Pharma and radiopharma validations

Свяжитесь с нами для получения дополнительной информации

Validations are a “GMP” requirement of good manufacturing practice that each manufacturer identifies what validation work is necessary to prove control of the critical aspects of their particular operation.

Comecer supplies FAT (Factory Acceptance Test) protocol validation for every Hot Cell/Dispensing system/Isolator.
Comecer performs SAT (Site Acceptance Test) and supply if request IQ & OQ protocols (Installation Qualification & Operational Qualification)

The validation protocols comply to the following standards:

  • ISO 14644 (Cleanrooms and associated controlled Environments)
  • ISO 10648 (Containment enclosures)
  • EEC-GMP (Good Manufacturing Practice — Annex 1 Manufacture of sterile Medicinal Products)
  • PDA – TR Nr 34 (Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products)

Sign up for your Comecer Account

If you already have a Comecer Account, log in for faster access. Members get access to our on demand and live webinars, guides, product data sheets, catalogues, exclusive videos, and more.

 
 
 
 
 
 
I have read and understood the information notice pursuant to Art. 13 GDPR (Information notice – Privacy Policy)
 
 
Cancel

Technical

Chiudi

Cancel

Statistical

Chiudi

Cancel

Targeting

Chiudi