GMP Facility Design and Layout | extraktlab

When it comes to GMP compliance, facility layout is an essential part of the process. Measuring up to GMP standards entails a lot of research and a lot of responsibility on your part and that means time spent planning and implementing GMP certified design into your facility. In order to do that properly, you need to know the ins and outs of GMP compliance and how the design and layout of your facility can impact your success on the matter. That’s where we come in.

In this episode of extrakTALKS, Dr. Jon discusses the best facility design layout for GMP. He will cover the importance of quality facility design from planning, development, layout and building up your facility to be GMP compliant. We will also cover the things not to do in your design and where issues like ethanol extraction become problematic in terms of GMP compliance. If you are looking for help with your facility design, this is the episode for you.

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Time Stamps:
[00:00] – Introduction Facility Design Layout for GMP
[01:43] – Free Resources – https//
[02:23<] – Process for creating api’s and final dosage forms
[03:43] – Follow a Development Process
[06:12] – The Layout Process
[07:30] – Building Remediation and environmental Impact of ethanol
[08:45] – Back to Basis of design
[09:36] – Define Stakeholders: Product Specialist or SME, Architect, Maintenance, etc
[11:53] – Define Layout Scope
[14:23] – Layout Conceptual Outputs: Tools to use
[14:55] – Accommodation Schedule Example
[17:27] – Adjacency Matrix – defines processes/ areas that need to be close. and how critical it is
[<19:02] – Past Experiences from GMP Engineering
[21:25] – Conceptual Layout
[24:28] – Levels of Protection
[26:23] – Layout Considerations
[30:24] – Material and Equipment Flows
[30:55] – example of a bad layout
[31:56] – Separation of raw materials
[33:31] – Multi Product Facilities and Cross contamination
[34:56] – Some smaller facilities swap out equipment in a controlled environment
[35:36] – Personnel flows
[37:00] – Facility Construction Issues
[37:54] – You absolutely need to have a good a subject matter expert