GMP News: New comprehensive GMP Inspection Database available

Just recently a so called "inspection tracker" was launched by Health Canada. Now, the agency offers an additional database which contains 3,821 inspections (per March 2015) which have been performed since 2012 - many of them outside Canada, e.g. in Europe or Asia. The information is available in an online database. The use of the database is very easy and search results are excellent.

By using the database even inspections in progress can be displayed. This is a service no other agency can provide. The database also offers further information about past inspections at the same production site. No further search is necessary because the information about past inspections will be displayed in the search result for a given production site. The rating of the inspection is also provided, and in case of GMP non compliance a detailed and very structured information about the findings is provided. The quality of information about the outcome of the inspection available from the database is outstanding. Again, no other agency worldwide is able not only to list the observations but also link them to the concrete GMP regulation paragraph in a structured and numbered table. 

The database also provides information about past and present non-compliance situations. However, it also shows when a company is currently licensed by Health Canada, as the company possibly improved its GMP status and was licensed again.

The database allows three different options to search for information. The first option contains 1,301 Inspections (per March 2015) from the past three years performed in Canada. A second option allows to access the non-compliance information. Currently 52 production sites with non compliance statements are listed in the database (some of the sites received their license again after re-inspection). The third option offers access to 2,520 inspections (per March 2015) performed outside of Canada.

To access the database please visit Health Canada Drug & Health product Inspections Webpage

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GMP News: New comprehensive GMP Inspection Database available

GMP News: MHRA revises its Guideline on Data Integrity in the short Term

The topic "Data Integrity" (electronically generated data as well as data on paper) has moved up recently in the ranking of the most important "hot GMP topics" - not least due to the fact that insufficient or missing data integrity have increasingly been cited as a GMP violation in FDA warning letters.

Just this past January the British authority MHRA has already published a "Data Integrity Guidance" which industry and associations commented on extensively. Already in March a revised version of this guidance was published. This revision is more accurate in some places and partially appears more rigorous with regard to the authority's expectations. Here are some examples:

• Primary Record: In the event that primary data are recorded simultaneously by multiple systems, the system that generates and stores the data has to be defined. A risk assessment respectively a risk management has to ensure that the so-defined primary records have the maximum possible accuracy, completeness and relevance. It is not allowed to define so-called static data (prints or manual records), if there are dynamic (electronic) data as primary records. If there are data anomalies (e.g. OOS results), all data (static and dynamic) will have to be included in a risk-based investigation. 
• True Copy: The new guidance defines a "true copy" as a precise and verified copy of an original recording. This record can either be static (pure paper records or a non-editable electronic file in pdf-format) or dynamic (editable electronic file in which, for instance, certain sections of a diagram can be enlarged or expanded). The MHRA expects critical data to be stored in dynamic form to make sure that in inspections they can get to detailed information, which cannot be retrieved with static data. 
• System Administrator Access: According to the new guidance, the authority expects that the generic system administrator access is not used. Instead every employee with administrative privileges is supposed to log in only with his individual password, to ensure that the actions recorded in the audit trail can be associated with the respective person.  

For further information please see the guideline entitled "MHRA GMP data integrity definitions and guidance for industry March 2015".

GMP News: MHRA revises its Guideline on Data Integrity in the short Term

WHO to ignore powerful producers of substandard medicine - Searching for Safety

WHO to ignore powerful producers of substandard medicine


4/8/2015


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Posted by Roger Bate




The World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began a few years ago. But the reality is that this interim report does not advance the effort far and instead of reporting to, and demanding action at, the World Health Assembly this coming May, it has postponed doing so until 2017.

Perhaps worst still one can see the hands of the usual suspects in this interim report – notably India. It should be remembered that India was the reason that the anti-counterfeit IMPACT initiative of WHO was scuppered a few years ago. It’s not that the Indian government wants the world flooded with inferior medicines, but it doesn’t want anything that will undermine the rapid growth of its generic drug industry, some of whom play fast and loose with the rules on drug manufacturing.

On page 5 of the report the MSM says it will undertake “a study to increase understanding and knowledge on the links between accessibility and affordability and their impact on the emergence of SSFFC medical products and to recommend strategies to minimize their impact”. A balanced study on this topic of pricing and access to medicines as they relate to drug quality, would be useful, whereby one would examine how driving prices too low can lead to cutthroat competition and lower quality, as well as how high pricing can encourage counterfeiters to enter markets. However, one can tell from the MSM text that only the latter type of concern will actually be investigated.

More worrying still is Annex 2, which covers items not to be covered by MSM on SSFFC. Page 16 items 2 and 3 of this Annex covers “authorized” products and “minor” infractions of reporting requirements. Excluding such products may seem reasonable but many of the problems we encounter with substandard medicine are made by authorized firms, with minor deviations in products and reporting. After all a product with the right ingredients produced in a compliant plant by a legal firm, but that doesn’t work, is just as bad as a total fake

Take Femulan (mycophenolic acid), until recently made by Landsteiner, a Mexican manufacturer. Femulan is a generic immunosuppressant used post-transplant in patients to limit organ rejection. As such it is extremely important that it work properly, in order to ensure that the risk, suffering and expense of a transplant does not go to waste. Femulan was authorized by the Mexican government, and also several other Latin American nations. When tested it conformed to the content requirement for the medicine. It was used widely, but unfortunately it didn’t work properly.

To work it required that the tablet did not dissolve and release the active ingredient when in the acidic stomach (or it would have not functioned properly), but that it did dissolve afterwards in the more alkaline small intestine. The innovator product had an enteric coating that ensured that this occurred. Femulan’s coating did not release the product in the stomach as per the innovator, but it also did not release in the small intestine so that patients were barely receiving any active ingredient.

It wasn’t until a study was undertaken and published in 2010 in Transplantation Proceedings, that Femulan was exposed as a non-equivalent copy of the innovator, which ultimately led to its withdrawal. Although it was still available in several Latin American countries until very recently, according to Jose Santiago, a physician based in Bogota, Colombia. The minor infractions of this product meant it probably would not be combatted under WHO SSFFC, but the product was completely useless to patients.
It is ironic that the reason that WHO IMPACT was undermined was because health activists, claimed that it was more important to combat substandard medicine than counterfeit medicine, and IMPACT was too focused on intellectual property violations and counterfeiting. The direction the WHO MSM is taking means it is unlikely to combat any of the most widespread problems with substandard medicine.














WHO to ignore powerful producers of substandard medicine - Searching for Safety

IPEC calls for excipient GMP standard implementation plans to be in place by Q4

IPEC calls for excipient GMP standard implementation plans to be in place by Q4

Snif Brasil - Novos investimentos da Chiesi no Brasil

Novos investimentos da Chiesi no Brasil

A Chiesi Farmacêutica, com sede na Itália, desenvolverá um programa de investimentos de cerca de R$ 25 milhões no Brasil. Parte do aporte será destinada à transferência de uma linha de produção de spray nasal de Parma para a região metropolitana de São Paulo, em Santana de Parnaíba, onde o grupo tem uma planta. O medicamento deixará de ser fabricado na Itália.

"Não temos mais espaço na unidade de lá. Ou trazíamos para o Brasil ou teríamos de terceirizar a fabricação", diz o presidente da empresa no país, José Fernando Albertini de Almeida. "Optamos por adotar uma estratégia de investimento na planta brasileira, que ainda tem área disponível." A companhia pretende dobrar seu faturamento no país até 2020. Para isso, prevê realizar aquisições. "Crescendo organicamente, poderemos chegar a 80% da meta. O restante, terá de ser através da compra de empresas ou de produtos", acrescenta o executivo. O Brasil é hoje o sexto maior mercado para a companhia -depois de Itália, Alemanha, Estados Unidos, França e Espanha- e deverá passar para a quarta colocação em cinco anos.

"Comparativamente com outros países, o Brasil continuará indo melhor. O setor farmacêutico no país deverá voltar a crescer de forma mais acelerada em 2017." € 1,342 bilhão foi o volume de negócios da empresa em 2014, o equivalente a R$ 4,4 bilhões 8,4% foi o crescimento na comparação com 2013 12% foi a expansão no mercado brasileiro 3.000 são os funcionários no mundo.

Snif Brasil

GMP News: Data Integrity - Again Import Alert issued for Indian company IPCA

Data Integrity has become one of the most important GMP compliance issues in past two years. This has enormous consequences for the concerned companies but also for companies and authorities in EU and US. It was the US FDA that has first experienced huge data integrity problems in companies worldwide. Many sites in India have been found to violate GMP requirements by Data Integrity issues. Tests have been repeated and original data have been deleted. This is called "testing into compliance". At the Webpage of the US FDA IPCA products are listed which are impacted by the Import Alert. Two facilities from IPCA have been found to be out of GMP compliance: One in Pithampur (Madhya Pradesh) and one in Piparia (Silvassa) (see also report by FiercePharma).

Products manufactured at those facilities might cause high risks to patients. The quality of the products can not be specified because the original test data were simply deleted. The company IPCA was already known for not meeting the GMP requirements. Already in July 2014 IPCA halts US shipment from the Ratlam plant after FDA found massive GMP violations. As a consequence the Canadian Authority (Health Canada) has banned a huge list of APIs and medicinal products from their market as well. Now they have informed the Bombay Stock Exchange about their problems (see message regarding Import Alert issues by IPCA)

But what are the consequences for companies and authorities in Europe and the US? Authorities might be asked why the same facilities that have been found to be involved in the falsification of data are still allowed to supply to EU patients. For example IPCA is still listed with a GMP certificate for the concerned facilities in EudraGMDP. And EU and US companies need to check very carefully which supplier, partners and own sites they have in India. Quite a few companies have been found to delete data and to perform testing into compliance. FDA has started to check whether companies have checked their suppliers for data integrity. The MHRA has put this on the agenda for their inspections as well.

GMP News: Data Integrity - Again Import Alert issued for Indian company IPCA

Brasil é pequeno no comércio mundial de medicamentos | Abiquifi

Brasil é pequeno no comércio mundial de medicamentos

Autor: Stella Fontes
Fonte: Valor Econômico

O Brasil avançou quatro posições no ranking mundial das exportações de produtos farmacêuticos entre 2004 e 2014, ao passar do 65º para o 61º lugar em termos de participação dos medicamentos na pauta de vendas externas de um país. Com índice de 0,66%, porém, o Brasil ainda está bem atrás da média mundial para esse mercado, de 2,8%, segundo levantamento da Associação da Indústria Farmacêutica de Pesquisa (Interfarma).
De acordo com o presidente executivo da entidade, Antônio Britto, a falta de fôlego das exportações da indústria farmacêutica se reflete em déficit comercial crescente ¬ hoje o Brasil responde pelo quinto maior déficit, com mais de US$ 6 bilhões. Olhando para a balança comercial local, a indústria farmacêutica responde pelo oitavo maior déficit, que representa 4,4% do saldo negativo do país.
“Há muitos obstáculos à competitividade do medicamento brasileiro no mercado mundial”, diz o executivo. “O ponto central é que o déficit comercial é crescente, mas a razão não está no desequilíbrio das importações, que cresce menos do que em outros países”, acrescenta.
Nos últimos dez anos, conta Britto, o volume de produtos farmacêuticos comercializados mundialmente (considerando-¬se exportações e importações) cresceu perto de 110%, enquanto a corrente de comércio farmacêutica do Brasil avançou 287%, alcançando US$ 1,6 bilhão em exportações e US$ 8,2 bilhões em importações. “O problema é que, embora as exportações brasileiras [de medicamentos] tenham crescido, o ritmo foi bem menor que a média mundial e hoje elas representam 0,31% do total exportado no mundo”, aponta o presidente da Interfarma.
No ranking geral de exportação de medicamentos, o Brasil ficou em 27º lugar. Ao mesmo tempo, no de importações, o país ocupa a 16ª posição, com 1,54% da importação global. Para dar musculatura às vendas externas, afirma Britto, o Brasil deveria adotar medidas de estímulo à produção de insumos, que hoje são importados maciçamente. Em 2011, as exportações brasileiras de insumos estavam na casa de US$ 800 milhões. Em 2014, caíram a US$ 560 milhões ¬ no mesmo ano, as importações desse tipo de produto totalizaram US$ 2,7 bilhões, frente a US$ 1 bilhão em 2005.
Outro item que poderia constar da pauta de exportações, os medicamentos básicos não teriam condições de concorrer com importantes fornecedores globais, como a Índia. “Esse mercado se tornou de commodity, já que não há mais a proteção de patente, e o genérico brasileiro não tem preço para enfrentar o produto indiano, por exemplo”, cita o executivo, acrescentando que, diante do tamanho do mercado farmacêutico doméstico, políticas de incentivo às vendas externas de remédios produzidos localmente não foram tratadas como prioridade.
A conclusão, conforme Britto, é que o Brasil teria de fomentar as exportações ¬ restringir as importações seria reduzir o acesso a medicamentos¬, com maior oferta e preço mais baixo do que a concorrência internacional. E uma potencial solução passaria pela retomada da produção local de insumos.

Brasil é pequeno no comércio mundial de medicamentos | Abiquifi