Bilderrahmen mit wichtigen Zertifikaten
Quality

Effective quality management


Companies expect one thing above all else from their contract manufacturers: consistently high quality.

BOLDER Arzneimittel is a manufacturing authorisation holder pursuant to § 13 (1) AMG (German Medicinal Products Act) and is certified according to EU-GMP and ISO 13485.

We would be happy to provide you with copies of the certificates on request.

Please contact us by email at request@bolder.de
or call us on +49 2234 37952-195.

These quality standards have been fully integrated into our processes. Moreover, we are continually improving them in line with the latest GMP guidelines.

The end result: exceptionally effective quality management.


BOLDER Quality Management


Quality assurance as a matter of principle


BOLDER pastilles are high-quality pharmaceutical products. We assure their quality strictly according to GMP and ISO.
 

This involves:

  • National and international customer audits and official inspections
  • Assistance with regulatory issues
  • Annual preparation of the Product Quality Review (PQR)
  • Supplier management
  • Oversight reviews by the management
  • Release office


Stringent analytical quality controls in our own laboratory


At BOLDER Arzneimittel, we always keep a close eye on the quality of your pastilles.

We operate a well-equipped GMP control laboratory at our factory.

We use the latest technology to analyse all raw materials, packaging materials and finished products. Our laboratory instruments are qualified, our test equipment calibrated and our analysis methods validated. All analyses are performed by qualified personnel. All results are documented with an analysis certificate.
 

Our quality control procedures cover:

  • Incoming goods inspection
  • Release testing of intermediate and finished products
  • Stability testing
  • Method development and optimisation
  • Method validation and transfer
  • Microbiological analyses

 



Assumption of responsibility by our in-house qualified persons


BOLDER Arzneimittel employs its own qualified persons. Every batch is certified by a qualified person.

In this way, we ensure that all medicinal product regulations pursuant to the AMG and AMWHV are being complied with at all times during production, testing and batch release. The certification of medicinal products is performed according to EU-GMP (Annex 16) and for medical devices according to ISO 13485 (conformity assessment).

Our qualified persons create and update the corresponding Quality Assurance Agreement (QAA) too.

 


Our QM services at a glance:

  • Assistance with regulatory issues
  • National and international customer audits and official inspections
  • Annual preparation of the Product Quality Review (PQR)
  • Analysis in BOLDER’s in-house GMP control laboratory
  • Batch release by in-house qualified persons