Quality assurance (QA) experts at Richter-Helm BioLogics keep an eye on internal standards and continually adjust them to progressive national and international demands. The quality assurance system is based on the cGMP requirements for the production of pharmaceuticals (EC guideline 91/356/EU on medicinal products for human use) and active components (ICH guideline Q7A for active pharmaceutical ingredients).
As an established, independent department, the quality assurance team is responsible for cGMP compliance at Richter-Helm BioLogics, conducting a cGMP audit and self-inspection programme in order to maintain standards as well as being involved in certain aspects of the qualification assessment of raw material suppliers, test laboratories or other service providers. Quality assurance itself is not only a regular target for external auditors commissioned by the authorities but also for auditors employed by international clients, so the experience gained from these audits is incorporated in the ongoing advancement of the QA system.
Quality assurance accompanies the product from its development through to the production and quality control, right up to the final release. Richter-Helm BioLogics' quality assurance department is involved in issuing almost all documents dealing with manufacture and controls as well as conducting the so-called 'batch record review' in preparation for the release of the product.
Our QA system complies with the standards applicable in each case. However, it is normally possible to make adjustments to suit the needs of the customer concerned in order to support interdisciplinary collaboration and help the project unerringly on its way to success.
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