Merck invests a lot of time and care in the optimal quality and supply reliability of its products. The necessary quality demands are laid down, resulting from internal and science-based requirements and from authority regulations.
As a rule, extensive documentation provides proof for the quality of the product and the assessment of supply reliability. In single cases, Merck requires an additional supplier audit of the customer, which is of special importance for the divisions of pharmaceuticals, food, cosmetics and liquid crystals. These auditing results provide a double benefit for Merck
The customers' particular product applications support the future development of products; the identified potentials for improvement help to further process optimization.
Our extensive documentation covers nearly all production processes and quality topics. Additionally, regular customers are offered the opportunity to get to know the quality of our production processes on site. The customer's request for an audit is received and verified according to standard procedures. A special task force is responsible for the planning, preparation, realization and follow-up of these audits.
Processes of different products or product groups can be audited within one single day, as explanation of relevant systems accompanies the auditing; questions that arise can be directly answered by the responsible experts. The audit results are documented in a report, to be issued by the customer and to be handed over to Merck within four week after the audit. The number of audit participants has been increasing, adding up to more than 100 customers in 2010.
Merck also carries out audits for audit organizations such as the German Association of Research-based Pharmaceutical Companies (VfA). These audit reports are recognized by a great number of renowned manufacturers.
The pharmaceutical business is a highly regulated industry. Standards and regulations like the CFR, ICH Q7 for actives or the IPEC PQG Guideline for Excipients are recognized GMP regulations for assuring the quality of pharmaceutical products. Country-specific regulations for active ingredients, such as section 11 of the AMWHV for Germany [Regulation regarding the Manufacture of Medicinal Products and APIs], explicitly demand an audit or alternatively the usage of adequate third party knowledge for supplier qualification.
As for monographed excipients, compliance with adequate quality assurance systems has to be additionally controlled through documents or audits. The obligation to secure the supply of all required raw materials arises from the social responsibility of pharmaceutical manufacturers. We at Merck are aware of the information obligation towards our customers; therefore, we actively engage in dialog with them.
In supplying food additives, compliance with regulations like the ISO 9000ff. or the GMP guidelines is indispensable. Regional standards like the FCC or the E-standards also have to be observed. Apart from the detailed definition of QM systems and the analytical quality of the substances, risk assessments (HACCP) and traceability are decisive and have to be ensured.
The responsibility to secure compliance with the regulations lies with the producer of foodstuff. Merck actively supports its customers by means of comprehensive quality management and quality assurance systems, which can also be presented in the audit.