The document provides guidance for good manufacturing practices regarding complaints, quality defects, and product recalls for medicinal products. It emphasizes applying quality risk management principles when investigating issues and making risk-reducing decisions such as recalls. Manufacturers should have procedures to properly handle complaints and investigations, identify root causes, and implement corrective actions. Recalls should be managed through established written procedures and competent authorities should be notified of quality defects that could require a recall.
This document discusses types of complaints regarding pharmaceutical products and the procedures for handling complaints and conducting product recalls. There are three main types of complaints: quality complaints, adverse reaction complaints, and other medically related complaints. All complaints should be documented in writing. Quality complaints are handled by quality control, while adverse reactions are reviewed by medical experts. Recalls are conducted when a product's quality is in question, with three degrees of recall depending on health risk. Procedures and documentation are required for complaint handling and recalls. Returned products must be properly stored, examined, and either reprocessed, destroyed, or have their disposition documented.
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.
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
This document provides guidance on quality risk management principles and tools. It describes a general quality risk management process that includes risk assessment, risk control, risk communication, and risk review. Risk assessment involves risk identification, analysis, and evaluation. Risk control focuses on reducing risks to an acceptable level through actions like risk mitigation or accepting the residual risk. Effective communication and ongoing review are also important parts of the quality risk management process. The guideline provides examples of tools that can be used for a risk management methodology, including Failure Mode Effects Analysis and Hazard Analysis Critical Control Points.
International conference-harmonisation-technical-requirements-registration-ph...ibrahimbouzina
This document provides guidance on quality risk management principles and tools for use across the pharmaceutical product lifecycle. It outlines a general quality risk management process that includes risk assessment, control, communication and review. The level of effort for quality risk management should be commensurate with the level of risk. Quality risk management can help facilitate more informed decision making and regulatory oversight while ensuring product quality protects patient safety.
The document outlines FDA procedures and responsibilities for product recalls. It discusses how recalls are initiated and classified into three classes based on health hazard. FDA monitors recall effectiveness and will terminate a recall when corrective actions are complete. Recalling firms are responsible for determining the scope and depth of recalls, communicating with FDA and customers, and issuing any necessary press releases. The document provides an overview of drug recalls that occurred in 2013.
The document discusses customer safety in hospitals. It outlines several goals and initiatives to improve safety, including correctly identifying customers, improving communication, safely using medications and alarms, preventing infections, reducing falls and errors, and ensuring the right procedure is done on the right patient. Medical errors are common but preventable. Adverse events increase costs and some safety measures require little funding. Checklists are recommended for surgeries, anesthesia and post-operative care to help avoid mistakes and omissions.
1) Recalls and returns are a fundamental element of good manufacturing practices and ensure that defective products are removed from the market.
2) Manufacturers are obligated to initiate a recall if one is necessary to protect public health, and regulatory authorities may order a recall.
3) It is important to monitor a recall closely and maintain thorough records to ensure its effectiveness in removing defective products from distribution and use.
This document discusses types of complaints regarding pharmaceutical products and the procedures for handling complaints and conducting product recalls. There are three main types of complaints: quality complaints, adverse reaction complaints, and other medically related complaints. All complaints should be documented in writing. Quality complaints are handled by quality control, while adverse reactions are reviewed by medical experts. Recalls are conducted when a product's quality is in question, with three degrees of recall depending on health risk. Procedures and documentation are required for complaint handling and recalls. Returned products must be properly stored, examined, and either reprocessed, destroyed, or have their disposition documented.
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.
The document discusses Good Laboratory Practices (GLP). It provides definitions and history of GLP. GLP refers to a quality management system for laboratories conducting non-clinical safety studies. It aims to ensure reliability and integrity of test data. Key aspects of GLP include organization, SOPs, facilities, equipment, test systems, study planning and reporting, archiving. Non-compliance can result in disqualification and rejection of study data by regulatory agencies.
This document provides guidance on quality risk management principles and tools. It describes a general quality risk management process that includes risk assessment, risk control, risk communication, and risk review. Risk assessment involves risk identification, analysis, and evaluation. Risk control focuses on reducing risks to an acceptable level through actions like risk mitigation or accepting the residual risk. Effective communication and ongoing review are also important parts of the quality risk management process. The guideline provides examples of tools that can be used for a risk management methodology, including Failure Mode Effects Analysis and Hazard Analysis Critical Control Points.
International conference-harmonisation-technical-requirements-registration-ph...ibrahimbouzina
This document provides guidance on quality risk management principles and tools for use across the pharmaceutical product lifecycle. It outlines a general quality risk management process that includes risk assessment, control, communication and review. The level of effort for quality risk management should be commensurate with the level of risk. Quality risk management can help facilitate more informed decision making and regulatory oversight while ensuring product quality protects patient safety.
The document outlines FDA procedures and responsibilities for product recalls. It discusses how recalls are initiated and classified into three classes based on health hazard. FDA monitors recall effectiveness and will terminate a recall when corrective actions are complete. Recalling firms are responsible for determining the scope and depth of recalls, communicating with FDA and customers, and issuing any necessary press releases. The document provides an overview of drug recalls that occurred in 2013.
The document discusses customer safety in hospitals. It outlines several goals and initiatives to improve safety, including correctly identifying customers, improving communication, safely using medications and alarms, preventing infections, reducing falls and errors, and ensuring the right procedure is done on the right patient. Medical errors are common but preventable. Adverse events increase costs and some safety measures require little funding. Checklists are recommended for surgeries, anesthesia and post-operative care to help avoid mistakes and omissions.
1) Recalls and returns are a fundamental element of good manufacturing practices and ensure that defective products are removed from the market.
2) Manufacturers are obligated to initiate a recall if one is necessary to protect public health, and regulatory authorities may order a recall.
3) It is important to monitor a recall closely and maintain thorough records to ensure its effectiveness in removing defective products from distribution and use.
This document outlines standard operating procedures for product recalls. It defines three classes of recalls based on risk to health, with Class I being potentially life-threatening. It describes initiating a recall due to complaints, failed tests, or health risks. It also details the preliminary assessment, identifying the root cause, deciding whether to recall, notifying departments and recipients, segregating products, monitoring recall progress, reporting, and actions to prevent future issues.
This document outlines the process for handling pharmaceutical product complaints. It defines a complaint and discusses the need for proper complaint handling procedures. It classifies complaints as critical, major, or minor and describes the 4 main steps to handling complaints: receiving complaints, technical investigation, corrective and preventive actions/feedback, and trend analysis/reporting. Key aspects of each step like documentation, sampling, testing, reporting, and record keeping are described. Regulatory guidelines for complaint management are also provided.
PHARMACEUTICAL QUALITY ASSURANCE : Mr. Prashant JadhavPRASHANT JADHAV
The document discusses quality assurance and good manufacturing practices in the pharmaceutical industry. It defines quality assurance according to WHO as activities that provide confidence that quality requirements are being met. Quality assurance is part of quality management and includes planned activities to ensure products and services meet quality standards. Good manufacturing practices are regulations and guidelines for manufacturing drugs, medical devices, and foods to minimize risks that cannot be eliminated through testing. GMPs help ensure drug products are safe, pure and effective.
This presentation introduces pharmaceutical quality assurance and quality control. It discusses that quality assurance covers all aspects of production from raw materials to finished products. Quality control ensures drugs are safe, effective and consistent. The presentation covers in-process quality control, production processes like blending and milling, and quality control of the storage facility. It also discusses technology transfer requirements for pharmaceutical production like manufacturing instructions, analytical methods and batch records.
As you know, pharma compliance is a critical issue, particularly in China. The Chinese government’s recent crackdowns on the business practices of various pharmaceutical companies have sent shockwaves throughout the industry and the price to pay for non-compliance is exceedingly high, with massive revenue losses and irreclaimable reputational damages
To address this pertinent issue, IBC Asia is convening the forthcoming Pharma Compliance Summit
(Mar 2015) in Shanghai, China. Set to be an informative and insightful event, this conference will prepare participants in dealing with the latest legal compliance landmines and equip them with an in-depth understanding of how to mitigate non- compliance risks at every part of the pharma value chain.
Top companies will share best practices of internal compliance programs and third party due diligence strategies; Gain these exclusive insights and incorporate them into their own company, reaping maximum benefits.
Your expert speaker faculty includes:
• Leon Wang, Vice President, AstraZeneca China
• Heike Deters, Head of Compliance, Bayer Healthcare China
• Dr Wang Xianlin, Member, Expert Advisory Group of Anti-Monopoly Commission, State Council People’s Republic of China
• Maija Burtmanis, Regional Legal & Compliance Director JAPAC, AbbVie
• Gareth Lee, General Counsel & Head of Compliance APAC, Allergan
• Cristopher Landrito, Regional Compliance Manager APAC, Merck
• David Shen, General Counsel & VP Legal, AstraZeneca China
• Dr Wu Ke, President, Shanghai BravoBio
• Alejandro Castro, Regional Audit Manager Asia Pacific, Novartis
• Linda Ling, Senior Healthcare Compliance Manager, OTC China, Johnson & Johnson
http://www.pharmacompliance-china.com
This document provides information about product recalls in the Philippines. It defines a product recall as the removal of a product from the market due to defects or safety issues. Recalls can be initiated voluntarily by a company or ordered by the Philippine Food and Drug Administration (FDA). The FDA will classify recalls as Class I, II, or III based on the health hazard level. For ordered recalls, the FDA notifies companies and specifies actions to be taken. Companies must coordinate recall strategies and reports with the FDA, and recalls should be treated urgently to protect public health.
This document discusses quality control of medicinal products. It defines quality control as procedures to ensure identity and purity of pharmaceuticals, ranging from simple chemical tests to complex pharmacopoeial standards. The document outlines types of counterfeit medicines that may have incorrect ingredients or dosages. It also discusses analytical processes for quality control, including standard methods, field tests, and ensuring precision and accuracy. Quality assurance involves four phases from evaluating new methods to external audits.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
Assessment of Good Pharmacy Practice (GPP) in Pharmacies of Community Setting...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
This document summarizes a presentation on ICH Guideline Q9 on quality risk management. The objectives are to understand the concept of quality risk management, risk, and ICH Q9's role in new drug development. It discusses quality risk management as a systematic process to assess, control, communicate and review risks to drug quality across the product lifecycle. ICH Q9 provides principles and tools for quality risk management that can be applied at various stages including development, manufacturing, and distribution. It emphasizes linking quality risk management activities to protecting patient safety.
This document provides a procedure documentation list for quality improvement in healthcare facilities. It contains 10 chapters that cover topics such as access assessment and continuity of care, patient care, medication management, patient rights and education, infection control, continuous quality improvement, facility management and safety, human resource management, and information management systems. The list includes over 150 topics that healthcare facilities should document procedures for to improve quality. It is intended to help facilities standardize processes and ensure compliance with quality standards.
This document discusses out-of-trend (OOT) results, which occur when a result does not follow the expected trend based on past data. It notes that identifying OOT results is becoming a regulatory issue and introduces some statistical approaches for doing so, like using a minimum of 25 batches to set a trend range of average ±3 standard deviations. Some challenges of implementing OOT identification for commercial batches are determining the appropriate statistical approach, data requirements, and investigation process. The conclusion states that identifying OOT results is important for regulators and industry, and the method should not be too complex.
Pharmacovigilance role through investigating Out of Specification (OOS) for F...Mohamed Raouf
Pharmacovigilance role in Investigating OOS for Finished Product on the Stability Program through Health Hazard Assessment & Post monitoring and effectiveness check.
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.
GMP refers to the integrated management control system and facilities used for manufacturing drugs intended for human use to ensure they are safe and effective. Key aspects of GMP include clearly defined and validated manufacturing processes, trained operators, comprehensive record keeping, quality control, and compliance with regulations. GMP guidelines specify requirements for facilities, equipment, production, packaging, testing, distribution, and quality management.
AN OVERVIEW ON PHARMACO THERAPEUTIC COMMITTEE - M.L.SUSHMITHAlakshmisushmitha2
The Pharmacy and Therapeutics Committee (PTC) is an advisory committee composed of physicians, pharmacists, nurses, and administrators that assists in developing policies related to drug evaluation, selection, and use in hospitals. The PTC prepares the hospital drug formulary, selects drug suppliers, adds or removes drugs from the formulary, develops drug information resources, monitors adverse drug reactions, and ensures drug quality and safety. It also establishes emergency drug lists, reports defective drug products, and conducts drug utilization reviews to optimize prescribing and medication management in the hospital.
This document outlines a course on quality control and quality assurance aspects of the pharmaceutical industry. The course will cover key topics like cGMP, quality certifications, documentation, and regulatory affairs. Upon completing the course, students will understand cGMP requirements, quality documentation, certifications for pharmaceutical companies, and the roles of quality assurance and quality control departments. The course is divided into five units which will cover quality management systems, organization and facilities, quality control testing, documentation, validation, calibration, complaints, and warehousing.
This document discusses product complaints and recalls. It defines a complaint as any expression of dissatisfaction with a product. Complaints can come internally from production or quality control or externally from customers. Complaints are classified as critical, major, or minor depending on their severity and health risks. The document outlines guidelines for designating a person to handle complaints, investigating complaints, providing corrective actions and feedback, and analyzing complaint trends. It also defines and discusses the types and procedures for product recalls when serious quality issues are found.
This document outlines standard operating procedures for product recalls. It defines three classes of recalls based on risk to health, with Class I being potentially life-threatening. It describes initiating a recall due to complaints, failed tests, or health risks. It also details the preliminary assessment, identifying the root cause, deciding whether to recall, notifying departments and recipients, segregating products, monitoring recall progress, reporting, and actions to prevent future issues.
This document outlines the process for handling pharmaceutical product complaints. It defines a complaint and discusses the need for proper complaint handling procedures. It classifies complaints as critical, major, or minor and describes the 4 main steps to handling complaints: receiving complaints, technical investigation, corrective and preventive actions/feedback, and trend analysis/reporting. Key aspects of each step like documentation, sampling, testing, reporting, and record keeping are described. Regulatory guidelines for complaint management are also provided.
PHARMACEUTICAL QUALITY ASSURANCE : Mr. Prashant JadhavPRASHANT JADHAV
The document discusses quality assurance and good manufacturing practices in the pharmaceutical industry. It defines quality assurance according to WHO as activities that provide confidence that quality requirements are being met. Quality assurance is part of quality management and includes planned activities to ensure products and services meet quality standards. Good manufacturing practices are regulations and guidelines for manufacturing drugs, medical devices, and foods to minimize risks that cannot be eliminated through testing. GMPs help ensure drug products are safe, pure and effective.
This presentation introduces pharmaceutical quality assurance and quality control. It discusses that quality assurance covers all aspects of production from raw materials to finished products. Quality control ensures drugs are safe, effective and consistent. The presentation covers in-process quality control, production processes like blending and milling, and quality control of the storage facility. It also discusses technology transfer requirements for pharmaceutical production like manufacturing instructions, analytical methods and batch records.
As you know, pharma compliance is a critical issue, particularly in China. The Chinese government’s recent crackdowns on the business practices of various pharmaceutical companies have sent shockwaves throughout the industry and the price to pay for non-compliance is exceedingly high, with massive revenue losses and irreclaimable reputational damages
To address this pertinent issue, IBC Asia is convening the forthcoming Pharma Compliance Summit
(Mar 2015) in Shanghai, China. Set to be an informative and insightful event, this conference will prepare participants in dealing with the latest legal compliance landmines and equip them with an in-depth understanding of how to mitigate non- compliance risks at every part of the pharma value chain.
Top companies will share best practices of internal compliance programs and third party due diligence strategies; Gain these exclusive insights and incorporate them into their own company, reaping maximum benefits.
Your expert speaker faculty includes:
• Leon Wang, Vice President, AstraZeneca China
• Heike Deters, Head of Compliance, Bayer Healthcare China
• Dr Wang Xianlin, Member, Expert Advisory Group of Anti-Monopoly Commission, State Council People’s Republic of China
• Maija Burtmanis, Regional Legal & Compliance Director JAPAC, AbbVie
• Gareth Lee, General Counsel & Head of Compliance APAC, Allergan
• Cristopher Landrito, Regional Compliance Manager APAC, Merck
• David Shen, General Counsel & VP Legal, AstraZeneca China
• Dr Wu Ke, President, Shanghai BravoBio
• Alejandro Castro, Regional Audit Manager Asia Pacific, Novartis
• Linda Ling, Senior Healthcare Compliance Manager, OTC China, Johnson & Johnson
http://www.pharmacompliance-china.com
This document provides information about product recalls in the Philippines. It defines a product recall as the removal of a product from the market due to defects or safety issues. Recalls can be initiated voluntarily by a company or ordered by the Philippine Food and Drug Administration (FDA). The FDA will classify recalls as Class I, II, or III based on the health hazard level. For ordered recalls, the FDA notifies companies and specifies actions to be taken. Companies must coordinate recall strategies and reports with the FDA, and recalls should be treated urgently to protect public health.
This document discusses quality control of medicinal products. It defines quality control as procedures to ensure identity and purity of pharmaceuticals, ranging from simple chemical tests to complex pharmacopoeial standards. The document outlines types of counterfeit medicines that may have incorrect ingredients or dosages. It also discusses analytical processes for quality control, including standard methods, field tests, and ensuring precision and accuracy. Quality assurance involves four phases from evaluating new methods to external audits.
PIC/S is an organization that was established to harmonize and improve Good Manufacturing Practice standards among member countries. It brings together regulatory authorities and pharmaceutical quality systems to ensure uniformity. PIC/S provides guidelines for industry, inspectors, and regulatory authorities to facilitate information sharing and mutual understanding, with the goal of protecting public health by helping to ensure the quality and safety of medical products globally.
Assessment of Good Pharmacy Practice (GPP) in Pharmacies of Community Setting...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
This document summarizes a presentation on ICH Guideline Q9 on quality risk management. The objectives are to understand the concept of quality risk management, risk, and ICH Q9's role in new drug development. It discusses quality risk management as a systematic process to assess, control, communicate and review risks to drug quality across the product lifecycle. ICH Q9 provides principles and tools for quality risk management that can be applied at various stages including development, manufacturing, and distribution. It emphasizes linking quality risk management activities to protecting patient safety.
This document provides a procedure documentation list for quality improvement in healthcare facilities. It contains 10 chapters that cover topics such as access assessment and continuity of care, patient care, medication management, patient rights and education, infection control, continuous quality improvement, facility management and safety, human resource management, and information management systems. The list includes over 150 topics that healthcare facilities should document procedures for to improve quality. It is intended to help facilities standardize processes and ensure compliance with quality standards.
This document discusses out-of-trend (OOT) results, which occur when a result does not follow the expected trend based on past data. It notes that identifying OOT results is becoming a regulatory issue and introduces some statistical approaches for doing so, like using a minimum of 25 batches to set a trend range of average ±3 standard deviations. Some challenges of implementing OOT identification for commercial batches are determining the appropriate statistical approach, data requirements, and investigation process. The conclusion states that identifying OOT results is important for regulators and industry, and the method should not be too complex.
Pharmacovigilance role through investigating Out of Specification (OOS) for F...Mohamed Raouf
Pharmacovigilance role in Investigating OOS for Finished Product on the Stability Program through Health Hazard Assessment & Post monitoring and effectiveness check.
The document discusses the regulatory IND (Investigational New Drug) process for bringing a new drug to market in the United States. It outlines the requirements for submitting an IND application to the FDA, including non-clinical data from animal and early human studies demonstrating safety and effectiveness. Key components that must be addressed are chemistry and manufacturing controls, pharmacology and toxicology data, clinical protocols, and plans for interaction and meetings with FDA regulators during the process.
Marv Shepherd, PSM president, Member USP Package Storage and Distribution Expert Committee, and Professor at the University of Texas at Austin speaks about updates to United States Pharmacopeia's good distribution practices.
GMP refers to the integrated management control system and facilities used for manufacturing drugs intended for human use to ensure they are safe and effective. Key aspects of GMP include clearly defined and validated manufacturing processes, trained operators, comprehensive record keeping, quality control, and compliance with regulations. GMP guidelines specify requirements for facilities, equipment, production, packaging, testing, distribution, and quality management.
AN OVERVIEW ON PHARMACO THERAPEUTIC COMMITTEE - M.L.SUSHMITHAlakshmisushmitha2
The Pharmacy and Therapeutics Committee (PTC) is an advisory committee composed of physicians, pharmacists, nurses, and administrators that assists in developing policies related to drug evaluation, selection, and use in hospitals. The PTC prepares the hospital drug formulary, selects drug suppliers, adds or removes drugs from the formulary, develops drug information resources, monitors adverse drug reactions, and ensures drug quality and safety. It also establishes emergency drug lists, reports defective drug products, and conducts drug utilization reviews to optimize prescribing and medication management in the hospital.
This document outlines a course on quality control and quality assurance aspects of the pharmaceutical industry. The course will cover key topics like cGMP, quality certifications, documentation, and regulatory affairs. Upon completing the course, students will understand cGMP requirements, quality documentation, certifications for pharmaceutical companies, and the roles of quality assurance and quality control departments. The course is divided into five units which will cover quality management systems, organization and facilities, quality control testing, documentation, validation, calibration, complaints, and warehousing.
This document discusses product complaints and recalls. It defines a complaint as any expression of dissatisfaction with a product. Complaints can come internally from production or quality control or externally from customers. Complaints are classified as critical, major, or minor depending on their severity and health risks. The document outlines guidelines for designating a person to handle complaints, investigating complaints, providing corrective actions and feedback, and analyzing complaint trends. It also defines and discusses the types and procedures for product recalls when serious quality issues are found.
This presentation discusses various topics related to clinical research management including:
- Preparation of clinical studies according to ICH guidelines.
- The difference between audits and inspections, who conducts them, and what they audit.
- Monitoring clinical studies to ensure adherence to protocols, SOPs, and regulations.
- Pharmacovigilance including adverse event reporting procedures.
- Documentation requirements for clinical research.
- Budgeting considerations for clinical trials including personnel, technology, data management.
- Vendor management activities like contracting, governance, and relationship management.
A structured approach to the investigation process should be used with the objective of determining the root cause.
The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk, in line with ICH Q9.
This document provides guidance for assessing the comparability of biotechnological products before and after changes to the manufacturing process. It aims to assist manufacturers in collecting relevant technical information to demonstrate that manufacturing changes will not adversely impact quality, safety or efficacy. The guidelines cover analytical techniques, characterization, specifications, stability and other quality, nonclinical and clinical considerations for evaluating comparability. The goal is to ensure the quality, safety and efficacy of products produced by changed processes through evaluating relevant data. A finding of comparability does not require identical quality attributes but highly similar attributes without adverse impacts on safety or efficacy.
Best Practice Document on Handling of Market Complaints.pdfTom Aspinall
Market complaints in the pharmaceutical industry refer to issues raised by consumers or regulatory bodies regarding product quality, safety, or marketing practices. These complaints are crucial for maintaining industry standards, ensuring patient safety, and regulatory compliance.
The document discusses product complaints and recalls in the pharmaceutical industry. It defines a complaint as customer dissatisfaction about a product and outlines four types of complaints. It details the four-step process of handling complaints, which includes receiving, investigating, implementing corrective actions, and reporting. The document also defines a recall as removing a product from distribution due to quality, safety or efficacy issues. It describes the reasons and types of recalls, as well as the classification, levels and timelines involved in an effective recall system.
medical devices and invitro diagnosis by rahul sagar, m. pharm(dra), bbau luc...Brajesh Kumar
This presentation provides an overview of medical device validation. It discusses the categories of medical devices and regulatory requirements for validation. The presentation covers validation concepts for medical devices including process validation and risk assessment. Analytical and clinical validation methods are described for in vitro diagnostic tests. Finally, the FDA regulatory perspectives on medical devices based on risk classification are summarized.
The document discusses Good Manufacturing Practices (GMP) for distribution, distribution records, handling returned goods, and recovery/reprocessing of materials. It provides guidelines for distribution procedures including first expiration, first out (FEFO) and batch recall systems. It also outlines requirements for distribution records, handling returned products, and reprocessing materials to ensure quality is maintained.
This document provides guidance for good manufacturing practices for medicinal products in the European Union. It discusses the importance of a pharmaceutical quality system to ensure quality and compliance throughout the product lifecycle. Key aspects of an effective quality system include managing product and process knowledge; designing and developing products with GMP in mind; specifying production and controls; defining roles and responsibilities; controlling materials; managing outsourced activities; monitoring processes and taking corrective actions; and continually improving processes and products. Senior management must provide leadership and ensure the quality system is properly implemented and maintained.
This document provides guidance for good manufacturing practices for medicinal products in the European Union. It discusses the importance of a pharmaceutical quality system to ensure quality and compliance throughout the product lifecycle. Key aspects of an effective quality system include managing product and process knowledge; designing and developing products with GMP in mind; specifying production and controls; defining roles and responsibilities; controlling materials; managing outsourced activities; monitoring processes and taking corrective actions; and continually improving processes and products. Senior management must provide leadership and ensure the quality system is properly implemented and maintained.
GMP helps in providing quality standard product. Subpart - E is related to Control of Components and Drug product containers and closures. Subpart - F is related to Production and Process control.
Common arab guidelines in pharmacovigilanceNahla Amin
The document outlines guidelines for good pharmacovigilance practices for Arab countries. It discusses 10 modules that cover key aspects of pharmacovigilance systems including quality systems, the pharmacovigilance system master file, inspections, audits, risk management, safety reporting and communication. The guidelines were developed by the Arab League to harmonize pharmacovigilance standards across countries in the region based largely on European Union guidelines. The guidelines aim to help national regulatory authorities ensure marketing authorization holders have appropriate systems, processes and resources for pharmacovigilance obligations.
This document discusses guidelines for pharmacovigilance (PV), which is the monitoring of drugs for safety issues. Some key points:
- Clinical trials must have strict ethics and safety protocols to protect subjects and maintain trust. Post-approval monitoring is also important.
- Marketing authorization holders are responsible for PV of their approved drugs. This includes reporting safety issues, having a qualified person responsible for PV, and maintaining a detailed PV system.
- Competent authorities conduct inspections to ensure marketing authorization holders follow PV requirements. They also monitor for safety signals and ensure timely communication of issues.
Volume 9 A Guidelines On Pharmacovigilance by Dr. Siddharth S Chachad, Medica...Until ROI
The document discusses guidelines for pharmacovigilance in clinical trials and post-marketing. It outlines responsibilities for monitoring safety, reporting adverse events, and taking action if new risks emerge. Marketing authorization holders must establish systems for safety reporting, literature review, and responding to regulators. Competent authorities conduct inspections and oversight to ensure compliance.
This document provides guidance on quality risk management for the pharmaceutical industry. It outlines principles of quality risk management including responsibilities, risk assessment, risk control, risk communication, and risk review. The goal is to offer a systematic approach to quality risk management that supports existing quality practices and regulations. Quality risk management can help pharmaceutical companies and regulators make more effective risk-based decisions regarding drug quality across the product lifecycle. It is intended to complement, not replace, current regulatory requirements and quality systems.
This document discusses product complaint handling procedures. It defines a complaint and provides reasons for having a complaint handling process. It describes the types of complaints that may occur and the steps involved in handling complaints which include receiving the complaint, investigating it technically and through documentation, determining if it is confirmed or not, taking corrective actions and feedback to customers, and performing monthly reporting and trend analysis. It also discusses regulatory guidelines around complaint handling and provides an example standard operating procedure on complaint handling.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
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This document provides guidance on good manufacturing practices for medicinal products. It discusses the importance of a pharmaceutical quality system to ensure that manufactured medicines are fit for use and comply with regulatory standards. Key elements of the quality system include good manufacturing practices, quality control, product quality reviews, and quality risk management. The quality system requires participation across all departments and levels of the company to ensure product safety, quality and efficacy.
This document discusses key aspects of designing pharmaceutical manufacturing facilities according to current Good Manufacturing Practices (cGMP). It covers process design tools like block flow diagrams, process flow diagrams, and piping and instrumentation diagrams that are used to design the facility layout and process flows. The document also discusses various unit operations in solid dosage manufacturing like material handling, milling, blending, compression, and coating. Facility design must meet regulatory requirements to facilitate operations, control materials, and prevent contamination according to cGMP.
This document lists various prequalified active pharmaceutical ingredients from the WHO. It includes the product ID, INN, grade, therapeutic area, applicant, date of prequalification, and confirmation date. There are over 400 entries listed with information about different APIs that have been prequalified for treatments of conditions like HIV/AIDS, malaria, tuberculosis, hepatitis, and others.
Danh mục 37 thuốc sản xuất trong nước được cấp giấy phép lưu hành tại Việt Nam - Đợt 185.
Quyết định được Cục Quản lý Dược Việt Nam ban hành vào tháng 7 năm 2023.
Danh mục 259 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 185.
Danh mục được ban hành bới Cục Quản lý Dược Việt Nam tháng 7 năm 2023.
Ngày 21/06 vừa qua, cục Quản lý Dược vừa ban hành quyết định về việc công bố danh mục thuốc biệt dược gốc - đợt 2 năm 2023.
Ban hành kèm theo quyết định này bao gồm 83 thuốc biệt dược gốc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP-EU.
Hướng dẫn thực hành này cung cấp thông tin cho các nhà sản xuất thức ăn có chất sát khuẩn không an toàn do thuốc chuyển sang thức ăn chăn nuôi không chứa thuốc hoặc một loại thức ăn khác. Mục đích của hướng dẫn này:
• “Sản xuất và phân phối thức ăn có chứa thuốc” đề cập đến việc sử dụng thiết bị để sản xuất, chế biến, đóng gói, giữ và phân phối thức ăn.
• “Thức ăn chăn nuôi” được sản xuất có thêm hóa chất bảo quản. Thức ăn cho động vật như vậy có thể được gọi trong hướng dẫn này là “thức ăn có tẩm thuốc” hoặc “thức ăn không có tẩm thuốc”, tùy thuộc vào việc thức ăn đó có được pha chế để chứa một loại thuốc mới dành cho động vật hay không. Để thuận tiện, chúng tôi gọi những loại thuốc mới dành cho động vật này đơn giản là “thuốc”.
• “Thuốc mang theo” đề cập đến sự hiện diện của thuốc trong lô thức ăn chăn nuôi tiếp theo.
• “Ô nhiễm không an toàn”: đề cập đến mức độ nhiễm bẩn, do một loại thuốc được phép sử dụng trong thức ăn chăn nuôi, gây ra rủi ro không thể chấp nhận được đối với sức khỏe con người hoặc động vật.
Nói chung, các tài liệu hướng dẫn của FDA không thiết lập các trách nhiệm có thể thực thi về mặt pháp lý. Thay vào đó nó mô tả Cơ quan về một chủ đề và chỉ nên được xem dưới dạng khuyến nghị, trừ khi các yêu cầu pháp lý hoặc quy định cụ thể được trích dẫn. Việc sử dụng từ nên trong hướng dẫn của Cơ quan có nghĩa là điều gì đó được gợi ý hoặc khuyến nghị, nhưng không bắt buộc.
Xem thêm các tài liệu khác trên trang của công ty cổ phần tư vấn thiết kể GMP EU.
Cục Quản lý Thực phẩm và Dược phẩm Hoa Kỳ đưa ra hướng dẫn cho các nhà sản xuất và phân phối sữa cho trẻ sơ sinh về các yêu cầu ghi nhãn nhất định đối với các sản phẩm này. Hướng dẫn này đặc biệt chú trọng đến số lượng các công thức sữa cho trẻ sơ sinh có bao bì tương tự nhưng khác nhau về thành phần hoặc mục đích sử dụng. Ngày càng nhiều các sản phẩm ghi sai nhãn về hàm lượng chất dinh dưỡng, do vậy hướng dẫn này cung cấp thông tin có thể giúp các nhà sản xuất hiểu và tuân thủ các yêu cầu ghi nhãn liên quan.
Hướng dẫn này không bao gồm đầy đủ tất cả các quy định liên quan đến việc ghi nhãn sữa công thức dành cho trẻ sơ sinh. Vì vậy bạn có thể xem thêm các hướng dẫn khác tại www.fda.gov/FoodGuidances hoặc các tài liệu trên kênh của công ty cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược vừa ban hành danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đó, ban hành kèm theo Quyết định này danh mục 69 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 64 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 05 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam hiệu lực 03 năm (Phụ lục II kèm theo).
Xem thêm các tài liệu khác trên trang của công tư cổ phần tư vấn thiết kế GMP EU.
Ngày 25/05 vừa qua, Cục quản lý Dược đã ban hành quyết định số 352/QĐ-QLD về việc ban hành danh mục 231 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 184.
Theo đề nghị của Trưởng phòng Đăng ký thuốc, Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 231 thuốc sản xuất trong nước được cấp giấy đăng ký lưu hành tại Việt Nam - Đợt 184, cụ thể:
1. Danh mục 172 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm (Phụ lục I kèm theo).
2. Danh mục 52 thuốc sản xuất trong nước được gia hạn giấy đăng ký lưu hành hiệu lực 03 năm (Phụ lục II kèm theo).
3. Danh mục 07 thuốc sản xuất trong nước được gia hạn đăng ký lưu hành đến 31/12/2025 (Phụ lục III kèm theo).
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược đã ban hành quyết định số 371/QĐ-QLD về việc công bố danh mục thuốc biệt dược gốc Đợt 1 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược, quyết định:
Công bố Danh mục 56 thuốc Biệt dược gốc Đợt 1 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác trên trang của công ty cổ phần Tư vấn thiết kế GMP EU.
Ngày 26/05 vừa qua, Cục Quản lý Dược vừa ra quyết định số 370/QĐ-QLD về việc ban hành danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục Quản lý Dược quyết định:
Ban hành kèm theo Quyết định này danh mục 50 thuốc nước ngoài được cấp, gia hạn giấy đăng ký lưu hành tại Việt Nam - Đợt 111 bổ sung, bao gồm:
1. Danh mục 41 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục I kèm theo).
2. Danh mục 01 thuốc nước ngoài được cấp giấy đăng ký lưu hành hiệu lực 03 năm - Đợt 111 bổ sung (tại Phụ lục II kèm theo).
3. Danh mục 07 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành hiệu lực 05 năm - Đợt 111 bổ sung (tại Phụ lục III kèm theo).
4. Danh mục 01 thuốc nước ngoài được gia hạn giấy đăng ký lưu hành đến 31/12/2025 - Đợt 111 bổ sung (tại Phụ lục IV kèm theo).
Ngày 24/05 vừa qua, Bộ Y tế vừa ban hành quyết định về việc công bố danh mục thuốc có chứng minh tương đương sinh học đợt 2 - năm 2023.
Theo đề nghị của Trưởng phòng Đăng ký thuốc - Cục quản lý Dược, quyết định:
Công bố Danh mục 28 thuốc có chứng minh tương đương sinh học Đợt 2 - Năm 2023 tại Phụ lục kèm theo Quyết định này.
Xem thêm các tài liệu khác của Công ty cổ phần Tư vấn thiết kế GMP EU.
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
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Tài liệu Gmp eu chapter 8 cập nhập mới nhất
1. 1
EUROPEAN COMMISSION
HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Health systems and products
Medicinal products – quality, safety and efficacy
Brussels, 13 August 2014
Ares(2014)2674297
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
EU Guidelines for
Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use
Part 1
Chapter 8: Complaints, Quality Defects and Product Recalls
Legal basis for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC on the
Community code relating to medicinal products for human use and Article 51 of Directive
2001/82/EC on the Community code relating to veterinary medicinal products. This document
provides guidance for the interpretation of the principles and guidelines of good manufacturing
practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal
products for human use and Directive 91/412/EEC for veterinary use.
Status of the document: Revision
Reasons for changes: Extensive changes have been made to this Chapter which now reflect that
Quality Risk Management principles should be applied when investigating quality defects or
complaints and when making decisions in relation to product recalls or other risk-mitigating
actions. It emphasises the need for the cause(s) of quality defects or complaints to be
investigated and determined, and that appropriate preventative actions are put in place to guard
against a recurrence of the issue and clarifies expectations and responsibilities in relation to the
reporting of quality defects to the Competent Authorities.
Deadline for coming into operation: 1 March 2015.
2. 2
Principle
In order to protect public and animal health, a system and appropriate procedures should be in
place to record, assess, investigate and review complaints including potential quality defects,
and if necessary, to effectively and promptly recall medicinal products for human or veterinary
use and investigational medicinal products from the distribution network. Quality Risk
Management principles should be applied to the investigation and assessment of quality defects
and to the decision-making process in relation to product recalls corrective and preventative
actions and other risk-reducing actions. Guidance in relation to these principles is provided in
Chapter 1.
All concerned competent authorities should be informed in a timely manner in case of a
confirmed quality defect (faulty manufacture, product deterioration, detection of falsification,
non-compliance with the marketing authorisation or product specification file, or any other
serious quality problems) with a medicinal or investigational medicinal product which may
result in the recall of the product or an abnormal restriction in the supply. In situations where
product on the market is found to be non-compliant with the marketing authorisation, there is no
requirement to notify concerned competent authorities provided the degree of non-compliance
satisfies the Annex 16 restrictions regarding the handling of unplanned deviations.
In case of outsourced activities, a contract should describe the role and responsibilities of the
manufacturer, the marketing authorisation holder and/or sponsor and any other relevant third
parties in relation to assessment, decision-making, and dissemination of information and
implementation of risk-reducing actions relating to a defective product. Guidance in relation to
contracts is provided in Chapter 7. Such contracts should also address how to contact those
responsible at each party for the management of quality defect and recall issues.
Personnel and Organisation
8.1 Appropriately trained and experienced personnel should be responsible for managing
complaint and quality defect investigations and for deciding the measures to be taken to
manage any potential risk(s) presented by those issues, including recalls. These persons
should be independent of the sales and marketing organisation, unless otherwise justified.
If these persons do not include the Qualified Person involved in the certification for
release of the concerned batch or batches, the latter should be made formally aware of any
investigations, any risk-reducing actions and any recall operations, in a timely manner.
8.2 Sufficient trained personnel and resources should be made available for the handling,
assessment, investigation and review of complaints and quality defects and for
implementing any risk-reducing actions. Sufficient trained personnel and resources should
also be available for the management of interactions with competent authorities.
8.3 The use of inter-disciplinary teams should be considered, including appropriately trained
Quality Management personnel.
8.4 In situations in which complaint and quality defect handling is managed centrally within
an organisation, the relative roles and responsibilities of the concerned parties should be
documented. Central management should not, however, result in delays in the
investigation and management of the issue.
3. 3
Procedures for handling and investigating complaints including possible quality defects
8.5 There should be written procedures describing the actions to be taken upon receipt of a
complaint. All complaints should be documented and assessed to establish if they
represent a potential quality defect or other issue.
8.6 Special attention should be given to establishing whether a complaint or suspected quality
defect relates to falsification.
8.7 As not all complaints received by a company may represent actual quality defects,
complaints which do not indicate a potential quality defect should be documented
appropriately and communicated to the relevant group or person responsible for the
investigation and management of complaints of that nature, such as suspected adverse
events.
8.8 There should be procedures in place to facilitate a request to investigate the quality of a
batch of a medicinal product in order to support an investigation into a reported suspected
adverse event.
8.9 When a quality defect investigation is initiated, procedures should be in place to address at
least the following:
i. The description of the reported quality defect.
ii. The determination of the extent of the quality defect. The checking or testing of
reference and/or retention samples should be considered as part of this, and in certain
cases, a review of the batch production record, the batch certification record and the
batch distribution records (especially for temperature-sensitive products) should be
performed.
iii. The need to request a sample, or the return, of the defective product from the
complainant and, where a sample is provided, the need for an appropriate evaluation
to be carried out.
iv. The assessment of the risk(s) posed by the quality defect, based on the severity and
extent of the quality defect.
v. The decision-making process that is to be used concerning the potential need for risk-
reducing actions to be taken in the distribution network, such as batch or product
recalls, or other actions.
vi. The assessment of the impact that any recall action may have on the availability of
the medicinal product to patients/animals in any affected market, and the need to
notify the relevant authorities of such impact.
vii. The internal and external communications that should be made in relation to a quality
defect and its investigation.
viii. The identification of the potential root cause(s) of the quality defect.
ix. The need for appropriate Corrective and Preventative Actions (CAPAs) to be
identified and implemented for the issue, and for the assessment of the effectiveness
of those CAPAs.
4. 4
Investigation and Decision-making
8.10 The information reported in relation to possible quality defects should be recorded,
including all the original details. The validity and extent of all reported quality defects
should be documented and assessed in accordance with Quality Risk Management
principles in order to support decisions regarding the degree of investigation and action
taken.
8.11 If a quality defect is discovered or suspected in a batch, consideration should be given to
checking other batches and in some cases other products, in order to determine whether
they are also affected. In particular, other batches which may contain portions of the
defective batch or defective components should be investigated.
8.12 Quality defect investigations should include a review of previous quality defect reports or
any other relevant information for any indication of specific or recurring problems
requiring attention and possibly further regulatory action.
8.13 The decisions that are made during and following quality defect investigations should
reflect the level of risk that is presented by the quality defect as well as the seriousness of
any non-compliance with respect to the requirements of the marketing
authorisation/product specification file or GMP. Such decisions should be timely to ensure
that patient and animal safety is maintained, in a way that is commensurate with the level
of risk that is presented by those issues.
8.14 As comprehensive information on the nature and extent of the quality defect may not
always be available at the early stages of an investigation, the decision-making processes
should still ensure that appropriate risk-reducing actions are taken at an appropriate time-
point during such investigations. All the decisions and measures taken as a result of a
quality defect should be documented.
8.15 Quality defects should be reported in a timely manner by the manufacturer to the
marketing authorisation holder/sponsor and all concerned Competent Authorities in cases
where the quality defect may result in the recall of the product or in an abnormal
restriction in the supply of the product.
Root Cause Analysis and Corrective and Preventative Actions
8.16 An appropriate level of root cause analysis work should be applied during the
investigation of quality defects. In cases where the true root cause(s) of the quality defect
cannot be determined, consideration should be given to identifying the most likely root
cause(s) and to addressing those.
8.17 Where human error is suspected or identified as the cause of a quality defect, this should
be formally justified and care should be exercised so as to ensure that process, procedural
or system-based errors or problems are not overlooked, if present.
8.18 Appropriate CAPAs should be identified and taken in response to a quality defect. The
effectiveness of such actions should be monitored and assessed.
8.19 Quality defect records should be reviewed and trend analyses should be performed
regularly for any indication of specific or recurring problems requiring attention.
5. 5
Product Recalls and other potential risk-reducing actions
8.20 There should be established written procedures, regularly reviewed and updated when
necessary, in order to undertake any recall activity or implement any other risk-reducing
actions.
8.21 After a product has been placed on the market, any retrieval of it from the distribution
network as a result of a quality defect should be regarded and managed as a recall. (This
provision does not apply to the retrieval (or return) of samples of the product from the
distribution network to facilitate an investigation into a quality defect issue/report.)
8.22 Recall operations should be capable of being initiated promptly and at any time. In certain
cases recall operations may need to be initiated to protect public or animal health prior to
establishing the root cause(s) and full extent of the quality defect
8.23 The batch/product distribution records should be readily available to the persons
responsible for recalls, and should contain sufficient information on wholesalers and
directly supplied customers (with addresses, phone and/or fax numbers inside and outside
working hours, batches and amounts delivered), including those for exported products and
medical samples.
8.24 In the case of investigational medicinal products, all trial sites should be identified and the
countries of destination should be indicated. In the case of an investigational medicinal
product for which a marketing authorisation has been issued, the manufacturer of the
investigational medicinal product should, in cooperation with the sponsor, inform the
marketing authorisation holder of any quality defect that could be related to the authorised
medicinal product. The sponsor should implement a procedure for the rapid unblinding of
blinded products, where this is necessary for a prompt recall. The sponsor should ensure
that the procedure discloses the identity of the blinded product only in so far as is
necessary.
8.25 Consideration should be given following consultation with the concerned Competent
Authorities, as to how far into the distribution network a recall action should extend,
taking into account the potential risk to public or animal health and any impact that the
proposed recall action may have. The Competent Authorities should also be informed in
situations in which no recall action is being proposed for a defective batch because the
batch has expired (such as with short shelf-life products.)
8.26 All concerned Competent Authorities should be informed in advance in cases where
products are intended to be recalled. For very serious issues (i.e. those with the potential
to seriously impact upon patient or animal health), rapid risk-reducing actions (such as a
product recall) may have to be taken in advance of notifying the Competent Authorities.
Wherever possible, attempts should be made to agree these in advance of their execution
with the concerned Competent Authorities
8.27 It should also be considered whether the proposed recall action may affect different
markets in different ways, and if this is the case, appropriate market-specific risk-reducing
actions should be developed and discussed with the concerned competent authorities.
Taking account of its therapeutic use the risk of shortage of a medicinal product which has
no authorised alternative should be considered before deciding on a risk-reducing action
such as a recall. Any decisions not to execute a risk-reducing action which would
otherwise be required should be agreed with the competent authority in advance.
6. 6
8.28 Recalled products should be identified and stored separately in a secure area while
awaiting a decision on their fate. A formal disposition of all recalled batches should be
made and documented. The rationale for any decision to rework recalled products should
be documented and discussed with the relevant competent authority. The extent of shelf-
life remaining for any reworked batches that are being considered for placement onto the
market should also be considered.
8.29 The progress of the recall process should be recorded until closure and a final
report issued, including a reconciliation between the delivered and recovered
quantities of the concerned products/batches.
8.30 The effectiveness of the arrangements in place for recalls should be periodically evaluated
to confirm that they remain robust and fit for use. Such evaluations should extend to both
within office-hour situations as well as out-of-office hour situations and, when performing
such evaluations, consideration should be given as to whether mock-recall actions should
be performed. This evaluation should be documented and justified.
8.31 In addition to recalls, there are other potential risk-reducing actions that may be
considered in order to manage the risks presented by quality defects. Such actions may
include the issuance of cautionary communications to healthcare professionals in relation
to their use of a batch that is potentially defective. These should be considered on a case-
by-case basis and discussed with the concerned competent authorities.