Dahuin,
Carole is correct in that it is difficult to give accurate input without more detail on the product type. The testing of the number of samples or replicates on stability is dependent on many factors including the attribute being evaluated, method variability, product homogeneity among others. Key is to generate a sampling plan justified scientifically to support your stability test plan to confirm stability throughout the proposed shelf life. Typically more testing (replicates and sampling) is conducted early in the development program to understand the product where methods are typically minimally validate (Sensitivity, Linearity, Accuracy and Precision), however, full method validation should include evaluation of variability (lot to lot, sample to sample, laboratory, day to day, etc) including stack up tolerance and incorporate these into a sampling plan where the result can be relied on to represent that attribute. I have typically tested Beginning, Middle and End samples for each attribute with sufficient replicates to understand the variability (statisticians are useful in this regard). Then narrowed down replicates as justified by the data. Again, all of this depends on your product, drug substance, versus drug product, IVD, etc.
There are a number of ICH guidance documents on stability for drug products and Drug Substance but the level of detail on sampling and replicates needs to be justified by the developer/innovator. The Agencies do expect to know your sampling plan for the release of each batch to the market.
Hope this is helpful, please feel free to connect if needed.
rosariodar07@gmail.com,
Dar
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Darlene Rosario
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
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Original Message:
Sent: 05-22-2014 10:15
From: Carole Harris
Subject: Stability Testing- sample testing
The requirements for stability testing are linked to the standards to which you are claiming conformity. You did not state what type of products. If you are working with IVDs, here are a few standards to consider, depending upon the intended market:
CLSI EP25-A Evaluation of Stability of In Vitro Diagnostic Reagents
EN 13640 Stability testing of in vitro diagnostic reagents
ISO 23640 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
Best of luck-
Carole
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Carole Harris RAC
International Regulatory Program Manager
Asuragen, Inc
Austin TX
United States
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Original Message:
Sent: 05-21-2014 04:02
From: Dahuin Lee
Subject: Stability Testing- sample testing
My question concerns whether it is mandatory to test one sample 3 times (per a test parameter) in stability testing as required in the validation testings.
Reference to any published guidelines/regulations would be helpful (FDA/EU/ICH).
Thank you.
Sincerely,
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Dahuin Lee
Regulatory Affairs Associate
Seoul
Korea, Republic of
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