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  1. 3. velj
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  2. 3. velj
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  3. 3. velj
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  4. 3. velj

    The issued a due to non-compliance with , including and Validation issues, to a Canadian manufacturer of over-the-counter drug products.

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  5. 23. sij

    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.

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  6. 23. sij

    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.

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  7. 23. sij

    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.

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  8. 23. sij

    The United States 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>.

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  9. 23. sij

    The United States is currently introducing some changes to the format of the and to its Pharmacopeial Forum - a bimonthly online journal in which USP publishes proposed revisions for public review.

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  10. 15. sij
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  11. 15. sij

    The U.S. has issued a 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.

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  12. 13. sij

    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?

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  13. 13. sij

    The U.S. has issued a 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.

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  14. 13. sij

    The U.S. 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 test results.

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  15. 13. sij

    From inadequate cleaning to poor laboratory controls of quality and purity - a manufacturer of homeopathics in the U.S. received a from the .

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  16. 13. sij

    A new Ph. Eur. chapter 2.8.26. Contaminant pyrrolizidine alkaloids (PAs) has been proposed for comment in the recent issue of .

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  17. 18. pro 2019.

    More and more cases of drug substance and drug product batches contaminated with have come up since they first showed up in June 2018. Reason enough to discuss all relevant aspects of risk mitigation.

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  18. 18. pro 2019.

    Is there anything like European Warning Letters? Basically, no. However, there are "Non-Compliance Reports" published in the database. Now, what has the EMA has complained about in the last 3 months?

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  19. 18. pro 2019.

    Water systems are among the most important systems in the pharmaceutical industry. What are the requirements for the qualification and running of these systems? What does the FDA expect today? A current provides a few answers.

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  20. 18. pro 2019.
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