CRED Managing Variations Effectively

B. Quality Changes

I. Active Substance (AS) Within this section, the following changes are classified: a) Manufacture: addition of new manufacturing site, changes to manufacturing process of AS, in-process controls; b) Control of the active substance: changes in the specifications of AS & intermediates; c) Changes in the container closure system of AS; d) Stability of the AS (e.g. retest period or storage conditions); e) Design space and post-approval change management protocol (PACMP) and implementation .

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