Tablets & Capsules


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eye on use your on-site time as efficiently and effectively as possible. With hundreds of pharmaceutical cus- tomers vying to schedule on-site audits, most excipient suppliers sim- ply don't have time to host a pharma- ceutical customer's audit team for more than a day. So prepare. Avoid gathering documents and filling out paperwork on-site. You can usually do that work in advance, allowing you or your auditor to spend this valuable time walking the plant and observing critical manufacturing and laboratory operations. As you prepare, consider these questions: Where will the finished product be sold? If your finished product will be sold in the USA or Europe, then your auditor needs to keep the ap - pro priate US and EU excipient GMP regulatory expectations in mind. Regardless of where the excipient is manufactured, it must meet the stan- dards for the market in which the fin- ished pharmaceutical product(s) will be distributed. Does the excipient present any potential risk to patient safety? If you have 20 different excipients from 20 different suppliers to audit, you'll naturally want to prioritize your audits to focus on the excipients that present the greatest risk to patient safety. Similarly, if you've experienced problems with particular excipient suppliers, assign them a higher prior- ity over the supplier who has proven trustworthy time and again. Are you overlooking your small- est suppliers? Chances are good that you already know your top suppliers quite well. But how about the com- pany that provides you with a single drum of an ingredient once a year? Often, you won't know many details about that company or its manufac- turing practices and that's where prob lems usually arise. What information can you gather from the supplier in advance of an on-site visit? Any background infor- mation or documentation you can acquire in advance of your visit will allow you to spend more time assess- ing the site. Ask the supplier to re - spond to a pre-audit questionnaire or to complete an "Excipient Infor - mation Package," such as the one offered online by IPEC-Americas. Also ask for copies of documents that describe the procedures you deem important. Is the excipient supplier certified by International Pharmaceutical Excipients Auditing (IPEA) or has it been audited by Rx-360 or a similar organization? If so, request a copy of the certification report or audit re - port and review it before your visit. The certification audit report may in fact provide sufficient detail to elimi- nate the need for a site audit. At the very least, it will enable you to con- duct a more focused visit. IPEA certi- fications are based on a 4-day audit of the manufacturing facility, whereas most pharmaceutical manufacturers can only schedule a 1-day audit with the supplier. As you can imagine, a certification report will provide many more details about the supplier than what an auditor can learn in single Tablets & Capsules September 2014 41 Irwin B. Silverstein and Jim Morris NSF International excipients Guest columnists Irwin Silverstein and Jim Morris discuss how to develop an annotated checklist before you conduct on-site audits of excipient suppliers. The upfront work will help you better assess the quality and safety of the supplier's products. It may even eliminate the need for a site visit. Pharmaceutical manufacturers in the USA and Europe continue to live with uncertainty. More than 2 years since the passage of the FDA's Safety and In no vation Act (FDASIA) and 18 months since publication of the EU's Falsified Medicines Directive, it re mains un clear how these bodies will apply the regulations to the glo - bal sup ply chain of pharmaceutical excipients. One thing is clear, however: Stan - dards for excipient manufacturers and pharmaceutical buyers of excipients are becoming more stringent. That's why supplier risk profiles, supplier certifications, and effective strategies of assessment must be part of your program to audit vendors. After work - ing closely with regulators and con- ducting hundreds of audits, we know it's best to err on the side of caution when auditing excipient suppliers. That means preparing for the audit before you arrive at the supplier's manufacturing site. Audit prep First draw up a checklist and an audit plan, which for experienced auditors may be more of an aide memoire. Either way, the goal is to

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