cGMP

Within Pharmazell Quality is not only a set of rules, but a mindset.
Quality systems and programs are developed at a Corporate level and then implemented on each site. Corporate QA continuously monitors these programs to assess their effectiveness and need for improvement. This approach assures a constant high quality for all products made at all locations.
Experience gained by Quality Assurance functions over the last decades enable us to acquire excellent expertise in meeting consistently the cGMP requirements.
Our products are manufactured in accordance with the most stringent requirements of our customers and authorities e.g ICH Q7A, EU GMP Guideline Part II and US FDA 21 CFR 210, 211.
Commercially used products are manufactured and tested according to validated processes and methods using fully qualified equipment and facilities. We are following our registered process as outlined in our CEP and ASMFs.

 

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  • Qualified Equipment and Utilities
  • Validated Methods, Processes and Cleaning
  • Change Control
  • DMF filing

For our active pharmaceutical ingredients we received official GMP certification based on EU directive 2001/83.
PharmaZell successfully passed numerous health authority GMP inspections (e.g. FDA, German Health Authority, PMDA) and frequent customer audits on its sites.
PharmaZell welcomes customer audits as they allow us to continuously improve our working practices