Good Manufacturing Practice for Pharmaceutical Operations

Aims: 
To provide a detailed analysis of the GMP requirements for manufacturing pharmaceuticals, and to provide a broad understanding of risk analysis and problem solving techniques and their role in establishing and maintaining appropriate GMP controls.

Outline Syllabus: 

• Risk analysis methodologies: Hazard Analysis and Critical Control Points (HACCP) and Failure Mode and Effects Analysis (FMEA)
• GMP requirements for materials management
• GMP requirements for pharmaceutical manufacturing
• Sampling and Test Plans
• cGMP requirements for Equipment management
• Process Analytical Technology.
• Roles & responsibility of the line supervisor in a pharmaceutical manufacturing environment,
• GMP compliant structured training programs.
• Root Cause Analysis and problem solving techniques
• Corrective and Preventive Action Models

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• State the specific requirements of GMP as they relate to purchasing, receipt, storage and dispensing of raw materials and packaging materials.
• State the specific requirements of GMP as they relate to production, and labelling and packaging operations.
• State specific requirements of GMP for completing batch records.
• Understand the scope of failure investigations in order to conduct and document effective investigations.
• Define the current trends in International GMP compliance.

(2) Discipline skills

• Prepare Process Maps to define the manufacturing process
• Prepare a Process Control Plan using a risk assessment tool
• Audit pharmaceutical manufacturing processes for GMP compliance.
• Develop practical strategies for GMP upgrades.
• Managing pharmaceutical operations in a way that ensures compliance to cGMP requirements.
• Respond to cGMP licensing audit reports.
• Develop staff GMP training.