GMP Drug Manufacturing Policy Development

GMP Drug Manufacturing

Our Drug Manufacturing Client is currently in Phase 3 Clinical Trails. They retained the services of the Brevitas team to provide GMP policies related to the manufacturing operations performed at their CMO’s. The development of these policies is part of the preparation of their drug-to-market approval process.

Industry

Biologics

Area of Expertise

Quality Management

Duration

3 Months

Services Provided

Development and Finalization of 7 policies for GMP Manufacturing Environment

Impact

Our client now has policies pertaining to their CMOs GMP Manufacturing operations

Business Challenge

A Drug Development Client currently in Phase 3 Clinical Trials required several policies to be developed as they move closer to market approval. The project involved the development of 7 policies aligned with the CMO’s and industry best practices and regulatory guidelines.

Our Approach

We conducted various meetings as a preliminary phase to understand the current operations and different vendors involved in the manufacturing process. Once we gained an appropriate understanding, the policies were developed and reflected the appropriate regulatory guidelines.

Results Achieved

From inception to completion, the Brevitas team contributed to the success of the project by developing the following policies:

  • Facility Requirements for GMP Manufacturing
  • Utility Requirements for GMP Manufacturing
  • Equipment Requirements for GMP Manufacturing
  • Manufacturing of Sterile Products
  • Facility, Utility and Equipment Validation
  • Cleaning and Process Validation
  • Vendor Management

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