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.
Here's how it works: Download your copy of this document and if for any reason your aren't completely satisfied after two entire months just give us a call, and we'll personally guarantee you get a complete refund.
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.
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
