Quality Management

Quality Management, Pharmaceutical Quality Assurance and GMP Compliance

An efficient Quality Management (QM) system is an indispensable tool for ensuring maximum product quality and product safety in the production and distribution of pharmaceutical products.

According to the Austrian Regulation on Operating Instructions for Medicinal Products (Arzneimittelbetriebsordnung, AMBO 2009), pharmaceutical Quality Assurance (QA) systems are required for all companies that manufacture, control or market medicinal products.

In 2012, the revised Chapter 1: Pharmaceutical Quality System of the EU GMP Guidelines emphasized that GMP is not only relevant for all production processes, but also affects ALL life-cycle phases of a medicinal product. Starting with the manufacture of investigational medicinal products through the licensing and marketing to the discontinuation of a product, QM covers ALL processes that can individually or collectively influence the quality of a medicinal product.

How can DREHM Pharma support you with Quality Management?

**Team Qualitätsmanagement** [Meet the Team!][7]

Team Quality Management Meet the Team!

A functioning QM system is your key to success! QA is not a static process and can only function optimally if it corresponds to the continually changing circumstances of a company and is fully supported and implemented by all staff.

However, no two companies are alike. At DREHM Pharma, our employees have years of experience in production and quality control and can assist you in all aspects of QM and develop a customized solution to match your specific needs.

Our offerings at a glance:

  • Creation or optimization of a QM system, tailored to match your business and your needs
  • Review of an existing QM system, including gap analysis and individual analysis
  • Ongoing support for your QM system in line with current legal requirements
  • Creation and revision of Standard Operating Procedures (SOP)
  • Creation and revision of Site Master Files and Quality Manuals
  • Personnel training
  • GMP consulting
  • Preparation and assistance with inspections by authorities
  • Support and completion of self-inspections

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We are pleased to support you with our extensive experience and knowledge!