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Transfer of soft capsule products between 2 CMOs: best practices
The transfer of softgel capsule manufacturing between contract manufacturing organizations (CMOs) is a complex process that is often underestimated.
In-process controls (IPC) for soft capsules
While the release tests for solid dosage forms and softgel capsules are typically well defined in the pharmacopeias, IPC testing is rarely discussed. This article gives an overview on the most common IPC testing methods for each step of softgel manufacture.
1. Gelatin mass preparation
As the characteristics of the gelatin mass may impact the processability, appearance and physical stability of the capsules, appropriate IPC testing include the following: