GOOD DOCUMENTATION AND QUALITY …

good DOCUMENTATION ANDQUALITY management PRINCIPLESV imal SachdevaTechnical Officer (Inspector), WHO Prequalification of Medicines ProgrammeContents1. Why good DOCUMENTATION is essential?2. What constitutes good DOCUMENTATION ?3. QUALITY management4. Deviation control5. Change control6. Risk management7. Product QUALITY review8. SummaryWhy good DOCUMENTATION is essential? An essential part of the QUALITY assurance system and should exist for all aspects of GMP (reference: WHO GMP,Volume 2) good DOCUMENTATION practice is an expected practice! Correct, complete, current, and consistent informationeffectively meet customer and stakeholder' requirements Helps to reduce observations raised on inadequatedocumentation constitutes good DOCUMENTATION ? Approve, review and update documents Changes & current revision status of documents identified Relevant versions of applicable documents available at points of use Documents remain legible and readily identifiable Documents of external origin identified and their distribution controlled Prevent unintended use of obsolete documents, and on poor DOCUMENTATION practices Document error correction not signed/dated, and didn t include areason for the correction Write-overs, multiple line-through and use of "White-out" or othermasking device Sample sequence table and audit trail not documented (if its not documented, it didn t)

GOOD DOCUMENTATION AND QUALITY MANAGEMENT PRINCIPLES Vimal Sachdeva Technical Officer (Inspector), WHO Prequalification of Medicines Programme

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