Excipients Step into the Spotlight - Pharmaceutical Technology

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PharmTech Europe

Excipients Step into the Spotlight
Industry and regulatory experts discuss excipient testing, regulatory expectations, supply-chain challenges, and pricing in this Speakers Roundtable. This article contains bonus online material and podcasts.

Pharmaceutical Technology
Volume 6, Issue 34, pp. 38-42

Supply security dictates transparency

PharmTech: IPEC recently developed a guide for excipient qualification that addresses GMPs and GDPs. In addition, as reported in Pharmaceutical Technology's May 2010 supplement, International Pharmaceutical Excipient Auditing (IPEA), an IPEC subsidiary, received ANSI accreditation of its excipient supplier GMP certification program. How can industry benefit from these programs?

Carter: The focus of the guide is to help excipient users make correct decisions about the proper steps during drug development to formulate with the correct excipient grade. This goes a long way toward having a successful supplier relationship throughout the product's life cycle. The guide helps excipient manufacturers understand what information is important to share and why it is needed. This guide also highlights key information needed from both parties to select and qualify the correct grade for the user's formulation and finished drug-manufacturing process. Excipient makers typically offer several USP-NF grades of excipients designed to optimize performance in different processes or formulations.

PharmTech: There's been ample talk throughout industry about auditing, including shared and third-party audits, and related challenges. What is truly needed to move forward in this direction?

Berg: A key topic here is transparency of the original manufacturer. Some suppliers are not the original manufacturer. They provide value by repackaging and testing, and they accept responsibility for the quality. For these suppliers, it is critical that pharmaceutical customers know who the original manufacturer is and verify that a robust supplier-quality program is in place. I would expect this review of original manufacturers and the review of the company's supplier-quality controls to be a part of the supplier audit.

Pharmaceutical companies need to request transparency and treat the information honorably to earn a supplier's trust and, in turn, suppliers need to provide transparency. All three parties need to come together in business review meetings, so that each one can appreciate the total value chain for the material and ensure that there is a shared commitment to protecting material authenticity.

PharmTech: Will FDA provide any guidance on the use of paper audits? Does the agency recommend auditing every single supplier and distributor in one's supply chain-and if so, should those be on-site, in-person audits?

Motta: A vendor questionnaire provides some preliminary indication that a supplier can be qualified and can be used to gather information in advance of doing a site audit. Accuracy and integrity of information received from suppliers can be established through an ongoing program for supplier monitoring, which should include periodic site audits. FDA supports the product manufacturer decision to use an accredited third-party whose auditors possess adequate qualifications to perform audits of excipient manufacturers to replace or supplement the drug manufacturers' own audit. However, the manufacturer must determine whether the audit performed by the third-party is adequate. Manufacturers might need to perform complementary audits to gather enough information to satisfy their internal procedures for supplier quality management. Manufacturers should implement a comprehensive risk-management system approach through the entire product life cycle to include how often and how in-depth to audit their suppliers. A supplier that has never been audited by the drug product manufacturer may be considered a "higher risk." We believe site audits are an integral part of assuring ingredient quality and supply-chain integrity. An adequate on-site in-person audit of the excipient manufacturer process and practices may be the best way to get an accurate assessment of the capability of the excipient manufacturer to manufacture under CGMP conditions and to meet the quality requirements of the product manufacturer for the particular excipient.


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