What is validation?
Validation is defined as the process of, "establishing documented evidence, which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes".
Validation is the cornerstone of Quality Assurance and our policy is to ensure that Quality Assurance arrangements are enhanced by our work.
Validation follows regulations and guidelines set forth by the US Food and Drug Administration (FDA) in the Federal Food, Drug and Cosmetic Act; Title 21 CFR Parts 210 and 211, Current Good Manufacturing Practices (cGMP) for finished pharmaceuticals. The relevant portions of the US Pharmacopoeia 23/NF18 Title 9 CFR supplement validation requirements.
This is accomplished through the development of written protocols, execution of the protocols, and documentation of the findings. The protocol represents an approved written plan to test, inspect, research, and document results. Each protocol must contain defined acceptance criteria.
Advanced can assist your company with equipment qualifications, requalifications, IQ,OQ,PQ, and provide turn-key validation packages which includes written protocols, and final reports summarizing all of the data collected.
Capabilities
Our staff has performed equipment/system validation and performance qualifications for the following:
- Temperature mapping of ovens/dryers (walk-in and laboratory)
- Drying rooms,
- Autoclaves
- Coolers
- Refrigerators
- Freezers
- Cool storage rooms
- Cold storage rooms
- Incubators
- Environmental chambers/stability rooms (temperature and relative humidity mapping)
- Utilizing Kaye Validator®, Digistrip®, and Kaye ValProbe® systems