CLEANROOM VALIDATION
CLEANROOM VALIDATION
Validation is an essential part of Good Manufacturing Practices (GMP). It is, therefore, an element of the quality assurance program associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use.
Cleanrooms and associated controlled environments provide for the control of contamination of air and, if appropriate, surfaces, to levels appropriate for accomplishing contamination-sensitive activities. Contamination control can be beneficial for protection of product or process integrity in applications in industries such as pharmaceuticals, medical devices, healthcare, food, aerospace and microelectronics.
Following the EU GMP, U.S. FDA, ISO/TC, PIC/S Guides, WHO | TRS or other regulatory requirements, validate with us your clean room process!
We are ready to help you in force to create appropriate approach, completing each step in this process to reach the goal – to establish the confidence that the manufactured products will consistently meet their product specifications.
Our specialized team of experts is ready to assist you on the road to GMP compliance.
