Regulatory Compliance

Our regulatory expert teams support a high-performance supply chain to ensure delivery of Life Science products on time, every day.

Different regulatory teams work hand-in-hand to provide regulatory excellence for our Life Science business.

Regulatory Excellence

Regulatory Compliance

Products which have been classified as genetically modified organisms (GMO) are regulated by Directives 2001/18/EC and 2009/41/EC of the European Parliament and of the Council and their national implementation in the member States respectively. This legislation obliges Merck to request certain information about you and the establishment where the GMOs are being handled. That is because establishments located in the European Union will require licensing where the GMOs are being handled. When placing an order for a GMO product, Customer Service will request an Enduser Declaration to be completed prior to processing the order. Refer to the applicable Country Enduser Declaration Form for more information.

Emprove branded excipients with standard documentation and/or support, such as:

  • EXCiPACT™ certification
  • Excipients aligned with IPEC PQG GMP
  • Emprove Dossiers
    • Material Qualification Dossiers – Free to download and is intended to help qualify excipients
    • Quality Management Dossiers – Fee for access and is intended to support questions during quality risk assessment according to ICH Q9 and EU 2015/C95/02.
    • Operation excellence Dossiers - Fee for access and is intended to support information such as process optimization and safety risk assessment activities (such as ICH Q3D, elemental impurities).
    • Generally, contains the following quality certifications and/or statements:
      • Nitrosamine statement
      • TSE/BSE Certificate
      • Allergen Certificate
      • Mycotoxin/Aflatoxin Certificate
      • GMO (genetically modified organism) Certificate
      • Melamine Declaration
      • Kosher Certificate
      • Halal Certificate

EXCiPACT™ - Reducing the Burden of Audits

Second Successful EXCiPACT™ Audit Including ANSI Requirements

Being one of the first companies to successfully complete a comprehensive EXCiPACT™ GMP&GDP audit 3 years ago, we successfully passed the first recertification audit in June 2016. This audit also covered the GMP requirements according to NSF/IPEC/ANSI -363-2014. With the new certificate, the compliance of our management system to both standards on GMP for Pharmaceutical Excipients was confirmed. The recertification is complemented by annual surveillance audits to control the continued quality of excipients.

What is EXCiPACT™?

Until 2013, there were no certifiable GMP and GDP (Good Manufacturing Practice, Good Distribution Practice) standards for the pharmaceutical excipients that make up the bulk of most drug formulations. So the pharmaceutical excipients industry launched EXCiPACT™ – a certification scheme for pharmaceutical excipients that grants an independent, one-stop ‘seal of approval’ by third-party auditors. With EXCiPACT™, a single audit will be all it takes to prove an excipient complies with current GMP and GDP requirements. This certification for manufacturers, suppliers and distributors of pharmaceutical excipients minimizes risks to customers and helps to reduce the burden of audits and thus costs.

Benefits:

  • More safety: through certified compliance to recognized GMP and GDP standard
  • Cost and time savings: only a single audit is needed to prove GMP/GDP compliance
  • Worldwide acceptance: building on existing ISO standards, and supported by major industry organizations

What is NSF/IPEC/ANSI -363-2014?

Until 2015, there were no certifiable GMP and GDP standards for companies not applying the ISO 9001 Quality management standards. With NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients as the first American National Standard, this gap has been closed.

The new standard provides a harmonized and comprehensive set of criteria for the quality management systems used in the manufacture of pharmaceutical excipients worldwide. It was developed in partnership with the International Pharmaceutical Excipients Council (IPEC) with input coming from academic fields, industry and the U.S. Food and Drug Administration.

Excipient manufacturers with EXCiPACT™ and/or the NSF/IPEC/ANSI 363 standard certification demonstrate that their excipients are manufactured according to the appropriate GMPs for pharmaceutical use, representing the best industry practice currently available.

To learn more about EXCiPACT™ please visit www.excipact.org.

To learn more about NSF/IPEC/ANSI -363-2014, please click here.