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Tablets & Capsules October 2020 15 References 1. 21CFR820.3(s): (Revised as of April 1, 2019). Avail- able at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/ cfCFR/CFRSearch.cfm?fr=820.3. 2. European Pharmacopoeia 9.5, July 2018. 3. USP-NF 2020. 4. US FDA, "Guidance for Industry: Systems approach to pharmaceutical CGMP regulations," September 2006, which references the ICH Harmonised Tripartite Guide- line Q8 Pharmaceutical Development, now available as ICH Q8(R2). Chris Moreton is partner and vice president of pharmaceuti- cal sciences at FinnBrit Consulting, Waltham, MA (www. finnbrit.com). He has more than 30 years of experience in the pharmaceutical industry and is a past chair of IPEC-Amer- icas. Moreton has authored and co-authored scientific papers, articles, and book chapters and lectured extensively on excipients, drug delivery, preformulation, and formulation at universities, training courses, and symposia in the US, Europe, and Japan. pharmacopeia monograph exists and the supplier has its own specification. This is why we need to think beyond the tests in the pharmacopeia monograph when considering the specifi- cation for a particular excipient. Excipient performance typically is not addressed directly in the monograph. The closest the monograph comes to a functionality test is probably a test to differentiate between different grades of the same material, as with hypromellose, for exam- ple. However, the relevance of the polymer's viscosity in dilute solution to the application in a matrix-con- trolled-release tablet is questionable. Conclusions Excipient performance is very different from API per- formance. For APIs, we can use assay and related sub- stances to assess chemical purity, which is related to qual- ity. Excipients often contain other (concomitant) minor components that may influence performance in a given application. The pharmacopeia monograph or suppli- er's specification typically only addresses the excipient's identity and possibly the means to differentiate between grades of the same material. QbD DoE can help users control their excipients. However, excipient users must agree upon test methods and limits for such extra specifi- cations with their excipient suppliers. T&C EXPERIENCE THE DIFFERENCE THE ELIZABETH DIFFERENCE. Compression Tooling | Tablet Presses | Turrets | Replacement Parts| Field Services & Training Blister Packaging Tooling & Feeders | Tablet Press & Turret Repairs We understand that your products are trusted by consumers each and every day. Consistent quality of your solid dose products is expected and non-negotiable. Your products depend upon the integrity of your equipment and tooling. For over 65 years, Elizabeth Companies have put a personal guarantee on customer satisfaction and takes pride in delivering innovative solutions. We promise our customers an unequaled level of customer service, trust, product performance, and prompt & courteous communication. ELIZ.COM | 412-751-3000 @ELIZCOMPANIES