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CGMP

USFDA New Data Integrity and Compliance Guideline

(published in Dec 2018) Background : The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (cGMP) for drugs, as required in 21 CFR parts 210, 211, and...

DEFINITIONS AS PER CGMP

Production/manufacturing:- All operations involved in obtaining a product from the receipt of materials through processing to packaging and labelling. Quality Control Unit:- It is the department designated as responsible for the certification of quality of...

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