Retention Sample Management is an important aspect of the Pharma Industry to meet cGMP requirements (ICH Q7). It is also called a Reserve Sample / Control Sample.
Handling of Retention Sample
A retention sample refers to a portion of a product that is kept for later testing or analysis. This is often done to verify the quality or composition of a batch of goods and ensure that it meets the desired specifications. Retention samples are commonly used in industries such as food, pharmaceuticals, and cosmetics, where product quality is critical. The sample is usually stored under specific conditions to preserve its quality and is only analyzed if there is a problem with the batch or if routine testing is required.
Collection, Storage, Retrieval, Review, and Disposition of Retention Samples / Reserve Samples are provided here for guidance purposes.
Collection and Storage of Retention Samples
Management of Reserve Samples for Drug Products
Reserve Samples shall be collected for each batch, Market, and each pack style in which the drug has been actually marketed.
Twice the quantity shall be collected as per the list.
Enter the details in Reserve Sample Register.
Reserve Samples shall be pasted as “Reserve sample not for sale”.
Store the reserve samples in the Reserve sample room. (Storage condition: NMT 25°C)
Management of Reserve Samples for Drug Substances and Excipients
Officer –QC shall collect the Raw material reserve samples and hand – them over to the Reserve sample In-Charge.
Enter the details in the Reserve Sample register for Drug substances and Excipients”.
Store the Reserve samples under the specified storage conditions.
Location Updation and documentation.
Refer never before Pharma Guidance – Corrective and Preventive Actions Guidance
Retrieval of Retention Samples
Retrieval of Reserve Samples for Drug Substances and Excipients
- Get the Approved Request (for Drug Products) & for Drug Substances & Excipients.
- Check the Quantity and Issue the required Quantity.
- Documentation.
Visual Inspection of Retention Samples
Drug Products Management
- Visual Inspection of Reserve samples shall be done annually
- One batch in a month for each product shall be considered for Visual Inspection
- Prepare a monthly schedule.
- Check Pack condition, Description, Physical appearance, color change, and obnoxious odor [if any].
- Documentation.
Looking for the Latest never before Pharma Guidelines only at PharmaeliX – OOS SOP Latest Guidance 2023, Reference Ph.Eur. FDA
Destruction of Retention Samples
Drug Products
- Reserve samples for Drug products shall be maintained for one year after the expiration date of the product.
- Prepare the List of samples to be destructed.
- Deface the product by drawing a cross [X] on the entire label
- Forward the samples to ETP along with supporting documents.
- Documentation.
Drug Substances and Excipients
- Check the lost lot of drug product to which the material is dispensed and that product expiration date + 1 year / based on the revised date of destruction updated.
- Prepare the List of samples to be destructed.
- Deface the product by drawing a cross [X] on the entire label
- Forward the samples to ETP along with supporting documents.
- Documentation.
Monitoring of reserve sample rooms
- Temperature shall be monitored and recorded twice a day.
- Any discrepancy in maintaining the environmental conditions shall be investigated throughout the incident.
Stay tuned here for never-before pharma articles – Latest ICH Quality Guidelines 2023
Trackbacks/Pingbacks