In the interest of safety, purity, and effectiveness, pharmaceutical and life science industries must comply with the FDA's Good Manufacturing Practices. Validation is a critical part of ensuring that GMP regulations are followed and the costly consequences of non-compliance are avoided.
Our Validation Services for GMP compliance allow manufacturers, processors, and distributors to document and evaluate the practices that support consistent production and quality control. The validation of a GMP system can help to reduce the potential risks generated by unreliable equipment or systems.
Transcat's proven validation expertise is invaluable to organizations that must comply with current good manufacturing practices (cGMP), which are the most recent regulations covering production that may involve materials, facilities, equipment and employee training. Qualifications can be performed as an initial component of validation. They can document a system's efficacy and ability to deliver quality products. A qualification can also confirm that equipment is properly installed. Our teams have the capabilities to perform the following:
- ReQualification (RQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
We also develop customized protocols for ‚ and perform ‚ the four types of validations done in accordance with GMP:
- Prospective validation (New Systems)
- Retrospective validation (Legacy Systems that have not been fully Validated in the past)
- Concurrent validation (System previously Validated but currently in Use)
- Revalidation (As part of your Quality System)
Ensuring FDA GMP Regulatory Compliance
Our experienced technicians collaborate with your quality assurance teams to successfully complete the testing and reports that validate your production and laboratory equipment. As a provider of validation services for pharmaceutical and life sciences companies, Transcat has the foundation of knowledge to help you meet GMP requirements. To take advantage of our flexible scheduling and highly efficient validation processes, request a quote from Transcat Compliance Services today.