Dealing with different product requirements is often difficult, especially when the regulation office or center may differ as well. Over the years, individual post-approval change requirements have been scattered in documents from different centers and, if you have a good enough memory, then maybe you picked the right reporting requirement based on the product and the regulatory component your product’s jurisdiction fell under. Well now, at least for glass vials and stoppers, and the some of the common changes that may be needed post-approval, the FDA has issued a single guidance document titled Container Closure System and Component Changes: Glass Vials and Stoppers (here) that incorporates changes and the suggested reporting requirements as well as the type of change (PAS, CBE-30, CBE, or Annual Report) that will usually be required.
While the guidance does not provide data on all of the possible changes that may be requested for vials and stoppers, it does provide a great resource, identifying requirements for common changes in one place. The changes identified are applicable to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Please note that there may be different recommendations for similar changes between the two centers so be certain you don’t try to mix and match. Also, this guidance applies only to glass vials and stoppers and does not apply to other container-closure types.
The Agency said, in the announcement of this final guidance, “[T]he guidance supersedes the guidance initially issued in March 2021 titled ‘COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers.’ FDA revised and issued the final guidance because many of the recommendations set forth in the 2021 guidance are applicable outside the context of the COVID-19 public health emergency. In preparing this final guidance, FDA considered comments received on the 2021 guidance.”
