Q.What is GMP? What are the basic requirements for GMP? Ans: GMP: Good Manufacturing Practice is that part of Quality Assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorization or product specification. The basic requirements of GMP: i. Suitable Premises & Equipment ii. Good Traceability iii. Consistent Manufacturing Procedures iv. Practices Regularly Monitored by Auditing v. Ability to Investigate & Solve Problem vi. Accurate Testing Methods vii. Adequate Cleaning Procedures viii. Correct Materials, Labels & Containers ix. Adequately Trained Staff x. Clearly Documented & Approved Procedures
Posted on: Sun, 14 Sep 2014 09:05:27 +0000
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