GMP guidance

HHAC provides its clients with advice and support in all areas of quality control, from analytical issues such as method development and validation to the planning of stability testing. Pharmaceutical manufacturers receive competent advice and support with regard to GMP during the setting up and further development of quality management systems.

  • Our clients attach the highest important to the work and results of service providers. As it is often advisable to ensure that supplier qualification is performed by an independent third party, HHAC performs audits on behalf of clients. The inspection results are documented for our clients in a professional audit report.
  • We further support our clients in designing QM systems. This mainly involves compiling and maintaining QMH documents.
  • Experienced and qualified HHAC employees carry out GMP training courses. We offer on-the-job training and additional coaching on GMP issues affecting all aspects of quality control.
  • Drawing on over 20 years’ experience, we communicate HHAC’s expertise in the installation and qualification of analytical equipment.
  • Thanks to the experience gained from approximately 250 transferred analytical methods, HHAC is highly skilled in method optimisation. Our daily experience with method transfer and adaptation means that improving the performance of a method is one of the main issues from which our clients benefit, either as a main or subsidiary product.
  • We also provide client support and advice in method validations. We draw up method validation protocols, discuss appropriate acceptance criteria with our clients and can compile validation reports.
  • We are also able to organise lab-to-lab transfers, draft method transfer protocols and compile method transfer reports.
  • As part of stability testing, we can compile test protocols, determine sampling requirements and provide logistical support.