CRED Managing Variations Effectively

Risk analysis: EXAMPLE B.II.b.3 (a) Type IA minor change to manufacture of FP <>

Key issues to consider when deciding on the category? Ask : is this a minor IA, IB or major change Type II ? alter quality: Hi/Lo? Could it be serious? Think : what is the risk that this change will

Consider

1. Relative duration and temperature 2. Evenness of heating in the tray drier

3. Stability of active to heat 4. Impact on other excipients

Risk assessment controlled by what the product is

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