GMP Drug Manufacturing Policy Development
Our Drug Manufacturing Client is currently in Phase 3 Clinical Trails. They retained the services of the Sciras 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 Sciras 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
