Pharmaplace AG

GMP audits

In the pharmaceutical industry, there is only limited opportunity for changing suppliers – meaning that the same applies to market penetration. This primarily results from the good manufacturing practice (GMP) for active agents, evidence of which must be provided by the pharmaceutical industry by means of an audit at the premises of the active agent manufacturer.

pharmaplace's goal is to ensure that audits remain economical for pharmaceutical companies in terms of personnel and finances, and it has successfully carried out third-party audits in Asia for many years. It provides support and relieves the strain on participating companies while preparing and carrying out this important process.

The auditing is performed by a German auditor based in Shanghai and their team, in accordance with pharmaplace's regulations and guidelines. Journeys are therefore short and work can be performed in a very cost-effective manner thanks to a well-conceived planning system (bundling effect). This is reflected in the fact that we have performed over 250 audits to date.

The benefits for you:

  • Auditing costs reduced by up to 60%
  • Additional auditing capacity without deploying your own personnel resources
  • Valid auditing procedure
  • Comprehensive audit report in accordance with ICH Q7

It goes without saying that we can also supply you with audits that have previously been carried out, provided that we obtain the consent of the authorised party (holder of the audit report) and the active agent manufacturer. Distributors of active agents also make considerable use of our service.

For more details on the auditing procedure and the conditions for submission, e-mail info@pharmaplace.de or contact Mr Walkling personally (g.walkling@pharmaplace.de).

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