Tablets & Capsules


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TABLETS & CAPSULES Tablets & Capsules (ISSN 1549-9928 print; ISSN 1938-9159 online) is published by CSC Publishing, Inc, 1155 Northland Drive, Saint Paul, MN 55120. w w w . t a b l e t s c a p s u l e s . c o m October 2020 Volume 18 Number 7 In this issue of Tablets & Cap- sules, we discuss how COVID- 19 is impacting FDA inspec- tions, how to ensure excipient quality using QbD, and how a submission stage gate sys- tem can improve drug product development results. Elsewhere in the issue, we examine nat- ural alternative excipients for solid dose products; the differ- ences between validation, veri- cation, and monitoring of blis- ter pack inspection systems; and changes to dietary supplement labeling requirements. Finally, our Eye on Excipients column explores orodispersible minitablets, and on the Back Page, we learn how to evaluate and minimize powder transfer risks when working with a CMO. QUALITY, VALIDATION, & REGULATORY COMPLIANCE COVID-19's impact on FDA inspections and manufacturer risk 8 John Giannone, Ed Wyszumiala, Danita Broyles, and Joy Brown Excipient quality: Beyond the pharmacopeia monograph 11 Chris Moreton Issue focus: Quality, validation, and regulatory compliance 16 Using a development and submission stage gate system to help improve drug product development outcomes 18 Deepak Thassu ALSO IN THIS ISSUE Tablet & capsule identi cation: A survey of what's available 22 Using natural alternative excipients for tableting and capsule lling 24 RĂ¼ diger Dartsch Blister packaging: A survey of what's available 28 Validation, veri cation, and monitoring of tablet and capsule blister pack inspection systems 30 Robert S. Conrad Eye on Excipients 33 Michael Black, Maj-Britt Cepok, and Oliver Luhn Back page Cover 3 Roger A. Barnum DEPARTMENTS Research 6 Markets 6 Industry news 6 Calendar 37 Supplier news 37 People news 37 Product update 38 Advertiser index 38 Spotlight on Nutraceuticals 32A (This section appears four times yearly in issues delivered to our nutraceutical readership.)

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