Qualification of systems and equipment is therefore a part of the process of validation.
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.
Even though it is not mandatory, it is the document that outlines the principles involved in the qualification of a facility, defines the areas and systems to be validated and provides a written program for achieving and maintaining a qualified facility with validated processes.
It is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation.
We offer a full range of qualification and validation services for your c GMP/c GLP facility.FDA, or any other food and drugs regulatory agency around the globe not only ask for a product that meets its specification but also require a process, procedures, intermediate stages of inspections, and testing adopted during manufacturing are designed such that when they are adopted they produce consistently similar, reproducible, desired results which meet the quality standard of product being manufactured and Complies the Regulatory and Security Aspects.Such procedures are developed through the process of validation.Large projects: When you have a large volume of qualifications or re-qualifications that need to be completed.We can handle projects that are larger in scale on condensed timelines due to the skill of our staff, and the quantity of validation equipment we have available. Our team is not only familiar with Ellab’s equipment, but also other systems. Often clients hire us to perform some of the more complicated qualifications such as autoclaves and Steam-in-Place.We are only successful through your success Unexpected projects: There are so many resources at your facility.