- OBJECTIVE :
- To lay down a procedure for collection, storage, retrieval and disposition of reserve samples of drug products.
- RESPONSIBILITY :
- Quality Assurance Officer for collection, storage, retrieval and disposal of reserve samples.
- Head of Quality Assurance Department to ensure compliance.
- PROCEDURE :
- Every batch/lot of each drug product in all forms of its packing shall be sampled for reserve sample separately.
- During the primary packing of drug product the concerned QA Officer shall collect reserve samples that are representative of batch of drug product. The reserve sample shall be collected at equal intervals throughout primary packing operation of the batch.
- The quantity of reserve samples should be atleast twice the quantity necessary to perform all the required tests.
- The reserve samples shall be stored in the same immediate container-closure system in which the drug product is to be marketed.
- The reserve samples shall be stored under conditions consistent with the product labeling.
- If the drug products are bulk packed, then the reserve samples shall be kept in the same type of packing like that of bulk packing but in small scale.
- The Officer-QA shall enter the details in “Reserve sample register ” for drug products (annexure-1).
- For all drug products , the reserve samples shall be retained for not less than one year after the expiration date of the drug product.
- For drug product that is exempted from bearing an expiration date, the reserve sample must be retained for not less than 3 years after the batch of the drug product is distributed.
- Reserve samples shall be examined visually at least once a year for all commercial batches for evidence of deterioration, unless visual examination would affect the integrity of the reserve samples (containers).
- The results of periodic examination of reserve samples shall be recorded with other stability data of drug product.
- Any evidence of reserve sample deterioration shall be investigated and documented.
- At least one packed unit from each lot is to remain unopened in the event chemical testing has to be performed.
- In case of retrieval of any reserve sample the concerned personnel shall fill the “Reserve sample issue request” (annexure-2) and get the approval from Head of Quality Assurance Department Officer-QA shall issue the drug product requested and fill the request.
- After the completion of retention period, the concerned Officer-QA shall destroy the sample by incinerating and enter the disposed off date and signature in the reserve sample register for drug products.
- Forms and Records (Annexures)
- Specimen format of “Reserve sample Register ” – Annexure 1.
- Specimen format of “Reserve Sample Issue Request ” – Annexure 2.
- Distribution
- Master copy – Quality Assurance
- Controlled copies- Quality Assurance, Production, Quality Control.engineering
- History
Date Revision Number Reason for Revision – 00 New SOP
Annexure – 1
RESERVE SAMPLE REGISTER FOR DRUG PRODUCTS
Name of the Drug Product :
| Batch No.
|
Packing
|
Quantity
|
Expiry
date |
Retention
date |
Deposited by | Disposed by | Remarks | ||
| Signature | Date | Signature | Date | ||||||
ANNEXURE – 2
RESERVE SAMPLE (DRUG PRODUCT)
ISSUE REQUEST
QUALITY ASSURANCE
Product :
Batch No.:
Packing :
Qty required :
Requested by :
Date :
Purpose :
Approved by :
Date :
Qty issued :
Issued by
Date
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