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POINT and CLICK VALIDATION PROTOCOLS.


USEFUL LINKS.
UK

  • Food and Drug Administration (FDA) Home Page
  • FDA - Centre for Biologics Evaluation and Research
  • FDA - Centre for Drug Evaluation and Research
  • FDA - Code of Federal Regulations
  • FDA - Inspection References: Index
  • FDA - Inspection Guides
  • FDA - New guidance documents
  • FDA - Warning Letters - General Searches

Pharmaceutical Inspection Co-operation Scheme

Australia

Jargon Buster

Europe

  • European Medicines Agency (EMA)
  • "Eudralex" Rules Governing Medicinal Products In The EU
  • Quality Working Party Guidelines - for EU Marketing Authorisation Applications

Qualified Person

  • Guidance Notes to Assist the QP
  • Royal Society of Chemistry
  • Institute of Biology
  • Royal Pharmaceutical Society of Great Britain

International Conference On Harmonisation

WHO - World Health Organisation

Pharmacopoeias

  • US Pharmacopoeia
  • European Pharmacopoeia (EDQM)
  • British Pharmacopoeia



DISASTER RECOVERY PLANS & PROCEDURES.
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PONT and CLICK VALIDATION PROTOCOLS.