Standards and Guidelines
Below Standards & Guidelines followed by Akility.
ISPE - GAMP® 5 (Good Automated Manufacturing Practice) guidance:
- GAMP® 5 : A Risk-Based Approach to Compliant GxP Computerized Systems - ISPE 2008
- GAMP® 5 : Quality Risk Management Approach
- IT Infrastructure Control and Compliance - ISPE 2017
- Considerations for a Corporate Data Integrity Program - ISPE 2017
- GAMP® Guide: Records & Data Integrity - ISPE 2017
Eudralex (European Commission) GMP references :
- EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
- EudraLex - Volume 4 - Annex 11 - Computerised Systems
- EudraLex - Volume 4 - Annex 15 - Qualification and Validation
- EudraLex - Volume 4 - Chapter 7 - Outsourced Activities
- EudraLex - Volume 4 - Glossary
Eudralex (European Commission) GDP references :
- Good Distribution Practice (GDP) of medicinal products for human use
- Good Distribution Practice (GDP) for active substances for medicinal products for human use
- Questions and Answers on GDP
Falsified Medicines Directive (FMD)
Directive 2011/62/EU of the European parliament and of the council of 8 June 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products:
Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (text with EEA relevance) :
- Commission delegated regulation (EU) 2016/161 of 2 October 2015 (English)
- Règlement délégué (UE) 2016/161 de la commission du 2 octobre 2015 (Français)
- Other languages
EMA (European Medicine Agency) references :
- ICH guideline Q9 on quality risk management
- EMA GMP Data Integrity Guidance - August 2016
- European Medicines Agency (EMA) Master Data Management Roadmap - April 2015
FDA (US Food & Drug Administration) references :
- 21 CFR Part 11 (eCFR) - Electronic Records; Electronic Signatures
- 21 CFR Part 11 - Electronic Records; Electronic Signatures — Scope and Application
- 21 CFR Part 210 (eCFR) - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General
- 21 CFR Part 211 (eCFR) - Current Good Manufacturing Practice for Finished Pharmaceuticals
- Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry - December 2018
- Current expectations and Guidance, including Data Integrity and Compliance with cGMP - June 2016
MHRA (Medicines & Healthcare products Regulatory Agency) references :
- MHRA GxP Data Integrity Guidance and Definitions - March 2018
- MHRA GxP Data Integrity Definitions and Guidance for Industry - Draft version for consultation July 2016
Santé Canada - Health Canada references :
- Good Manufacturing Practices (english)
- Lignes directrices des Bonnes Pratiques de Fabrication (français)
PIC/S (Pharmaceutical Inspection Co-operation Scheme) references :
- PIC/S PI 011-3 - Good practices for computerized systems in regulated GxP environments
- PIC/S PI 041-1 - Good practices for data management and integrity in regulated GMP/GDP environments - 10 August 2016 (draft 2)
- PIC/S PI 041-1 - Good practices for data management and integrity in regulated GMP/GDP environments - 30 November 2018 (draft 3)
USP (US Pharmacopeia) references :
- USP <1058> Analytical Instrument Qualification
- Harmonizing USP <1058> and GAMP for Analytical Instrument Qualification
WHO (World Health Organisation) references :
PDA Journal (Parenteral Drug Association) references :
- Data Integrity—A Study of Current Regulatory Thinking and Action - 2015
- Data Integrity Case Studies - March 2017
IVT Network (Institute of Validation Technology) references :
- Audit Trails Reviews for Data Integrity - Oct. 2015
- Data Integrity Strategies for Quality Control Laboratories - March 2017 (pdf version)
ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé- France) references :
Microsoft GxP references :
- Microsoft Azure GxP Guidelines (April 2018)
COBIT (Control Objectives for Information and Related Technologies) references :