Many industries are required to follow the Food and Drug Administration’s Good Manufacturing Practices to maintain strict standards for safety, purity, and product performance. To reduce the risk of not-compliance with the Good Manufacturing Practices, validation services are necessary for your business, laboratory or organization.
At Sercom, we provide comprehensive cGMP validation services and are prepared to meet the needs of your company. Additionally, validations provide a way to ensure consistent production and quality control as well as avoiding the downsides from poorly performing systems.
Qualifications are typically conducted as an initial step of validation. Qualifications also help provide documented evidence of equipment performance and capability to deliver compliant, high-quality products. Finally, qualifications verify that equipment has been properly installed.
cGMP Validation Services Include:
> Installation Qualification (IQ)
> Operational Qualification (OQ)
> Performance Qualification (PQ)
> Scheduled Re-Qualification (RQ)
Our technicians are experienced in generating, customizing and executing pre-approved qualification protocols in accordance with FDA cGMP regulation and industry best practices. Our highly trained technicians consistently deliver fast turnaround times while maintaining the highest standards of quality and accuracy.
Fill out the form below or contact Sercom at (970) 482-8410 to discuss your cGMP validation requirements or to request a customized service quote.
Contact us to receive a free quote, schedule an appointment with a technician or get answers to any of your questions.
