Standard Operation Procedures

GMP document management

Standard Operation Procedures
85,00 EUR
app. 112.20USD
(Non-german customers)

101,15 EUR
(German customers incl. 19% tax)



FDA
EMA
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
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Description of the Standard Operation Procedures - GMP document management

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.

Table of Content

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

GMP document management
85,00 EUR
Additional 19% tax for customers from Germany
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