Good Manufacturing Practice guidelines for pharmaceutical manufacturing (GMP) in the section of requirements for drug stability (CFR 211.166), and expiration dating , US FDA guidelines for stability studies, has provided profound and particular information related to conducting stability studies and assigning expiry dates to pharmaceutical products. we are providing you a list of some fundamental guidelines in the following summary.
A. Every pharmaceutical product’s expiry date with respect to the specific storage condition mentioned on the label should be assigned after appropriate analysis of data obtained from an appropriate stability testing .
B. The stability testing program must include:
1) The Numbers and sizes of containers per sample time;
2) Should Test Pharmaceutical drug product in the original marketed container and closure system at an proper storage conditions
3) An apropriate number of batches must to be studied for long-term stability testing for a new pharmaceutical product in beginning, and then one production batch every year.
C. Expiry date must be derived on the basis of data gathered by conducting accurate and precise stability indicating assay methods for the all active ingredients in your pharmaceutical product
D. Approximate expiry dates can be assigned depending on the data obtained from accelerated stability studies as long as it can be demonstrated that these accelerated studies are scientifically accurate and precise ,long-term studies are being conducted to assure that the predicted expiry date. It will be more precise that if there is increased sampling frequency toward the end of the expiration dating period.
Example a solid dosage forms can be allows a 2-year tentative expiry date at room temperature if the drug has maintained 90% of its initial strength after 90 days storage at 40 C and 75% relative humidity.
E. long term stability studies must be carried out to demonstrate the time at which the lower 95% confidence bound of the mean degradation curve intersects the acceptable lower limit for drug degradation.
F. If a pharmaceutical product is packed in a different packaging system than original while doing stability study , one should demonstrate that these component are not going to affect the stability of drug molecule , with proven data.
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