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Change in Hard Gelatin Capsule Shell Supplier

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Change in Hard Gelatin Capsule Shell Supplier

By EMBO CAPS® by Suheung

Change in Hard Gelatin Capsule Shell Supplier

By EMBO CAPS® by Suheung
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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.

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