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CURRENT GOOD MANUFACTURING PRACTICES
(COCGM)
Format: Video
O V E R V I E W
This unit introduces trainees to current Good Manufacturing Practices (GMP) and impresses upon them the importance of complying with GMP regula¬tions. After completing this unit, trainees should be able to explain GMP and describe the areas of GMP that involve operators. After seeing several dramatic representations of events based on GMP noncompliances, trainees should be able to describe how a noncompliance can happen and what the consequences can be. Finally, trainees should be able to describe GMP require¬ments associated with documenta¬tion and inspections.
O B J E C T I V E S
Overview
- Identify the "Current Good Manufacturing Practices.
- State the goal of GMP.
- Identify the major areas covered by GMP.
- Describe the areas of GMP that involve operators in pharmaceutical plants.
Raw Material Handling
- Describe possible effects of violating GMP regulations associated with handling raw materials.
Cross Contamination
- Describe possible effects of violating GMP regulations associated with cross contamina¬tion.
Packaging
- Describe possible effects of violating GMP regulations associated with packaging.
Documentation and Inspections
- Describe GMP requirements and operator responsibilities associated with documenta¬tion.
- Describe two types of quality assurance inspections.
- State general guidelines for responding to an inspector's questions during an inspection.
S U B J E C T S
Overview
- The "Current Good Manufacturing Practices"
- Basic goal of GMP
- Major areas of GMP
- GMP regulations and plant operators
Raw Material Handling
Cross Contamination
Packaging
Documentation and Inspections
- Documentation requirements
- Information management
- Inspections
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