GMP - Good Manufacturing Practice

BOLDER Arzneimittel manufactures pastilles only to the highest quality standards for pharmaceuticals and medical devices.

The current GMP guidelines are the general framework. The principles of "Good Manufacturing Practice" are of benefit to you not only as a formal prerequisite but also as a guarantee of sustained high quality and reliability. Of course, we also conform to the requirements of other standards such as the DIN EN ISO standard 13485 for medical devices and the HACCP criteria (Hazard Analysis Critical Control Point) for high quality foodstuffs.

The principles of Good Manufacturing Practice (GMP) cover, amongst other things, the following areas:

  • Systematic quality assurance
  • Qualified personnel
  • Modern, regulated premises and equipment
  • Validated manufacturing process
  • Documentation of procedural specifications and records
  • Batch traceability