Quality System and Audit

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FDA Statement on new testing results, including low levels of impurities in ranitidine drugs

Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates – from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives. Helping assure the quality and safety of these products is one of our greatest responsibilities. Over the past several weeks, [...]

2019-11-08T17:37:19+00:0008.11.2019|Quality System and Audit, Regulatory Affairs|

Infarmed: Suspensão de autorizações de distribuição por grosso de medicamentos de uso humano

O Infarmed suspendeu a autorização para o exercício da atividade de distribuição por grosso de medicamentos de uso humano das seguintes entidades: Medivip - Distribuição De Produtos Farmacêuticos, Lda. (Autorização N.º A019/12/H/003/2019, de 2019-04-03), com armazém sito em Rua da Bica, n.º 15, Edifico Vipfarma I e II, Ninho do Mocho – Quinta do Estrangeiro, [...]

2019-11-04T22:10:57+00:0004.11.2019|Quality System and Audit, Regulatory Affairs|

EMA to provide guidance on avoiding nitrosamines in human medicines

EMA’s Executive Director has asked the human medicines committee (CHMP) to provide guidance for avoiding the presence of nitrosamine impurities in human medicines containing chemically synthesised active substances. 'We will continue to work with our partners to address the presence of nitrosamines and reassure patients about the quality of their medicines,' says the Executive Director Professor Guido [...]

FDA warns company for putting consumers at risk with drug manufacturing data integrity violations

Today the U.S. Food and Drug Administration posted a warning letter to Ningbo Huize Commodity Co., an over-the-counter (OTC) drug manufacturer, for significant current good manufacturing practice (CGMP) violations, including data integrity issues. “Americans deserve to have confidence in the quality of drugs the FDA regulates – from the prescription medicines they take to the over-the-counter products [...]

2019-09-02T21:27:23+00:0002.09.2019|Quality System and Audit, Regulatory Affairs|

(Cas) AEMPS: La UE y los EEUU alcanzan un hito en el reconocimiento mutuo de las inspecciones de los fabricantes de medicamentos

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. Tras haberse completado la evaluación de los organismos de inspección, a partir del 11 de julio de 2019 se completa la [...]

2019-07-24T21:25:24+00:0024.07.2019|Quality System and Audit, Regulatory Affairs|

EMA: EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers

With the recognition by the US Food and Drug Administration (FDA)of Slovakia, 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. “We welcome the implementation of this agreement, which means authorities on both sides of the Atlantic will [...]

2019-07-17T20:37:39+00:0017.07.2019|Quality System and Audit, Regulatory Affairs|

Infarmed: Declaração CE de conformidade falsa de dispositivos médicos do fabricante Sri Trang Agro-Industry Public Company Ltd (mercado europeu)

Foi identificada, no mercado europeu, a existência de uma Declaração CE de Conformidade falsa, relativa a vários produtos alegadamente do fabricante Sri Trang Agro-Industry Public Company Ltd (Tailândia) e mandatário Sungo Certification Company Ltd (Reino Unido). Este fabricante informou que apenas coloca no mercado europeu luvas de exame e tem como mandatário a empresa Medical [...]

2019-07-08T20:40:06+00:0008.07.2019|Quality System and Audit, Regulatory Affairs|

EMA: One additional country to benefit from EU-US mutual recognition agreement for inspections

On 26 June 2019, Germany was included into the mutual recognition agreement between the European Union and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of this additional EU Member State to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. The agreement mutually recognises inspections of manufacturing sites [...]

2019-07-02T21:39:25+00:0002.07.2019|Quality System and Audit, Regulatory Affairs|

EMA: Two additional countries to benefit from EU-US mutual recognition agreement for inspections

On 10 June 2019, Luxembourg and the Netherlands were included into the mutual recognition agreementbetween the European Union (EU) and the United States Food and Drug Administration (FDA). The FDA thus confirmed the capability of these two additional EU Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). The agreement [...]

2019-06-17T21:37:43+00:0017.06.2019|Quality System and Audit, Regulatory Affairs|

ANSM: Grossistes-répartiteurs: l’ANSM prend des mesures à l’encontre des “short-liners”

Face aux enjeux des ruptures de stock et aux risques d’introduction de médicaments falsifiés dans le circuit légal, l’ANSM a poursuivi en 2018 ses actions vis-à-vis des grossistes-répartiteurs. Les inspections, conduites par les Agences Régionales de Santé (ARS) en lien avec l’ANSM, ont mis en évidence qu’il existe encore des grossistes-répartiteurs qui ne remplissent pas [...]

2019-05-09T22:40:51+00:0009.05.2019|Quality System and Audit, Regulatory Affairs|

EMA: Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In April 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Bulgaria and Cyprus were included into the mutual recognition agreement between the EU and the US on 29 April 2019. The agreement mutually recognises inspections of manufacturing sites [...]

2019-05-05T21:14:04+00:0005.05.2019|Quality System and Audit, Regulatory Affairs|

Infarmed: Novo portal Inspeção+ simplifica a gestão de processos de inspeção

Inspeção + é o nome do novo portal do Infarmed que pretende simplificar a gestão de processos de inspeção. À semelhança do desenvolvimento de outras plataformas informáticas no Infarmed também este portal surge no âmbito do SIMPLEX+, visando, entre outros aspetos, a desmaterialização e agilização da conclusão dos processos de inspeção às entidades do circuito [...]

2019-04-12T20:37:56+00:0012.04.2019|Quality System and Audit, Regulatory Affairs|

EMA: EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This [...]

2019-02-21T22:15:31+00:0022.02.2019|Quality System and Audit, Regulatory Affairs|

EMA: Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at a level equivalent to the United States (US). Poland and Slovenia were included into the mutual recognition agreement between the EU and the US on 7 February 2019. The agreement mutually recognises inspections of manufacturing [...]

2019-02-13T18:52:28+00:0013.02.2019|Quality System and Audit, Regulatory Affairs|

(Cas) AEMPS: Presencia de nitrosaminas en los medicamentos denominados “sartanes”. Conclusión de la revisión de la Agencia Europea de Medicamentos

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. El Comité de Medicamentos de Uso Humano (CHMP) de la Agencia Europea de Medicamentos (EMA) ha concluido el arbitraje realizado por [...]

2019-02-12T20:41:32+00:0013.02.2019|Quality System and Audit, Regulatory Affairs|

EMA launches checklist to facilitate validation for initial marketing authorisation applications

A survey launched by EMA in September 2016 shows that validation issues occur in 90% of initial marketing authorisation applications (MAAs). They create additional workload for companies and potential delays at a critical moment for the timely start of the procedure. To make the validation process more efficient, predictable and easier to navigate, EMA is encouraging applicants [...]

EMA: Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities

Companies that make sartan blood pressure medicines (also known as angiotensin II receptor blockers) are being required to review their manufacturing processes so that they do not produce nitrosamine impurities. Companies will have a transition period to make any necessary changes, during which strict temporary limits on levels of these impurities will apply. After this [...]

FDA sends warning to company for marketing dangerous unapproved stem cell products that put patients at risk and puts other stem cell firms, providers on notice

The U.S. Food and Drug Administration has warned Genetech, Inc. of San Diego, California and its president, Edwin N. Pinos for marketing stem cell products without FDA approval and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including some violations that may have led to microbial contamination, potentially causing [...]

(Cas) AEMPS: Declaración Responsable de actividades de fabricación y/o importación de Productos Cosméticos. Actualización de la información y de los modelos para su presentación

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.Con fecha 17 de diciembre de 2018 se ha actualizado la información y los modelos de Declaración Responsable de actividades de fabricación [...]

2018-12-20T23:01:00+00:0021.12.2018|Quality System and Audit, Regulatory Affairs|