A major pharmaceutical selected RCM to provide advisory services to senior management on how to prioritization GMP activities and related tasks.
A major pharmaceutical selected RCM to provide advisory services to senior management on how to prioritization GMP activities and related tasks. The associated tasks were to meet regulatory requirements for their Clean Room initiatives, and to plan readiness activities for future operational purposes.
Ensure compliance with FDA regulations and guidelines.
- RCM deployed an onsite Senior Contract Manufacturing Consultant (CMC) and a Regulatory Subject Matter Expert (SME) to assess the existing documentation, cleaning activities, and room preparedness related to the Clean Room departments applying best practices solutions.
- Revised associated documentation and provided readiness for corresponding approvals.
- Revised existing SOPs related to Clean Room operations and activities and provided training to related personnel.
RCM accomplished the following results:
- Provided standardization guidance in Clean Room operation.
- Provided recommendations to maximize Clean Room utilization.
- Maximized internal workflow while maintaining compliance.
- Trained the Trainers for Clean Room utilization.
Key Project Elements
Assessing current documentation
Advising on Clean Room Best Practices
Updating Clean Room SOPs
Training the Trainer for key personnel