OFFICIAL SOURCE DIRECTORY
A bounded library of official original documents and indexes relevant to cleaning validation, GMP, HBEL and quality risk. The summaries are our own descriptions; follow the original link for the complete source.
Showing all 7 sources
HBEL · European Medicines Agency (EMA)
EMA scientific guideline for establishing health-based exposure limits used when assessing risk in shared manufacturing facilities.
Cleaning validation · Pharmaceutical Inspection Co-operation Scheme (PIC/S)
PIC/S recommendations addressing validation planning, equipment qualification, process validation and cleaning validation. Document edition: October 2026.
Quality risk management · International Council for Harmonisation (ICH)
ICH guideline describing the quality risk management process, decision-making and supporting methods for pharmaceutical quality. Document edition: January 2023.
Qualification and validation · European Commission
EU GMP annex addressing the planning, documentation and lifecycle of qualification and validation activities. Document edition: March 2015.
Data integrity · Pharmaceutical Inspection Co-operation Scheme (PIC/S)
PIC/S guidance on data governance and the integrity of paper-based and computerised records in regulated GMP/GDP environments. Document edition: July 2021.
GMP · European Medicines Agency (EMA)
EMA index of scientific guidelines for human medicines, including quality and manufacturing guidance.
GMP · Pharmaceutical Inspection Co-operation Scheme (PIC/S)
Official PIC/S publication index for inspection-related guidance and explanatory documents.
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