Annual stability batches

Preventative Action. This citation could have been avoided by a stability testing program SOP, which specifies batches that are to be entered into the annual stability program (i.e., one batch per year of each product in each container-closure made that year). If this is an inordinate amount of work, a PAS could be submitted for a reduced... 

If the pilot plant where the primary stability batches are made is located at the intended commercial site (i.e., on the same campus as the intended commercial facility), the site-specific stability recommendations are met and no additional data will be needed. A commitment should be made to place the first three production batches and annual batches thereafter on long-term stability studies. 

Extension of a product expiration date can be done in two ways. The first method allows an update via the annual report based on three production scale batches completing stability through the desired expiration date. These can be either the original primary stability batches (if made at production scale) or the post-approval commitment production scale batches. 

Once a product gains FDA approval for marketing, the sponsor should maintain a readily retrievable profile of commercial batches. This includes individual batch release data and stability data. These data should be compiled throughout the year and tabulated prior to the anniversary of NDA approval for submission in the annual product report to FDA. By maintaining an ongoing database, which is reviewed as new information is added, changing trends in the data can be observed and management notified if any of these trends are unfavorable. 

Chemistry—Application/compendial release requirements and stability testing. For stability testing, one batch should be on long-term stability testing with data being reported in the annual report. 

Information available—One batch with three months accelerated stability data reported in a supplement and one batch on long-term stability reported in the annual report. 

Chemistry—Identify location of new site and updated batch records. No other documentation is required beyond application/compendial release requirements, although one batch produced at the new site should be placed on long-term stability and the data should be reported in the annual report. Dissolution data other than normal release requirements are not required nor is in vivo bioequivalence testing required. 

A container closure system for the transportation of bulk drug products to contract packagers should be described in the application. The container closure system should be adequate to protect the dosage form, be constructed with materials that are compatible with product being stored, and be safe for the intended use. The protective properties of the shipping container are verified by the practice of including annual batches of the packaged product in postapproval stability studies. 

Significant Body of Data Not Available. Up to three batches with tliree months accelerated stability data reported in supplement up to three batches on long- term stability data reported in annual report. 

One batch on long-term stability reported in annual report. 

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