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“Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container” published by EMA will come into force on 1 October 2019 (Part II)

  • 30 сентября 2019
  • active substance, API, aseptic processing, ATMP, cell based medicinal products, container, decision tree, documentation, dossier, EMA, excipients, filtration, finished dosage form, finished product, GMP, medicinal product, part, Ph. Eur., post-aseptic processing terminal heat treatment, primary, quality, SAL, sterilisation, sterilisation assurance level, sterility, terminal sterilisation,
  On 8 March 2019, the European Medicines Agency (EMA) published final version of Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container. This guideline will come into force on 1 October 2019.       Guidance is also provided on the documentation expected for sterile finished products, sterile active
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Review of widely used ranitidine medicines to treat conditions such as heartburn and stomach ulcers due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen!

  • 23 сентября 2019
  • 4-(methyl)(nitroso)amino)butanoic acid, acceptable intake, active substance, AI, API, Article 31, benefit-risk balance, cancer, candesartan, carcinogen, CEP, cimetidine, detection, DIPNA, drug product, EC, EDQM, EIPNA, EMA, esomeprazole, European Commission, famotidine, FDA, finished product, HCl, heartburn, histamine receptors blocker, human, hydrochloride, ICH M7, impurity, irbesartan, lansoprazole, LC-MS, limit, losartan, MA, MAH, medicinal product, medicines, method, N-nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, Nexium, nitrosamine, nizatidine, NMBA, olmesartan, omeprazole, OTC, Pepcid, Prevacid, Prilosec, ranitidine, referral procedure, review, root cause, sartans, specific ring structure, stomach, Tagamet, tetrazole, ulcers, valsartan,
  EMA is to start a review of ranitidine medicines after tests showed that some of these products contained an impurity called N-nitrosodimethylamine (NDMA) at levels which raise concerns according to the principles of the ICH M7 guideline. The results on a limited sample of products showed that for the majority of both ranitidine APIs
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