GEA Pharmaceutical A/S's and PharmaZell’s quality system comply with the Guidelines of ICH Q7A, corresponding to the EU GMP Guidelines Part II.

All products are manufactured and tested according to validated processes and methods. The system assures a constant high quality for all products made at all locations. GMP certificates issued by a European authority are available for all products currently manufactured at any site of the PharmaZell group.

For all active pharmaceutical ingredients PharmaZell holds Drug Master Files (DMFs) and/or Certificates of Conformity with the European Pharmacopeia (CEPs) with health authorities in the US, Europe, Japan, Canada and Australia.
• Qualified Equipment and
Utilities
• Validated Methods, Processes
and Cleaning
• Change Control
• DMF filing
Pharmaceutical manufacturing is running under cGMP for study medication.

A great experience is accumulated for technological transfers of pharmaceutical production into large scale GMP production sites.

These documents are prepared during product development, submitted to the authorities, maintained and updated during the life cycle of the products. The sites of the PharmaZell group are regularly audited by the European and US authorities and also regularly receive audits by our customers. Quality audits of our customers can be arranged with the Head of Quality Assurance.

GEA welcomes client audits as they allow to continuously improve existing working practices.

 
QUALITY SYSTEMS & REGULATORY COMPLIANCE
QUALITY SYSTEMS & REGULATORY COMPLIANCE