Returned Drug Products - GMP SOP
It is essential to define the management of returned products that are sent back to the initial distributor for any reason whatsoever. These returns must be carefully analysed prior to any salvaging, redistribution or disposal because goods that have left the control of the warehouse should only be returned to saleable stock if they are proven to meet the product’s appropriate standards of safety, identity, strength, quality and purity.
The purpose of this Standard Operating Procedure (SOP) is to describe the site’s roles and responsibilities and the order of events for goods returned from the market to the warehouse. This 9-page Standard Operating Procedure (SOP) includes 2 attachments: an investigation form for returned goods and a returned-goods process flow diagram.
Table of Content
1. Regulatory Basis, Reference Documents
4. Responsibilities and Accountabilities
4.1 Returned Goods Manager
4.2 Quality Manager
5.5 Acceptance Criteria
5.6 Decision for the Re-use of Drug Product
5.7 Third Party Manufacturing / Packaging / Warehousing
6.1 Returned Goods
Attachment 1: Investigation Form for returned goods
Attachment 2: Returned Goods Flow Diagram
|SKU||Returned Drug Products - GMP SOP|
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 SEVEN ENTIRE DAYS just give us a call, and we'll personally guarantee you get a complete refund.
- Validation Master Plan - Drug Substance Manufacturing (API)Regular Price $200.00 Today $179.00+ 19% german VAT when applicable
- Pest Control Program - GMP SOPRegular Price $120.00 Today $89.00+ 19% german VAT when applicable
- Deviations (Failure Investigations, Non-Conformance) - GMP SOPRegular Price $95.00 Today $79.00+ 19% german VAT when applicable
- Annual Product Review - GMP SOPRegular Price $120.00 Today $99.00+ 19% german VAT when applicable