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hello everyone now let us discuss about good manufacturing practices guide for active pharmaceutical ingredients part 10. this comes under Q7 quality guideline of ich current session we will be discussing about change control which comes under Section 30. a form will change control system should be established to evaluate all changes that may affect the production and control of the intermediate or APA written procedures should provide for the identification documentation appropriate review and approval of changes in raw materials specifications analytical methods facilities support systems equipment including the computer hardware processing steps labeling and packaging material and computer software any proposals from GMP relevant changes should be drafted reviewed and approved by the appropriate organizational units and reviewed and approved by quality units a potential impact of the proposed change on the quality of intermediate or API should be evaluated a potential impact of the
