SOP for Raw Material CoA Retention Procedure
Purpose:
To establish a standard procedure for the retention of raw material Certificate of Analysis (CoA) that ensures that the CoA is available when needed and can be retrieved easily.
Scope:
This SOP applies to the retention of raw material Certificate of Analysis for all raw materials used in the manufacturing of the Company’s products.
Responsibilities:
The Quality Control (QC) department is responsible for the retention of raw material CoAs. The Warehouse department is responsible for ensuring that all raw material CoAs are collected from suppliers and forwarded promptly to QC.
Procedure:
1. Upon receipt of the raw material, a copy of the CoA should be sent to QC.
2. QC will review the CoA document and file it in a manner that ensures ease of retrieval and monitoring.
3. The CoA document should be filed in the appropriate raw material storage area and should be associated with the respective raw material using a unique identifier.
4. QC will maintain the CoA documents for a minimum period per the SOP for retention of documents, after which time the documents will be destroyed per the retention policy.
Abbreviations used:
CoA – Certificate of Analysis
QC – Quality Control
SOP – Standard Operating Procedure
Documents:
SOP for Raw Material CoA Retention Procedure
Reference:
SOP for Retention of Documents
SOP Version:
Version 1.0, Date: 1st August 2021