QUALITY OF PHARMACEUTICAL EXCIPIENTS
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The international standard for quality management ISO 9001 has been under review since June 2012 and is to replace the 2008 version in 2015. In May 2014, the Draft International Standard (DIS) was released – an important step on the way to revision.
With ISO 9001:2015, ISO members are fulfilling their claim to regularly evaluate standards with regard to their adequacy, relevance and timeliness. The increasing plurality of ISO 9001 users was factored in, as were changing interests of users and technological advances in the widest sense. On this page, you will be able to learn of the state of development of the revision, what topics are under discussion, and what information is available from DQS.
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GDP Compliance
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GMP Compliance
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Quality Standards
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Patient Safety
The international EXCiPACT™ certification program – the product of the joint efforts of manufacturers and end users of pharmaceutical excipients – is designed for excipient manufacturers and suppliers. It improves safety and transparency in pharmaceutical production and raises the quality of excipients along the entire supply chain. To obtain EXCiPACT™ certification, companies need to already have an ISO 9001 quality management system in place. Also, they need to already conform to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) quality standards.
- Internationally recognized proof that your GMP/GDP system meets the high standards of drug manufacturers
- Global acceptance by all key players and regulators
- Significant reduction in audit time by largely eliminating the need for supplier audits by drug manufacturers
- Considerable cost savings from reducing audits without compromising on quality
- Improved transparency and dependability within the pharmaceutical excipient supply chain
EXCiPACT™ assumes that you already have an ISO 9001 quality management system in place. The EXCiPACT™ certification process consists of an independent audit of your GMP or GDP system by our knowledgeable experts. Any gaps between ISO 9001 and EXCiPACT™ requirements are identified and cataloged. Then, we analyze your management system, capturing all its processes, policies and documents, and evaluate it in a system audit. If you satisfy the requirements, you receive a certificate that is valid for three years. We conduct surveillance audits in the next two years, followed by recertification after three years.
