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1. Ch. Safwat Elmansy

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 (‫التلوث‬ )
• Cross contamination ( ‫التلوث‬
‫العابر‬ )
• Mix up (‫الخلط‬ )
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