Production – Batch Release

Manufacturing

The production of medicinal products often requires specialized production centers. Many contract manufacturers offer these services, as well as contract labs. Production in terms of a batch release is often performed by office establishments. Such businesses need a manufacturing license, limited to „office work.” Quality management systems for medicinal products and a qualified person (in accordance with § 7Arzneimittelbetriebsordnung, Austria and Article 48, EC Directive 2001/83) are also required.

How can DREHM Pharma support you with Production and Batch Release?

DREHM Pharma holds a production license limited to „office work” and is experienced in developing and delivering successful batch releases (e.g. importing products from non-EU countries).

Regular inspections by the Austrian authorities confirm GMP compliance.

**Team Entwicklung** [Meet the Team!][8]

Team Production Meet the Team!

DREHM Pharma can manage all production processes:

  • Procurement of Active Pharmaceutical Ingredients (API)
  • Search for contract manufacturers
  • Pre-audit and audit of contract manufacturers and contract laboratories
  • Audit of API manufacturers
  • Audit of packaging manufacturers
  • Audit of contract packers
  • Batch release of manufactured drugs, including all document checks
  • Contract preparation with contract manufacturers and contract laboratories

DREHM Pharma has qualified persons dedicated to these projects to ensure regular back-up and support.

We like to share our experience with you!