Process Validation
Process validation is a legal requirement in the pharmaceutical industry. The concept of process validation is recognition that quality cannot be tested into the product and must be designed into the process/product to reduce the risk of non-conformances during/after manufacturing. Premier Validation's Process Validation Services involve a comprehensive and in depth exploration and evaluation of every aspect of the manufacturing environment, including but not limited to :
- Manufacturing Facilities
- Utilities and Related Services
- Equipment and Maintenance
- Cleaning
- PLCs and SCADA Systems
- Manufacturing and Packaging Processes
Process Validation Deliverables
Premier Validation's Process Validation Services include the following deliverables :
- Validation Master Plan
- Validation Project Plan
- Validation SOPs
- Validation Protocols
- Validation Summary Reports and Recommendations
With extensive, hands-on process validation experience, Premier Validation's professionals have a proven system in place to offer clients a turnkey approach to validating their manufacturing processes. Our process validation services can be as expansive as the development and implementation of a validation program for an entire manufacturing operation or as focused as a specific project tailored to an individual facility, utility system, equipment, manufacturing process or software application. The bottom-line benefit of Premier Validation's Manufacturing Process Validation Services translates to effective business risk management, enhanced product quality and, ultimately, increased market share.
