Aims and Objectives:
This course aims to introduce the requirements for design of facilities, equipment and processes in the pharmaceutical and related industries.
On completion of this course you 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 and 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 and interpretation of the data
This course 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 and 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 and 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.
Format and Course Length:
The 3-day course involves a lively mix of case studies / workshops and intensive tutorial sessions. The delivery method is collaborative with a small group and facilitator, which has been shown to enhance learning and critical thinking skills of participants. You will receive copies of all presentation slides and a Certificate.
Scheduled sessions run from 9am to 5pm unless otherwise specified.
Call us or click here to e-mail us and register your interest.