83-200, г. Starogard Gdanski, Koteze, ул. Sokola 1, Польша
Tел./факс: (+48) 58 531 02 59
Tел: (+48) 606 93 82 51

How to demonstrate comparability for ATMPs?

  • 18 мая 2020
  • advice, API, approach, ATIMP, ATMP, change, CHMP, clinical, comparability, data, development, drug product, drug substance, efficacy, EMA, exercise, final, finished, GMP, manufacturing, methodology, non-clinical, pivotal, process, product, profile, program, quality, RBA, risk-based, safety, scientific, site, stability, stage, statistical, studies, transfer,
  CHMP scientific advice questions are often related to the suitability of comparability proposals following changes to ATMP manufacturing processes or due to introduction of additional manufacturing sites. Manufacturing process changes may encompass improvements/change in Such changes are frequent, especially in the early stages of development of ATMPs. A suitable comparability program is required to
Читайте дальше

EU GMP Guide – Annex 21: Importation of medicinal products

  • 23 апреля 2020
  • Annex 21, GMP, IMP, import, investigational medicinal product, medicinal products, QP, QP certification, QP confirmation,
On 20 March 2020, the European Commission (EC) released for 3 months consultation (till 20 June 2020) a draft version of Annex 21: Importation of medicinal products of the EU GMP Guide. The draft document is establishing a common understanding of the term importation which is defined as the action of physically bringing medicinal product,
Читайте дальше

Metformin diabetes medicines and N-nitrosodimethylamine (NDMA) – a probable human carcinogen

  • 7 декабря 2019
  • acceptable, active substance, AI, API, authority, cancer, carcinogen, CEP, daily, diabetes, drug, drug product, EDQM, EMA, EU, FDA, GMP, HCl, HSA, human, hydrochloride, ICH M7, impurity, intake, investigation, manufacturing process, market, medicinal product, medicines, metformin, N-nitrosodimethylamine, NDMA, nitrosamine, recall, root cause, Streuli Pharma AG, Swissmedic, type 2, withdrawal,
  EMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. At this point, there are no data indicating that EU metformin medicines are affected. Authorities in the EU are in the process of working with companies to test EU
Читайте дальше

Nitrosamines in human medicines – consequences for MAHs

  • 7 октября 2019
  • 4-(methyl)(nitroso)amino)butanoic acid, acceptable intake, active substance, AI, analysis, API, ASMF, authorities, cancer, candesartan, carcinogen, CEP, change, chemically synthesized, CHMP, competent, confirmatory, contamination, cross-contamination, detection, DIPNA, drug product, EIPNA, EMA, evaluation, finished product, formation, generics, GMP, HCl, human, hydrochloride, ICH M7, impurity, interim, irbesartan, limit, losartan, MA, MAH, manufacturer, manufacturing, manufacturing authorisation, marketing authorisation holder, medicinal product, medicines, method, MIA, mitigate, N-nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, nitrosamine, NMBA, non-sartans, olmesartan, OTC, pioglitazone, process, public health, ranitidine, referral procedure, review, risk, sartans, specific ring structure, temporary, test, testing, tetrazole, valsartan, variation,
EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders (MAHs) for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities
Читайте дальше

“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
Читайте дальше

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, market, 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, recall, referral procedure, review, root cause, sartans, specific ring structure, stomach, Tagamet, tetrazole, ulcers, USA, valsartan, withdrawal,
  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
Читайте дальше

EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers – implications for QPs

  • 29 августа 2019
  • agreement, batch, consequence, EC, EU, FDA, GMP, human, implication, inspection, manufacturer, manufacturing, medicines, milestone, MRA, Mutual Recognition Agreement, phase, QP, site, testing, transition, US, USA, waiver,
With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories. It means that the US Food and
Читайте дальше

The exemption from EU batch re-testing for imported ATMPs

  • 27 августа 2019
  • 11.17, applicant, ATMP, authorised, autologous, batch, control, country, EEA, EMA, EU, exemption, GMP, guidelines, import, MA, MAH, paragraph, patient, product, Q&A, QP, quality, re-testing, section, specific, third,
On 21 August 2019 EMA has published document entitled Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country. The exemption from re-testing batches upon import into the EU for authorised ATMPs may only be granted where the conditions laid down in paragraph
Читайте дальше

Use of OOS batches of authorised cell/tissue-based ATMPs – Section 11.5 of the Guidelines on GMP for ATMPs

  • 27 июня 2019
  • ATMP, authorized, batches, CAT, cell/tissue-based, EMA, GMP, guidelines, implementation, MA, OOS, patient, provision, Q&A, section 11.5, use,
On 25 June 2019 EMA has published document entitled Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based advanced therapy medicinal products prepared by EMA’s CAT, together with the GMDP Inspectors Working Group and the Blood Products Working Party.   Source: EMA   Related entries: GMP for Advanced Therapy Medicinal Products (ATMPs)
Читайте дальше

Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part VIII)

  • 29 мая 2019
  • 4-(methyl)(nitroso)amino)butanoic acid, active substance, angiotensin-II-receptor antagonists, angiotensin-II-receptor blockers, API, ARBs, Article 31, azilsartan, cancer, candesartan, carcinogen, CEP, conditions to MA, diabetes, DIPNA, drug product, EC, EDQM, EIPNA, EMA, eprosartan, European Commission, Hetero Labs, human, hypertension, impurity, interim, investigation, irbesartan, legally binding decision, limit, losartan, MA, MAH, manufacturer, manufacturing, manufacturing process, manufacturing site, marketing authorisation holder, medicinal product, medicines, N-nitrosodiethylamine, N-nitrosodiisopropylamine, N-nitrosodimethylamine, N-nitrosoethylisopropylamine, NDEA, NDMA, nitrosamine, NMBA, olmesartan, pioglitazone, review, root cause, sartans, scientific conclusion, specific ring structure, suspension, telmisartan, temporary, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,
  On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers, ARBs) review their manufacturing processes so that they do not produce nitrosamine impurities. An initial investigation report on the root cause of the presence of N-nitrosodimethylamine (NDMA) provided by Zhejiang Huahai Pharmaceutical, China upon
Читайте дальше