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The
#EMA has published the highlights for human medicines for 2019. These include 30 new#APIs and one#Cannabis product. https://www.gmp-compliance.org/gmp-news/medicinal-products-for-human-use-emas-highlights-2019?utm_source=twitter&utm_medium=news&utm_campaign=7676 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The
#EDQM recently announced some upcoming changes to the European Pharmacopoeia and#Pharmeuropa. https://www.gmp-compliance.org/gmp-news/update-on-ph-eur-and-pharmeuropa?utm_source=twitter&utm_medium=news&utm_campaign=7703 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Four of five
#WarningLetters issued by the#FDA recently broached the issue of handling deviations and inadequate#CAPA. https://www.gmp-compliance.org/gmp-news/inadequate-capas-once-more-in-the-focus-of-fda-warning-letters?utm_source=twitter&utm_medium=news&utm_campaign=7642 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The
#FDA issued a#WarningLetter due to non-compliance with#cGMP, including#DataIntegrity and Validation issues, to a Canadian manufacturer of over-the-counter drug products. https://www.gmp-compliance.org/gmp-news/data-integrity-and-validation-issues-identified-during-gmp-inspection?utm_source=twitter&utm_medium=news&utm_campaign=7677 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Join the Pharma Congress Production & Technology on 24/25 March in Düsseldorf/Neuss – and benefit from “users reporting for users” about their projects, how they were realized in practice, the challenges they were facing and possible solution approaches. https://www.pharma-congress.com/?utm_source=twitter&utm_medium=banner&utm_campaign=pharma-congress-17683 …pic.twitter.com/lWBG1fzHJ7
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#EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. https://www.gmp-compliance.org/gmp-news/pilot-programme-on-gmp-inspections-of-manufacturers-of-sterile-medicines?utm_source=twitter&utm_medium=news&utm_campaign=7646 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The USP General Chapters—Packaging and Distribution Expert Committee is proposing a new general chapter <668> Cured Silicone Elastomers for Pharmaceutical Manufacturing and Packaging Components. https://www.gmp-compliance.org/gmp-news/usp-proposes-new-general-chapter-668-cured-silicone-elastomers?utm_source=twitter&utm_medium=news&utm_campaign=7686 …
Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The United States
#Pharmacopeia recently posted an update on the delayed implementation of General Chapters <661.1> and <661.2> together with information on the revision of General Chapter <661>. https://www.gmp-compliance.org/gmp-news/update-on-the-implementation-of-usps-revised-plastic-packaging-chapters?utm_source=twitter&utm_medium=news&utm_campaign=7687 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The United States
#Pharmacopeia is currently introducing some changes to the format of the#USP and to its Pharmacopeial Forum - a bimonthly online journal in which USP publishes proposed revisions for public review. https://www.gmp-compliance.org/gmp-news/changes-to-pharmacopeial-forum?utm_source=twitter&utm_medium=news&utm_campaign=7685 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
A report indicates persistent challenges and concerns with
#FDA foreign#inspections. https://www.gmp-compliance.org/gmp-news/report-challenges-with-fda-inspections?utm_source=twitter&utm_medium=news&utm_campaign=7638 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The U.S.
#FDA has issued a#WarningLetter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program and the missing authority and resources for the quality unit to carry out its responsibilities. https://www.gmp-compliance.org/gmp-news/fda-warning-letter-for-chinese-manufacturer-highlights-the-importance-of-the-quality-unit?utm_source=twitter&utm_medium=news&utm_campaign=7659 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The currently valid ISO 14971 of 2007 will now be replaced by the version from 2019 (revision 3). The standard is applicable to all phases of a medical device´s life cycle. What is new? https://www.gmp-compliance.org/gmp-news/risk-management-standard-for-medical-devices-iso-149712007-revised?utm_source=twitter&utm_medium=news&utm_campaign=7658 …
Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The U.S.
#FDA has issued a#WarningLetter to Wild Child WA Pty Ltd., that summaries three significant GMP issues identified during an inspection of the company's manufacturing facility in Western Australia. https://www.gmp-compliance.org/gmp-news/warning-letter-for-not-meeting-fda-usp-requirements?utm_source=twitter&utm_medium=news&utm_campaign=7652 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The U.S.
#FDA recently warned Teligent Pharma, Inc., for different significant violations of cGMP at the company's facility in Buena, New Jersey. The FDA cites the company, among others, for failing to thoroughly investigate#OOS test results. https://www.gmp-compliance.org/gmp-news/warning-letter-for-inadequate-oos-investigations-and-complaint-handling?utm_source=twitter&utm_medium=news&utm_campaign=7654 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
From inadequate cleaning to poor laboratory controls of quality and purity - a manufacturer of homeopathics in the U.S. received a
#WarningLetter from the#FDA. https://www.gmp-compliance.org/gmp-news/us-manufacturer-of-homeopathic-medicines-and-nutritional-supplements-receives-fda-warning-letter?utm_source=twitter&utm_medium=news&utm_campaign=7641 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of
#Pharmeuropa. https://www.gmp-compliance.org/gmp-news/ph-eur-draft-chapter-for-pa-contaminants-in-herbal-drugs?utm_source=twitter&utm_medium=news&utm_campaign=7648 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
More and more cases of drug substance and drug product batches contaminated with
#Nitrosamines have come up since they first showed up in June 2018. Reason enough to discuss all relevant aspects of risk mitigation. https://www.gmp-compliance.org/training/gmp-course-conference/nitrosamine-impurities?utm_source=twitter&utm_medium=event&utm_campaign=nitrosamine-impurities-17758 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Is there anything like European Warning Letters? Basically, no. However, there are "Non-Compliance Reports" published in the
#EMA#EudraGMDP database. Now, what has the EMA has complained about in the last 3 months? https://www.gmp-compliance.org/gmp-news/is-there-anything-like-european-warning-letters?utm_source=twitter&utm_medium=news&utm_campaign=7624 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Water systems are among the most important systems in the pharmaceutical industry. What are the
#GMP requirements for the qualification and running of these systems? What does the FDA expect today? A current#WarningLetter provides a few answers. https://www.gmp-compliance.org/gmp-news/cgmp-qualification-running-of-water-systems?utm_source=twitter&utm_medium=news&utm_campaign=7602 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The
#PICS has published a draft Recommendation on risk-based change management within the#PQS. https://www.gmp-compliance.org/gmp-news/pic-s-how-inspectors-should-evaluate-a-pqs?utm_source=twitter&utm_medium=news&utm_campaign=7619 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi
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