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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