Drugs-GMP Cleanroom Manufacturing Facility

GMP Cleanroom Manufacturing Facility
The modern era on the state of art manufacturing facilities (world class facility) are designed and constructed in accordance with strict cGMP requirements. The cGMP requirements are for the production of Pharmaceuticals, Medical Device and Cosmetics which need to be carried out in clean rooms (controlled conditions).

Design, construction, and commercialization of Cleanrooms facilities are an expensive process that requires detailed planning and resources. It also dictates the quality and compliance of products that are to be manufactured and their profitability over the long run. Therefore, these activities must be planned in detail with the end in mind including the regulatory, project funding, future expansion, for the types of products according to intended commercial markets in addition to the facility’s country of location. After all, it would just be too cumbersome and expensive to make any significant changes to the facility design or construction after it is completed and has become operational if errors are found or worse, regulatory agencies deny its approval for manufacturing.

Clean room consultants:-

Clean rooms are designed based on case to case requirement. Every place or process requires a certain classification of cleanliness and accordingly the clean room system has to be designed.

Role of clean room consultants
The clean room consultants are technical persons with many years of real time work experience in Pharmaceuticals and Medical Device Industries, so the consultants are capable to understand the product and decide on what the regulatory requirements should be followed.

  • Cleanroom consultants draft the layout based on uniflow concept and production process flow.
  • Consultants decide on what class of room, pressure, temperature, roof & flooring to be made.
  • They prepare Clean room vendor quote.
  • Cleanroom consultant verifies and guide on various issues raised during clean room installation.
  • They verify the validation reports provided by the vendor.

When designing, constructing, or validating a new facility, it is important that the consultants and technical persons have an in depth knowledge in various aspects of the regulations of medicinal product, and also recognize that many of these regulations impose additional requirements that must be considered during all activities.

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :- info@avscertification.com
Telephone :- +91 - 9881946595

Design & Developed By : Logic Palace Systems and Softwares
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