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Customer audits – Ensuring and guaranteeing quality through dialog

Pharma | Food

Клиентский аудит

Merck Millipore 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 Millipore 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 Millipore
The customers’ particular product applications support the future development of products; the identified potentials for improvement help to further process optimization.

Audits in Merck Millipore

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 Millipore within four week after the audit.
The number of audit participants has been increasing, adding up to more than 70 customers in 2007.

Merck Millipore 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 renown manufacturers.

Merck4Pharma

Стандарты и инструкции такие как Свод Федеральных постановлений (CFR), ICH или IPEC нормативы общепринятые GMP инструкции для уверенности в качестве фармацевтического продукта. Определенные для страны инструкции для активных инградиентов, таких как 11-й параграф AMWHV для Германии [Инструкция согласно Производства Медицинских продуктов и Активных инградиентов], недвусмысленное требование надзора или альтернативного использование адекватного знания третьего лица для квалификации поставщика.

Что касается монографических добавлений, согласно с адекватными системами проверки качества, должны дополнительно управляться через документы или ревизии. Обязательство обеспечить поставку всего необходимого сырья, является результатом социальной ответственности фармацевтических пероизводителей. Мы в Мерке знаем об информационном обязательстве к нашим клиентам, поэтому мы активно участвуем в диалоге с ними.

Merck4Food

Comprehensive quality management and quality assurance systems
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.

Ответственность за обеспечение, согласно инструкциям, лежит на производителях пищевых продуктов. Мерк Millipore активно поддерживает своих клиентов посредством всестороннего качественного управления и систем проверки качества, которые могут также быть представлены при проверке

назад

© Merck KGaA, Darmstadt, Germany, 2012


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