The Annex 1 Revision of the EU GMP Guide was finalised in 2022. Previously there were two drafts (2017 & 2020), now the final version will come into force at 25th August 2023. The new Contamination Control Strategy (CCS) hugely affects Cleaning Validation.
In the manufacture of medicinal products and APIs, the cleaning of facilities and equipment is an important measure to avoid contamination and cross contamination. In compliance with the GMP regulations, cleaning is performed and documented according to the described procedures. In the past, cleaning effectiveness was often monitored only visually. However, residuals of APIs and excipients as well as of detergents are increasingly an issue in inspections and audits. The success of cleaning procedures has to be validated. In addition to the FDA “Guide to Inspection – Validation of Cleaning Validation Processes”, the PIC/S document PI 006 and Annex 15 address cleaning validation in a separate chapter. Moreover, the ICH Guideline Q7 “GMP for APIs” also requires cleaning validation – as well as two guidelines by APIC, the association of European API manufacturers.
A Guideline from EMA on Dedicated Facilities and Exposure Limits for Cleaning Validation and the revised Annex 15 deal now with a PDE (Permitted Daily Exposure) Approach.
The Annex 1 revision and it’s Contamination Control Strategy (CCS) also has an impact, especially on Cleaning Validation for sterile dosage forms.