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Externe verwijzingen

EU referenties:

  • Eudralex volume 4 Good Manufacturing Practice (GMP): Medicinal Products for Human and Veterinary Use
  • EU Annex 11: EudraLex, Volume 4, GMP Annex 11: Computerised Systems
  • EMA Questions & Answers: Good manufacturing practice, Data Integrity

UK & MHRA referenties:

  • MHRA ‘GXP’ Data Integrity Guidance and Definitions, March 2018

US referenties:

  • US 21 CFR Part 210, 211, 11 
  • US Food and Drug Administration, Guidance for Industry, Data Integrity and Compliance in CGMP, December 2018

Algemene referenties:

  • ISPE - International Society for Pharmaceutical Engineering
  • WHO - Guideline Good Data and Record Management Practices (June 2016)
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