abiquifi Alerta (022/2015)

Nos links abaixo informação sobre a Warning Letter do FDA para a empresa indiana DR. REDDY’S para as unidades de produção de IFA’s de Srikakulam e Miryalaguda nas quais são produzidas várias importantes moléculas e uma unidade de produção de medicamentos oncológicos:

http://www.in-pharmatechnologist.com

http://www.reuters.com

http://www.bloomberg.com

abiquifi Alerta (021/2015)

Bloomberg detalha alguns aspectos de inspeções do FDA em instalações da ZHEJIANG HISUN PHARMACEUTICALS CO. e da ZHEJIANG HISOAR PHARMACEUTICAL CO., grandes e sofisticadas empresas chinesas produtoras de IFA´s e medicamentos que abastecem grandes empresas globais e, certamente, também de países emergentes.

Apesar do tamanho das empresas, as práticas que levaram o FDA a banir seus produtos para entrada nos EUA são as mesmas observadas anteriormente em inspeções similares.

Pode-se também notar a enorme resistência enfrentada pela Autoridade Sanitária Americana para auditar as produções de insumos que são exportados aos EUA por empresas chinesas:

http://www.bloomberg.com

abiquifi Alerta (020/2015)

FDA NEWS informando sobre outro site de produtor indiano de IFA – Megafine Pharma – que se junta a outros 46 sites de fabricação de medicamentos e de IFA’S cujos produtos estão banidos para entrada nos EUA:

http://www.fdanews.com

http://www.megafine.in

abiquifi Alerta (019/2015)

Warning Letter do FDA datada de 28 de setembro, indicando a empresa indiana UNIMARK REMEDIES, LTD – localizada na 337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District, India -, por NÃO-CONFORMIDADES em seus processos produtivos:

http://www.fda.gov

É uma grande empresa, com presença global, produtora não só de dezenas de IFA´s, como formulações farmacêuticas e produtos biológicos.

abiquifi Alerta (018/2015)

Resumo da Carta de Não-Conformidade para o fabricante Chinês ZHUHAI UNITED LABORATORIES CO., LTD, com site de produção em Sanzao Science &Technology Park, National Hi-Tech Zone, Zhuhai, Guangdong, 519040, China:

The company was not operating its aseptic manufacture operations in compliance with EU GMP Annex 1. This was evident from by the high number of observations regarding the aseptic manufacturing facilities design, equipment, operations, environment monitoring and media fill validation. However, the QA system of the company failed to notice these problems and therefore was considered weak and inappropriately implemented. Detailed list of critical and major deficiencies is included in regulatory risk assessment.

Produtos fabricados no site:

Amoxicillin Sodium sterile, Potasium Clavulanate sterile and Amoxicillin Sodium and Potasium Clavulanate steril, Ticarcillin Disodium/Clavulan, Cefotaxime Sodium Sterile e Imipenem/Cilastatin Sodium.

abiquifi Alerta (017/2015)

Resumo da Carta de Não Conformidade para o fabricante Chinês JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD. com site de produção em No. 6121 Longquan Road, Zhangqiu, Shandong Province, 250 200, China:

In total 18 deficiencies were identified by the inspection team, one of them was classified as critical and six as major. The critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall, which during the inspection the Company was requested to remove. The material stored in this area was to be managed outside of the Quality Assurance system and the investigation carried o ut by the inspection team concluded there was a serious risk of data falsification. One of the six major deficiencies was related to a very similar issue, as access to a locked garage was given to the inspection team only hours after requesting it. In both cases the explanations provided were not sound and different versions were given during the inspection. The remaining five major deficiencies were related to specific aspects of the Quality Assurance System with regards to training, cleaning validation, breaches of data integrity in the context of HPLC analysis, microbiological laboratory, qualification of contract manufacturer of a key intermediate of Nitrofurantoin production.

Produtos fabricados no site:

Foscarnet Sodium, Rosuvastatin Calcium, Carprofen, Dantrolene Sodium, Trospium chloride, Nitrofurantoin, Nitrofurantoin Macrocrystals, Nitrofurantoin Monohydrate, Tolperisone hydrochloride, Nitrofu razone (FDA), Furazolidone, Feprazone, Cyclandelate, Phenylbutazone, Haloperidol, Clozapine, Carbamazepine, Berberine Tannate, Methylbenactyzine Bromide, (+)-Sotalol Hydrochloride, Dipyridamole, Cimetidine, Allantoin, Bifendate, 1-Aminohydantoin, 1-Aminohydantoin Hydrochloride, Laurocapram, Foscarnet Sodium Hexahydrate, Bromfenac Sodium, Cidofovir Dihydrate, Racecadotril, Florfenicol.

abiquifi Alerta (016/2015)

Resumo da Carta de Não Conformidade para o fabricante Indiano PARABOLIC DRUGS LIMITED, com site de produção em PDL-2, Plot No. 45, Industrial Area, Phase II, Panchkula District, Haryana, 134 113, India:

The quality management system was found to be seriously uncontrolled and deficient in all “Principles” (except principle 2.13 and 2.14) reported in the EU- GMP requirements as evidenced by critical and major deviations found in the following areas: inadequate storage and control of documents and samples and material, falsification of documents and data, integrity and security of data in the QC laboratory, Change Control, Deviations management and Risk management. In total 27 deficiencies were found: 3 classified as Critical were found in the area of Documentation man agement system, Falsification and Security and integrity data; 7 classified as Major deficiencies were found in the area of QC, Personnel, Documentation and Change Control.

Produtos fabricados no site:

This inspection was performed in the framework of the CEP dossier for the manufacture of Dicloxacillin sodium. The found deficiencies could affect the other penicillin family APIs manufactured at the site (AMOXICILLIN TRIHYDRATE, PIVAMPICILLIN,FLUCLOXACILLIN SODIUM,CLOXACILLIN SODIUM, AMPICILLIN TRIHYDRATE, AMPICILLIN ANHYDROUS,BACAMPICILLIN HYDROCHLORIDE).

abiquifi Alerta (015/2015)

Abaixo a comunicação de NÃO-CONFORMIDADE emitida pela Autoridade Sanitária Francesa, com validade para a Europa, e a suspensão do Certificado de Conformidade da EDQM para a empresa chinesa HUZHOU SUNFLOWER PHARMACEUTICAL CO., LTD. produtora de POVIDONE-IODINE, produto de larga utilização em todo o mundo:

Report No: 15MPP013

STATEMENT OF NON-COMPLIANCE WITH GMP

Exchange of information between National Competent Authorities (NCAs) of the EEA following the discovery of serious GMP non-compliance at a manufacturer (1)

Part 1

Issued following an inspection in accordance with:

Art. 111(7) of Directive 2001/83/EC as amended

The competent authority of France confirms the following:

The manufacturer: HUZHOU SUNFLOWER PHARMACEUTICAL CO., LTD.

Site address: 692 North Zhiyuan Road, Wukang Town, Huzhou, Zhejiang Province, 313 200, China

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2015-01-30 , it is considered that it does not comply with the Good Manufacturing Practice requirements referred to in

• The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC

(1) The statement of non-compliance referred to in paragraph 111(7) of Directive 2001/83/EC and 80(7) of Directive 2001/82/EC, as amended, shall also be required for imports coming from third countri es into a Member State.

Part 2

1 NON-COMPLIANT MANUFACTURING OPERATIONS

1.2 Non-sterile products

1.2.1 Non-sterile products (processing operations for the following dosage forms)

1.2.1.17 Other: active substance

Manufacture of active substance. Names of substances subject to non-compliant:

POVIDONE, IODINATED

3. NON-COMPLIANT MANUFACTURING OPERATIONS – ACTIVE SUBSTANCES

Active Substance: POVIDONE, IODINATED

3.1 Manufacture of Active Substance by Chemical Synthesis

3.1.1 Manufacture of active substance intermediates

3.1.3 Salt formation / Purification steps:

Complexation reaction

3.5 General Finishing Steps

3.5.2 Primary Packaging (enclosing / sealing the active substance within a packaging material which is in direct contact with the substance)

3.5.3 Secondary Packaging (placing the s ealed primary package within an outer packaging material or container. This also includes any labelling of the material which could be used for identification or traceability (lot numbering) of the active substance)

3.6 Quality Control Testing

3.6.1 Physical / Chemical testing

abiquifi Alerta (014/2015)

Mais notícias sobre não conformidades nas produções da empresa chinesa ZHUHAI UNITED LABORATOPRIES, CO – uma grande organização que produz antibióticos (Amoxicilina, Penicilina) e vários outros produtos, inclusive INSULINA RECOMBINANTE. 

A empresa teve seus Certificados de Conformidade SUSPENSOS pela EDQM – Autoridade Sanitária da Europa. 

abiquifi Alerta (013/2015)

Warning Letter do FDA para a empresa da República Tcheca VUAB PHARMA, grande produtora dos insumos farmacêuticos ativos NISTATIN para uso humano e veterinário e dos oncológicos DACARBAZIN e OXALIPLATIN.

http://www.gmp-compliance.org

Repetem-se os problemas com a integridade de dados e as medidas corretivas adotadas de insumos importantes, que, no caso dos oncológicos, são utilizados na forma injetável em pacientes com câncer.