As a pharmaceutical professional, you are faced with the ongoing challenge of ensuring the quality, safety, and efficiency of your products, while also managing guidelines established by the FDA and global regulatory bodies. Pharmaceutical validation is an important aspect of quality assurance. It provides documented evidence that your systems, facilities and processes perform their intended functions according to established specifications.
Transcat's pharmaceutical validation services deliver distinct advantages to the manufacturers of finished pharmaceuticals and components. We have in-depth knowledge of regulated process equipment and the GMPs of regulatory agencies. With each study, we offer:
- Validation technicians with extensive technical expertise
- Access to calibrated instrumentation and superior standards
- Qualification, validation, revalidation and calibration capabilities
- The delivery of validation documents
- A proven record of validations performed for the pharmaceutical industry
We conduct validations when a new system, equipment or facility is adopted by an organization, or when a periodic study is needed. Our FDA qualifications/Validations are created to meet our customer's quality system and may be requalification, operational, performance and installation qualification services.
