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


Related articles

7 Steps to a Cleaner Environment

The risk to a finished products sterility increases, as operator activities increase within an asept...

Read more

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

The Importance of Cleanroom Validation

Cleanroom validation offers ISO compliance and peace of mind.

Read more