GMP
Download as PPTX, PDF
0 likes20 views
Good Manufacturing Practices (GMP) establish basic requirements for quality management in manufacturing processes. Key requirements include clearly defined and reviewed processes, qualified personnel and facilities, validated equipment and procedures, detailed written instructions and records, proper storage and distribution, and systems to prevent contamination, cross-contamination, and mix-ups. Adhering to GMP helps ensure quality products and prevents health risks to patients.
GMP
- 2. Quality Management : Good Manufacturing Practices (GMP) Basic Requirements for GMP Clearly defined and systematically reviewed processes Qualification and validation is performed Appropriate resources are provided: Qualified and trained personnel Premises, space, equipment and services Materials, containers, labels Procedures, storage, transport Laboratories and in-process control
- 3. Quality Management : Good Manufacturing Practices (GMP) Basic Requirements for GMP Clear, written instructions and procedures Trained operators Records of actions, deviations and investigations Records for manufacture and distribution Proper storage and distribution Systems for complaints and recalls
- 4. Contamination (悋惠惓 ) Cross contamination ( 悋惠惓 悋惺悋惡惘 ) Mix up (悋悽愀 ) Should Prevent: Quality Management : Good Manufacturing Practices (GMP)
- 5. Factors contributing to quality products Starting materials Personnel Procedures Validated processes Equipment Premises Environment Packing materials
- 6. Poor cGMP conditions can ultimately pose a life threatening health risk to a patient