The goal of the commercial stage is to produce cGMP Bulk Drug Substance utilizing an approved process under a regulatory license to supply customer material needs. But Commercial Supply goes beyond making the Bulk Drug Substance. At FUJIFILM Diosynth Biotechnologies our Post-Approval activities include: process surveillance, annual product quality review (APR) and annual regulatory support.
An important element of the commercial stage is process surveillance. At FUJIFILM Diosynth Biotechnologies we have a Process surveillance that equates to the FDA’s process validation guidance “continued process verification” stage. Process surveillance consists of collecting, analyzing and providing the appropriate process control changes based on that data.
Activities in Process Surveillance typically include:
- Collection of surveillance parameters data for all commercial batches manufactured. Surveillance parameters include but are not limited to Critical Parameters and In-Process Controls
- Trending of Surveillance Parameters
- Statistical Analysis shall be performed on Critical Process and Quality Attributes
- Regulatory/QA support for periodic review of surveillance parameter data in compliance with US, EU, and Canadian regulations.
- Preparation of surveillance parameter data report after completion of each manufacturing campaign
Annual Product Quality Review
The purpose of Product Quality Review is to evaluate if the process is operating consistently within its validated state, to determine if there is a need for specification revision, to highlight trends and identify any needed corrective action, process improvement and/or re-validation.
Annual Regulatory Support
Annual documentation support for repeat regulatory requirements in accordance to jointly established Regulations.
Typical Regulatory Support Activities include:
- Review and comments on all regulatory submissions as related to our customer’s product(s)
- Inspection support and responses to any observations directly related to Manufacture of our customer’s Product
- Updates to regulatory submissions, including support for supplements, variations and annual reports
- Site master file updates
Our approach to Commercial Manufacturing sets FUJIFILM Diosynth Biotechnologies with a unique and powerful combination of capability and process understanding. Creative and comprehensive approaches to solving classic manufacturing problems gives us and our customers an edge to managing processes in clinical and commercial environments. The process by which the product is manufactured is just as important as the end product itself and we seeks to manage that information to provide the best end results for our customers and to their patient.