Our Offering
Service
Take control
of Annex 1
Build your roadmap to compliance in cleaning, disinfection and decontamination with our expert team of Global Technical Consultants.
Annex 1 masterclass
webinar series
STARTS OCTOBER 13TH 2022
Learn more about the new Annex 1 requirements and how to be compliant by the deadline with our new Masterclass webinar series.
CLICK HERE FOR DETAILS
Our experts can help you achieve compliance with Annex 1 and our Masterclass will focus in on these six key areas in cleaning, disinfection and decontamination:
Contamination Control Strategy (CCS)
Cleaning and disinfection is listed as a key element that should be included within the CCS.
Cleaning and Disinfection
A distinction has been made requiring a cleaning step be performed prior to disinfection.
Disinfectant Selection
A burden of proof has been placed on the end user to certify the quality of in-use disinfectants.
Residues
Disinfectant residues are to be managed using a risk based approach, focussing on their removal to ensure effective disinfection.
Validation
There is a clear mandate to validate the disinfection process in the specific manner and on the surfaces the products will be used.
Transfer Disinfection
Appropriate risk assessment and mitigation via a disinfection programme is required through all stages of transfer.
Find out more about how Ecolab can help you build your roadmap to compliance: complete our Annex 1 enquiry form here
COMPLETE REQUEST FORMWhy has Annex 1 been updated?
Annex 1 has been modified to reflect the change in technology within the last 10 years, to harmonise with ICH chapters on Quality Risk Management and Pharmaceutical Quality system, and to provide greater clarity for interpretation of the content.
EudraLex Volume 4
EudraLex Volume 4 covers Good Manufacturing Practice (GMP) guidelines and Annex 1 is specific to the manufacture of sterile medicinal products.
Who are the Global Technical Consultants?
Our team of GTCs are Pharmaceutical Microbiologists with decades of industry experience.
