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.......

Read more just click into the link below/Veja mais no link abaixo:

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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Learn the Top 8 Chemical Management Errors - Free WhitePaper

Find them and fix them now!

Effective inventory management of any kind involves getting the right inventory to the right place at the right time in the right quantity. When an organization's chemical inventory management is out of control, the inventory data is inaccurate and chemicals won't be on hand or in the correct location -- causing confusion on the lab bench and non-compliance with all sorts of regulations.

From ordering too much chemical inventory to throwing away expired chemicals that were misplaced, learn the top 8 chemical management errors and what you need to do to eliminate them.

This white paper shows you how to fix chemical errors by implementing a chemical inventory system that ensures researcher adoption, lab efficiencies and accurate, real-time chemical data.

You'll learn how to:

• Optimize chemical safety & inventory data
• Automate audit trails and regulatory reports
• Manage and mitigate the amount of chemicals on-site
• Reduce inventory management costs

Request your copy of the white paper today!

http://info.chemsw.com/acton/fs/blocks/showLandingPage/a/2235/p/p-00a6/t/page/fm/0

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Microtest - Six Steps to Qualifying Disinfectants - WhitePaper

Six Steps to Qualifying Disinfectants:

Maintaining aseptic conditions and preventing microbial contamination is paramount for all pharmaceutical and medical device manufacturing environments, yet the qualification of chemical disinfectants used are often overlooked. For all parties involved, internally and externally, the qualification of disinfectants must be addressed.

This white paper outlines six steps that provide a framework to assist companies in qualifying the disinfectants used in their environmental cleaning process. Each step contains valuable information that can help pharmaceutical and medical device manufacturers prevent problems from arising going forward.

Download the paper.

The new product development reality

While winning FDA or other regulatory approval is a formidable hurdle, it is no longer the end game when it comes to defining if the development of a product is truly successful. In today's health care reality, the new finish line is unrestricted and affordable patient access to innovative medicines and technologies that actually change the practice of medicine for unmet medical needs—from major public health challenges to orphan diseases

The new product development reality

GMP News: EMA updates "Compilation of Community Procedures on Inspections and Exchange of Information"

GMP News: EMA updates "Compilation of Community Procedures on Inspections and Exchange of Information"

COMPENDIUM: Expert advice on solubility enhancement

COMPENDIUM: Expert advice on solubility enhancement: WHITEPAPER FREE

Must-read solubility enhancement compendium

The result of many years of research, BASF’s solubilization compendium covers basic principles of solubility enhancement, delivering expert advice and practical tips on:

• Solubilizing compounds with poor solubility and bioavailability profiles
• Creating solid solutions and dispersions
• Investigating solubilization efficacy using a high-throughput robot
• Selecting the most suitable solubilization product

In addition, the publication provides detailed descriptions of all relevant BASF excipients, including Soluplus and various Kolliphor and Kollidon grades.

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FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER 62, PART I (REVISED) | Barry A Friedman, PhD LLC

FREQUENTLY ASKED QUESTIONS — USP GENERAL CHAPTER 62, PART I (REVISED) | Barry A Friedman, PhD LLC:

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The Attraction and Challenge of Continuous Manufacture

Moves toward greater processing efficiency and continuous manufacturing are intertwined. The practices associated with quality by design (QbD) and defining the design space are being applied to bring knowledge-led practice to batch process development, but there are some unique challenges relating to the transition to continuous manufacturing. Download Now!

Jamie Clayton, Operations Manager with powder characterization specialist Freeman Technology, discusses:

• the potential benefits of continuous manufacture against the backdrop of current practice and the prevailing economic climate
• the analytical practice needed to support new manufacturing models
• dynamic powder testing as an analytical method with a contribution to make in the development of efficient, integrated, continuous processes 

Key elements for success Implementing PAT in an Oral solid dosage plant

Para ler o artigo click no link abaixo!
http://proddownloads.vertmarkets.com.s3.amazonaws.com/download/685ec40e/685ec40e-d667-4500-820e-a04b0010153f/original/francois_keyelementsforsuccess.pdf?cid=c59b8476-8e81-43ef-9f21-6c8cb027930f
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Smart Phones | GMP Compliance? There's An App for That! | Pharmaceutical Manufacturing

GMP Compliance? There's An App for That!

PharmaManufacturing.com
06/11/2012

Pharma Quality professional Ajay Pazhayattil has created an Android App called eGMP, which is available at no charge for use on any android phone or tablet. 

Summarizing global GMP's in one place, it is designed, Pazhayattil says, to improve cGMP awareness for professionals on the fly.  It can be specifically used by QA/Compliance auditors during site audits, GMP
trainers, during brainstorming sessions and for quick quoting of specific GMP sections.

The App provides all major GMP's from around the world. Pazhayattil designed it, in part, to avoid having to travel with bulky GMP handbooks.

For Androids:
1) Google Play

2) Search for: eGMP

3) Install & Use.

Senado aprova política nacional de combate à pirataria de remédios e cosméticos.

Marcos Chagas

Repórter da Agência Brasil

Brasília - O Senado superou hoje (13) a primeira etapa da criação de uma política nacional de combate à pirataria de produtos submetidos à Vigilância Sanitária. O foco principal é integrar as diversas ações governamentais de enfrentamento da pirataria de produtos que devem passar pelo crivo da Agência Nacional de Vigilância Sanitária (Anvisa). Projeto de lei nesse sentido, de autoria do senador Humberto Costa (PT-PE), foi aprovado em caráter terminativo na Comissão de Assuntos Sociais (CAS). Agora, a matéria seguirá para a análise da Câmara dos Deputados.

Segundo levantamento da Organização Mundial de Saúde (OMS), citado pelo Instituto Brasileiro de Ética Concorrencial (Etco), na América Latina, no Sudeste da Ásia e na África estima-se que 30% dos produtos à venda no mercado e usados pela população têm origem fraudulenta. A Anvisa, por sua vez, estima esse percentual em 20% no Brasil.

Os dados foram apresentados pela relatora Vanessa Grazziotin (PCdoB-AM). Ela lembrou que a OMS estima em 25% o percentual de falsificação ou adulteração de medicamentos vendidos em países em desenvolvimento como Brasil, Turquia, Rússia e Índia.

A relatora citou, por exemplo, a pirataria de cosméticos, que tem características peculiares. “A produção ilegal ocorre dentro das fronteiras do país, em fabriquetas de fundo de quintal ou em pequenos laboratórios”. Ela acrescentou que a produção está mais próxima dos locais de consumo, o que dificulta a interceptação dos produtos. A senadora citou que as denúncias veiculadas recentemente de uso de formol (formaldeído) em cremes para o cabelo trouxeram à tona um pouco da realidade da fabricação e do uso ilegal de cosméticos no Brasil.

Fonte: Agência Brasil.

Disponível em: <http://agenciabrasil.ebc.com.br/noticia/2012-06-13/senado-aprova-politica-nacional-de-combate-pirataria-de-remedios-e-cosmeticos>. Acesso em: 13 junho 2012.

Sindusfarma _

Sindusfarma _:

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FDA identifies 22 Chinese companies out of GMP compliance

GMP News: FDA identifies 22 Chinese companies out of GMP compliance:

The US FDA has published a list of 22 Chinese companies who fail to comply with the GMP regulations. All companies manufacture Heparin.

The FDA states in an import alert: "As part of FDA's activities intended to protect the health and safety of U.S. consumers, FDA often conducts inspections of foreign establishments that produce FDA-regulated articles intended for use in the United States. One basis for detention without physical examination is that the firm's quality system is inadequate for the prevention of contamination or otherwise does not conform to CGMP. Heparin contaminated with oversulfated chondroitin sulfate (OSCS) clearly indicates that the "methods used in" or the "controls used for" the "manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity" with CGMP. OSCS is not part of the manufacturing process for heparin and its presence suggests that somewhere in the supply chain OSCS has been added intentionally to heparin for financial reasons because it is a very cheap material prepared by a simple synthetic process. In addition, it mimics certain heparin properties so that it would pass then current United States Pharmacopeia (USP) specifications for Heparin Sodium USP. (The USP has since revised in 2009 its monograph for Heparin Sodium USP to incorporate tests that can detect the presence of OSCS).

Manufacturers must have adequate traceability, qualification, and testing systems in place in order to satisfy applicable CGMP requirements. Where there is an inspection that identifies an inadequate system in this regard, the firm's drug(s) or other products appear to be adulterated and are subject to imports refusal per 801(a)(3).

Furthermore, if the firm appears to have been responsible for introducing contaminated forms of heparin or heparin-related products into the supply chain, then there is an appearance that the firm's quality system is inadequate or otherwise does not conform to CGMP. If the firm demonstrates that they have appropriate controls in place, the firm's drugs or other products may no longer appear to be adulterated.

The attachment to this alert identifies firms for which we have information indicating that the different forms of heparin or heparin-related products appear to be adulterated for one of the reasons described above. It appears per 801(a) that the methods used in and controls used for the manufacture, processing, packing, or holding of the drugs or other products from the firms listed in the attachment do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B); therefore such articles are subject to refusal of admission into the United States"

Details on the companies can be found in the Import Alert published by FDA.

Source: FDA Import Alert

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EU Annex 11 – Computer System Inventory | askaboutvalidation.com

EU Annex 11 – Computer System Inventory


12 June 2012 




EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines Annex 11 for computerised systems includes the requirement for the regulated company to maintain an up to date listing of relevant systems (GMP Computerised Systems) and their GMP functionality (inventory).


This is also a Japanese regulatory requirement and also an expectation of the FDA although not included within the regulations (21 CFR 211) it is often requested prior or during an inspection.


This post looks at the methods for developing the inventory for computerised systems to meet the requirements of EU Annex 11.


What Systems To Include In the Computer Inventory?


EU Annex 11 applies to all forms of computerised systems used as part of a GMP regulated activities. Therefore this should be the basis of which systems should be included. Computer systems are used throughout the business with every desk having a PC. So the definition of a GMP computerised system is critical to defining what systems to include within the system register.


Some guidance can be taken for the definition of GMP computerised systems guidance can be taken from ICH Q7 which states.


The term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labelling, relabeling, quality control, release, storage and distribution.


Also the scope of the Japanese regulations can also help in the definition of a GMP Computerised System.


Systems to make decisions on market release of drugs and quasi-drugs, and to create and retain market distribution records
Systems to create and retain manufacturing orders and manufacturing records, etc.
Systems to control/manage manufacturing processes and to retain relevant data
Systems to manage storage and inventory, etc. of raw materials and products (including intermediates; the same shall apply hereinafter)
Systems to control/manage laboratory instruments used for QC tests and systems to retain QC test results and relevant data
Systems to control/manage equipment and facilities, including HVAC and water supply systems, etc., which may have a significant impact on quality of products, and systems to retain relevant data
Systems to create, approve and retain documents (SOPs, Quality Standard Code, Product Standard Code, etc.)
The regulated company within the Site Validation Master Plan or Computer Systems Validation Policy / Procedure must define the scope of GMP Computerised Systems to be included within the system inventory.


What To Include In The System Inventory


To comply with EU Annex 11 Computerised Systems the minimum that must be included within the system register is the list of the computer systems and details of the functions of the computerised system.






The Inventory is key to supporting inspection readiness and therefore other useful information should be included including:


Validation Status
Software Category (Commercial Off The Shelf or Bespoke)
Electronic Records / Signatures
Periodic Review Schedule
Business Process Owner
System Owner
Other decisions may also be recorded within the computer systems inventory, such as the decision to validate. Computer Systems may reside within the GMP classification but do not have any impact to Product Quality or GMP Requirements.


For example a Building Management System (BMS) used for environmental control of a GMP area (e.g. a warehouse) which has a fully independent monitoring system for recording and alarming the environmental conditions will not need the same level of controls as the Monitoring System. The monitoring system is a Direct Impact system while the BMS is Indirect Impact system. The level of validation and the operational controls will be more stringent for the monitoring system than the BMS which can be handled following Good Engineering Practices (GEP).


Using Good Engineering Practices


Note that using GEP is not an excuse for not applying any controls. Commissioning will be need to be performed and documented for the system to ensure that it meets with requirements and operational controls (such as change management) will need to be addressed. However the level of formal Validation and Quality Oversight (e.g. Periodic Review, etc.) will not necessarily be required.


The decision as to the Impact of the system should be documented and approved by the quality unit.


Developing the Computer System Inventory


The system inventory should be searchable and provide the facility to be filtered to provide information during regulatory inspections or customer audits. This should allow computerised systems to be filtered based on the processes (products) they are used in.


To provide this functionality an electronic system (e.g. spreadsheet, database, etc.) should be considered. However unless a fully integrated electronic inventory is used which would provide the electronic approval (electronic signatures) for the rationale then a hybrid system should be considered.


The paper record provides the primary record with the approval of the rationale and should include:


Details of the system Boundary
Description of the use of the system
System Impact
Supplier / Integrator Details
List of components
Classification of Hardware (Standard / Bespoke)
Classification of software (COTS, Bespoke, etc.)
Details of Electronic Records
Details of Electronic Signatures
Validation Status
While this list is not exhaustive other items can be included as required. For example the reference to the initial validation report may be included, the reference to the last periodic review and / or the next periodic review.


Validation of the Electronic Inventory


I often asked whether the electronic inventory requires validation. I suggest that you register the inventory, perform your initial impact / risk assessment to determine the level of controls which should be applied.


In general the paper record should be considered as the master record and therefore the level of controls should be minimal. Security access controls should be considered so that only authorised users can have access.


The output for regulatory inspection (list of associated computerised systems) should be checked against the paper records and approved for issue by the person responsible within the QA or Validation departments.


Author


Barry Tedstone
computersystemsvalidation.blogspot.com


Related Reading


Annex 11 Vs CFR’s
Annex 11 System Description
An Easy to Understand Guide to Annex 11
Spreadsheet validation with FDA 21 CFR Part 11
Category : software-validation, validation-articles




EU Annex 11 – Computer System Inventory | askaboutvalidation.com:

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Anvisa publica novo guia sobre Revisão Periódica de Produtos

de Blog da Saúde

Divulgação

Já está disponível no site da Anvisa o guia de Revisão Periódica de Produtos. O documento é direcionado aos detentores de registro de medicamento no Brasil e define princípios e práticas aceitáveis para a realização da Revisão Periódica. Embora o procedimento da Revisão possa ser feito de outras formas, o guia serve de orientação  para que as empresas atendam os requisitos regulatórios.

A Revisão Periódica de Produto (RPP) é uma ferramenta de qualidade adotada pelas principais autoridades regulatórias do mundo.  Desde a publicação da Resolução RDC 17/2010, sua utilização tornou-se obrigatória no Brasil. O guia tem o objetivo de orientar o setor regulado e os inspetores da vigilância sanitária, já que a RPP pode ser cobrada durante uma inspeção para verificação do cumprimento de Boas Práticas de Fabricação ou durante uma inspeção de investigação.

O conteúdo do guia é baseado em referências internacionais, bem como na experiência nacional e tem o objetivo de realçar alguns pontos em que se observa que não há um entendimento claro ou padronizado por parte dos profissionais da área.

Fonte: Imprensa/ Anvisa

FDA warns 8 manufacturers for failing to register plants

FDA warns 8 manufacturers for failing to register plants

Recall of Introvale birth control pills

Recall of Introvale birth control pills:


Some packages of the birth control pill Introvale were filled improperly, prompting a recall of 10 lots the drug, so that women are not impacted.


The blister packs holding the pills are usually made with rows of pills for each of 13 weeks. In the problematic lots, the placebo normally located in the the 13th row of blister packs, was also put in the ninth row, according to the announcement released by the U.S. Food and Drug Administration.


Sandoz, a Princeton-based generic branch of Novartis AG, produced the pills.


The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the United States between January 2011 and May 2012.


The FDA statement said that a consumer noticed the problem and reported it to authorities.


Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week.


The company said there was not a safety concern, but it could not rule out unintended pregnancy if the wrong pills are taken over several days, the FDA said.


The FDA said that in the unlikely event that a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and talk to their doctor.


To report the problem to the company, the Sandoz drug information direct line is             800-525-2492       (24 hours/day, seven days a week) or via email at qa.druginfo@sandoz.com.


The FDA announcement has a photo of the blister pack.


Posted by David Sell @ 8:25 AM  Permalink | Post a comment




Read more: http://www.philly.com/philly/blogs/phillypharma/Recall-of-Introvale-birth-control-pills.html#ixzz1xQilG8hV 
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Formaldeído banido como conservante | Cosmetics Online Brasil

Formaldeído banido como conservante | Cosmetics Online Brasil:

Formaldeído banido como conservante

A Anvisa divulgou a RDC 29/12 que aprova o Regulamento Técnico do Mercosul sobre a “Lista de Substancia de Ação Conversante permitidas para Produtos de Higiene Pessoal, Cosméticos e Perfumes” – a novidade é a exclusão do formaldeído e o uso do triclosan como preservantes em cosméticos. Essa RDC incorpora a Resolução GMC 8/2011 e revoga a GMC 05/99 e &2/00.


A íntegra da RDC 29/12 está disponível no link: http://www.in.gov.br/visualiza/index.jsp?data=04/06/2012&jornal=1&pagina=81&totalArquivos=176


Sebastião D. Gonçalves, especialista em conservantes, comentou a nova RDC exclusivamente para CosmeticsOnline. (vídeo) 

Formaldeido

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GMP News: Incorrect Handling of OOS Results found in 10 FDA Warning Letters in 2011

GMP News: Incorrect Handling of OOS Results found in 10 FDA Warning Letters in 2011

A review of the 2011 FDA Warning Letters shows that the incorrect handling of OOS results is still a hot topic in FDA inspections and inspection follow up activities (483s, etc.). In total 10 companies (6 drug product manufacturers and 4 API manufacturers) received a FDA Warning Letter relating to OOS investigations in the calendar year 2011. Here are some examples of these citations:

• Failure to investigate and document out-of-specification results obtained for … .
• Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed, and you failed to extend the investigation to other batches of the same drug product that may have been associated with the specific failure or discrepancy.
• Your firm's out-of-specification (OOS) investigations did not include analysis of all available data.
• Inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its specifications or quality standards.
• Your firm has failed to conduct an investigation for numerous OOS results (e.g., for colony forming units, conductivity, assay, etc.). Many of these OOS results were not reported to your client.
• Your QCU approved and released a batch of … despite an initial OOS bulk assay result.  These results were later confirmed through repeat testing, but further testing of additional samples produced passing results.  Your QCU released the batch even though the investigation did not identify a discernable cause.
• Your QCU failed to detect multiple discrepancies in sample weights and dilution factors between the analyst's notebook and the Calculation Sheet. As a result, incorrect data was recorded for multiple products and finished products not meeting specifications were released. Specifically, a lot of … was released and distributed even though it did not meet the established specification of … % label claim. The correct calculation would have reported a … % label claim.
• Your QCU did not require a second, independent person to review the raw data, calculations and records before releasing these lots for distribution.
• The inspection also found that your analyst did not record these out-of specification results in the OOS logbook as required by your SOP.
• Your investigation failed to follow your procedures when your firm … initiated Phase 2 sample testing prior to completing Phase 1 of the investigation, and … only analyzed two samples as opposed to the required three samples

According to these citations, giving adequate attention to out-of-specification (OOS) results in batch release decision remained the dominant theme in 2011 in the FDA Warning Letters.

In order to assist the pharmaceutical industry in a FDA/GMP-compliant handling of OOS Results, the ECA Quality Control Working Group has established a general SOP for the handling of OOS results.

More than 100 members participated in a review team specifically formed for that purpose and gave their comments and feedback during the development process of this SOP. Version 01 of this OOS SOP has been finalised in the meantime and will be presented at ECA's OOS Forum, from 19-20 June 2012 in Prague, Czech Republic. Some of the review team members will also show different views or alternative approaches for handling OOS results at the OOS Forum.

Author:

Dr Günter Brendelberger

Anvisa proíbe protetor solar mais fraco

IDVF:

As regras para fabricar e importar protetores solares no Brasil se tornaram mais rígidas ontem.

A Agência Nacional de Vigilância Sanitária (Anvisa) publicou no Diário Oficial uma resolução que aumenta de 2 para 6 o menor Fator de Proteção Solar (FPS) contra os raios ultravioleta do tipo B, responsáveis por queimaduras e câncer.

A mudança é considerada um avanço pelos dermatologistas, mas ainda insuficiente para proteger contra os danos da exposição ao sol. O FPS mínimo recomendado é 30.

— Foi um passo importante, porque a medida também engloba outros cosméticos. Mas o mínimo fator para a proteção solar ser eficaz é 30, com necessidade de reaplicação a cada duas horas — afirma o especialista em fotoproteção da Sociedade Brasileira de Dermatologia (SBD) Sergio Schalka.

A radiação ultravioleta é do tipo UVA, que causa envelhecimento e câncer, e UVB, responsável por queimadura e câncer.

A Anvisa determinou também mudanças nos rótulos e nos testes de comprovação de eficácia.

A partir de agora, os fabricantes não podem mais afirmar nas embalagens que os produtos oferecem 100% de proteção, e têm que avisar sobre a necessidade de reaplicálos.

As empresas terão que especificar o grau de resistência da fórmula à água e ao suor (resistente ou muito resistente), de acordo com testes mais rígidos que serão adotados. As formas de avaliar a eficácia de proteção contra os raios ultravioletas também foram aperfeiçoadas, seguindo padrões usados nos Estados Unidos e na Comunidade Europeia.

— Já seguíamos padrões internacionais, que foram atualizados.

Por isso, o Brasil também está atualizando as suas regras. O que muda são fatores técnicos, de cálculo. Isso não significa que os produtos no mercado hoje são inseguros — diz Schalka.

Outra novidade é a criação de um padrão para medir o fator de proteção contra os raios UVA, o que até então não existia. Se um fabricante quiser anunciar esta característica na embalagem de um produto, terá que comprová-la com a realização de testes.

Esse fator terá que ser de, no mínimo, um terço do FPS, relação considerava suficiente pelos dermatologistas.

— Isso é muito positivo porque representa uma preocupação com a exposição aos raios UVA, que até pouco tempo atrás não era considerado prejudicial.

Mas eles causam envelhecimento da pele e contribuem para o desenvolvimento de câncer — avalia Schalka.

As novas regras valem para qualquer produto que anuncie fator de proteção solar na fórmula, como protetores labiais, batons e hidratantes.

Para Marcus Maia, coordenador da Campanha do Câncer da Pele da SBD, faltou a Anvisa determinar que os rótulos informem sobre a quantidade ideal de protetor a ser usado: — As pessoas costumam usar um quinto do necessário e isso diminui a eficácia do produto.

Os fabricantes terão dois anos para se adaptar à regra, que segue parâmetros já adotados pelo Mercosul. O braço da Nivea no Brasil disse que desde 2011 vem se adequando às normas.

AAvon disse que suas fórmulas são adequadas às novas regras, que são muito parecidas com as da Comunidade Europeia, onde a empresa está presente. 

Fonte: Juliana Câmara - O Globo - 05/06/2012

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