Regulatory Open Forum

Recently the office of generic drugs issued the below information regarding stability. It appears that the one small scale batch is still a 10% no matter the delivery system. The pilot scaled is going to require justification for any amount you produce. Hope this helps.

Although the ICH stability guidances were developed by ICH to provide guidance on the information that should be provided in new drug applications to ensure the stability of new drug substances and drug products, we believe the recommendations should be applied to ANDAs as well.

 

When following the ICH stability recommendations, the applicant should:

 

1.      Submit data from three pilot scale batches or two pilot batches and one small scale batch. If the size of the pilot does not follow ICH recommendations, the applicant should provide a justification.

 

2.      At the time of submission, provide 6 months of data that include accelerated and long-term conditions. FDA recommends following ICH with respect to utilization of intermediate conditions to support shelf-life.

 

3.      Use multiple lots of drug substance as appropriate.

 

4.      Manufacture and package the drug product using principles that are representative of the commercial process.

 

5.      Provide a fully packaged primary exhibit batch.

 

6.      Use three batches when using bracketing and matrixing designs under ICH Q1D.

 

7.      Provide statistical analysis of the data as appropriate, in accordance with ICH Q1E, Appendix A.

 

If you choose to deviate from the above recommendations, you should justify the approach you are taking.