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Given the cost of auditing suppliers, regulators in the U.S. and Europe have encouraged manufacturers to work with third-party auditors to certify that they are using raw materials that meet current good manufacturing practices (cGMP). A number of programs are available to conduct auditing of an excipient manufacturer, in- cluding IPEC's joint audit service and the U.S. Pharmacopeial Convention's (USP's) excipient verification program and certification scheme. The EXiPACT certifi-cation scheme provides independent auditing and certification of excipient manu-facturers, suppliers and dis- tributors, to ensure they are in line with cGMP and current good distribution practices (cGDP) throughout the pharmaceutical supply chain. These auditing services are available to help minimize costs and time for both excipient suppliers and drug product manufacturers.
IPEC's position paper emphasizes that the assessment of all associated risks of an excipient and its suppliers can only be achieved by the manufacturing authoriza- tion holder through open communication, collaboration and flow of information be- tween all parties along the excipient supply chain. This collaboration is critical to avoid gaps in a holistic risk-assessment process. For example, the risk-assessment application process could lead to situations in which an excipient from a single manufacturer could be classified by different manufacturers into different risk classes (low, medium, high), depending on its intended use and application. This could result in differing expectations relating to the appropriate GMPs necessary in the manufacture of the same excipient.3
ANSI Standard Released in
the U.S. In the U.S., the first American National Standard for GMP of pharmaceutical excipients, NSF/ IPEC/ANSI 363, was published in 2015 by NSF International: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients. The new standard and auditing program assists pharmaceutical companies in verifying reg- ulatory compliance and strengthening safety and quality throughout the excipient supply chain. The standard incorporates a risk assessment process that can be applied to any excipient and a framework for excipient quality control that is consistent with the ICH Q 8-10 principles.
The NSF/IPEC/ANSI 363 standard for pharmaceutical excipient GMPs provides a harmonized and comprehensive set of criteria for the quality management systems used in the manufacture of pharmaceutical excipients worldwide. Also, the Food and Drug Administration Safety and Innovation Act (FDASIA) now requires U.S. manufacturers to verify and document that the raw materials used in finished products are also meeting appropriate GMPs. Drug makers are expected to conduct audits of excipient manufacturers and distributors to ensure a secure supply chain.
Supply Chain Issues
The IPEC-PQG GMP Guide 2006 and IPEC GDP Guide 2006 provide the basis for managing a quality-based, safe, and traceable pharmaceutical exipients supply chain. According to these guidelines, all parties in the supply chain must share responsibility for the quality and safety of the materials and products. Ultimately, the drug manufacturer is accountable for assessing the risk in the supply chain, implementing a risk management program, and having a risk mitigation strategy in place. The manufacturer must have complete knowledge of the supply chain, the history and reputation of each party involved, practices followed at each step, and match
risk and controls with audit and verification throughout the supply chain.
There are multiple complex issues in the global excipient supply chain, particularly when excipients are imported. Concerns about imports have been raised as the excipient industry has experienced more FDA import holds. An unexpected hold can delay drug production, negatively impacting its timeline to market or cause a shortage in drug supply, which can have devastating consequences. Other supply chain chall- enges include a supplier not agreeing to an audit or many global locations to audit. In-house auditors maybe unfamiliar with chemical processing; there is also a concern surrounding travel costs and language barriers. As a result, third-party auditing services are practical and save costs.
References
1. World Excipients Market Expected to Reach $6.4 Billion by 2020, Allied Market Research. Drug Development & Delivery. April 2016. Accessible at:
http://drug-dev.com/ Main/Back-Issues/World-Excipients-Market-Expected-to-
Reach-64-Billi-1101.aspx
2. Nice Insight 2015 Excipients Study
3. Van Arnum P, Quality Risk Assessment for Excipients: An Industry Perspective. DCAT Value Chain Insights, May 26, 2015.
To learn more about Nice Insight contact Guy Tiene at
Guy@thatsnice.com or visit
www.niceinsight.com and the annual study websites: clinical services at
www.niceinsightcro.com, contract development and manufacturing at
www.niceinsightcdmo.com, pharmaceutical excipients suppliers at
www.niceinsightexcipients.com and pharmaceutical equipment (products, systems and services) at
www.niceinsightpharmaequipment.com.
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www.niceinsight.com Pharmaceutical Outsourcing | 28 | July/August 2016
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