In partnership with NUS

Academy of GxP Excellence since 2009

Objective

 

The objective of this course is to understand the approach to GMP Facility Design and how to employ Good Engineering Practice (GEP) as one of the tools to aid the design process.

This course provides an overview of the design process, criteria and good practices like GEP and “risk-based approach” for GMP Manufacturing Facilities with clear future Qualification and maintenance in mind.

 

Description

 

The successful delivery of regulated manufacturing facilities poses significant challenges to manufacturers, engineering professionals, facility design/construct contractors and equipment suppliers. A systematic approach to Process/Facility Design is one of the foundations to a “fit for intended use”, compliant and cost-effective operating site. The course steps through the design definition, scope, applying key criteria, clean design principles to develop a strong front end design package.

The last few years have seen several initiatives to best use of resources whilst being cost effective and compliant with regulatory requirements. These initiatives are consensus with inputs from industry, ISPE, ASTM, FDA, ICH and so on.  This course applies some of the initiatives and other tools to enhance the facility design process:

 

  • GEP – ISPE has released the good practice guide on GEP and its principles are promoted in ASTM E2500 and ISPE’s “Science and Risk-Based approach for the Delivery of Facilities”, to name a few.  The course applies these principles, methods and standards to the design process.  Advantages are clear defined deliverables, avoiding the “re-inventing the wheel” syndrome and reducing equipment qualification burden. GEP – once established is for the long term, saving resources, time and cost

  • Risk-based approach – applying a rational approach to emphasize on critical process parameters.

  • Project quality system – to enhance the communication and design deliverables between Client and Contractor

 

Therefore, the course participants will learn the key criteria and tools to Process/Facility Design illustrated with case studies to develop a strong front-end design package.  The standards and documents generated are transportable to the Qualification process.

 

Course Outline

  • Overview of regulatory and statutory requirements to Facility & Equipment

  • Good Engineering Practice – key concepts, common practices, standards, engineering specifications.  Examples of Drawing/Equipment Control, Material of Construction, Piping Specifications.

  • GEP – ISPE has released the good practice guide on GEP and its principles are promoted in ISPE’s “Science and Risk-Based approach for the Delivery of Facilities”, as an example.  The course applies these principles, methods and standards to the design process.  Advantages are clear defined deliverables, avoiding the “re-inventing the wheel” syndrome and reducing equipment qualification burden. GEP – once established is for the long term, saving resources, time and cost

  • Risk-based approach – applying a rational approach to emphasize on critical process parameters, with respect to engineering and facility design.

  • Facility/Process Design – Life Cycle Model, Industry Trend, User Requirement Specification (examples).

  • Process Design – Process map, URS, Pre-qualification documentation, Clean Design principles, Case Study illustration.

  • Facility Design – Building, Room Classifications, Layouts (People. Material & Equipment Flow), Utilities, Cost Estimates, Case Study illustration

  • Case Studies – Critical Utilities (Purified water system/WFI/Steam), Liquids/Cream Facility, Solid Dosage/Liquids Facility

 

Learning Outcome

 

The course participants will learn the key criteria and tools to Process/Facility Design illustrated with case studies to develop a strong front-end design package. 

Join Our Mailing List

Keep in touch with us by joining our mailing list or follow our company page at LinkedIn

Get connected with us!

Any questions for us? Feel free to let us know.

USA 

+1 770-753-6032

 CANADA
+1 416-385-3922

 GREATER CHINA

+86 139 10489545

SOUTHEAST ASIA

+65 68365524

All rights reserved by PharmEng Regulatory Affairs. Disclaimer