PPQ Stability Regulatory Guidance

Is possible only to include clinical batches into the stability program and not include PPQ batches in stability? Will this be acceptable by any agency? Please kindly reference HA guidance, if necessary.

PPQ batches must be submitted for stability; and not only PPq batches, but some portion of annual commercial batches as well as part of an ongoing stability program. This is stated as a clear regulatory requirement for FDA ragulated industries within the CFR21:


“…it is imperative that stability studies are not limited only to initial production batches but a portion of annual production batches be the subject of an ongoing stability program.”

It must be understood that initial production batches should be PPQ batches as per FDA guidance on Process Validation