CRED Managing Variations Effectively

B. Quality Changes

II. Finished product (FP) Within this section, the following changes are classified: a) Changes to description and composition of the finished product; b) Manufacture: new manufacturing or quality control sites, changes to manufacturing process of FP, in-process controls; c) Control of excipients; d) Control of the FP: changes to the specification of FP; e) Changes in the container closure system of FP; f) Stability of the FP (e.g. shelf life or storage conditions); g) Design space and post-approval change management protocol (PACMP) and implementation.

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Introduction to Classification of CMC (Quality) / Clinical / PhV Variations