Transcription of 11.I In-process control - GMP Publishing
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11.I In-process control - GMP Publishing
(1)GMP Manual (Up07) Maas & Peither AG GMP PublishingC. Gausepohl / P. In-process controlAuthors: Dr. Christian Gausepohl / Paolomi Mukherji / Update 07In- process controls (IPC) are checks that are carried out before the manufacturingprocess is completed. The function of In-process controls is monitoring and ifnecessary adaptation of the manufacturing process in order to comply with thespecifications. This may include control of equipment and environment, materials should be tested for identity, strength, quality and purityas appropriate and approved or rejected by the Quality control unit during theproduction process . Rejected In-process materials should be identified and con-trolled under a quarantine system designed to prevent their use in procedures should be established and followed that describe the In-proc-ess controls and tests as specified: Tablet or capsule weight variation, Disintegration time, Content uniformity and homogeneity, Dissolution time and rate, Clarity, completeness or pH of solutions.
In-process controls may be performed in regular intervals during a process step (e.g. tabletting, encapsulation) or at the end of a process step (e.g. granulation, blending).
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