Aims and Objectives
This subject aims to introduce the requirements for design of facilities, equipment and processes in the pharmaceutical and related industries.
The subject content will be designed around the topics outcomes mentioned above. At least one case study on an engineering breakdown will be used to illustrate the points made. Topics include, but are not restricted to:
V-model approach to Validation - the role of Specifications and Design Review
- Facility Layout and Design Principles.
- cGMPs for Critical Services-Water, Gas, HVAC.
- Process Design.
- Water Systems: Design, Control & Validation.
- GMPs for Critical Equipment - IQ and OQ.
On completion of this subject students will be able to:
- Describe basic facility layouts
- Review the GMP standards & requirements for engineering & maintenance services
- Describe the current international industry standards for utilities such as water, pharmaceutical gases & Cleanroom HVAC
- State the requirements for design of pharmaceutical water systems
- Develop a validation protocol for water system qualification
- State regulatory requirements for HVAC systems & environmental monitoring of cleanrooms
- Provide examples of environmental programs & interpretation of the data
Content
This subject consists of 4 modules or topics:
#1 Facility Layout and Design Principles
- 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.
- Appreciate the different surface finishes and options
- Design cleanrooms for containment.
#2 Design and Construction of Critical Services-Water, Gas, HVAC
- Discuss GMP standards & requirements for engineering & maintenance services.
- Appreciate current international industry standards utilities such as water, pharmaceutical gases & Cleanroom HVAC.
#3 Water Systems: Design, Control & Validation
- 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.
#4 GMPs for Critical Equipment - IQ and OQ
- Appreciate content of practical qualification protocols for critical equipment & the preparation of selected example IQ/OQ protocols.
- Define the difference between critical and non-critical equipment.
- Explain how to develop an equipment support, maintenance and documentation package ready for qualification.
