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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