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Tablets & Capsules SDD
imageIn this issue of T&C Solid Dose Digest:
 
 
 
 
 
 
 
wilson

jost
 
In Tablets & Capsules magazine
 
Raising the bar for quality
 
Chris Coker and Brian Garrett, Lonza
 
Complying with cGMP standards can help pharmaceutical and nutraceutical companies meet basic quality requirements, but to really cultivate a reputation for quality, a company needs to challenge itself to go beyond compliance. Here are three practices that can help companies raise the bar for quality and efficient production.
 
Exceed expectations
Identify your customers' expectations and then work within the quality-by-design (QbD) model to exceed them. Determine your product's critical-to-quality (CTQ) attributes and design your processes and equipment to achieve them. Leverage innovation and process controls to reduce negative variations and use ongoing internal and customer feedback to continuously improve.
 
To learn more about this topic, you can read the article "Back Page: Raising the bar for quality." You can also find articles under "Quality assurance" and "Quality by Design (QbD)" in Tablets & Capsules' Article Archive.
 
 
natoli

nilfisk
 
Ask an Expert
 
Dust containment technology
 
Q: How have HPAPIs changed dust containment technology?
 
 
imageThe market for highly potent active pharmaceutical ingredients (HPAPIs) has been growing rapidly for some time. The pharmaceutical industry estimates that 25 percent of new drugs currently in development are potent [1], but this figure is likely low because the industry has been citing it since at least 2007 [2]. The use of HPAPIs has skyrocketed since then, in large part due to the development of new oncology drugs [3], and the growth seems likely to continue.
 
 
 
vacumax

recro
 
More Questions and Answers
 
Ingredient characterization
 
Q: What important methods should we use when characterizing tablet and capsule ingredients?
 
A: Yury Lagoviyer, Jost Chemical, says:
 
imageWhen formulating tablets or capsules using a quality-by-design approach, proper and exhaustive ingredient characterization is extremely important. In addition to the usual physical and chemical release testing (for example, compendial, if applicable), characterization of excipient performance in a typical customer's application is paramount. More often than not, this testing is not a part of product release specifications. To optimize our products and help customers in their formulation, product development, and troubleshooting work, Jost Chemical uses a variety of test methods to characterize the physicochemical properties of its ingredients.
 
 
 
kikusui

camfilapc
 
Industry news
 
 
 
 
 
 
 
gelita

tc
 
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Events and continuing education
 
 
 
 
 
 
 
 
 
 
 
 
To find more events and continuing education opportunities at the Tablets & Capsules website, click here.
 
March 11, 2019
 
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Send your feedback or questions to Peggy Wright at pwright@cscpub.com.
Peggy Wright
T&C Solid Dose Digest
Editor
pwright@cscpub.com
 
Judie Hadley
T&C Solid Dose Digest
Circulation
jhadley@cscpub.com
 
Kurt Beckman
T&C Solid Dose Digest
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Nate Todd
Tablets & Capsules
Editor
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