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Quality

Our laboratory operates a comprehensive quality management system based on GMP and DIN EN ISO/IEC 17025.

We are registered as an external laboratory for the testing of medicinal products pursuant to section 67,1 German Medicines Act (AMG) and are subject to monitoring by the competent authority.

The quality of our quality management system, which has been in existence for many years, is regularly confirmed through inspections by the authorities and monitoring by the accreditation body, as well as numerous client audits.

Numerous internal measures are undertaken to ensure the quality of our work. These include regular participation in inter-laboratory testing, carrying out comparative laboratory analyses, further staff training in seminars and training courses and laboratory audits conducted by external assessors.

The assessors of the accreditation body regularly confirm that quality management is not only described in a manual, but that all the staff also put it into practice. The flexible accreditation, which gives the laboratory a free choice of standardised or equivalent test procedures within the accredited test areas and the modification and further/new development of test procedures, confirms the laboratory’s high level of expertise.

Inspections

At HHAC, internal monitoring of the quality system and inspections by clients and authorities form part of the everyday routine. No critical deviations have been determined or documented in any of these inspections by clients and authorities. The timely conclusion of corrective and preventive actions (CAPAs) is a matter of course.

Documentation

Documentation complies with GMP standards, cf. WHO Annex 7, chapter 6.

Archiving

Storage of the GMP documentation is performed according to the highest standards. The duration of archiving complies with clients’ wishes (e.g. 10, 15 years).

QA agreement

All specific details of the responsibilities between client and supplier are effected and guaranteed in individually defined standards in the form of liability limitation agreements (LLA).