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GMP document management
Standard Operating Procedure

Description:
Good manufacturing practice (GMP) regulations require that all documentation be issued, managed and controlled using a document management system.

This 11-page Standard Operating Procedure (SOP) describes the procedures for completing all GMP-relevant paper documentation pertaining to preparation, approval, control, amendment, withdrawal, distribution and archiving. This SOP will guide you through the process of setting up a new GMP document management system and help you to optimise an existing document management system.

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	Price:	79.– EUR * (appr. 102.- USD)

* additional 19% tax for customers from germany / no shipping costs will be charged



	Delivery item:
		Open Word Document* You will be able to enter your data into the Word document. Please note: We do not deliver hard copies.



	Further details of this Standard Operation Procedure: Table of Content of this Standard Operating Procedure: 1. Regulatory Basis, Reference Documents 2. Purpose 3. Scope 4. Responsibilities and Accountabilities 4.1 Quality Unit: responsible for 4.2 Department Heads: responsible for 5. Procedure 5.1 Preparation/Updation and Approval of Documents: 5.2 Distribution of Documents: 6. Definitions 7. Document archival 8. Destruction of documents Attachment 1 Archived GMP Document/Record Issue & Retrieval Record Attachment 2 Distribution Record of GMP Document Attachment 3 GMP Document/Record Destruction record

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GMP document management Standard Operating Procedure

GMP document management
Standard Operating Procedure