> Quality System and Audit

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to [...]

(Cas) AEMPS: Distribución irregular de principios activos por la empresa Intabiotech SLU, concesionaria de ND Pharma & Biotech

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Nota informativa sobre la distribución de principios activos sin cumplir con las obligaciones y los controles de calidad exigidos en la [...]

2018-10-21T11:39:33+00:00 21.10.2018|Quality System and Audit, Regulatory Affairs|

EMA: EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision; Aurobindo Pharma stopped from supplying irbesartan to the EU

EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management at the company’s Chuannan site in Linhai, China. The inspection findings included deficiencies in the way the company investigated impurities in its valsartan products and led EU authorities to issue a statement of non-compliance with [...]

2018-10-17T20:12:18+00:00 17.10.2018|Pharmacovigilance, Quality System and Audit|

Infarmed: Autoridade da Concorrência e Infarmed assinaram protocolo de cooperação

A Autoridade da Concorrência (AdC) e o Infarmed assinaram hoje um protocolo inédito de cooperação para a constituição de instrumentos de articulação e de intercâmbio de informação, capazes de incrementar a eficácia de atribuições e competências das duas entidades. A deteção atempada de falhas de mercado ou distorções concorrenciais é um dos objetivos partilhados pela [...]

2018-09-24T19:03:12+00:00 25.09.2018|Quality System and Audit, Regulatory Affairs|

EMA: Portugal to also benefit from EU-US mutual recognition agreement for inspections

Agreement now operational between 15 EU Member States and FDA The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The US Food and Drug Administration (FDA) confirmed on 14 September 2018 the capability of one additional EU Member [...]

2018-09-24T18:55:46+00:00 25.09.2018|Quality System and Audit, Regulatory Affairs|

L’ANSM engagée dans une coordination internationale pour l’inspection des fabricants de substances actives

La supervision des fabricants de substances actives en pays tiers à l’espace économique européen représente un enjeu sanitaire majeur pour les autorités compétentes européennes. C’est pourquoi l’ANSM est impliquée depuis 2008 dans une collaboration internationale sur l’inspection des fabricants de substances actives. Ce réseau permet de partager des informations sur les inspections des Bonnes Pratiques [...]

2018-09-24T18:20:04+00:00 24.09.2018|Quality System and Audit, Regulatory Affairs|

Infarmed: Food and Drug Administration (FDA) reconhece qualidade das inspeções do Infarmed

A Food and Drug Administration (FDA), autoridade reguladora do medicamento dos Estados Unidos, reconheceu a capacidade e a qualidade das inspeções desenvolvidas pelo Infarmed. Isto significa que a FDA deixará de realizar inspeções em Portugal e vai reconhecer os resultados associados às inspeções de Boas Práticas de Fabrico de medicamentos realizadas pelo Infarmed. Além de [...]

2018-09-20T22:39:21+00:00 21.09.2018|Quality System and Audit, Regulatory Affairs|

FDA global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to [...]

2018-09-05T21:56:10+00:00 05.09.2018|Quality System and Audit, Regulatory Affairs|

EMA: EU and Japan reinforce their collaboration on inspections of medicine manufacturers

Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vaccines The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites. The current mutual recognition agreement (MRA) between the EU and Japan has been operational since 29 [...]

2018-07-22T10:36:19+00:00 22.07.2018|Quality System and Audit, Regulatory Affairs|

(Cas) AEMPS: Consideraciones sobre los productos sanitarios utilizados para la obtención de células autólogas y la clasificación del producto resultante como medicamento de terapia avanzada

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La Agencia Española de Medicamentos y Productos Sanitarios informa sobre la consideración que tienen los productos sanitarios que se ofrecen para [...]

2018-07-15T21:51:20+00:00 16.07.2018|Quality System and Audit, Regulatory Affairs|

L’ANSM confirme la bonne qualité de la nouvelle formule du Levothyrox

Suite aux résultats d’analyses sur la nouvelle formule de Levothyrox récemment rendus publics par l’Association française des malades de la thyroïde (AFMT), l’ANSM a réalisé dans ses laboratoires de nouveaux contrôles sur des comprimés de Levothyrox nouvelle formule et ancienne formule (Euthyrox) qui visaient à confirmer la conformité du principe actif (lévothyroxine). Les analyses chromatographiques (05/07/2018)  (729 ko) démontrent [...]

2018-07-05T22:05:41+00:00 06.07.2018|Pharmacovigilance, Quality System and Audit|

EMA: Reinforced EU/US collaboration on medicines

Update on the European Commission/EMA–FDA bilateral of 18-19 June 2018 Senior officials from the European Commission (EC), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2018 bilateral meeting in Brussels, Belgium, on 18 and 19 June. The two-day bilateral regulatory dialogue allowed the strategic partners to review their ongoing cooperative initiatives, [...]

2018-06-26T21:37:37+00:00 26.06.2018|Quality System and Audit, Regulatory Affairs|

L’ANSM a réalisé dans ses laboratoires plusieurs contrôles sur la composition de Levothyrox nouvelle formule qui ont confirmé sa bonne qualité

Les résultats d’analyses sur la nouvelle formule de Levothyrox rendus publics ce jour par l’AFMT ne sont ni détaillés, ni accompagnés d’informations sur le laboratoire ou la méthode utilisée. Aussi, il n’est pas possible, à ce jour, de se prononcer sur leur validité. L’ANSM rappelle qu’elle a mené depuis septembre 2017 des analyses pour vérifier [...]

2018-06-17T17:17:22+00:00 18.06.2018|Quality System and Audit, Regulatory Affairs|

EMA: Two more EU Member States benefit from EU-US mutual recognition agreement for inspections

Agreement now operational between 14 EU Member States and FDA The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress. The US Food and Drug Administration (FDA) confirmed the capability of two additional EU Member States (Lithuania and Ireland) to [...]

2018-06-05T22:43:11+00:00 06.06.2018|Quality System and Audit, Regulatory Affairs|

EMA: Increasing oversight of API manufacturing through international collaboration

Report on the International API inspection programme published The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016, published today. APIs are the substances responsible for the activity [...]

2018-04-15T21:45:04+00:00 16.04.2018|Quality System and Audit, Regulatory Affairs|

EMA: Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement

The aim of this public consultation is to collect relevant information from stakeholders to help the Good manufacturing practice (GMP)/Good distribution practice (GDP) Inspectors Working Group to develop an effective and harmonised risk-based approach for dealing with the supply of critical medicines in case of serious GMP non-compliance. This will amend the compilation of community [...]

FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

The U.S. Food and Drug Administration today issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices. As part of an ongoing effort to prevent patient infections associated with the [...]

2018-03-14T22:39:40+00:00 15.03.2018|Quality System and Audit, Regulatory Affairs|