Phone +49 7621 76176 Mo - Fr 9.00 - 17.00 (GMT)
Currency:
USD - EUR
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.
GMP Money Back Guarantee
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 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
Customers who bought this item also bought:
Pest control program
95,00 EUR
20.74% also purchased this product.
Deviations (failure investigations, non-conformance)
85,00 EUR
18.52% also purchased this product.
Supplier audit program
85,00 EUR
10% also purchased this product.
Self-inspection program
85,00 EUR
9.26% also purchased this product.
Computer system validation and maintenance checklist
190,00 EUR
8.89% also purchased this product.
Validation master plan drug substance manufacturing (API)
170,00 EUR
7.78% also purchased this product.
21-CFR 820 Quality systems checklist
230,00 EUR
6.3% also purchased this product.
Site master file (SMF) for API - drug substances
245,00 EUR
5.93% also purchased this product.
Contract testing laboratory - quality questionnaire
210,00 EUR
5.19% also purchased this product.
PAI protocol for API
195,00 EUR
3.7% also purchased this product.
Qualification master plan for refrigerated shipment
185,00 EUR
1.48% also purchased this product.
Product Recall
120,00 EUR

eCommerce Engine © 2006 xt:Commerce Shopsoftware