Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.
Source: GMP Draft Annex 1
ISO 14644-1:2015 Compliant Cleanroom Monitoring
We discuss the changes to sampling procedures and monitoring plans for cleanrooms and clean zones in...Read more
7 Steps to a Cleaner Environment
The risk to a finished products sterility increases, as operator activities increase within an asept...Read more
The Importance of Cleanroom Validation
Cleanroom validation offers ISO compliance and peace of mind.Read more