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44 September 2014 Tablets & Capsules lot to cover in one day, but when you review the specific questions on the checklist carefully, you'll notice many items can be completed before your visit using information provided by the supplier in a pre-audit question- naire or the "Excipient Information Package." Then review the checklist again. Many questions can only be addressed by making careful, on-site observations. T&C Irwin B. Silverstein, PhD., is a consul- tant and Jim Morris is a senior executive at NSF Health Sciences, a division of NSF International, 789 Dixboro Road, Ann Arbor, MI 48105. Tel. 734 769 8010. Website: www.nsf.org. In 2010, Silverstein led the ANSI accreditation process for the IPEA Excipient GMP • Be safe in the amount or "dose" used, • Perform their intended function in the product, • Have no adverse effect on bio - availability, and • Be manufactured in accordance with the appropriate current GMPs. Your auditing checklist will help you remember to address all the top- ics required by regulators. We rec- ommend that you download the free "Good Manufacturing Practices Audit Guide for Pharmaceutical Excipients" from the IPEC-Americas website. Under the "Reference Center" tab, select "Regulatory Reference Page" and then midway down the page, click "IPEC Excipient GMP Related Guidance Documents." Table 1 lists some of the many topics an audit addresses. That is a Certification program, and he is a mem- ber of the NSF International committee developing the ANSI standard for excip- ient GMPs. E-mail: irwin.s@verizon.net. Morris has worked in pharmaceutical operations and quality management in t h e U S A a n d E u r o p e . E - m a i l : jmorris@nsf.org. Table 1 Topics to address during on-site audits Quality manuals Control of Control of Change controls Management Customer focus Quality policies documents records responsibility and commitment Quality objectives Responsibility, Management review Resource Human resources Competence, Personnel and quality authority, and and involvement management awareness, hygiene system planning communication and training Buildings and Equipment Computer systems Utilities Water supply Work environment Air handling facilities construction and maintenance Controlled Cleaning and Pest control Lighting Drainage Washing and Planning of environments sanitary conditions toilet facilities product realization Determination Customer Design and Purchasing Purchasing Verification of Production and review of communication development processes information purchased products instructions requirements related and records to the product Equipment cleaning Recovery of In-process In-process Packaging and Record keeping Validation of solvents, mother liquors, blending/mixing controls labeling processes for and second-crop production crystallizations and service provision Identification Handling, storage, Delivery and Monitoring and Laboratory controls Finished testing Out-of-specification and traceability and preservation distribution measurement and release test results of the product Retained samples Certificates of analysis Impurities Stability Control of Continuous Corrective and nonconforming improvement preventive actions products Meet T&C staff at AAPS in San Diego Booth 3318