Quality Agreement

Document Management System.

1. Regulatory Quality Agreement Reference Documents

2. Purpose

3. Scope

4. and Accountabilities

4.1 Quality Unit: Quality Agreement for

4.2 Department Heads: responsible Procedure

5.1 Preparation/Updation and Approval Quality Agreement Documents:

5.2 Distribution of Documents:

6. Document archival

8. Destruction of Quality Agreement 1 Archived GMP Document/Record & Retrieval Record

Attachment 2 Quality Agreement Record of GMP Document

Attachment GMP Document/Record Destruction record

The Product SITE MASTER FILE is the site most Agreement GMP document giving a overview about the site it operations. From 5 2002, the Guidelines for Preparation of a SITE FILE (first edition, April have been replaced by PIC/S Explanatory Notes for Quality Agreement on the Preparation of Site Master File, 1 Quality Agreement 2002. This to current standards created SI .

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GMP Quality Agreement

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

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