Retention Time Product, Raw Material, Records in Pharmaceuticals

Standard Operating Procedure of Retention Time Product, Raw Material, Records in Pharmaceuticalsis describe in this post.

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1. Purpose:

1.1. To ensure appropriate retention time of Product/Raw Material/other records in 

Pharmaceuticals.

2. Scope:

2.1. It is applied to QC Retained Samples of raw materials, packing material and finished products, also on BMRs and general records

3. Responsibilities:

3.1. Q.A Manager

3.2. Q.C Manager

3.3. Production Manager

3.4. Inventory Control Manager

4. Procedure:

Sr. No.	Materials	Retention Time	Remarks (if any)
1.1.	Retained Sample of Finished Goods	1 year after expiry date	-----
1.2.	Raw Materials Samples	1 year after expiry date	-----
1.3.	Packing Materials Samples	3 years maximum	Retention time started from date of sampling
1.4.	In-process Samples of products	1 year after expiry date of product	-----
1.5.	Batch History Records	1 year after expiry date	-----
1.6.	QC/QA/Production files and Records	5 years maximum	Retention time started from the date of last entry made in log/record
1.7.	General Records	10 years maximum	Retention time started from the date of completion of respective record

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