industry. It covers several key topics:
1. Sanitation of manufacturing premises is important to ensure good hygiene of facilities, equipment, processes, and personnel. Cleaning and validation procedures should be established and records maintained.
2. Proper controls must be established to prevent mix-ups and cross-contamination during production. This includes separation of products, labeling, cleaning procedures, and qualified personnel.
3. Waste and scrap from manufacturing must be properly handled, collected, stored, and disposed of according to established guidelines. Hazardous and pharmaceutical wastes require special treatment and disposal.
This document discusses Good Manufacturing Practice (GMP) in the pharmaceutical industry. It provides the history and regulations around GMP, explains why following GMP is important, and outlines the key elements that make up a GMP system.
GMP guidelines were established in the 1960s after thousands of babies were born with birth defects due to the drug Thalidomide. Regulations were put in place to ensure drug safety and quality. Following GMP helps build quality into manufacturing processes and products to avoid mistakes that could harm patients. Key aspects of GMP include controlling quality, using well-trained staff, thorough documentation, and adequate premises and equipment. The overall goal is to establish a system that consistently produces high quality pharmaceutical products.
This document discusses the batch manufacturing record (BMR) process for pharmaceutical companies. It provides details on:
- The responsibilities of quality assurance, production, and quality control in preparing, processing, reviewing, and approving BMRs.
- The documentation required in a BMR including equipment used, process parameters, batch details, packaging information, and analytical testing results.
- The standard operating procedures for issuing a BMR, documenting the batch production process, reviewing the completed BMR, and retaining records.
The document discusses Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGMP). It defines GMP as ensuring products are consistently manufactured and controlled according to quality standards for their intended use. cGMP emphasizes that expectations are dynamic and evolve over time. The document outlines several key GMP considerations including organization and personnel qualifications, facility and equipment design, production and process control, packaging and labeling, handling and distribution, and documentation through records and reports.
Quality control in pharmaceutical laboratoriesSagar Kamble
This document discusses quality control practices for laboratories. It is divided into four parts. Part one covers management and infrastructure topics like organization, quality systems, documentation, and facilities. Part two discusses materials, equipment, and calibration procedures. Part three outlines working procedures for sample intake, testing, and results. Part four describes inspecting the laboratory and ensuring safety, including proper handling of chemicals, protective equipment, and waste disposal. The overall aim is to discuss quality control systems and inspecting laboratories to ensure correct, reliable testing.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
Mr. Krushnakant K. Wable gave a presentation on current good manufacturing practices (cGMP) under the guidance of Dr. Sonali Mahaparale and Dr. D. Y. Patil. The presentation defined cGMP as regulations enforced by the FDA to ensure proper design, monitoring, and control of manufacturing processes and facilities. It also explained that cGMP helps assure the identity, strength, quality and purity of drug products. The presentation covered key components of cGMP like personnel, premises, equipment, standard operating procedures, raw materials, self inspections, and warehousing. It emphasized that cGMP helps prevent contamination, mix-ups, failures and errors to ensure products meet quality standards.
This document provides an overview of pharmaceutical documentation and quality control processes. It discusses the importance of documentation in areas like manufacturing, batch records, and quality control. The key points covered are:
- Pharmaceutical documentation includes master formulas, batch records, quality control records, and distribution records.
- Documents must be properly controlled and approved to ensure accurate information. Controlled documents are identified, dated, approved, and retained for a specified period.
- Batch records are built from approved master formulas and provide a history of each batch production for quality purposes. They include processing details, materials used, equipment, and lab results.
- Quality control documentation helps ensure compliance and that products meet specifications. Proper documentation is
GMP (good manufacturing practices) and cGMP (current good manufacturing practices) are quality standards for the manufacture of pharmaceutical products and medical devices. They help ensure that products are consistently produced and controlled according to quality standards for safety and efficacy. Key aspects of GMP include establishing processes and procedures for production, cleaning, maintenance, personnel training, and quality testing of products. Following GMP guidelines helps manufacturers produce pharmaceuticals that meet the necessary quality standards.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
WHO Good Manufacturing Practice Requirements
Good Manufacturing Practice is the part of quality assurance that ensures that products are consistently manufactured and controlled to the quality standards appropriate to their intended use.
NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGESganpat420
Abstract
Introduction
Global pharmaceutical industry
Indian pharmaceutical industry
Indian Pharmaceutical Market
Opportunities
Challenges
Conclusion
References
An out of specification (OOS) occurs when analytical results fall outside established specification ranges. There are guidelines from organizations like MHRA, CDER, and PIC/S for handling OOS events. OOS can occur during stability studies, finished products, or raw materials due to laboratory errors, process issues, or sample homogeneity problems. Investigations follow a phased approach starting with the quality control laboratory and then involving manufacturing operations if needed. The fate of an OOS batch may include reprocessing, reworking, or destruction depending on the investigation conclusions.
PIC/S is a combine term used for the execution of activities of Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
harmonize, educate, and update aspects relating to Good Manufacturing Practice among member countries
harmonized relation among regulatory authorities and governments
members
history
role
objective and function
guidlines
Quality control measures in pharmaceutical industryChemOnTheGo
QUALITY CONTROL
ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY
OBJECTIVES OF QUALITY CONTROL
STEPS IN QUALITY CONTROL
COST OF QUALITY CONTROL
TOTAL QUALITY MANAGEMENT
QUALITY CIRCLE
ICH Q10 provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes a quality management system for the pharmaceutical industry. The objectives of the Q10 model are to achieve product realization, establish and maintain a state of control, and facilitate continual improvement. ICH Q10 covers pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. It is intended to enhance existing good manufacturing practice requirements and be used together with them.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
This document provides an overview of FDA regulations 21 CFR Parts 210 and 211, which establish current Good Manufacturing Practices (cGMP) for manufacturing, processing, packing, or holding of drugs.
The summary includes definitions of key terms such as batch, component, drug product, and quality control. It also summarizes some of the major requirements for facilities, equipment, components, containers and closures, organization and personnel, and production and process controls to ensure identity, strength, quality and purity of drug products. The goal of Parts 210 and 211 is to provide minimum requirements and requirements for quality systems, not prescribe specific ways to meet those requirements.
A Study on Documentation Maintenance in the Pharmaceutical Industry which includes the main records to be maintained and the quality attributes to be studied about the Quality Management System. Quality attributes include the study of quality audit, quality review, and quality documentation.
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 guidelines on Good Manufacturing Practices (GMP) for equipment used in the pharmaceutical industry. It discusses the selection criteria, design and construction, installation, cleaning and maintenance, documentation requirements for equipment. Automatic, mechanical and electronic equipment must be routinely calibrated and inspected according to a written program. Proper documentation and record keeping is essential to ensure equipment is functioning properly and producing quality products.
- Good Manufacturing Practices (GMP) regulations were established in the early 1900s as the pharmaceutical industry grew with no standards for product quality. GMP aims to ensure quality, safety and efficacy of drugs.
- Key events that led to strengthened GMP regulations include The Jungle exposing unsanitary meat conditions in 1905, contaminated sulfathiazole tablets killing hundreds in 1941, and the thalidomide tragedy in the 1960s from birth defects.
- Major GMP regulations and guidelines have been established by the FDA and other agencies worldwide since then to enforce manufacturing standards for facilities, equipment, components, processes, training and more.
Good Manufacturing Practices (GMP) provide quality assurance guidelines for manufacturing medicines safely, effectively and consistently. GMP involves defining and documenting manufacturing processes, training personnel, validating equipment and facilities, controlling materials, documenting procedures, and inspecting to ensure compliance. Following GMP helps ensure medicines are produced and controlled according to their marketing authorization and quality standards through all stages of manufacture.
The document discusses the selection and certification process for vendors, including defining vendors and the selection process, the purposes of vendor qualification and certification to comply with regulations and for business purposes, and the various types of vendors categorized by the level of testing they perform themselves versus what the manufacturer requires. It also outlines the key factors considered in vendor selection such as reputation, capacity, location, price, and technical evaluation through testing samples.
The Factors That Affect To Location Of Industrygeographypods
The document summarizes the key factors that affect the location of industry:
1) Land availability and cost, access to raw materials, labor supply, transportation infrastructure, energy sources, proximity to markets, and government incentives all influence where industries choose to locate.
2) Modern industries are less restricted in their location choices and may prioritize quality of life factors for workers, though access to raw materials, labor, transportation, and markets remain important determinants for many industries.
This document discusses Good Manufacturing Practices (GMPs) in food processing. It covers several key areas:
1. The introduction outlines the development of GMPs due to commercial and legislative pressures to ensure quality and safety.
2. Buildings and facilities are important to prevent contamination and must be properly designed, constructed, and maintained. This includes considerations for grounds, plant construction, sanitary operations, and sanitary facilities.
3. Microbiological, chemical, and physical hazards are addressed through controls like hygienic practices, effective cleaning and sanitation procedures, environmental monitoring, supplier controls, and recall systems.
The document discusses different types of industry and factors that influence industrial location. It covers primary, secondary, tertiary and quaternary industries. Key factors in industrial location include availability of raw materials, labor supply, markets, transportation access, capital, energy sources, and government policies. Location theories aim to maximize profits and minimize costs by considering these various economic and transportation factors. Theories discussed include Weber's least-cost model and the concept of agglomeration economies.
The document discusses Good Manufacturing Practices (GMP) with a focus on quality control. It outlines key aspects of GMP compliance that should be reviewed during an on-site quality control laboratory inspection, including documentation, personnel qualifications, equipment and instrument validation, testing procedures, data verification, and facilities and environmental monitoring. The inspection aims to ensure proper implementation of quality standards and systems across all aspects of the quality control process.
Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drug substances and drug products, medical devices, in vivo and in vitro diagnostic products, and foods.
This presentation was presented by me to explain the various factors affecting industries by taking the case study of Tata Steel, Gujarat and Punjab.
It was a part of the subject "Facilities Design" of Industrial Engineering at Thapar University, Patiala
Drug regulatory affairs (DRA) is the process by which pharmaceutical companies interact with regulatory authorities and internal departments throughout the lifecycle of a product. DRA provides guidance on navigating the lengthy and costly drug development process, which can take over 8-15 years and $800 million to develop a new drug. DRA assists departments like product development, clinical research, manufacturing, and marketing by preparing and submitting various regulatory filings and maintaining documents required for licensing and market approval. By acting as an interface and providing regulatory expertise, DRA plays a key role in supporting all aspects of drug development and avoiding delays, making it essential, or the "backbone" of the pharmaceutical industry.
1. The document discusses procedures for handling complaints and product recalls in the pharmaceutical industry. It defines complaints, outlines standard operating procedures for complaint handling, investigation and corrective actions.
2. Recall procedures include classification of recalls based on health hazards, forming a recall team, developing a recall strategy, notifying customers, and terminating a recall once all affected products are removed from the market.
3. Key aspects of complaint handling covered are documentation of complaints, investigating complaints by analyzing customer and retained samples, determining if complaints are confirmed or non-confirmed, and providing feedback to customers.
This document provides definitions and descriptions related to Good Manufacturing Practices (GMP) regulations for pharmaceutical manufacturing. It defines key terms like active pharmaceutical ingredient, batch, and validation. It describes GMP requirements for facilities, equipment, documentation, personnel training, hygiene practices, and prevention of cross-contamination. The goal of GMP is to ensure manufactured products are safe, pure and effective.
The document outlines the key aspects of current good manufacturing practices (cGMPs) that pharmaceutical manufacturers must follow. cGMPs come from the Food, Drug and Cosmetic Act and are enforced by the FDA. They help ensure safety and quality by requiring strict control over facilities, equipment, components, packaging, labeling, and processes. Key parts of cGMP regulations address organization, buildings, equipment, materials control, production, packaging, holding, distribution, and records. Failure to comply can result in serious legal and business consequences like product recalls or plant shutdowns.
The document discusses quality management systems (QMS) and good manufacturing practices (GMP) and their benefits for businesses. It provides an overview of the key elements of a QMS and explains that a QMS establishes procedures and processes to ensure quality control across all aspects of a business. It then describes GMP guidelines which outline manufacturing and testing standards for pharmaceuticals and medical devices to ensure product quality and compliance. The document notes that many countries have legislation requiring companies to follow GMP procedures.
Instant GMP Compliance Series - Improving DocumentationInstantGMP™
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.
Quality assurance aims to ensure that pharmaceutical products meet quality standards by building quality into every stage of design, development, and manufacturing. It involves planned and documented activities like process validation, quality audits, and staff training to verify that products satisfy quality requirements. Quality control is the part of GMP concerned with testing and release of materials and products to ensure they meet specifications before release or use. Together, quality assurance and quality control comprise a quality system that helps deliver pharmaceuticals free of contamination and suitable for their intended use.
Quality control involves sampling, testing, and ensuring products meet specifications before release. It is focused on identifying defects in finished products. Key responsibilities include testing raw materials, conducting in-process testing, and approving or rejecting starting materials, packaging, intermediates, and finished products. Quality control aims to fulfill quality requirements and ensure only products passing tests are released.
GMP & Quality Assurance Training by Fakultas Farmasi Universitas AndalasAtlantic Training, LLC.
GMP and quality assurance systems ensure that products are consistently manufactured and controlled according to quality standards for their intended use. QA encompasses all aspects that influence quality, including GMP and quality control. GMP specifies the production and control procedures that need to be followed. QC, as part of GMP, covers sampling, testing, and release of products to ensure the necessary tests are conducted and products meet specifications before release. Together, QA, GMP and QC work to build quality into every aspect of production from start to finish.
1. GMP aims to ensure quality, safety and efficacy of pharmaceutical products through proper manufacturing and quality control.
2. Key aspects of GMP include facilities and equipment design, sanitation, personnel training, validation processes, documentation systems, and quality control testing.
3. Adhering to GMP guidelines helps manufacturers consistently produce pharmaceuticals that meet specifications and protects patients from defective products.
GMP aims to ensure quality, safety and efficacy of medicines by requiring manufacturers to follow quality standards and comply with marketing authorizations. Inspections verify compliance and identify any deviations between dossiers and actual practices. Quality assurance, GMP, quality control, and quality risk management are interrelated aspects of quality management that are important for producing pharmaceuticals to the required standards.
2-Quality-assurance-6th-Sem Quality control and GMPVenkatesh Mantha
The document defines key concepts in quality assurance, quality control, and good manufacturing practices (GMP) for pharmaceuticals. It discusses that quality assurance is a process-oriented approach to ensuring quality, while quality control is a product-oriented approach focused on identifying defects. GMP involves all aspects of pharmaceutical production to minimize risks and ensure quality, safety, and efficacy. It outlines responsibilities for quality control, production, and procedures to verify that medicines meet specifications from raw materials to patient use.
Good Laboratory Practice (GLP) guidelines provide standards for laboratory experiments and tests performed to support research, nonclinical studies, and regulatory submissions. The key goals of GLP are to ensure quality, reliability, and integrity of data through adherence to standard operating procedures, trained personnel, appropriate facilities and equipment, records management, and quality control. GLP aims to promote valid and robust research that can be reproduced internationally and supports regulatory review and decision making.
This document provides an overview of key quality assurance and quality management concepts including quality management systems, quality assurance, quality control, and good manufacturing practices (GMP). It defines these terms and describes their purposes and responsibilities. A quality management system consists of quality planning, assurance, control, and improvement to ensure products meet requirements. Quality assurance focuses on preventing defects, quality control identifies defects, and GMP provides minimum standards for pharmaceutical production and quality.
USFDA guidelines on process validation a life cycle approachRx Ayush Sharma
The document summarizes the US FDA's 2011 guidance on process validation, which outlines a lifecycle approach. It discusses the three stages of process validation according to the guidance: (1) Process Design which defines the commercial process based on development, (2) Process Qualification which evaluates the process's capability for commercial manufacturing, and (3) Continued Process Verification which gains ongoing assurance that the process remains in control during routine production. The lifecycle approach integrates validation strategies from previous guidelines and emphasizes continual process improvement, understanding sources of variation, and controlling variation to ensure consistent quality.
1. The document discusses the key differences between quality assurance (QA) and quality control (QC). QA focuses on processes and aims to prevent defects, while QC focuses on products and aims to identify defects.
2. It also provides an overview of Good Manufacturing Practices (GMP), which ensure products are consistently produced according to quality standards. GMP covers all aspects of production from materials to equipment to personnel.
3. The main GMP principles are that manufacturing processes are clearly defined and validated, adequate resources are provided, instructions are written clearly, procedures are followed correctly, and comprehensive records are kept.
This document provides an overview of Good Manufacturing Practices (GMP) for pharmaceutical manufacturing. It defines GMP as ensuring products are consistently manufactured and controlled to quality standards for their intended use. The document outlines key aspects of GMP, including facilities and equipment qualification, training, documentation, production and process controls, packaging and labeling, quality testing, and distribution. It explains that GMP is important for producing safe, effective drugs and minimizing risks that cannot be detected through final testing alone. International GMP guidelines from organizations like WHO, FDA, and ICH are also referenced.
Quality assurance and quality control are important concepts in pharmaceutical manufacturing. Quality assurance refers to planned and systematic activities that ensure quality in processes, while quality control refers to activities that ensure quality in products. Some key differences are that quality assurance focuses on preventing defects through proper processes, while quality control identifies defects in finished products. Total quality management aims to produce perfect products through quality measures at every stage of production and requires team effort across an organization.
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This document discusses good laboratory practices in a pharmaceutical lab. It outlines the members of a group project on this topic and provides an introduction to pharmaceutical lab testing. It then covers topics like GMP, GLP, quality control, quality assurance, reducing human errors, and the scope of QA and QC in a pharmaceutical lab. Key points include that pharmaceutical labs test raw materials, finished products, and conduct validation, stability, and analytical method development testing. GMP and GLP aim to minimize risks and ensure consistent quality production. QA and QC work to guarantee drug quality and safety at all stages from development to sales.
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Quality assurance, quality control, and good manufacturing practices (GMP) are interrelated aspects of quality management in the pharmaceutical industry. Quality assurance ensures that adequate quality systems and processes are in place, quality control checks finished products, and GMP provides standards for production and controls to ensure consistent quality. Together they form a system to minimize risks and ensure that pharmaceutical products meet quality standards for patient safety.
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2. 2 | PQ Workshop, Abu Dhabi | October 2010
Why GMP?
Provides a high level assurance that medicines
are manufactured in a way that ensures their
safety, efficacy and quality
Medicines are manufactured to comply with their
marketing authorization
Quality is built in
– Testing is part of GMP, but alone does not provide a
good level of quality assurance
3. Why inspect?
Verify compliance with GMP
Verify compliance with marketing authorization
– Dossier: "Dedicated equipment is used"
Inspection: Observation that this means "dedicated while used
for the product or not being used for another product"
– Dossier: "The vials are removed from the lyophilliser and
crimped in a grade A environment"
Inspection: Correct, but before crimping they are stored in an
uncontrolled corridor
3 | PQ Workshop, Abu Dhabi | October 2010
4. 4 | PQ Workshop, Abu Dhabi | October 2010
WHO GMP
Quality assurance of pharmaceuticals
A compendium of guidelines and related materials
Volume 2, 2nd updated edition
Good manufacturing practices
and inspection
5. Guidelines and references
GMP applies to both Active Pharmaceutical
Ingredients (APIs) and Finished Pharmaceutical
Products (FPPs)
– FPP:
WHO Good Manufacturing Practices for pharmaceutical
products: main principles. WHO Technical Report
Series, No. 908, 2003, Annex 4.
– API:
WHO good manufacturing practices for active
pharmaceutical ingredients - Annex 2, WHO
Technical Report Series 957, 2010 (Based on ICH
5 Q7)
5 | PQ Workshop, Abu Dhabi | October 2010
6. Other WHO GMP Guidelines
Pharmaceutical excipients
Sterile pharmaceutical products
Biological products
Pharmaceutical products containing hazardous
substances
Investigational pharmaceutical products for clinical trials i
Herbal medicinal products
Radiopharmaceutical products
Water for pharmaceutical use
HVAC for non-sterile pharmaceutical dosage forms
Validation
6 | PQ Workshop, Abu Dhabi | October 2010
7. Good Manufacturing Practices (FPP):
1. Quality assurance
2. Good manufacturing practices for pharmaceutical
products
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production and analysis
– General
– The contract giver
– The contract accepter
– The contract
7 | PQ Workshop, Abu Dhabi | October 2010
8. Good Manufacturing Practices (cont'd)
8. Self-inspection and quality audits
– Items for self-inspection
– Self-inspection team
– Frequency of self-inspection
– Self-inspection report
– Follow-up action
– Quality audit
– Suppliers’ audits and approval
9. Personnel
– General
– Key personnel
10. Training
8 | PQ Workshop, Abu Dhabi | October 2010
9. Good Manufacturing Practices (cont'd)
11. Personal hygiene
12. Premises
– General
– Ancillary areas
– Storage areas
– Weighing areas
– Production areas
– Quality control area
13. Equipment
9 | PQ Workshop, Abu Dhabi | October 2010
10. Good Manufacturing Practices (cont'd)
14. Materials
– General
– Starting materials
– Packaging materials
– Intermediate and bulk products
– Finished products
– Rejected, recovered, reprocessed and reworked materials
– Recalled products
– Returned goods
– Reagents and culture media
– Reference standards
– Waste materials
– Miscellaneous
10 | PQ Workshop, Abu Dhabi | October 2010
11. Good Manufacturing Practices (cont'd)
15. Documentation
– General
– Documents required:
• Labels
• Testing procedures
• Specifications for starting and packaging materials, for
intermediate and bulk products and for finished products
• Master formulae and Batch Processing Records
• Packaging instructions and Batch Packaging Records
• Standard Operating procedures (SOP's) and records
• Logbooks
11 | PQ Workshop, Abu Dhabi | October 2010
12. Good Manufacturing Practices (cont'd)
16. Good practices in production
– General
– Prevention of cross-contamination and bacterial
contamination during production
– Processing operations
– Packaging operations
17. Good practices in quality control
– Control of starting materials and intermediate, bulk and
finished products
– Test requirements
– Batch record review
– Stability studies
12 | PQ Workshop, Abu Dhabi | October 2010
13. GMP is actually Good Common Sense
Quality Management
Quality Assurance
13 | PQ Workshop, Abu Dhabi | October 2010
GMP
Production and Quality Control
Section 1 and 2
14. Quality management in the drug industry
Philosophy and essential elements:
"The concepts of quality assurance, GMP, quality
control and quality risk management are
interrelated aspects of quality management, and
should be the responsibility of all personnel. ……
their relationship and their fundamental
importance to the production and control of
pharmaceutical products."
14 | PQ Workshop, Abu Dhabi | October 2010
Glossary
15. Quality Management
The basic elements are:
– An appropriate infrastructure or “quality system”
encompassing the organization structure,
procedures, processes and resources
– The systematic actions necessary to ensure adequate
confidence that a product (or service) will satisfy given
requirements for “Quality”
The totality of these actions is referred to as “Quality
Assurance”
15 | PQ Workshop, Abu Dhabi | October 2010
16. 16 | PQ Workshop, Abu Dhabi | October 2010
The five P's
Premises
Primary materials
People
Processes defined and recorded
17. Quality Assurance
Quality assurance is a management tool
In contractual situations, it also serves to generate
confidence in a supplier
QA, GMP and Quality Control are interrelated aspects
of Quality Management
– They are described on the following slides in order to
emphasize their relationship and their fundamental
importance to the production and control of
pharmaceutical products 1.1
17 | PQ Workshop, Abu Dhabi | October 2010
18. Quality Assurance
Wide-ranging concept
– covers all matters that individually or collectively
influence the quality of a product
Totality of the arrangements
– to ensure that the drug is continuously of the right
quality for the intended use
Quality Assurance incorporates GMP
– and also includes product design and
development, with special focus on process
design 1.1
18 | PQ Workshop, Abu Dhabi | October 2010
19. The position of QA
19 | PQ Workshop, Abu Dhabi | October 2010
DDiirreeccttoorr
QQAA
PPrroodduuccttiioonn QQCC llaabb OOtthheerr DDeeppttss
20. Quality Assurance means to assure:
Products are designed and developed correctly
– Complying with, e.g. GMP, GCP, GLP
Production and control operations are defined
Managerial responsibilities are defined
– In job descriptions
The manufacture, supply and use of correct starting
and packaging materials 1.1 a- d
20 | PQ Workshop, Abu Dhabi | October 2010
21. Quality Assurance means to assure:
21 | PQ Workshop, Abu Dhabi | October 2010
(cont'd)
Controls are performed, including
intermediates, bulk, calibration and validation
Correct processing and checking of the
finished product
Products are sold/supplied only after review
by the authorized person
– Complying with marketing authorization,
production and QC requirements
1.1 e - h
Proper storage, distribution and handling
22. Quality Assurance means to assure:
22 | PQ Workshop, Abu Dhabi | October 2010
(cont'd)
Procedures for self-inspection and quality
audits are applied
Deviations are reported, investigated and
recorded
System for change control is applied
Regular evaluation of product quality to
verify consistency and continued
improvement
1.1 i - l
23. Quality Assurance includes:
Responsibility of the Manufacturer for the quality of the
product
– Fit for intended use
– Comply with marketing authorization
– Safety, efficacy and quality
Commitment of senior management and involvement of all
staff
Comprehensively designed and well implemented quality
system
Full documentation and monitoring of effectiveness
Competent personnel, sufficient premises, equipment and
facilities 1.3
23 | PQ Workshop, Abu Dhabi | October 2010
24. Good Manufacturing Practices
That part of QA that ensures that products are
consistently produced and controlled
– Quality standards
– Marketing authorization
Aim: Diminishing risks that cannot be controlled
by testing of product
– Contamination and cross-contamination
– Mix-ups (confusion) 2.1
24 | PQ Workshop, Abu Dhabi | October 2010
25. Basic requirements for GMP:
Clearly defined and systematically reviewed
processes
Qualification and validation is performed
Appropriate resources are provided:
– Qualified and trained personnel
– Premises, space, equipment and services
– Materials, containers, labels
– Procedures, storage, transport
– Laboratories and in-process control
25 | PQ Workshop, Abu Dhabi | October 2010
2.1 a - c
26. Basic requirements for GMP: (cont'd)
Clear, written instructions and procedures
Trained operators
Records of actions, deviations and
investigations
Records for manufacture and distribution
Proper storage and distribution
Systems for complaints and recalls 2.1 d - j
26 | PQ Workshop, Abu Dhabi | October 2010
27. GMP = continuous urge for improvement
Involvement of the management
Annual Product Quality Review
Quality risk management
Complaints handling
Self-inspection
27 | PQ Workshop, Abu Dhabi | October 2010
28. Involvement of the management
The senior management is responsible to attain the
company's quality objectives
All different departments and all levels within
departments should be involved; and it's the senior
management who should facilitate this
Also suppliers and distributors should be involved
The senior management should make available the
required resources
The basis of the quality system is the quality statement
and quality policy, by the senior management
28 | PQ Workshop, Abu Dhabi | October 2010
29. Product Quality Review
Objectives of Product Quality Review:
To review and verify the consistency and
appropriateness of the existing process
To identify and highlight any trends in the
process, e.g. in analytical results, yields etc.
To identify any possible product or process
improvements
29 | PQ Workshop, Abu Dhabi | October 2010
30. Product Quality Review (cont'd)
Review of starting materials/ packaging
materials, especially from new sources
Review of in-process control results and finished
product analytical control results
Amount of batches and packaging units
produced and their yields
Reviews of:
– Out-of-spec situations, rejections, deviations, changes
– Plus investigations and analysis of causes
30 | PQ Workshop, Abu Dhabi | October 2010
31. Annual Product Quality Review (cont'd)
Review of Marketing Authorization variations
submitted, granted or refused (incl. third countries)
Review of stability programme and trends
Review of adequacy of previous decisions on
changes or improvements or corrective actions
For new Marketing Authorizations (plus new
variations) a review of post marketing commitment
The qualification status of all relevant equipment
and utilities (like water, HVAC, gases, etc.)
Review of Technical Agreements (if applicable)
31 | PQ Workshop, Abu Dhabi | October 2010
32. 32 | PQ Workshop, Abu Dhabi | October 2010
5.1
Complaints handling
Complaints: Principle
“All complaints and other information
concerning potentially defective products
must be carefully reviewed according to
written procedures and corrective action
should be taken.”
33. 33 | PQ Workshop, Abu Dhabi | October 2010
5.2 – 5.3
Complaints Procedure
Designated responsible person:
– To handle complaint
– Decide on measure to be taken
– May be authorized person - if not, must advise
authorized person of results
– Sufficient support staff
– Access to records
Written procedure (SOP):
– Describes action to be taken
– Includes need to consider a recall (e.g. possible
product defect)
34. 34 | PQ Workshop, Abu Dhabi | October 2010
5.4 – 5.6
Complaints Procedure – cont'd
Thorough investigation:
– QC involved
– With special attention to establish whether
"counterfeiting" may have been the cause
– Fully recorded investigation – reflect all the details
Due to product defect (discovered or suspected):
– Consider checking other batches
– Batches containing reprocessed product
35. Complaints Procedure – cont'd
35 | PQ Workshop, Abu Dhabi | October 2010
5.7 – 5.9
Investigation and evaluation should result in
appropriate follow-up actions
– May include a "recall"
All decisions and measures taken should be
recorded
Referenced in batch records
Records reviewed - trends and recurring problems
36. Complaints - other actions
Inform competent authorities in case of serious
quality problems such as:
36 | PQ Workshop, Abu Dhabi | October 2010
5.10
– Faulty manufacture
– Product deterioration
– Counterfeiting
Have a thorough recall procedure that is consistent
with the complaints handling procedure
Trend complaints, their investigations and results
37. Self-Inspection
Purpose is to evaluate whether a company’s
operations remain compliant with GMP
The programme should
– cover all aspects of production and quality control
– be designed to detect shortcomings in the implementation of
GMP
– recommend corrective actions
– set a timetable for corrective action to be completed
Should be performed routinely
Also on special occasions such as
– Recalls
– Repeated rejections 8.1
37 | PQ Workshop, Abu Dhabi | October 2010
38. 38 | PQ Workshop, Abu Dhabi | October 2010
8.3, 8.4
Self-Inspection (cont'd)
Performed by team appointed by management, with:
– authority
– sufficient experience, expertise in their own field.
knowledge of GMP
– may be from inside or outside the company
Frequency should normally be at least once a year
– May depend on company requirements
– Size of the company and activities
39. 39 | PQ Workshop, Abu Dhabi | October 2010
8.5, 8.6
Self-Inspection (cont'd)
Report prepared at completion of inspection,
including:
– results
– evaluation
– conclusions
– recommended corrective measures
Follow-up action
– Effective follow-up programme
– Company management to evaluate both
the report and corrective actions
40. Summary and conclusions:
GMP compliance is not an option
Quality should be built into the product
GMP's are very similar and are really
Good Common Sense
Good Practices cover all aspects of
manufacturing activities prior to supply
The role and involvement of senior
management is crucial
40 | PQ Workshop, Abu Dhabi | October 2010
<number>
October 27, 2014
The product complaint principle is defined in the WHO GMP.
The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the marketing authorization, and do not place the patient at risk because of inadequate safety, quality or efficacy.
Complaints must be handled positively and carefully reviewed, and corrective actions must be taken as necessary. This can mean amending a manufacturing process as well as implementing a recall of a defective product from all markets where it has been distributed.
<number>
October 27, 2014
First of all a written complaints handling procedure should be available.
The basic requirements for such a procedure are:
A designated person must be appointed with authority to conduct complaints reviews in accordance with the SOPs. The person designated may be the authorized person responsible for quality control. If not, then that QC person must be kept informed of all complaints being investigated. The designated person must have sufficient staff to be able to review all the complaints received in an effective and rapid manner. They must to be able to access all the relevant records concerning the product under discussion.
Required actions are described.
The complaint is acknowledged and a response to the customer is provided.
Written and verbal comments are recorded.
<number>
October 27, 2014
The QC department should be involved throughout the investigation. The investigation should be thorough and fully recorded– and reflect all the details of the investigation in the records.
Special attention must be given to try and establish whether "counterfeiting" may have been the cause.
If there is a product defect (discovered or suspected), then the company should consider checking other batches, and may have to check batches containing reprocessed product.
<number>
October 27, 2014
Investigation and evaluation should result in appropriate follow up actions taken. This may include a "recall" of the product, or batch.
All decisions and measures taken should be recorded.
The complaint should also be referenced in batch records – and may thus help during the review or annual product review, trend analysis etc.
Complaint records should be reviewed on a regular basis as defined in the SOP. Trends and recurring problems should be identified and proper action taken to prevent recurrence of the problem/cause. As complaints are investigated and records are built up, then trends may start to become clear. A regular review of complaint records to establish whether there is a trend for a particular product, dosage form, customer, distribution channel or similar should be undertaken. This is where the true value of a good complaints handling procedure shows. It may be that a particular formulation or particular machine is giving rise to complaints. This trend analysis process is an opportunity for continuous improvement.
It may be that a particular customer is engaged in fraudulent behaviour.
<number>
October 27, 2014
The competent authority must be informed of any serious quality problems that are revealed by the complaint investigation
<number>
October 27, 2014
The purpose of self-inspection is to evaluate the manufacturer’s compliance with GMP in all aspects of production and quality control.
It also assists in ensuring quality improvement. There should be a programme that covers all aspects of production and quality control. It should be designed to detect shortcomings in the implementation of GMP and recommend corrective actions. The company should set a timetable for corrective action to be completed. You can verify this during your assessment.
<number>
October 27, 2014
The self-inspection team is appointed by the management of the company and is made up of a mixture of people, including experts in GMP and persons familiar with the area to be inspected. It is useful to have people from production, QC and engineering on the team, as they will bring different perspectives to the inspection.
The team leader needs to be someone who has access to the resources to produce a report at the end of the process, and with the authority and experience to organize and manage a team activity. Hence it is usually, but not always, a manager or supervisor.
The leader should be from a different department so that he/she can take a more impartial viewpoint.
It is important that the team members are encouraged to be objective in their evaluation.
The frequency with which self-inspections are carried out will depend on the company. For a small company that can cover all its operations in one inspection, a three or six-monthly review might be sufficient. However, for a larger company that needs to split the inspection into a number of sections, a programme of monthly inspections covering the whole factory in three to six months might be more appropriate.
<number>
October 27, 2014
All inspections need reports as an outcome; otherwise there is no formal record of the findings and recommendations.
This report should be issued as quickly as possible while things are fresh in people’s minds. It does not need to be an elaborate, wordy document that no one will read. A simple list of findings with recommendations for corrective action is sufficient. However, it is important that responsibility for action and a time frame are agreed, either during the inspection or soon after the report is issued.
A self-inspection without follow-up is unlikely to be particularly effective and it is important that the company management ensures that the corrective measures are carried out to the agreed timetable.