Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability. Although “equipment cleaning” is part of current Good Manufacturing Practice requirements the term “cleaning validation” was not popular until late 1980s.
The need for a systematic approach to proving the effectiveness of all the cleaning procedures was achieved in 1993 with a revised Food and Drug Administration Inspection Guide on Cleaning Validation.
API Cleaning Validation Protocol
This template will provide the user everything to compile the cleaning validation protocol of a pharmaceutical formulation industry. The format and the contents of this template confirm the ICH and APIC guidelines for Cleaning Validation. The template is self explanatory and complete in every aspect. Only putting the particular data or credentials will make it ready for approvals.
Click here to download protocol.
Cleaning Validation Expert
Pharmaceutical Formulation Industry