Reserve Sample Storage
Controlled Chambers for Retain Samples and Customer Complaint Testing
Retain Samples
FDA Title 21 Section 211.170 indicates that reserve samples of active ingredients as well as drug products that are representative of entire lots shall be retained. Each reserve sample needs to have sufficient sample quantity to conduct each test needed to meet its specification at least twice. 21 CFR states that each reserve sample needs to be maintained for one (1) year after the expiration date of the drug product, or for active ingredients, one (1) year after the expiration date of the last lot of the drug product containing the active.
21 CFR 211.137 does allow some OTC drugs to be exempt from expiration dates. If this is the case, the reserve sample must be retained for a period of 3 years after the distribution of the last lot containing the active ingredient.
As you are aware, this can amount to a great volume of retain samples. In addition, 21 CFR 211.170 indicates that not only does the reserve sample need to be stored under conditions that are consistent with the product or ingredient labeling, statistical procedures need to be in place to determine the number of reserve samples that must also undergo a visual inspection for evidence of deterioration annually. Any reserve samples with visual evidence of physical deterioration are subject to the provisions of 21 CFR 211.192. The results of the investigation from provision 21 CFR 211.192 are then recorded and need to be maintained with the other stability data for the product or active.
IAL maintains controlled chambers that are cGMP compliant and we able to handle your reserve samples. Reserve samples arriving at the laboratory need to have a completed IAL Sample Submission Form and other appropriate documentation. Upon receipt, IAL will perform a cGMP quality verification utilizing our Retain Sample Receipt Form. Information such as lot number, NDC number, packaging and date of expiry and destruction are recorded. In addition, IAL will conduct a visual inspection to include but is not limited to tamper evident seals, discoloration, evidence of moisture, and package misshapen upon receipt. IAL is very flexible and will work with you to customize the inspection parameters to meet your standards.
After the reserve sample quality verification is completed, the reserve sample(s) is logged into our sample login system. Each reserve sample is given a unique identification code and logged in with appropriate information. IAL will track the samples according the unique identification code that is assigned. If you require, IAL will set up a schedule of reserve sample pulls from the controlled chambers to conduct physical inspections. The Reserve (Retain) Sample Inspection Report covers the essential packaging indicators of physical deterioration. IAL will customize our inspections to meet your in-house standards.
Customer Complaint Testing
IAL Laboratories works diligently to focus on our client's needs. We realize when retain samples are stored at our facilities, it would be helpful for IAL to offer testing of retain samples when customer complaints are received. A comprehensive physical testing program has been developed to handle potential complaints.
The comprehensive physical testing program includes many different tests depending upon the nature of the customer complaint. The following is a listing of the typical testing that we offer:
- Disintegration
- Weight
- Dimension and Shape (length, width, thickness)
- Color Change and Uniformity
- Tablet Capping
- Tablet Lamination
- Sticking and Filming
- Cracking
- Chipping
- Mottling
- Printing, Double Impression, Lack of Impression
- Package Integrity
- Package Labeling
- Crushing Strength
- Liquids
- Container Integrity
- Leak Testing
IAL can also test for other types of customer complaints, such as potency, content uniformity, and impurities. With these types of complaints, our chemists will work closely with your staff to determine the best approach to resolve the complaint issue.
Contact us to obtain excellence in service and quality data, and to allow us to become a valuable and trusted member of your team.
