Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
The document provides an overview of a 2-day technical seminar on vendor validation presented by APPON Quality Circle. It discusses key topics covered in the seminar including why vendor validation is important, areas that require validation, methods of validation, requirements, vendor monitoring, evaluation, and disqualification. Vendor validation helps ensure consistent quality of materials and compliance with regulations to reduce risks and costs. A risk-based approach is recommended to qualify and monitor vendors based on performance metrics and compliance.
Validation of utility system (water system)ShameerAbid
The document discusses validation of a pharmaceutical water system. It covers the key stages of validation including design qualification, installation qualification, operational qualification, and performance qualification. It also discusses revalidation, sanitization procedures, alert and action levels, and ongoing operation, maintenance and control requirements for the water system. The goal of validation is to demonstrate that the water system can consistently produce water meeting quality specifications.
The document discusses good manufacturing practices (GMP) for pharmaceutical products. It provides background on regulatory requirements for GMP internationally and outlines key aspects of GMP documentation and records management. Effective documentation is important for ensuring quality, traceability of activities, and compliance with GMP regulations.
In this slide contains definition, importance, benefits of annual product review.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). It states that APQRs are required by regulatory agencies to verify process consistency, assess trends, determine needed specification or production changes, and evaluate revalidation needs. They help ensure quality standards are met and facilitate communication between manufacturing, quality, and regulatory functions. The document outlines the responsibilities, key activities, data requirements, and documentation involved in properly conducting an APQR.
Master batch record,batch production record ,Quality Audit Type and plan &Rec...KarishmaFuse
Standard Operating procedure(SOP), Preparation review ,Approval Issuance of master batch Record MBR and Batch Production Record (BPR) and Quality Audit Type, plan and Objectives.
The document provides an overview of a 2-day technical seminar on vendor validation presented by APPON Quality Circle. It discusses key topics covered in the seminar including why vendor validation is important, areas that require validation, methods of validation, requirements, vendor monitoring, evaluation, and disqualification. Vendor validation helps ensure consistent quality of materials and compliance with regulations to reduce risks and costs. A risk-based approach is recommended to qualify and monitor vendors based on performance metrics and compliance.
Validation of utility system (water system)ShameerAbid
The document discusses validation of a pharmaceutical water system. It covers the key stages of validation including design qualification, installation qualification, operational qualification, and performance qualification. It also discusses revalidation, sanitization procedures, alert and action levels, and ongoing operation, maintenance and control requirements for the water system. The goal of validation is to demonstrate that the water system can consistently produce water meeting quality specifications.
The document discusses good manufacturing practices (GMP) for pharmaceutical products. It provides background on regulatory requirements for GMP internationally and outlines key aspects of GMP documentation and records management. Effective documentation is important for ensuring quality, traceability of activities, and compliance with GMP regulations.
In this slide contains definition, importance, benefits of annual product review.
Presented by: Ravi Sanker babu .D.V (Department of pharmaceutical analysis and quality assurance).
RIPER, anantapur.
The document discusses the requirements and procedures for conducting an Annual Product Quality Review (APQR). It states that APQRs are required by regulatory agencies to verify process consistency, assess trends, determine needed specification or production changes, and evaluate revalidation needs. They help ensure quality standards are met and facilitate communication between manufacturing, quality, and regulatory functions. The document outlines the responsibilities, key activities, data requirements, and documentation involved in properly conducting an APQR.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Auditing of vendors and production departmentArpitSuralkar
This document outlines procedures for auditing vendors that produce capsules and sterile products. It discusses the benefits of vendor audits such as cost savings, process improvements, and risk reduction. The document describes the vendor selection process and provides a checklist for auditing vendors, which includes evaluating their premises, personnel, documentation, validation procedures, samples, stability studies, and drug recall processes. The goal of vendor audits is to inspect vendors' quality management systems and ensure they meet requirements for producing capsules and sterile medical products.
Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
This document provides a Validation Master Plan (VMP) for Pharma Co., Inc.'s Springfield, NY facility. It outlines the facility's validation program, including responsibilities, scope, and procedures. Key points include:
- The VMP defines requirements and approach for validating systems, equipment, and processes to ensure compliance.
- Responsibilities are divided among groups including Quality Assurance, Engineering, Manufacturing, and Quality Control.
- The scope includes validation of facilities, utilities, equipment, processes, cleaning, sterilization, computer systems, and laboratory equipment.
- Standard operating procedures and subordinate VMPs provide detailed governance and documentation of the validation program.
- Attachments
The document provides information about auditing a microbiological laboratory. It defines quality audits and outlines the scope and objectives of auditing. Key areas that are audited include laboratory equipment, standard operating procedures, documentation, environmental monitoring, and testing processes. The document discusses auditing the laboratory facility, equipment, documentation systems, and testing methods to ensure compliance with standards.
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.
Good Manufacturing Practice for Pharmaceutical Products.pdfMd. Zakaria Faruki
According to the WHO-
"GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification".
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
The document discusses validation of critical utility systems used in pharmaceutical manufacturing facilities. It focuses on validation of HVAC, water, and steam systems. For HVAC validation, it provides details on DQ, IQ, OQ, and PQ protocols including objectives, responsibilities, tests performed. It discusses user requirements, specifications for HVAC control and monitoring. For water system validation, it discusses purification methods, grade of water, and protocols for IQ, OQ and PQ. It also discusses two types of steam systems - house steam and clean steam - and validation considerations for each.
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.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
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.
This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II. It is a GMP requirement that manufacturers control the critical aspects of their particular operations through qualification and validation over the life cycle of the product and process. Any planned changes to the facilities, equipment, utilities and processes, which may affect the quality of the product, should be formally documented and the impact on the validated status or control strategy assessed. Computerised systems used for the manufacture of medicinal products should also be validated according to the requirements of Annex 11. The relevant concepts and guidance presented in ICH Q8, Q9, Q10 and Q11 should also be taken into account.
Highlights of the guidance are given in following presentation.
Auditing of vendors and production departmentArpitSuralkar
This document outlines procedures for auditing vendors that produce capsules and sterile products. It discusses the benefits of vendor audits such as cost savings, process improvements, and risk reduction. The document describes the vendor selection process and provides a checklist for auditing vendors, which includes evaluating their premises, personnel, documentation, validation procedures, samples, stability studies, and drug recall processes. The goal of vendor audits is to inspect vendors' quality management systems and ensure they meet requirements for producing capsules and sterile medical products.
Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
The document summarizes ICH Q10, which provides a harmonized model for a pharmaceutical quality system throughout the lifecycle of a product. It describes the contents and sections of ICH Q10, including management responsibility, continual improvement of process performance and product quality, and continual improvement of the pharmaceutical quality system. The goal is to establish an effective quality management system for the pharmaceutical industry and enhance the quality and availability of medicines.
This document provides a Validation Master Plan (VMP) for Pharma Co., Inc.'s Springfield, NY facility. It outlines the facility's validation program, including responsibilities, scope, and procedures. Key points include:
- The VMP defines requirements and approach for validating systems, equipment, and processes to ensure compliance.
- Responsibilities are divided among groups including Quality Assurance, Engineering, Manufacturing, and Quality Control.
- The scope includes validation of facilities, utilities, equipment, processes, cleaning, sterilization, computer systems, and laboratory equipment.
- Standard operating procedures and subordinate VMPs provide detailed governance and documentation of the validation program.
- Attachments
The document provides information about auditing a microbiological laboratory. It defines quality audits and outlines the scope and objectives of auditing. Key areas that are audited include laboratory equipment, standard operating procedures, documentation, environmental monitoring, and testing processes. The document discusses auditing the laboratory facility, equipment, documentation systems, and testing methods to ensure compliance with standards.
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.
Good Manufacturing Practice for Pharmaceutical Products.pdfMd. Zakaria Faruki
According to the WHO-
"GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification".
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
The document discusses validation of critical utility systems used in pharmaceutical manufacturing facilities. It focuses on validation of HVAC, water, and steam systems. For HVAC validation, it provides details on DQ, IQ, OQ, and PQ protocols including objectives, responsibilities, tests performed. It discusses user requirements, specifications for HVAC control and monitoring. For water system validation, it discusses purification methods, grade of water, and protocols for IQ, OQ and PQ. It also discusses two types of steam systems - house steam and clean steam - and validation considerations for each.
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.
Presentation complied by Drug Regulations – a not for profit organization from publicly available material form FDA , EMA, EDQM . WHO and similar organizations.
Visit www.drugregulations.org for the latest in Pharmaceutic
It is process of “Establishing documentary evidence that provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes”.
In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.
Validation is action of proving in accordance with the principles of good manufacturing practices, that any procedure, process, equipment, material, activity or system actually leads to expected results.
Cleaning validation is documented evidence with a high degree assurance that one can consistently clean a system or a piece of equipment to predetermined and acceptable limits.
The primary regulatory concern driving the need for cleaning validation is cross contamination of the desired drug substance either by other API from previous batch runs or by residues from the cleaning agents used.
The prime purpose of validating a cleaning process is to ensure compliance with federal and other standard regulations
1. Cross contamination with active ingredients
Contamination of one batch of product with significant levels of residual active ingredients from previous batch cannot be tolerated.
In addition to the obvious problems posed by subjecting consumers or patients to unintended contaminants, potential clinically significant synergistic interactions between pharmacologically active chemicals are a real concern.
2. Contamination with unintended materials or compounds
While inert ingredients used in drug products are generally recognized as safe for human consumption, the routine use, maintenance and cleaning of equipment's provide the potential contamination with such items as equipment parts, lubricants and chemical cleaning agents3. Microbiological contamination
Maintenance , cleaning and storage conditions may provide adventitious microorganisms with the opportunity to proliferate within the processing equipment.
This document discusses process validation. It defines process validation as establishing documented evidence that a process will consistently produce a product meeting its predetermined specifications. The key aspects of process validation are to obtain consistent and reliable data, demonstrate that the process remains in control, and show the process works as intended. There are different types of process validation including prospective, retrospective, and concurrent validation. Process validation involves multiple phases from process design and qualification to process verification and monitoring. It is important for quality, safety, efficacy and compliance with global regulatory agencies.
Auditing of Granulation Operation in Dry Production AreaPritam Kolge
Auditing of Granulation Operation in Dry Production Area.....
This topic comes under Audits and Regulatory Compliance....
This is useful for M.Pharm (Pharaceutical Quality Assurance) Students who studying in First year sem II....
This Presentation Contain following...
#Objectives
#Fundamentals of Granulation
#Reasons for Granulation
#Methods of Granulation
#Agglomeration
#Fundamentals and Audit of Dry Granulation
#Steps in Dry Granulation
#Fundamentals and Audit of Fluid Bed Granulation
#Scale-Up of Fluid bed Granulation
#High share granulation-Fundamentals, Audit and Scale-Up
#Overview and Comparison of Different Granulating Techniques
#Audit of Mixing and Blending, Wet granulation, Wet milling, Drying, Milling
#Conclusion
#References
Thanks For Help and Guidance of Mr. D.P.Mali Sir
In Pharma and Biotech, Weightage of the Documentation is around 70 % because as per FDA "If you do not have Document, You dint have do it."
So Good Documentation Practice is of tremendous importance for the Industry to comply any regulation like FDA, GMP or ISO.
This presentation covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological
therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program.
The guidance information is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002).
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
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.
Leading Practices for Distribution SuccessNet at Work
This document summarizes a 1 hour webinar about NetSuite presented by Angela Davis and Laurence Donoghue of NetAtWork. The webinar covered NetSuite's financial management, marketing, and order management capabilities for wholesale distribution. It also reviewed NetSuite's subscription model and implementation approach, including a 100 day implementation process with training, configuration, testing, and go-live support. Attendees were invited to ask questions during the webinar.
Css 2013 temperature controlled transport - risk mitigation - luc huybreght...Pauwels Consulting
This document discusses temperature controlled transport according to EU GDP regulations. It provides an overview of GDP requirements and emphasizes the importance of quality control and integrity across the entire supply chain. It then outlines a risk mitigation approach for temperature controlled transport, including mapping processes, assessing risks, and developing control strategies based on probability and severity scores. The goal is to guarantee quality from manufacturer to patient.
BioStorage is an off-site biospecimen storage facility that adheres to industry best practices like ISBER guidelines. It has over 5600 square feet of space with 24/7 monitoring and backup systems. BioStorage offers biological specimen management, transportation, lab equipment maintenance, freezer sales, and contract research services like cell culture and antibody production.
[Infographic] A One Page Guide to Global GDP GuidelinesPharma IQ
http://www.coldchainiq.com/regulatory-resources/white-papers/a-one-page-guide-to-global-gdp-guidelines/
All GDP guidelines in one single place!
Good Distribution Practice (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification. There is no single global GDP standard. Cold Chain IQ has created this easy to-assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even stick it on your wall!
This document discusses best practices for building Drupal distributions. It recommends including responsive themes, faceted search, batteries included functionality, and demo content. It also addresses challenges like maintaining interoperable features, default configurations, and sustainability. Customizing the installation process, improving the admin experience, and using panels are also suggested to create a better distribution.
The purpose of Gap Analysis is to assist pharmaceutical manufacturers, distributors or 3 PLs (3rd Party Logistics Providers) to help them identify gaps in their cold chain supply chain network or systems.
What you will learn:
* The regulatory aspects related to the cold chain
* Responsibilities in the supply chain
* Requirements for the storage and handling of drug products
* Packaging, transportation and distribution of drug products
* Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
* Ways and means to develop an executable action plan
How you will benefit:
* Understand how to execute a cold chain regulatory gap analysis
* Discover what should be covered when looking at cold chain compliance
* Gap analysis: The first step to develop a cold chain compliance program
* Uncover the requirements for the storage and distribution of drug products
* Sharing the responsibilities for a good cold chain compliance
Susan M. Smith Assistant: Jennifer L. Jones
Tel: 410-247-2500, x204 Tel: 410-247-2500, x205
Email: ssmith@biostorage.net Email: jjones@biostorage.net
Laboratory Director: Repository Manager:
Dr. John P. Williams Michael J. Wilson
Tel: 410-247-2500, x206 Tel: 410-247-2500, x207
Email: jwilliams@biostorage.net Email: mwilson@biostorage.net
Quality Assurance Manager: IT Manager:
Lisa A. Johnson, PhD Thomas E. Brown
Tel: 410
This document provides an overview of supply chain transportation management. It discusses key concepts like the functions of transportation management, factors in selecting transportation modes, and strategies for fleet sizing and routing/scheduling. Transportation is described as a fundamental part of logistics that aims to move goods efficiently at a cost of 5-6% of product price on average. The document also briefly outlines emerging areas like multimodal transportation and how technology is shaping the future of transportation.
This document provides guidelines on good distribution practices for biological products in India. It outlines general principles for maintaining quality throughout the distribution chain from manufacturer to patient. Key points include:
- Establishing an organizational structure and quality system for all entities involved in storage and distribution. This includes training personnel, implementing standard operating procedures, and conducting self-inspections.
- Ensuring suitable premises, equipment, vehicles and environmental conditions for storage and transportation in compliance with product and regulatory requirements. Critical factors like temperature, humidity and cleanliness must be controlled.
- Maintaining appropriate documentation systems to allow for traceability of products and support recalls or returns if needed. Deviations from storage/transport conditions should be investigated and corrective actions
Who good distributionpracticesforpharmaceuticalproductsadeelzia84
The document summarizes the history and contents of the WHO Good Distribution Practices for Pharmaceutical Products guidelines. It was originally adopted in 2005 and revised in 2009 to improve security against counterfeit medicines. The goals are to ensure quality and identity of pharmaceuticals during distribution. It defines distribution and outlines general principles like traceability and responsibilities across the supply chain. Key points covered include regulations, personnel training, documentation, repackaging, recalls, investigating counterfeits, and next steps to finalize the guidelines.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
GLP (Good Laboratory Practice) is a quality system concerned with conducting non-clinical safety studies. It aims to ensure studies are accurately reported and not fraudulent. GLP has principles for organization, personnel, facilities, test systems, operating procedures, performance and reporting of studies. India's National GLP Compliance Monitoring Authority monitors adherence. GLP compliance certification is required for safety studies of products like pesticides, pharmaceuticals and food additives, and helps protect human and environmental health while facilitating international trade.
Kvalitetsledelse af jeres rengøringsydelserDansk Standard
Under overskriften Kom godt i gang med standarder har vi udgivet en række pixibøger, som giver et overblik over, hvordan du arbejder konkret med et emne i forhold til en standard. Bøgerne giver et overordnet indtryk af emner og metodik.
Pjecerne er skrevet til små og mellemstore virksomheder inden for alle brancher.
Intro til kvalitetsledelse og ISO-certificeringSven Brixen
Rådgivning i forbindelse med etablering af kvalitetsledelses-system i virksomheder, der f.eks. ønsker at arbejde i offshore-industrien og har behov for en ISO 9000 certificering.
Herudover beskæftiger jeg mig stadig med strategiudvikling og implementering samt ledelsessparring.
Hos Center for Lean har vi samlet vores Six Sigma viden i en powerpoint præsentation som vi deler med jer.
Heri vil i kunne læse om de forskellige Six Sigma bælter; White belt, Yellow belt, Green belt, Black belt, Master black belt og det at være Champion i Six Sigma. Derudover vil vi komme ind på DMAIC-modellen, Define, Measure, Analyze, Improve og Control.
Hvis du har spørgsmål til vores Six Sigma og ønsker at høre mere om det eller er interesseret i et virksomhedsforløb hos jer som er skræddersyet til jeres processer så kan i kontakte os på kurser@centerforlean.dk eller telefon nummer +45 4261 6167.
Vil du sætte en høj standard i dit innovationsprojekt?Dansk Standard
Mange innovative virksomheder er ikke klar over, hvad standarder kan gøre i forbindelse med produktudvikling, og hvordan man bedst skal benytte sig af standarder. Denne vejledning giver nogle svar på, hvordan man som innovativ virksomhed kan skabe værdi ved hjælp af standarder.
Short talk on evaluation of new model for financing health care in the region of Southern Denmark.
Given at annual meeting of the Danish Society for Health Economy.
Evaluation team: Lene von Bülow, Katrine Prisak, Lars Morsø and Christian von Plessen
3. Good Distribution Practice (GDP)
Udvikling, registrering, fremstilling, kontrol og kvalitetssikring af
effektive og sikre lægemidler er som bekendt
ressourcekrævende.
4. Aktiviteter og dokumentation jf. gældende
- regler,
- love,
- bestemmelser
- tilladelser
Efterlevet godkendte
- systemer,
- standarder
-specifikationer
Frigives til salg af
- QP
Er alt som det så skal være ………
eller er der mere vi skal tænke på ?
We come to your Aid
5. Svar:
Ja, der er mere vi skal tænke på!
Fordi, der kan være lang vej fra lægemiddelproducentens lager og til
patienten:
Succeed with Quality
7. Svar:
JA! GDP er lige så vigtigt som GMP
Fordi:
Risko for efterfølgende
forringelse,
forfalskning,
inden der når frem til patienten.
We come to your Aid
8. God distributionspraksis
Al engros- og detailforhandling skal gennemføres i
overensstemmelse med god distributionspraksis.
Succeed with Quality
9. VIGTIGE REGELSÆT
Bekendtgørelse om distribution af lægemidler, BEK nr 1359
af 18/12/2012
Vejledning af 5. november 2013 i god distributionspraksis for
humanmedicinske lægemidler
Quality Support when you need it
10. GDP BEKENDTGØRELSEN NR.: 1359 AF 18/12/2012
Kapitel 1 - Bekendtgørelsens område
Kapitel 2 - Definitioner
Kapitel 3 - Tilladelse til
engrosforhandling
Kapitel 4 - Registrering af formidling
af lægemidler
Kapitel 5 - God distributionspraksis
Kvalitetssikringssystem
Organisation og personale
Lokaler og udstyr
Modtagelse og levering
Kontrolbevis
Dokumentation for modtagne og
leverede lægemidler
Reklamationer og tilbagekaldelser
Forfalskede lægemidler
Lager, distribution og modtagekontrol
efter kontrakt
Selvinspektion
Diverse
Kapitel 6 - God distributionspraksis for
formidling
Kvalitetssikringssystem
Ind- og udgående lægemidler
Tilbagekaldelse
Sletning fra listen over registrerede
formidlere
Kapitel 7 - Inspektion, videregivelse af
oplysninger m.v.
Straf- og ikrafttrædelsesbestemmelser
We come to your Aid
11. GDP VEJLEDNINGEN AF 5. NOVEMBER 2013
KAPITEL 1 — KVALITETSSTYRING
KAPITEL 2 — PERSONALE
KAPITEL 3 — LOKALER OG UDSTYR
KAPITEL 4 — DOKUMENTATION
KAPITEL 5 — AKTIVITETER
KAPITEL 6 — KLAGER, RETURNERINGER, FORMODEDE FORFALSKEDE
LÆGEMIDLER OG TILBAGETRÆKNING AF LÆGEMIDLER
KAPITEL 7 — AKTIVITETER UDLAGT I KONTRAKT
KAPITEL 8 — SELVINSPEKTIONER
KAPITEL 9 — TRANSPORT
KAPITEL 10 — SPECIFIKKE BESTEMMELSER FOR FORMIDLERE ( 1 )
KAPITEL 11 — AFSLUTTENDE BESTEMMELSER
DEFINITIONER
Succeed with Quality
12. God distributionspraksis
Engros- og detailforhandling
gennemføres i overensstemmelse med GDP.
Tidligere GDP vejledning var fra 1994
Gældende GDP vejledning af 5. november 2013
Formålet nye GDP vejledning
sikre kontrol med distributionskæden
opretholde lægemidlernes
kvalitet
integritet.
”indpasset GMP tankegang i GDP’en”
13. God distributionspraksis
Risikostyring
blevet et gennemgående princip inden for GDP området.
Ledelsen
-‘s ansvar er præciseret, som er ansvarlig for kvalitet systemet,
- ‘s review skal udføres.
Afvigelseshåndtering er beskrevet i den nye vejledning.
Transport området
detaljeret beskrevet.
Aktiviteter udlagt i kontrakt
beskrevet
styring
14. Lokaler og udstyr, der skal:
udformes;
dimensioneres;
anvendes;
vedligeholdes
sådan, at:
• de er velegnede til deres formål;
• effektiv rengøring kan foretages.
Lagerlokaler skal være tilstrækkeligt store til at muliggøre
opretholdelse af god orden og efterlevelse af hensigtsmæssigt
vareflow, f.eks. først ind først ud-princippet. Et særligt område skal
være beregnet til varer til destruktion.
15. Lagerhold skal foregå ved:
opbevaringsbetingelser, der er fastsat i en eventuel
markedsføringstilladelse eller af fremstilleren.
Temperaturen i lagerlokaler og køleudstyr skal kontrolleres
og dokumenteres.
Lægemidler skal opbevares utilgængeligt for
uvedkommende.
jf. Bekendtgørelse om distribution af lægemidler, BEK nr 1359 af 18/12/2012
Bemærk:
Mht. først ind først ud-princippet (FIFO), så opererer GDP
vejledningen af 5. november 2013 med det mere moderne princip:
”First Expire First Out (FEFO).
17. Enhver engrosforhandler skal etablere og benytte et
effektivt kvalitetssikringssystem, der aktivt
involverer ledelsen og de ansatte i de berørte
afdelinger i virksomheden.
Engrosforhandleren skal skriftligt dokumentere
kvalitetssikringssystemet, herunder beskrive
ansvarsområder, arbejdsgange og
risikostyringsforanstaltninger i tilknytning til
virksomheden.
Jf. Bekendtgørelse om distribution af lægemidler, BEK nr. 1359 af 18/12/2012.
KVALITETSSYSTEM
18. KVALITETSSYSTEM
Grossister skal råde over et kvalitetssystem med en beskrivelse af:
Ansvarsområder;
Arbejdsgange;
Risikostyringsforanstaltninger;
Kvalitetssystemet skal omfatte:
organisationsstrukturen;
procedurer;
arbejdsgange;
ressourcer;
aktiviteter
-for at kvaliteten og integriteten af det leverede lægemiddel opretholdes og at
lægemidlet forbliver i den lovlige forsyningskæde under opbevaring og/eller
transport.
19. Kvalitetssystemet:
dokumenteres fuldt ud;
effektiviteten overvåges;
Inkludere kvalitetshåndbog, el. tilsvarende.
Kvalitetssystemet skal sikre:
Lægemidler:
aftages;
opbevares;
leveres;
udføres
i overensstemmelse med GDP
20. Ledelsens ansvarsområder er klart defineret;
Lægemidler leveres til de rette modtagere inden for en
tilfredsstillende frist.
Journaler udarbejdes samtidigt
Afvigelser fra fastlagte procedurer dokumenteres og
undersøges.
Kvalitetssystemet skal sikre:
KVALITETSSYSTEM
21. Bemærk:
Hensyntagen til:
størrelsen;
strukturen;
kompleksiteten,
- af distributørens aktiviteter ved udvikling
eller ændring af kvalitetssystemet.
22. Hvilke SOP’er skal kvalitetssystemet indeholde?
- hent inspiration fra Sundhedsstyrelsens Industrimøde
om GMP vejledningen, afholdt 10. marts 2014.
23. RISIKOSTYRING
En systematisk proces for:
vurdering;
kontrol;
kommunikation;
gennemgang
-af kvalitetsrisici.
Anvendes proaktivt og retrospektivt.
Baseret på:
videnskabelig viden;
erfaringer med processen;
24. Indsats, formaliteter og dokumentation:
skal stå i relation til risikoen.
Risikostyring af alle aktiviteter udlagt i kontrakt.
Risikovurdering for:
• Audit frekvens for aktiviteter udlagt i kontrakt;
• gentagelse af temperatur mapping;
• frekvens for kalibrering af udstyr til temperaturkontrol;
• kvalificeringsomfang af udstyr;
• valideringsomfang af processer;
• afvigelser, i forbindelse med dokumentation for korrekt opbevaring af
returnerede lægemidler;
• transport planlægning;
• leveringsruter,
• identificere behov for temperaturkontrol.
Jf. Vejledning af 5. november 2013 i god distributionspraksis for humanmedicinske lægemidler.
RISIKOSTYRING
26. Afvigelser
Afvigelser fra fastlagte procedurer skal dokumenteres og
undersøges.
Der foretages relevante korrigerende og forebyggende
handelinger for at korrigere og forhindre afvigelser i
overensstemmelse med principperne for styring af kvalitetsrisici.
28. PERSONALE
Ledelsesansvar
Ansvaret for kvalitetssystemet, kræver:
lederskab;
aktiv deltagelse og engagement fra personalet.
Ledelsen skal udpege en kvalitetsansvarlig person,
som har bemyndigelse og ansvar for:
Kvalitetssystemet:
• implementeres;
• vedligeholdes.
29. Ledelsesansvar
Ledelsen skal sikre:
Kvalitetssystemet har tilstrækkelige ressourcer,
kompetent personale;
velegnede og tilstrækkelige lokaler;
velegnet og tilstrækkeligt udstyr.
Ledelsens ansvarsområder skal være klart defineret.
PERSONALE
30. Ledelsens gennemgang og overvågning
Formel proces for regelmæssig vurdering af kvalitetssystemet;
Omfatter:
opfyldelse af kvalitetssystemets målsætninger;
vurdering af resultatindikatorer:
• reklamationer;
• afvigelser;
• korrigerende og forebyggende handlinger;
• ændringer af arbejdsgange;
• feedback vedr. aktiviteter i kontrakt;
• risikovurderinger;
• audits;
• inspektioner;
• undersøgelsesresultater;
• kundeaudits.
nye forskrifter; nye vejledninger;
innovationer, som kan forbedre kvalitetssystemet;
ændrede målsætninger.
Dokumenteres rettidigt.
Kommunikeres effektivt internt.
PERSONALE
31. Den kvalitetsansvarlige person
Ansvarsområder:
Kvalitetssystemet
implementeres;
vedligeholdes.
Dokumentationens:
Nøjagtighed;
Kvalitet.
Grund- og videreuddannelsesprogrammer:
gennemføres;
vedligeholdes.
PERSONALE
32. Den kvalitetsansvarlige person
Koordinere og straks foretage:
eventuelle tilbagekaldelser;
Sikre at:
relevante reklamationer håndteres effektivt;
leverandører og kunder godkendes.
Godkende aktiviteter udlagt i kontrakt.
Selvinspektioner gennemføres:
regelmæssigt;
efter fastlagt program;
korrigerende handlinger gennemføres.
PERSONALE
33. Den kvalitetsansvarlige person
Udarbejde passende dokumentation vedr.:
uddelegerede opgaver.
Beslutte omkring:
returnerede;
afviste;
tilbagekaldte;
forfalskede;
• produkter
Godkende returnerede lægemidler til salgbar lagerbeholdning.
Sikre:
yderligere national lovgivning vedr. bestemte produkter overholdes.
Bemærk:
Den kvalitetsansvarlige person må godt uddelegere arbejdsopgaver,
men ikke ansvarsområder.
PERSONALE
34. Organisationsdiagram
- skal være til stede
Stillingsbeskrivelser
for medarbejdere i nøglestillinger
• roller;
• ansvarsområder;
• stedfortrædere.
PERSONALE
37. Lokaler og udstyr, der skal:
udformes;
dimensioneres;
anvendes;
vedligeholdes
sådan, at:
• de er velegnede til deres formål;
• effektiv rengøring kan foretages.
Lagerlokaler skal være tilstrækkeligt store til at muliggøre
opretholdelse af god orden og efterlevelse af hensigtsmæssigt
vareflow, f.eks. først ind først ud-princippet. Et særligt område skal
være beregnet til varer til destruktion.
LOKALER
38. Lagerhold skal foregå ved:
opbevaringsbetingelser, der er fastsat i en eventuel
markedsføringstilladelse eller af fremstilleren.
Temperaturen i lagerlokaler og køleudstyr skal kontrolleres
og dokumenteres.
Lægemidler skal opbevares utilgængeligt for
uvedkommende.
jf. Bekendtgørelse om distribution af lægemidler, BEK nr 1359 af 18/12/2012
Bemærk:
Mht. først ind først ud-princippet (FIFO), så opererer GDP
vejledningen af 5. november 2014 med det mere moderne princip:
”First Expire First Out (FEFO).
LOKALER
39. LOKALER
De foreskrevne opbevaringsbetingelser skal opfyldes.
Uautoriseret adgang skal forhindres
forebyggende foranstaltninger
besøgende ledsages
40. Lokaler skal:
være rene og tørre ! have tiltrækkelig kapacitet !
være tilstrækkelig oplyste !
LOKALER
41. Der er særlige opbevaringsbetingelser/tilladelser for:
narkotioka;
psykotrope stoffer;
ratioaktive stoffer
brandfarlige eller eksplosionsfarlige produkter
Særlige modtageområder
adskilt fra:
• opbevaringsområder;
• leveringsområder.
LOKALER
42. Lokaler og lagerfaciliteter skal være:
rene
fri for affald og støv
Skal have:
rengørings:
• programmer;
• instruktioner;
• journaler.
Velegnet:
• rengøringsudstyr
• midler
Program for forebyggende skadedyrsbekæmpelse
Beskyttet mod:
insekter;
gnavere;
andre dyr.
LOKALER
43. Lægemidler, hvor der er krav om fysisk adskillelse:
fra tredjelande, som ikke er bestemt til EU-marked;
udløbne;
tilbagetrukne;
afviste;
forfalskede;
til destruktion.
Lægemidler, hvor der er krav om fysisk, -eller elektronisk
adskillelse:
mangler afgørelse;
formodning om forfalskning;
returnerede.
LOKALER
49. EDB-systemer
Inden et edb-system tages i anvendelse skal det påvises via passende:
validering
-eller
verifikation
- at systemet kan levere de ønskede resultater:
• præcise;
• konsistente;
• repeterbare.
UDSTYR
51. Hvorfor skal dokumentation være skriftlig?
Svar: Fordi skriftlig dokumentation gør det muligt at:
undgå fejl, der opstår på baggrund af mundtlig
kommunikation.
Opnå sporbarhed for distributionen af lægemidler.
Dokumentation omfatter:
• skriftlige procedurer;
• instruktioner;
• kontrakter;
• journaler;
• data.
DOKUMENTATION
52. Modtagelse af lægemidler
Formål:
Sikre at:
• den ankomne forsendelse er korrekt;
• lægemidlerne stammer fra godkendte leverandører;
• lægemidlerne ikke er blevet synligt beskadige under transporten;
• lægemidlerne hurtigt anbringes ved korrekte opbevaringsbetingelser;
• lægemidlerne er godkendt til salg, inden de overføres til salgbar lagerbeholdning.
-kontrolbevis ved levering fra andre EU/EØS-lande.
Dokumentation for modtagne lægemidler
Indehavere af en tilladelse til engrosforhandling af lægemidler skal opbevare dokumentation for alle
modtagne lægemidler i form af oplysninger om:
dato for modtagelsen,
præcis angivelse af lægemidlets navn,
modtaget mængde,
lægemiddelform, styrke og pakningsstørrelse,
leverandørens navn og adresse samt
modtagerens navn og adresse.
Ved modtagelse af lægemidler fra fremstiller, importør eller anden engrosforhandler skal dokumentationen
endvidere indeholde oplysninger om batchnummer og udløbsdato.
53. Opbevaring af lægemidler
adskilt fra andre produkter, som kan ændre
dem;
beskyttet mod skadelige virkninger af:
• lysforhold;
• temperaturer;
• fugt.
i overensstemmelse med
opbevaringsbetingelserne.
muliggøre, at de produkter, der udløber
først, sælges først.
undgå:
• spild;
• beskadigelse;
• forurening;
• sammenblanding,
• opbevaring direkte på gulvet
Jf. Vejledning af 5. november 2013 i god distributionspraksis for humanmedicinske lægemidler
54. Lægemidler, der nærmer sig deres udløbsdato:
Fjern fra den salgbare lagerbeholdning:
• fysisk
-eller
• elektronisk
Lægemidler til salg skal have en passende resterende holdbarhed.
Destruktion af ikke salgbare varer:
Lægemidler der skal destrueres:
identificeres;
opbevares særskilt;
skriftlig procedure.
efter gældende regler vedr.:
• håndtering;
• transport;
• bortskaffelse.
der skal føres/opbevares journaler
Opbevaring af lægemidler
55. Dokumentation for leverede lægemidler
Indehavere af en tilladelse til engrosforhandling af lægemidler skal opbevare og vedlægge
dokumentation for alle leverede lægemidler til apoteker samt til virksomheder og personer,
der ifølge dansk eller fremmed lovgivning har tilladelse til at udlevere lægemidler til brugerne,
herunder lægemidler eksporteret til lande udenfor EU/EØS (tredjelande), i form af oplysninger
om:
dato for leveringen,
præcis angivelse af lægemidlets navn,
leverede mængde,
lægemiddelform, styrke og pakningsstørrelse,
modtagerens navn og adresse samt
leverandørens navn og adresse.
Ved leverancer af lægemidler til anden engrosforhandler skal dokumentationen udover det
anførte endvidere indeholde oplysninger om batchnummer og udløbsdato.
Ved leverancer af lægemidler til dyr skal dokumentationen udover det anførte endvidere
indeholde oplysninger om batchnummer og udløbsdato.
59. Grossisters indgåelse af ny kontrakt med ny leverandør:
Vurdering af:
- egnethed;
- kompetence;
- pålidelighed.
• Med fokus på:
- omdømme eller pålidelighed;
- tilbud om lægemidler, der ofte forfalskes;
- tilbud om store mængder af lægemidler, som generelt kun
findes i begrænsede mængder,
- Unormale priser.
60. Kvalificering af kunder
Grossister må kun levere lægemidler til personer, som:
har engrosforhandlingstilladelse;
-eller
har bemyndigelse til at udlevere lægemidler til forbrugerne.
Kontroller og efterkontroller:
tilladelser i henhold til national lovgivning;
statuskontrol på en myndigheds website;
anmodning om dokumentation for kvalifikationer eller bemyndigelse
jf national lovgivning.
61. Grossister bør:
overvåge kundernes transaktioner;
undersøge alle uregelmæssigheder vedr. salg af:
• narkotika;
• psykotrope stoffer;
• andre farlige stoffer.
undersøge og rapportere usædvanlige salgsmønstre til de kompetente
myndigheder;
overvåge kundernes evt. pålagte forpligtelser til public service.
62. Aktiviteter udlagt i kontrakt
defineres;
fastlægges;
kontrolleres;
- for at undgå misforståelser.
Skriftlig kontrakt mellem kontraktgiver og kontrakttageren;
Fastlægge begge parters forpligtelser.
Kontraktgiver
Ansvar:
Vurdering af kontrakttagerens kompetence;
Sikre at GDP efterkommes:
via kontrakten;
via audits:
- inden aktiviteterne startes;
- ved ændringer;
videregive nødvendige oplysninger til kontrakttager.
63. Kontrakttager
Ansvar:
• Lokaler;
• Udstyr;
• Procedurer;
• Viden;
• Erfaringer;
• Kompetent personale.
Uddelegering til tredjepart:
• Kontraktgiverens:
• evaluering og godkendelse af aftalen;
• audit af tredjeparten.
Videregive oplysninger til kontraktgiver.
Transport udført af tredjepart
Kontrakt;
Grossisten skal informere om transportbetingelser;
64. Lager, distribution og modtagekontrol efter kontrakt
Engrosforhandleren (kontraktgiver) kan overlade til andre (kontrakttagere) at
udføre:
modtagelse (herunder modtagekontrol);
lagerhold;
distribution,
såfremt:
Fortsættes næste slide
65. Reklamationer og tilbagekaldelser
Der skal indføres et effektivt system til:
behandling af sager vedrørende reklamationer og mangler;
dokumenterer, hvorledes disse er blevet behandlet;
gør det muligt at tilbagekalde lægemidler i distributionsnettet omgående
og på ethvert tidspunkt efter ordrer fra Sundhedsstyrelsen eller i samarbejde
med fremstilleren, importøren eller indehaveren af markedsføringstilladelsen
for det pågældende lægemiddel.
Jf. Bekendtgørelse om distribution af lægemidler, BEK nr 1359 af 18/12/2012
66. Reklamationer
Journal:
• inkl. alle oprindelige oplysninger;
• tilgængelig for kompetente myndigheder.
Håndtering:
• jf. skriftlig procedure;
• udnævn ansvarlig for håndtering.
Skeln mellem:
• reklamationer vedr. lægemidlets kvalitet;
• underret straks fremstilleren/indehaver af markedsføringstilladelsen.
-eller
• reklamationer relateret til distributionen;
• grundig undersøgelse for at finde årsag.
Efter undersøgelse og evaluering:
• korrigerende handlinger;
• forebyggende handlinger;
• hvis relevant:
• underret Sundhedsstyrelsen.
Jf. Vejledning af 5. november 2013 i god distributionspraksis for humanmedicinske lægemidler
67. Tilbagekaldelse af lægemidler
Journal:
• der skal føres journal over enhver tilbagetrækning;
• tilgængelig for kompetente myndigheder;
• inkl. løbende status.
Håndtering:
• jf. skriftlige procedurer;
• evaluering af effektiviteten af procedurer, -mindst 1
gang om året.
• skal kunne iværksættes straks og til enhver tid;
68. Tilbagekaldelse af lægemidler
distributionsjournaler:
• let tilgængelige for ansvarlige for tilbagekaldelser;
• indeholde tilstrækkelige oplysninger om:
• distributører;
• kunder;
• kontaktoplysninger;
• batchnumre;
• leverede mængder,
• inkl.:
• eksporterede varer;
• lægemiddelprøver.
Hvis distributøren modtager en tilbagetrækningsmeddelelse:
• instruktionerne skal følges.
• kompetente myndigheder kan kræve godkendelse.
Endelig rapport.
69. Returnerede lægemidler
Vurdering:
• Skal vurderes før godkendelse til gensalg.
Håndteres ved:
• Skriftlig, risikobaseret proces.
• Hensyntagen til:
• pågældende produkt;
• specifikke opbevaringsbetingelser;
• tid, siden lægemidlet blev afsendt.
• Skal ske i overensstemmelse med:
• national lovgivning;
• kontraktlig aftale mellem parterne.
70. Returnering til salgbar lagerbeholdning kræver:
• uåbnet og ubeskadiget sekundæremballage;
• god stand;
• ikke udløbet;
• ikke tilbagekaldt;
• returnering inden for en acceptabel tidsfrist,
• transporteret, opbevaret og håndteret i overensstemmelse med specifikke
opbevaringsbetingelser;
• undersøgelse af lægemidlerne af en behørigt uddannet og kompetent person
• distributøren kan godtgøre, at lægemidlet oprindeligt blev leveret til den pågældende
kunde;
• batchnummeret er kendt;
• der er ikke mistanke om at lægemidlet er forfalsket;
• dokumentations for at særlige opbevaringsbetingelser (fx kølevarer) har været opfyldt;
hvor afvigelser kræver risikovurdering:
• levering til kunden;
• undersøgelse af lægemidlet;
• åbning af transportemballagen;
• tilbagelægning af lægemidlet i emballagen;
• indsamling og returnering til distributøren;
• returnering til køleskabet på distributionsstedet.
71. Forfalskede lægemidler
Engrosforhandlere og apoteker
skal sikre, at lægemidler, der er eller kan være forfalskede,
opbevares adskilt fra andre lægemidler.
Lægemidlerne skal desuden mærkes, så det er tydeligt, at
de ikke er til salg eller udlevering.
72. Hvad er et forfalsket lægemiddel?
Ethvert lægemiddel med en urigtig beskrivelse af dets:
identitet;
• emballage;
• etikettering;
• navn;
• sammensætning.
oprindelse;
• fremstiller;
• fremstillingsland;
• oprindelsesland,
• indehaveren af markedsføringstilladelsen;
historie;
• Optegnelser, dokumentation vedr.:
• distributionskanaler.
Forfalskede lægemidler
73. Skriftlige procedurer
Journaler;
Konsekvent tilgang,
• blandt alle parter i forsyningskæden.
Ved mistanke om forfalskning, eller konstatering af forfalskning:
• Grossister skal straks underrette:
• den kompetente myndighed;
• indehaver af markedsføringstilladelsen.
Transport:
• Leverandørgrossistens ansvar:
• beskytte lægemidlerne mod forfalskning.
75. SELVINSPEKTION
Engrosforhandleren skal med jævne mellemrum foretage selvinspektion som led i
kvalitetssikringssystemet for at:
kontrollere gennemførelsen og overholdelsen af principperne for god
distributionspraksis;
foreslå de ændringer, der måtte være nødvendige.
Der skal føres journaler over:
udførte selvinspektioner
korrigerende handlinger.
gennemføres inden for fastlagt tidsfrist;
76. omfatter:
• alle aspekter af GDP;
• overholdelse af:
- forskrifter;
- vejledninger;
- procedurer;
uvildigt og grundigt;
af udpegede og kompetente medarbejdere.
rapporter:
• indeholde alle iagttagelser;
• kopi til ledelsen.
Afvigelser:
• Root cause analysis
Korrigerende og forebyggende handlinger:
• dokumentation;
• opfølgning.
Audits fra uafhængige, eksterne eksperter erstatter ikke selvinspektioner.
SELVINSPEKTION
80. TRANSPORT
Leverandørgrossistens ansvar:
At beskytte lægemidlerne mod:
• beskadigelse;
• forfalskning;
• tyveri.
Sikre, at temperaturerne holdes inden for acceptable
grænser under transporten.
81. • kvalitet
• integritet
-ser det sådan ud? -eller sådan?
-sådan måske? -eller er det sådan, det forgår?
TRANSPORT
82. Hvor får man oplysninger om de korrekte transportbetingelser?
Svar:
• fra fremstilleren
• fra beskrivelse på ydre emballage
Afvigelser under transport
• Hvis der under transporten sker:
• temperaturudsving;
• produktbeskadigelser
• rapportering til:
• distributør;
• modtager.
• Følg procedure for:
- undersøgelse;
- håndtering.
TRANSPORT
83. Køretøjer og udstyr
Grossistens ansvar at sikre:
• Egnede
• Udstyret til at forhindre forringelse af lægemidlernes:
• kvalitet
• integritet
Skriftlige procedurer for:
• drift;
• vedligehold;
• rengøring;
• sikkerhedsforanstaltninger.
Udstyr til temperaturovervågning under transport i:
• Køretøjer;
• Beholdere;
• vedligehold;
• kalibrering mindst én gang om året.
TRANSPORT
84. Så vidt muligt dedikerede køretøjer og udstyr.
ellers procedurer:
• der sikrer, at lægemidlernes kvalitet ikke forringes.
!
TRANSPORT
85. Temperaturfølsomme produkter:
• termisk emballage;
• temperaturstyrede beholdere;
• temperaturstyrede køretøjer:
• udstyr til temperaturovervågning under transport:
-regelmæssig kalibrering;
-regelmæssigt vedligehold.
• temperatur mapping:
-repræsentative betingelser;
-sæsonudsving.
TRANSPORT