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Collection, Storage, and Control of Reserve Samples for Drug Products
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 the drug product, the concerned QA Officer shall collect reserve samples that are representative of a batch of the drug product. The reserve sample shall be collected at equal intervals throughout the primary packing operation of the batch.
The quantity of reserve samples should be at least 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 as that of bulk packing but on a small scale.
The Officer-QA shall enter the details in the “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 a 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 a periodic examination of reserve samples shall be recorded with other stability data of drug products.
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 approval from the Head of Quality Assurance Department Officer-QA shall issue the drug product requested and fill the request.
After the completion of the retention period, the concerned Officer-QA shall destroy the sample by incinerating it 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
Annexure – 1
RESERVE SAMPLE REGISTER FOR DRUG PRODUCTS
- Name of the Drug Product :
- Batch No.
- Packing
- Quantity
- Expiry
- date
- Retention
- date
- Deposited by
- Disposed of by
ANNEXURE – 2
RESERVE SAMPLE (DRUG PRODUCT)
ISSUE REQUEST
QUALITY ASSURANCE
- Product :
- Batch No.:
- Packing :
- Qty required :
- Requested by :
- Purpose :
- Approved by :
- Qty issued :
- Issued by