Brasil inicia distribuição de remédio para Alzheimer fabricado no país | Agência Brasil

Brasil inicia distribuição de remédio para Alzheimer fabricado no país

29/06/2012 - 18h30

• Saúde

Da Agência Brasil

Rio de Janeiro - O laboratório do Instituto Vital Brazil (IVB), localizado em Niterói, na região metropolitana da capital fluminense, entregou hoje (29) às secretarias estaduais de Saúde os primeiros lotes de rivastigmina, medicamento destinado ao tratamento dos portadores de Alzheimer. A fórmula foi desenvolvida nacionalmente após a patente do proprietário original ter expirado.

Estão sendo entregues quatro toneladas do remédio, que serão distribuídas gratuitamente. A quantidade é capaz de atender ao total da demanda do país. De acordo com dados da Associação Brasileira de Alzheimer (Abraz), cerca de 6% dos 15 milhões de pessoas com mais de 60 anos sofrem com a doença.

O vice-presidente do IVB, Bernardo Horta, disse que o projeto é fruto de uma nova política de governo federal que, por meio de legislações específicas, incentivou a produção nacional da rivastigmina, fortalecendo o campo da saúde através de uma parceria público-privada.

De acordo com Horta, o processo de produção teve início há dois anos, quando o IVB constituiu uma parceria que envolvia o laboratório Laborvida, do Rio de Janeiro, e o laboratório EMS, de São Paulo, o maior produtor do país no campo dos medicamentos genéricos.

“Foi necessária muita pesquisa para desenvolver a formulação do medicamento. Um laboratório multinacional detinha a sua patente, que foi posteriormente expirada. Isso propiciou o processo de desenvolvimento da formulação do medicamento. A partir daí, resultou o registro na Anvisa [Agência Nacional de Vigilância Sanitária], e foi então iniciada a sua produção”, disse Horta.

Segundo o vice-presidente, o remédio deve estar disponível a partir de julho, e será entregue trimestralmente. O Ministério da Saúde será o responsável pela distribuição nacional gratuita do medicamento, por intermédio do Sistema Único de Saúde (SUS).

“O medicamento vai ser distribuído hoje a todos os almoxarifados de todas as secretarias de todos os estados da Federação. Haverá ainda uma destinação ao almoxarifado do ministério em Brasília, [para formação] do chamado estoque estratégico, ou seja, se faltar esse medicamento em algum local, por acréscimo de demanda, vai existir umquantum que poderá ser encaminhado”.

O Alzheimer é uma doença degenerativa, caracterizada pela perturbação das funções cognitivas, e é ainda incurável e progressiva, levando à morte. Esses sintomas muitas vezes são acompanhados pela deterioração do comportamento social, da motivação e do controle emocional.

Para a distribuição dos lotes, o Instituto Vital Brazil firmou com o Ministério da Saúde contrato de cinco anos, com o compromisso de atender toda a demanda nacional necessária. O medicamento a ser entregue possui formulações que variam de 1,5 mg a 6 mg, em embalagens de 15 cápsulas cada.

Edição: Davi Oliveira

Brasil inicia distribuição de remédio para Alzheimer fabricado no país | Agência Brasil

FDA Updates List of Warning Letters - Pharmaceutical Technology

Jun 26, 2012 By: Susan Haigney

FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research (CDER).

Improper training and a lack of written procedures were among some of the citation trends. Deviations from current good manufacturing practice in the manufacture of APIs cited by CDER include:

• Failure to use dedicated production areas when performing operations with beta-lactam products.
• Failure to have laboratory records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards.
• Failure to ensure laboratory instrumentation that is critical for assuring the quality of APIs is calibrated according to written procedures and an established schedule.
• Failure to have a written procedure to investigate out-of-specification results.
• Failure to ensure proper training.
• Failure to ensure batch production records are prepared for each APIs and include complete information relating to the production and control of each batch.
• Failure of quality unit to review and approve all appropriate quality related documents.
• Failure of your quality unit to establish written procedures.
• Failure to validate those operations critical to the quality and purity of the API.

Violations in regulations for finished pharmaceuticals include:

• Not thoroughly investigated the failure of a batch to meet its specifications whether or not the batch has already been distributed.
• Not establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.
• Not establishing scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.
• Not establishing or following appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.

Warning Letters issued by the Office of Prescription Drug Promotion in 2012 cite drug manufacturing companies for overstating efficacy of products, misbranding, presenting misleading information, making unsubstantiated claims, and omitting risk information from advertising materials in a variety of media outlets.

A complete list of FDA-issued Warning Letters can be found at FDA.gov.

FDA Updates List of Warning Letters - Pharmaceutical Technology

GMP News: APIs from China and India - will Import go down in 2013?

APIs produced in third countries in Asia (like China and India) can only be imported into the EU if the regulatory authority of the exporting country issues a written confirmation that those APIs have been manufactured in GMP-compliant conditions which comply with the European regulations. Moreover, the statement must also comply with the European regulations and ensure that information about non-Compliance shall be immediately reported by the authority of the third country to the EU.

We already reported about the EU Commission proposal to introduce a template for the written confirmation of GMP Compliance (GMP News dated 3. May 2012).

It seems that neither authorities operating in the Indian provinces nor those operating in Chinahave recognised the requirement of the EU and taken adequate measures. Although the API industry in India is concerned by the new requirement, no measure has been taken. As a consequence, some APIs might not be available in 2013. This scenario has already been raised by different industry organisations. Now the British Authority (MHRA) has also expressed their concern.......

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GMP News: APIs from China and India - will Import go down in 2013?

The Top 10 GMP Deficiencies of PIC/S Members

Author:
Thomas Peither
Maas & Peither GMP Publishing, Germany, USA

 

The PDA Europe - PIC/S Workshop from May 9-10, 2012 in Geneva, was a big success for all the 180 participants coming from 45 countries. The debates were highly interesting and the workshops were booked out.

Boon Meow Hoe (HAS, Singapore Agency) and Hans Smallenbroek (IGZ, Netherlands Agency) opened the event by presenting the very interesting results of a PIC/S internal survey on GMP deficiencies. 39 PIC/S member agencies and 9 PIC/S applicants answered a questionnaire about the

• Top ten of the most frequent cited categories of GMP deficiencies and the
• Top five of the most severe GMP deficiencies (critical and/or major).

Only eight agencies did not answer to the questionnaire at all. Overall this can be considered as a great success and a valuable database for the conclusions below.

The questionnaire was limited to finished dosage forms only (human, veterinary, investigational products) and not for APIs. The deficiencies are based on a MHRA-list of 53 common deficiencies in the eight areas of:

• Quality System
• Personal Issues
• Premises and Equipment
• Quality Control
• Validation
• Production
• Material Management
• Regulatory Issues

Top 10 of most frequent categories

The top 10 most frequently cited categories of GMP deficiencies are (number of citations in brackets):

Rank 1   Documentation – manufacturing (24)

Rank 2   Design and maintenance of premises (22)

Rank 3   Documentation - quality system elements/procedures (20)

Rank 4   Personnel issues – training (19)

Rank 5   Design and maintenance of equipment (18)

Rank 6   Cleaning validation (14)

Rank 6   Process validation (14)

Rank 6   Product Quality Review (14)

Rank 7   Supplier and contractor audit (13)

Rank 8   Calibration of measuring & test equipment (12)

Rank 9   Equipment validation (11)

Top 10 of most severe GMP deficiencies

The top 5 most severe GMP deficiencies are (number of citations in brackets):

Rank 1   Design and maintenance of premises (15)

Rank 2   Contamination (chemical, physical, microbial) (12)

Rank 3   Design and maintenance of equipment (11)

Rank 4   Sterility assurance (9)

Rank 4   Batch release procedures (9)

Rank 4   Process validation   (9)

Rank 5   Cleaning validation (8)

Rank 6   Investigation of anomalies (7)

Rank 6   Documentation - quality system elements/procedures (7)

Rank 7   Regulatory issues - non-compliance with marketing authorisation (5)

Rank 7   Documentation – manufacturing (5)

The most frequent deficiencies were also evaluated by groups. Production and quality system turned out to be the two groups most cited.

In summary these are:

Ranking	Most frequent deficiencies	Most severe deficiencies
Rank 1	Production (99 citations, 24%)	Production (44, 27%)
Rank 2	Quality system (82, 20%)	Quality system (32, 20%)
Rank 3	Quality control (59, 14%)	Premises and equipment (28, 17%)
Rank 4	Premises and equipment (58, 14%)	Validation (22, 14%)
Rank 5	Validation (52, 12%)	Quality control (14, 9%)
Rank 6	Personnel issues (34, 8%)	Regulatory issues (9, 6%)
Rank 7	Material management (29, 7%)	Material management (8, 5%)
Rank 8	Regulatory issues (5, 1%)	Personal issues (5, 3%)

As can be clearly seen the most frequent deficiencies are also the most severe deficiencies, except for the two categories quality control and regulatory issues.

Observations

PIC/S observed that different participating authorities used different classification models for identifying GMP deficiencies. Also different levels of details of the deficiency classes were observed. This makes a comparison sometimes difficult. On the other hand there are no significant differences among the regions and there are close correlations between the most frequent and the most severe GMP deficiency classes.

„The 10 most frequently cited GMP deficiency classes show that the industry is weak in these areas and inspectors should communicate more effectively and efficiently with the industry on such weaknesses.“

It may be easy to detect e.g. documentation issues in manufacturing, which ranks as #1 deficiency while the #2 deficiency „design and maintenance of premises“ may be related to aged buildings or saving on maintenance budget. But every company has to draw its own conclusions on these observations.

Recommendations

It was recommended that all PIC/S Participating Authorities (PA) should conduct GMP deficiency analysis and trending within defined periods (e.g. annually). This would help to identify trends across different years. Therefore, a GMP deficiencies classification model may be required that would be accepted by most PIC/S PAs.

It was also a common sense that it may be useful to adopt such an analysis at PIC/S level on an annual basis. The data from each PIC/S PA could be collated for analysis/trending across all PIC/S PAs and applicants. This collated output may also be used as a training need analysis to identify common specific GMP areas to be focused on training and to pull all resources together within PIC/S.

Conclusion

The presentation of the survey was a good starting point for the discussions in the following two workshop days and interactive discussions. As a summary I noticed very open contributions from industry and authorities. Nobody hesitated to represent a different point of view or to comment on somebodies opinion.

Over the last twenty years I never visited an event so open minded between industry and authorities. It would certainly be a good step forward to see more such events.

A very important conclusion of the survey is that there already is a harmonisation of inspections across all PIC/S Participating Authorities. PIC/S can be proud to see this as a result of the long term engagement in GMP inspection harmonisation. I have no doubt that PIC/S will also play an important role in the further harmonisation of global GMPs.

GMP cGMP (current Good Manufacturing Practice):

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1st Brazil Science & Standards Symposium: - Evento Gratuito

1^st Brazil Science & Standards Symposium:

Drug Products for Chemical Medicines
Bioavailability, Bioequivalence, and Dissolution

Apoio Institucional:

Faculdade de Ciências Farmacêuticas da Universidade de São Paulo

United States Pharmacopeia

 

Visão geral

O 1º Science & Standards Symposium da USP-Brasil (S3) está se espandindo devido ao sucesso de encontros científicos anteriores promovidos pela USP-Brasil.

O enfoque do simpósio consistirá em tópicos relacionados à biodisponibilidade, bioequivalência e dissolução de medicamentos, bem como o uso de abordagens do Sistema de Classificação Biofarmacêutica (SCB) como uma forma de documentar a bioequivalência. Esse evento imperdível contará com um debate sobre o Compêndio de Medicamentos (MC), uma respeitada publicação do Conselho de Especialistas da USP. Também promoverá um fórum interativo e exclusivo, voltado a profissionais e associações representativas da indústria farmacêutica, com um painel de especialistas regionais e internacionais.

Acesse a agenda do 1º Brazil Science & Standards Symposium clicando aqui.

Objetivos

·      Analisar a evolução e a situação atual dos requisitos de bioequivalência no Brasil.

·      Examinar as abordagens do SCB conforme a Organização Mundial da Saúde (OMS), bem como as normas do Brasil e dos EUA.

·   Saber mais sobre os principais recursos do SCB, inclusive a determinação da solubilidade e permeabilidade de substâncias farmacêuticas. Analisar o uso correto de técnicas de dissolução em estudos de bioequivalência.

·      Explorar o papel do SCB para compreender o desempenho de formulações no contexto de atributos da qualidade essenciais.

·    Apresentar o MC, uma nova publicação com normas voluntárias para a análise de ingredientes farmacêuticos e medicamentos, as quais podem ser adotadas e reconhecidas em qualquer região do mundo.

·      Analisar o rápido avanço do Brasil na criação e manutenção de um sistema de medicamentos genéricos intercambiáveis.

·      Veja a agenda

Quando: 23 e 24 de agosto de 2012

Onde: Sheraton São Paulo WTC Hotel, São Paulo, Brasil

Avenida Nações Unidas, 12559, Brooklin Novo

São Paulo 04578-903

Telefone: +55-11-3055-8000

A inscrição para este evento é gratuita, porém obrigatória.

Inscreva-se agora clicando aqui.

Quem deve participar

Profissionais que atuam nas seguintes áreas: Pesquisa e desenvolvimento, Formulação, Produção, Agências reguladoras, Validação, Garantia de qualidade, Controle de qualidade, Profissionais de entidades reguladoras, Acadêmicos e Representantes de grupos comerciais.

Dúvidas/Informações

USP Brasil, 55-11-3245-6430, e-mail: uspbrazil@usp.org

This message was sent to agbastos@tekpharma.net from: USP-Brazil | Avenida Ceci, 1600- Tambore | Barueri, SP 06460-120, Brazil

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FDA wants foreign drug and API makers for supply chain security program - FiercePharma Manufacturing

FDA wants foreign drug and API makers for supply chain security program - FiercePharma Manufacturing:

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