Designing a Pharmaceutical Industry as per cGMP & International Regulatory Compliance

Designing a Pharmaceutical Industry as per cGMP & International Regulatory Compliance!

What are the best ways to design a Pharmaceutical plant so as to ensure that the plant is designed as per cGMP, WHO, USFDA, etc. norms?

Designing an Industry is not an easy task, there are so many parameters to be considered, that are highly technical, in fact, an Industrial design is one of the most challenging of all designs. Understanding the requirements and the production process is one of the key requirements in the design of a Pharma Plant.

Whether the Pharma unit is for an API (Active Pharma Ingredients), Bulk Drugs manufacturing, Formulations, Pelletization or Nutraceuticals, the design of a Pharma plant is to be undertaken with a lot of understanding and care. One has to be fully aware of the production processes of each of these units along with an overall experience in the operations of such an Industry.

An Architect who has worked with Regulatory Consultants and has enough technical knowledge in Mechanical, Chemical and Process Engineering will be able to design such a facility with proper spaces and economics. There are of course few important aspects that need to be followed while designing a Pharma Industry, these are listed below:

  1. Design of the facility, layout, production plant should be as per cGMP, WHO, USFDA & International Regulatory Norms.
  2. Man & Material flow should be very thoughtfully designed so as to have a Uniflow aspect.
  3. Spaces should be properly segregated as per HVAC zoning & room classification required.
  4. Cross-contamination should be avoided.
  5. Wastage of space should be avoided.
  6. Safety features should be built-in the design.
  7. Equipment should be properly sized and placed in the layout for a better understanding of the man-material flow.
  8. Architectural floor plans should be designed in consultation with other Engineering fields such as Electrical, Mechanical, Process, Chemical, and HVAC.
  9. Operational spaces should be easy to maintain and easy to navigate with proper access for man-material.
  10. Proper and approved materials should be used in the design and construction of the Pharma Unit as per regulatory requirements.

There are various other factors that should be considered in the design of a Pharma Plant and proper interaction with the QA / QC team and the operations manager will be crucial in the design and understanding of the requirements.

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If you are planning to build a new Pharmaceutical or Nutraceutical Plant, contact us and understand how we can guide you in your requirements.

 

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