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In-process quality control tests for capsule drug products are carried out at predetermined intervals by manufacturing personnel during product manufacture and their results are recorded in the batch record. Unfavorable results of these tests can be used as a guide for changing the manufacturing-process parameters.
During the encapsulation of soft gelatin capsules, the following parameters are usually closely monitored and controlled:
Gel ribbon thickness and uniformity across the ribbon
Softgels seal thickness during encapsulation
Capsule fill weight and its variation from capsule to capsule
Capsule shell weight and its variation from capsule to capsule
Moisture level of capsule shell before and after drying
Visual inspection, fill weight and fill-weight uniformity are the main in-process tests used for hard gelatin capsules.
