Utility Qualification
Utility Qualification for Pharma industry
Sathram Corp provides utility qualification services for Pharma industry which involves verifying the equipment and support systems used in producing drugs meet specific standards and regulations. The process typically includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
IQ involves ensuring that the equipment or utility system is installed correctly and meets all of the manufacturer’s specifications. OQ involves testing to verify that the equipment performs as expected under normal operating conditions. PQ integrates procedure, personnel, systems, and materials to verify that the pharmaceutical grade utility, environment, equipment, or support system produces the required quality results.
We possess talent that can handle the UQ services with top potential to improve the quality of the equipment in the Pharma Industry.
FAQ's
What is Utility Qualification?
Utility Qualification is a factor which involves verifying the equipment and support systems used in producing drugs meet specific standards and regulations.
Why is Utility Qualification important?
It ensures reliable utility performance, compliance with regulatory standards, and minimizes risk of contamination or operational failure.
How is Utility Qualification conducted?
Through systematic assessment, testing, and documentation of utility systems to ensure they meet predefined specifications.
What are the key components of Utility Qualification?
Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Who is responsible for Utility Qualification?
The CRO oversees the process, working with engineering and quality assurance teams.
