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Quality Management & Batch Release 

Anyone who needs an external Qualified Person, who has to update his pharmaceutical quality management or who seeks advice relating Good Manufacturing Practice (GMP) will find professional support in Diapharm.

On behalf of pharmaceutical companies Diapharm assumes responsibility for manufacturing and quality control. In the field of OTC products we act as an external Qualified Person (2001/83/EC) or Qualified Person for Pharmacovigilance (section 63 of the German Drug Law). The HÄLSA Pharma GmbH, a partner of Diapharm, possesses a manufacturing license (section 13 (1) of the German Drug Law) and therefore is authorised to perform batch releases of medicinal products for marketing.

For manufacturers of medical devices Diapharm will also assume the function of the Safety Officer or the Quality Management Officer. We coordinate certification procedures of medical devices and perform conformity assessment for CE labelling. HÄLSA Pharma either assumes the function of a Medical Devices Consultant or takes over full responsibility as a manufacturer (section 3 (15) of the German Medical Devices Law). The quality management of HÄLSA Pharma is certified according to ISO 9001, ISO 13485:2003 and GMP.

Quality Services & Release

quality management

GMP consulting

responsibilities acc. to the German Drug Law, e.g. Qualified Person for Pharmacovigilance

manufacturing license for medicinal products

responsibilities acc. to the Medical Devices Law e.g. Safety Officer

responsibility as manufacturer of medical devices

qualification and validation

product transfer

risk management

Besides the complete assumption of functional sections Diapharm also provides individual support for the creation and updating of the respective competences within the companies. Our expert QM and GMP consultants provide support for the installation and certification of quality management systems, prepare manufacturers for client audits for Good Manufacturing Practice (GMP), establish HACCP for food producers or support pharmaceutical companies which are expecting an audit by the supervisory authority.

As an external service provider for quality assurance Diapharm also files GMP documentations and risk management files. Ourexperts carry out compliance checks for manufacturing processes in order to testify conformity with all legal requirements. We organise and coordinate product transfers for the manufacturing of medicinal products in Germany or other countries and much more.

 

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