Download Guidance Document – Good Cleaning Validation Practice
In response to developments in the Regulatory environment relating to cleaning validation, plus a collective membership need, the PMTC hosted a ‘cleaning workshop’ in 2014 which was attended by 23 companies, the HPRA, academia and relevant governmental agencies (IDA, EI). This group of stakeholders identified a number of key areas of concern and interest relating to cleaning validation. These were:
1. Production of Guideline documentation
2. Production of a simple ‘app’ for presentation of cleaning calculations
3. To scope research programs for methodologies and the use of PAT & modelling in cleaning
The PMTC is currently addressing all three areas.
PMTC commissioned The Compliance Group to deliver a ‘good cleaning validation practice (GCVP)’ document which has been produced based on a review of current guidelines and input from HPRA, the PharmaChemical Ireland Cleaning Validation subteam and other Industry and is now available to download by filling in your details on the right.
A companion app is in preparation and will be available through this website soon. Once you have downloaded the Good Cleaning Validation Practice document you will be notified by email when this is ready