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Compliance with GMP for the Facility, Utilities and Services

Program details
Course code: 
MP6416

Aims:     
To provide an introduction to the requirements of Good Manufacturing Practices for supporting design of facilities, equipment and processes in the pharmaceutical and related industries, and to develop a broad understanding of the scope of Good Engineering Practices and Good Manufacturing Practices.

Outline Syllabus: 

  • Principles of production protection and containment
  • Facility Layout and Design Principles (people and materials flow).
  • Current BP/USP standards & microbiological controls.
  • cGMPs for Critical Services-Water, Gas, HVAC.
  • Process Design.
  • Facilities and equipment design principles to ensure cleanliness and maintainability
  • Cleaning Systems including CIP and SIP
  • Water Systems: Design, Control & Validation.
  • Fundamentals of Good Engineering Practices
  • System impact assessments
  • V-model approach to Validation – the role of Specifications and Design Review
  • Commissioning and Qualification
  • Process automation and associated controls.

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

(1) Knowledge and Understanding

  • Describe the current options for the design and layout of a manufacturing facility under Good Engineering Practices.
  • Demonstrate various approaches to design development and project management for pharmaceutical facilities.
  • Discuss the different surface finishes and options and their implications for cleanliness and maintainability
  • Discuss GMP standards & requirements for engineering & maintenance services.
  • Identify industry standards for utilities such as water, pharmaceutical gases & Cleanroom HVAC.
  • Understand the requirements for design, validation & control of pharmaceutical water systems according to cGMPs.
  • Be familiar with water system validation guidelines, IQ, OQ & PQ requirements, current BP/USP standards & microbiological controls.
  • Define the difference between critical and non-critical equipment.

(2) Discipline skills

  • Design cleanrooms for product protection
  • Design cleanrooms for product and material containment.
  • Prepare user requirements specifications
  • Prepare practical qualification protocols for critical equipment
  • Develop an equipment support, maintenance and documentation package ready for qualification.