Manufacturing sites changes

Examples of postapproval manufacturing site changes and filing consequences ... 

An applicant wants to move the manufacture of an immediate-release tablet (TCM) to a different manufacturing site that currently manufactures, and has satisfactory CGMP status for, capsules (CHG) and powders for oral solution (POW). This manufacturing site change should be filed in a prior approval supplement because the new manufacturing site doesn t have a satisfactory CGMP inspection for immediate-release tablets. 

Note FDA letter 2/18/97 revises SUPAC-IR to allow stand-alone packaging site changes for IR solid oral dosage forms as a CBE. Previously packaging site changes had to be part of a CBE manufacturing site change or be a prior approval supplement. 

A packaging site change for other than solid oral dosage-form drug products is considered a manufacturing site change, and the data package that should be submitted for approval is indicated in Section IX.C.2. 

Often changes to the API are proposed and implemented after product approval. A manufacturing site change (alternate site or company) for the API using similar equipment and synthesis will not typically effect the stability of the drug substance or the drug product equivalence of impurity profile, chemical and physical... 

EPA must be notified of the manufacturing site change within thirty days after beginning manufacture. The notification must contain ... 

---