TGA: Adoption of EU/ICH guidelines

TGA: Adoption of EU/ICH guidelines:
Following consultation with relevant industry groups, TGA, the Australian Therapeutic Goods Administration, has announced the adoption of a number of EU/ICH guidelines in Australia, effective 1 June 2013.
These include, inter alia:

• Guideline on plasma-derived medicinal products (EMA)
• Guideline on active substance master file procedure (EMA)
• Guideline on bioanalytical method validation (EMA)
• Impurities: Guideline for residual solvents ICHQ3C(R5)

Source:

TGA: Newsroom
mehr

GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

GMP News 12/06/2013

GMP-Audits of manufacturers of active substances: Minimum Requirements on Audit Reports and Qualification of Auditors

The European Medicines Agency EMA specifies in one of its questions and answers documents on the GMP guideline under the heading "EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances" its requirements for active substances. This list of frequently asked questions compiled by the Inspectors Working Group has recently been complemented by the following three questions and answers: 8. "During inspections, why do inspectors sometimes ask to see reports of audits of active substance manufacturers carried out by the medicinal product manufacturer?” 9. "What expectations do inspectors have for the content of reports of audits?" 10. "How should active substance auditors be qualified?" The answer to question No. 9 on the minimum requirements is especially interesting. The report of the audit of active substances should be sufficient since the requirements on this report are described in an unusual comprehensive and detailed manner. The following points are mentioned by way of example: A justification should be recorded for the duration of the audit, especially, if the audit had to be restricted to fewer days on site than initially planned for the scope of the audit.  The areas which were not covered by the audit should also be clearly recorded.  Auditors should identify and describe the high risk areas specific to the company being audited (for example, cleaning/cleaning validation, possible cross-contamination, sources for unknown impurities, mix-up of materials or products and so on). Areas of the site to which access was denied should be recorded.  Corrective and preventive actions (CAPAs) as well as the timescales for their completion should be assessed by the auditors to establish whether these are appropriate to the findings.  A proposed re-assessment period should be recommended. EMA’s requirements concerning the qualification of auditors are also clear and precise. No difference is made between contracted auditors and the manufacturing authorisation holder’s own auditors. Auditors are required to have sufficient scientific or technical experience for the area to be audited,  have undergone a training and assessment programme in the areas that are relevant to the audit. Auditors must also have been trained and assessed in their knowledge and understanding of EU GMP part II and in auditing techniques in general. The training and personal suitability evaluation (assessment) should be fully documented. With these exceptionally detailed requirements on the quality standards of an audit report of active substances and on the qualification of auditors EMA sets standards that have to be maintained in the future by the numerous Third Party Audit Organisations existing now if they want to survive on the market. Now, GMP auditors have a concrete list of criteria they can use in order to check easily and clearly the quality of audit reports and the qualification of auditors. You can find the compilation of EMA’s questions and answers on GMP for active substances here. http://www.gmp-compliance.org/enews_3739_GMP-Audits%20of%20manufacturers%20of%20active%20substances%3A%20Minimum%20Requirements%20on%20Audit%20Reports%20and%20Qualification%20of%20Auditors_rss.html

iPhone Biosensor Detects Toxins, Proteins, Bacteria and Viruses

iPhone Biosensor Detects Toxins, Proteins, Bacteria and Viruses:

Researchers and physicians in the field could soon run on-the-spot tests for environmental toxins, medical diagnostics, food safety and more with their smartphones.

University of Illinois at Urbana-Champaign researchers have developed a cradle and app for the iPhone that uses the phone’s built-in camera and processing power as a biosensor to detect toxins, proteins, bacteria, viruses and other molecules.

Having such sensitive biosensing capabilities in the field could enable on-the-spot tracking of groundwater contamination, combine the phone’s GPS data with biosensing data to map the spread of pathogens, or provide immediate and inexpensive medical diagnostic tests in field clinics or contaminant checks in the food processing and distribution chain.

“We’re interested in biodetection that needs to be performed outside of the laboratory,” said team leader Brian T. Cunningham, a professor of electrical and computer engineering and of bioengineering at the U. of I. “Smartphones are making a big impact on our society – the way we get our information, the way we communicate. And they have really powerful computing capability and imaging. A lot of medical conditions might be monitored very inexpensively and non-invasively using mobile platforms like phones. They can detect molecular things, like pathogens, disease biomarkers or DNA, things that are currently only done in big diagnostic labs with lots of expense and large volumes of blood.”

The wedge-shaped cradle contains a series of optical components – lenses and filters – found in much larger and more expensive laboratory devices. The cradle holds the phone’s camera in alignment with the optical components.

At the heart of the biosensor is a photonic crystal. A photonic crystal is like a mirror that only reflects one wavelength of light while the rest of the spectrum passes through.  When anything biological attaches to the photonic crystal – such as protein, cells, pathogens or DNA – the reflected color will shift from a shorter wavelength to a longer wavelength.

For the handheld iPhone biosensor, a normal microscope slide is coated with the photonic material. The slide is primed to react to a specific target molecule. The photonic crystal slide is inserted into a slot on the cradle and the spectrum measured. Its reflecting wavelength shows up as a black gap in the spectrum. After exposure to the test sample, the spectrum is re-measured. The degree of shift in the reflected wavelength tells the app how much of the target molecule is in the sample.



The entire test takes only a few minutes; the app walks the user through the process step by step. Although the cradle holds only about $200 of optical components, it performs as accurately as a large $50,000 spectrophotometer in the laboratory. So now, the device is not only portable, but also affordable for fieldwork in developing nations.

In a paper published in the journal Lab on a Chip, the team demonstrated sensing of an immune system protein, but the slide could be primed for any type of biological molecule or cell type. The researchers are working to improve the manufacturing process for the iPhone cradle and are working on a cradle for Android phones as well. They hope to begin making the cradles available next year.

Cunningham’s group is now collaborating with other groups across campus at the U. of I. to explore applications for the iPhone biosensor. The group recently received a grant from the National Science Foundation to expand the range of biological experiments that can be performed with the phone, in collaboration with Steven Lumetta, a professor of electrical and computer engineering and of computer science at the U. of I. They are also are also working with food science and human nutrition professor Juan Andrade to develop a fast biosensor test for iron deficiency and vitamin A deficiency in expectant mothers and children.

In addition, Cunningham’s team is working on biosensing tests that could be performed in the field to detect toxins in harvested corn and soybeans, and to detect pathogens in food and water.

“It’s our goal to expand the range of biological experiments that can be performed with a phone and its camera being used as a spectrometer,” Cunningham said. “In our first paper, we showed the ability to use a photonic crystal biosensor, but in our NSF grant, we’re creating a multi-mode biosensor. We’ll use the phone and one cradle to perform four of the most widely used biosensing assays that are available.”

Cunningham also is affiliated with the Institute for Genomic Biology, the Beckman Institute for Advanced Science and Technology, and the Micro and Nanotechnology Laboratory, all at the U. of I.

Source: University of Illinois News Bureau

Matéria na Revista Pharmacia Brasileira: Brasil busca solução para descarte inadequado de medicamentos — Descarte de Medicamentos

Matéria na Revista Pharmacia Brasileira: Brasil busca solução para descarte inadequado de medicamentos — Descarte de Medicamentos:

PHARMACIA BRASILEIRA 87 está disponível no site do CFF

Data: 20/05/2013

A “PB” traz uma ampla matéria, seguida de uma entrevista com a farmacêutica Simone Ribas, sobre o descarte inadequado de medicamentos e a construção da política de logística reversa, no Brasil.

Outro assunto de destaque desta é a revisão que o CFF fará dos ensaios realizados, no Brasil - e publicados - sobre os impactos causados pelos cuidados clínicos prestados por farmacêuticos a pacientes usuários dos serviços público e privado de saúde. Este trabalho é parte de uma nova política do CFF destinada a fortalecer as atividades profissionais na área clínica.

A “PB” 87 traz, ainda, uma entrevista com os farmacêuticos Márcio Antônio da Fonseca e Silva e Anselmo Gomes de Oliveira. Eles conquistam o prêmio científico internacional Alcalíber, concedido pelo Governo espanhol, pela pesquisa que realizaram sobre a leishmaniose (a doença e o tratamento medicamentoso).

O tão propalado novo modelo de ensino superior que se avizinha e as mudanças substantivas que ele produzirá nos cursos de graduação em Farmácia e na formação do farmacêutico é tema de outra entrevista. O entrevistado é o farmacêutico e professor Geraldo Alécio de Oliveira, especialista em ensino superior. Muitas outras matérias encontram-se no número 87 da “PB”.

A PHARMACIA BRASILEIRA, desde a edição anterior, tornou-se uma publicação veiculada, apenas eletronicamente. O CFF deseja, com esta decisão, fazer com que a revista atinja um número ilimitado de leitores. Para ler a “PB”, é bastante acessar o link para a revista disponibilizado na página do Conselho. O link encontra-se à direita da página e traz a foto da capa da revista. Boa leitura.

O editor.

Clique aqui e acesse 

Ações

'via Blog this'

GMP News: New FDA Guidance on Contracts

GMP News: New FDA Guidance on Contracts:

The U.S. Food and Drug Administration FDA has published the draft Guidance for Industry "Contract Manufacturing Arrangements for Drugs: Quality Agreements".

In the EU GMP Guide Chapter 7 on Outsourced Activities, expectations regarding quality contracts are clearly defined. In the US, not much detail was provided so far. CFR regulations do not explicitly require contract partners to document their respective responsibilities in contract manufacturing arrangements, but the regulations do require that Quality Unit responsibilities and procedures are in writing (21 CFR 211.22(d)). With the new Guidance, the FDA aims to describe the agency's current thinking on defining, establishing, and documenting the responsibilities in contract manufacturing of drugs subject to Current Good Manufacturing Practice (cGMP).

Quality Agreements covered in this document are not commercial or business agreements and FDA therefore recommends that Quality Agreements are separate documents.

The new draft guidance describes the obligations of the contracting parties, the delineation of responsibilities and how drug quality, safety, and efficacy can be assured in contract manufacturing. It applies to the commercial manufacturing of:

• Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates),
• finished drug products,
• combination products and
• biological drug products

The term "manufacturing" in the sense of this document includes processing, packing, holding, labelling operations, testing, and operations of the Quality Unit.

No matter, which activities are outsourced, the Quality Unit of the contract giver ("Owner") will stay ultimately responsible for approving and rejecting drug product manufactured by the contract manufacturer (21 CFR 210.3(12)). This is different to Europe, where the release (certification by a Qualified Person) can also be outsourced.

The basic sections which might be expected by FDA are:

• Purpose/Scope
• Terms (including effective date and termination clause)
• Dispute Resolution
• Responsibilities, including communication mechanisms & contacts
  a. Quality Unit responsibilities
  b. Facilities and equipment
  c. Materials management
  d. Product-specific terms
  e. Laboratory controls
  f. Documentation
• Change control and revisions

At the end of the document, hypothetical scenarios illustrate some common problems in contracted manufacturing arrangements. The scenarios also demonstrate FDA's thinking regarding possible resolution of the problems. The examples provided are not intended to be exclusive, but, instead, to provide industry and other stakeholders with some frequently-encountered fact patterns and our analysis of those facts.

This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register. Guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

Source: Guidance for Industry "Contract Manufacturing Arrangements for Drugs: Quality Agreements"

'via Blog this'

Medicamentos sem fabricante nacional têm corte de imposto - DIKAJOB

DCI

03/06/2013 - Sete medicamentos utilizados no Sistema Único de Saúde (SUS), e sem concorrentes fabricados no Brasil, tiveram o Imposto de Importação zerado.
A decisão da Câmara de Comércio Exterior (Camex) foi publicada na última sexta-feira no Diário Oficial da União.

De acordo com o Ministério do Desenvolvimento, Indústria e Comércio Exterior (MDIC), a diminuição das tarifas vai contribuir para a redução das despesas do SUS, porque os medicamentos são caros e provocam grande impacto no orçamento do Ministério da Saúde.
A medida abrange três medicamentos usados no tratamento da artrite reumatoide que são Abatacepte, Cetolizumabe Pegol e Golimumabe, dois remédios para a hepatite C que são os Telaprevir e Boceprevir, um medicamento indicado para prevenção de infecções respiratórias que é o Palivizumabe e o hemoderivado Fator VIII, usado no tratamento de hemofílicos.
Para os medicamentos contra a hepatite C, o Imposto de Importação caiu de 8% para 0%. Nos demais casos, a tarifa passou de 2% para 0%.

Para não descumprir as políticas comerciais vigentes no Mercosul, que limitam o número de produtos que podem ter tarifas diferentes do restante do bloco regional, a Camex teve de aumentar o Imposto de Importação dos congeladores blast freezers, utilizados para o congelamento de plasma sanguíneo.

Esse equipamento foi retirado da lista de exceções à tarifa externa comum e voltou a pagar 20% para entrar no País, essa é a mesma tarifa cobrada no restante dos países que fazem parte do Mercosul.

'via Blog this'

ABDI e Anvisa lançam guia de boas práticas em produtos para saúde - DIKAJOB

• 
  Postado por DIKAJOB em 28 maio 2013 às 16:30

Com o objetivo de ampliar a compreensão da indústria sobre a legislação e regras relacionadas aos padrões de qualidade de produtos e serviços do setor da saúde, a Agência Brasileira de Desenvolvimento Industrial (ABDI), a Agência Nacional de Vigilância Sanitária (Anvisa) e o Serviço Brasileiro de Apoio às Micro e Pequenas Empresas (Sebrae) lançaram, na última quinta-feira (23), em São Paulo (SP), o Guia de Auxílio na Implantação de Boas Práticas em Produtos para Saúde. O documento foi apresentado durante a IV Jornada de Ação em Política Industrial e Regulação para Produtos da Saúde, evento conjunto à Feira Hospitalar 2013.

 

O Guia é fruto da preocupação do setor público com a qualidade dos produtos e serviços frente à crescente demanda da população por acesso à saúde e as consequentes pressões sobre o complexo industrial, que precisa oferecer garantia de qualidade e baixo risco à população. Nesse cenário, a resolução de 28 de março de 2013 (RDC 16/13), referente às boas práticas de produtos para saúde, estabeleceu padrões de qualidade que devem ser seguidos por fabricantes e empresas que comercializam produtos para saúde no Brasil.

 

Construído a partir das perguntas sobre boas práticas apresentadas à Anvisa com maior frequência, e com base no que está disposto nas resoluções que devem ser atendidas, o Guia foi elaborado para servir de instrumento de trabalho e de utilidade técnico-operativa para as empresas em relação às exigências regulatórias contidas na RDC 16/13.

 

Fonte Site ABDI

Confira o guia atraves do link: guia BPF-ANVISA

'via Blog this'