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Links and documents
Please help us by reporting bad links via e-mail info@key2compliance.com or phone +46-(0)8 544 811 60.
For your convenience we have listed some of the most useful GMP reference links to relevant web sites and documents.
The documents directly available on the internet have a link to the document itself. The documents marked with * are not free, but can be ordered from the linked web site.
Compliance Links
» CFR (Codes of Federal Regulations, USA)
» Contamination Control / Cleanrooms
» European GMP
» FDA
» Industry Associations
» Magazines, Newsletters & Web news
» Standard organisations
» Other links
- CFR, Codes of Federal Regulations, USA
- Title 21 Food and Drugs
- 21 CFR 11, Electronic records; electronic signatures
- 21 CFR 58, Good Laboratory Practice for Nonclinical Laboratory Studies
- 21 CFR 210, CGMP in manufacturing, processing, packing, or holding of drugs; general
- 21 CFR 211, CGMP for finished pharmaceuticals
- 21 CFR 606, CGMP for blood and blood components
- 21 CFR 803, Medical device reporting
- 21 CFR 806, Medical devices; reports of corrections and removals
- 21 CFR 809, In vitro diagnostic products for human use
- 21 CFR 820, Quality System Regulation, Medical Device
- 21 CFR 821, Medical device tracking requirements
- 21 CFR 1271 Human cells, tissues, and cellular and tissue-based products
- US government internet law library to search CFRs
- EP– European Pharmacopoeia, European Department for the Quality of Medicines
- EMEA The European Agency for the Evaluation of Medicinal Products
- Eudralex, The Rules Governing Medicinal Products in the European Union
- Eudralex Vol 4, Medicinal products for human and veterinary use: Good manufacturing practices
- HMA, Heads of Medicines Agencies
- PIC/S Pharmaceutical Inspection Cooperation Scheme
- Svenska Läkemedelsverket
- Tillsyn av tillverkning av och handel med läkemedel - GMP/GDP
- Avvikelser funna vid inspektion av tillverkare och partihandlare
- FDA, Food and Drug Administration, USA
- CBER, Center for Biologics Evaluation and Research
- CDER, Center for Drug Evaluation and Research
- DMPQ, Division of Manufacturing and Product Quality
- CGMP Notes
- Preamble 21CFR210/211 (Text file)
- CDRH, Center for Devices and radiological health
- Medical Device Quality Systems Manual
- FDA Talk Papers
- Freedom of Information, Electronic reading room
- ORA, Office of Regulatory Affairs
- ORA Guide to Inspections
- Federal Food, Drug, and Cosmetic Act
- A3P, Association pour les Produits Propres et Stériles
- AAMI, Association for the Advancement of Medical Instrumentation
- AdvaMed, Advanced Medical Technology Association (Formerly HIMA)
- American Association of Blood Banks
- American Association of Pharmaceutical Scientists
- AOAC International, Association of Analytical Communities
- Biotechnology Industry Association
- Drug Information Association, DIA
- Food and Drug Law Institute
- HIMA (See AdvaMed)
- IFPMA, International Federation of Pharmaceutical Manufacturers Association
- IPEC, International Pharmaceutical Excipients Council
- ISPE, International Society for Pharmaceutical Engineering
- Medical Device Manufacturers Association (MDMA)
- Parenteral Drug Association, PDA
- Pharmaceutical Research and Manufacturers of America, PhRMA
- SFSTP, Société Française des Sciences et Techniques Pharmaceutiques
- RAPS, Regulatory Affairs Professionals Society
- The Parenteral Society
- Biopharm
- Cleanroom Technology
- Dickinson's FDA Review
- Dickinson's FDA Webview
- fdainfo.com
- FDAnews
- Journal Of Validation Technology
- Medical Device Link
- pharmaceuticalonline.com
- Pharmaceutical Engineering
- Pharmacetical Technology Europe
- PDA Letter
- PDA Journal
- Renhetsteknik
- The Gold Sheet
- AAMI, Association for the Advancement of Medical Instrumentation
- ANSI, American National Standards Institute
- ASQ, American Society of Quality
- ASTM, American Society for Testing and Materials
- GAMP (ISPE)
- Global Harmonization Task Force, GHTF (Medical Device)
- ICH, International Conference on Harmonization
- IEEE Standards Association (IEEE-SA)
- ISO
- USP, United States Pharmacopoeia
- U.S. National Institute of Standards and Technology, NIST
Note!
If you want a powerful tool for searching regulations and interpretations, take a look at KEY2GMP™, our on-line search system.
Document Links
» CFR (Codes of Federal Regulations, USA)
» Computer Systems & Software
» Design Control and Validation for Medical Device
» European GMP
» FDA
» Laboratories
» Medical Device, QSR
» Pharmaceuticals and API
» Sterile processing
» Validation / Qualification
- CFR, Codes of Federal Regulations, USA
- Title 21 Food and Drugs
- 21 CFR 11, Electronic records; electronic signatures
- 21 CFR 58, Good Laboratory Practice for Nonclinical Laboratory Studies
- 21 CFR 210, CGMP in manufacturing, processing, packing, or holding of drugs; general
- 21 CFR 211, CGMP for finished pharmaceuticals
- 21 CFR 606, CGMP for blood and blood components
- 21 CFR 803, Medical device reporting
- 21 CFR 806, Medical devices; reports of corrections and removals
- 21 CFR 809, In vitro diagnostic products for human use
- 21 CFR 820, Quality System Regulation, Medical Device
- 21 CFR 821, Medical device tracking requirements
- 21 CFR 1271 Human cells, tissues, and cellular and tissue-based products
- US government internet law library to search CFRs
- Directive 1999/93/EC - Electronic Signatures
- EU guide to Good Manufacturing Practice, Annex 11 Computerized Systems
- FDA Guidance for Industry - Computerized Systems used in Clinical Investigations, May 2007
- FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application
- FDA Guide to inspection of Computerized Systems In Drug Processing
- GAMP -Good Automated Manufacturing Practice Guide by ISPE*
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Jan 2002
- Glossary of Computerized System and software development terminology
- Human Drug CGMP Notes
- PDA Technical Report no. 32 - Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations*
- PDA (Parenteral Drug Association) Technical Report no. 31 - Validation and Qualification of Computerized Laboratory Data Acquisition Systems*
- PIC/S Guide "Good Practices for Computerised Systems in Regulated "GXP" environments"
- Design Control Guidance for Medical Device Manufacturers
- Global Harmonisation Task Force, Process validation guidance
- Guideline on General Principles of Process Validation
- Incorporating Human Factors Engineering into Risk Management
- Quality Systems Manual, Chapter 3 - Design Control
- Quality Systems Manual, Chapter 4 - Process validation
- Quality Systems Manual, Chapter 7 - Equipment and calibration
- Write It Right - Recommendations for Developing User Instruction Manuals for Medical Devices......
- APIC Publications (Active Pharmaceutical Ingredients Committee)
- APIC Position papers (Active Pharmaceutical Ingredients Committee)
- Eudralex, The Rules Governing Medicinal Products in the European Union
- Eudralex Vol 4, Medicinal products for human and veterinary use: Good manufacturing practices
- PIC/S Publications (Pharmaceutical Inspection Convention,Pharmaceutical Inspection Cooperation Scheme)
- Svenska Läkemedelsverket, Avvikelser funna vid inspektion av tillverkare och partihandlare
- Svenska Läkemedelsverket, Svensk läkemedelsstandard 2008.2
- Compliance Program Guidance Manual: Pre-Approval Inspections/Investigations
- CDER, Guidance Documents
- Debarment List
- Federal Food, Drug, and Cosmetic Act
- Freedom of Information, Electronic reading room
- Guidance for Industry and FDA (Draft), Current Good Manufacturing Practice for Combination Products
- Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations
- Human Drug CGMP Notes
- Medical Device Quality Systems Manual
- ORA Guide to Inspections
- Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach, Final Report
- FDA News, FDA Issues Final Report on Its "21 st Century" Initiative
- Post Approval Audit Inspections
- Preamble 21CFR210/211 (Text file)
- Search page for Warning Letters
- FDA Guidance for Industry; Investigating Out of Specification (OOS) Test Results for Pharmaceutical Production
- FDA Guide to inspections of Pharmaceutical Quality Control Laboratories
- FDA Guide to inspections of Microbiological Pharmaceutical Laboratories
- Compliance Program 7382.845, Inspection of Medical Device Manufacturers
- Design Control Guidance for Medical Device Manufacturers, March 11, 1997
- Federal Register/Vol. 61, No. 195 / October, 7, 1996 - 21 CFR 808, 812 and 820 incl. Preamble
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
- Global Harmonization Task Force SG3, Process Validation Guidance
- Global Harmonization Task Force, SG3, Implementation of Risk Management Principles and Activities Within a Quality Management System
- Guideline for the manufacture of IVD products
- Medical Device Quality Systems Manual
- QSIT Inspection Handbook
- EU Annex 15; Qualification and Validation
- FDA Guideline on General Principles of Process Validation
- FDA Guidance for Industry, Changes to an approved NDA/ANDA
- FDA Guidance for Industry, Investigators, and Reviewers Exploratory IND Studies
- FDA Guidance for Industry — CGMP for Phase 1 Investigational Drugs
- FDA Draft Guidance for Industry. Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients
- Field Compliance Program: Drug Manufacturing Inspections
- Field Compliance Program: Active Pharmaceutical Ingredients
- Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug Product
- Guide to Inspections of Oral Solid Forms Pre/Post Approval Issues for Development and Validation
- Guide to Inspections Validation of Cleaning Processes
- Human Drug CGMP Notes
- ICH Guideline: Q7 GMP Guidance for Active Pharmaceutical Ingredients
- ICH Guideline: Q8: Pharmaceutical Development
- ICH Guideline: Q9: Quality Risk Management
- ICH Guideline: Q10: Pharmaceutical Quality System
- Recommendation on the Validation of Aseptic Processes, PIC/S
- Validation Master Plan, IQ and OQ, Non-Sterile Process Validation, Cleaning Validation, PIC/S
- FDA CDRH Guidance for Sterilants and Disinfectants
- FDA Guideline for LAL test Validation
- FDA, Sterile Drugs Products Produced by Aseptic Processing CGMP, September 2004
- Field Compliance Program: Sterile Drug Process Inspections
- Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug Product
- Human Drug CGMP Notes
- "Inspection guides" and "Technical Guides"
- Recommendation on the Validation of Aseptic Processes, PIC/S
- EU Annex 15; Qualification and Validation
- FDA Guideline on General Principles of Process Validation
- FDA Draft Guidance for Industry; Analytical Procedures and Methods Validation
- FDA Reviewer Guidance; Validation of Chromatographic Methods
- FDA Guidance for Industry; Bioanalytical Method Validation
- FDA Guidance for Industry PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing,and Quality Assurance
- FDA Guidance for Industry; INDs for Phase 2 and 3 Studies
- FDA Compliance Policy: Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval (CPG 7132c.08)
- FDA Guideline for Submitting Samples and Analytical Data for Methods Validation
- PDA Technical Report No.33; Evaluation , Validation and Implementation of New Microbiological Testing Methods*
- ICH Guideline; Q2(R1) Validation of Analytical Procedures: Text and Methodology
- Validation Master Plan, IQ and OQ, Non-Sterile Process Validation, Cleaning Validation, PIC/S