What is a procedure of major changes in BMR as per QMS procedure changes like line clerance for every step?
Please follow internal SOP of Change control system. For any major change QA and concerned departments (R & D) has to perform Risk assessment as per internal SOP. R & D team who have developed the referred product should initiate revision in BMR based on the change proposal. If there is major change in master formula, processing steps, equipment, Process parameters etc. then it will require re-validation of manufacturing process.
For changing Line clearance system, QA inspectors should be appropriately trained and assessed before its implementation.
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