Write the basic requirements of cGMP/GLP ?
GMP 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 Authorisation or product
specification.
Good Manufacturing
Practice is concerned with both production and quality control. The basic
requirements of GMP are that -
•Suitable Premises & Equipment
•Good Traceability
•Consistent Manufacturing Procedures
•Practices Regularly Monitored by Auditing
•Ability to Investigate & Solve Problem
•Accurate Testing Methods
•Adequate Cleaning Procedures
•Correct Materials, Labels & Containers
•Adequately Trained Staff
•Clearly
Documented & Approved Procedures
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