Advertisement

Pharmaceutical Technology is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More X
DOWNLOAD WHITEPAPER

Change in Hard Gelatin Capsule Shell Supplier

The purpose of this MAPP is to establish the policy in the Office of Pharmaceutical Quality (OPQ) for a postapproval change in the supplier of a hard gelatin capsule shell. Background The intent of this MAPP is to clarify the reporting category for a change in supplier for a hard gelatin capsule shell. General Policy When an applicant changes the supplier of a hard gelatin capsule shell, with no change in capsule composition or appearance, the information should be submitted in an annual report. If a supplement is received containing a change in the supplier of a hard gelatin capsule shell, OPQ should inform the applicant that the described change is an annual reportable change.

Download to find out more.

Close
Close
Close

Go Top