Investigation

responsible for

4.2 Department Heads: Investigation for

5. Procedure

5.1 Preparation/Updation and of Documents:

5.2 Distribution of Investigation Definitions

7. Document archival

8. Destruction documents

Attachment 1 Archived GMP Investigation Issue & Retrieval Record

Attachment Distribution Record of GMP Investigation 3 GMP Document/Record Destruction Drug Product SITE MASTER Investigation (SMF) is the site important GMP document giving Investigation general overview about the and it operations. From Investigation November 2002, the Guidelines the Preparation of a Investigation MASTER FILE (first edition, 2000) have been replaced Investigation the PIC/S Explanatory Notes Industry on the Preparation Investigation a Site Master File, November 2002. This to Investigation industry standards created SITE FILE used as a Investigation the guidance of the Commission Directorate General III Investigation Harmonisation of Inspections in EU as well as Investigation PIC Recommen

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Investigation

GMP Investigation

Created to systematically identify Investigation opportunities, weaknesses and threats GMP regard to Organization, Personnel, Investigation Documents, Facilities, Utilities such GMP Water Systems, Clean Steam Investigation HVAC, Manufacturing and Analytical GMP Development Reports, Holding Time Investigation Key Excipients, Manufacturing Process, GMP and Microbiological Testing including Investigation Transfer, Method Validation and GMP Packaging Operations and Contractors Investigation The actual status of GMP actions on previous inspection Investigation well as regulatory documentation GMP be completed is also Investigation at different time points GMP this checklist. The PAI Investigation will enable you to GMP gaps at your site Investigation an early stage during GMP preparation, starting normally 12 Investigation before file submission and GMP give you the opportunity Investigation close the identified deficiencies GMP finalize the pending plans Investigation reports in an organized GMP timely manner. Crucial elements Investigation the PAI Protocol are GMP four monitoring key milestones Investigation 3, months before GMP submission and one week Investigation inspection. The actual progress GMP the PAI preparation status Investigation be monitored at any GMP The purpose of Investigation Standard Operation Procedure is GMP ensure that all changes Investigation to any aspect of GMP testing, holding and distribution Investigation assessed and consequently addressed GMP their impact on the Investigation strength, quality, and purity GMP the drug product including Investigation assessment of the qualification GMP validation status and the Investigation situation. The purpose of GMP procedure is to ensure Investigation all Deviations are: Investigated GMP 30 working days, all Investigation are completely documented, assessed GMP the responsible line units Investigation QA, corrective actions if GMP are implemented and implementation Investigation tracked, the complete process GMP managed, monitored and controlled. Investigation considers the integrity of GMP testing documentation records to Investigation of fundamental

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