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Good Manufacturing Practice: The Role of Local Manufacturers and Competent Authorities

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Li B, Suwan J, Martin JG, Zhang F, Zhang Z, Hoppensteadt D, Fareed J, Linhardt RJ. Oversulfated chondroitin sulfate interaction with heparin-binding proteins: New insights into adverse reactions from contaminated heparins. Biochem Pharmacol 2009;78:293-300.10.1016/j.bcp.2009.04.012273679119389385Search in Google Scholar

Gerber C, Toelle HG. What happened: the chemistry side of the incident with EMS contamination in Viracept tablets. Toxicol Lett 2009;190:248-53.10.1016/j.toxlet.2009.02.02019857795Search in Google Scholar

Wertheimer AI, Norris J. Safeguarding against substandard/counterfeit drugs: Mitigating a macroeconomic pandemic. Res Social Adm Pharm 2009;5:4-16.10.1016/j.sapharm.2008.05.00219285285Search in Google Scholar

Brown CA, Brown SA. Food and Pharmaceuticals: lessons learned from global contaminations with melamine/cyanuric acid and diethylene glycol. Vet Pathol 2010;47:45-52.10.1177/030098580935435220080484Search in Google Scholar

Tran H, Kleiner BH. Effective executive management in the pharmaceutical industry. J Health Care Finance 2005;32:8-15.Search in Google Scholar

Zakon o lijekovima [Act on medicinal products, in Croatian]. Narodne novine 71/2007 [displayed 12 February 2010]. Available at http://narodne-novine.nn.hr/clanci/sluzbeni/298616.htmlSearch in Google Scholar

Patel KT, Chotai NP. Pharmaceutical GMP: past, present, and future - a review. Pharmazie 2008;63:251-5.Search in Google Scholar

Jarvis B. Good manufacturing practice. In: Robinson RK, Batt CA, Patel PD, editors. Encyclopedia of food microbiology. New York: Academic Press Ltd; 2000. p. 961-72.10.1006/rwfm.1999.0755Search in Google Scholar

Directive 2001/83/EC of the European Parliament and of the Council on the community code relating to medicinal products for human use [displayed 6 December 2010]. Available at http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdfSearch in Google Scholar

Pravilnik o uvjetima i postupku utvrđivanja zahtjeva dobre proizvođačke prakse te o postupku davanja proizvodne dozvole i potvrde o provođenju dobre proizvođačke prakse [Ordinance on conditions and procedures for evaluating the GMP requirements and on procedures for granting the manufacturing license and GMP certificate, in Croatian]. Narodne novine 74/2009 [displayed 12 February 2010]. Available at http://narodne-novine.nn.hr/clanci/sluzbeni/2009_06_74_1774.htmlSearch in Google Scholar

EudraLex. The Rules Governing Medicinal Products in the European Union Volume - 4; Good Manufacturing Practice Part I Basic requirements for Medicinal Products Chapter II Personnel [displayed 12 February 2010]. Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/pdfs-en/cap2en200408_en.pdfSearch in Google Scholar

EudraLex. The Rules Governing Medicinal Products in the European Union Volume - 4; Good Manufacturing Practice Part I Basic requirements for Medicinal Products Chapter III Premise and Equipment [displayed 12 February 2010]. Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/pdfs-en/cap3_en.pdfSearch in Google Scholar

EudraLex. The Rules Governing Medicinal Products in the European Union Volume - 4; Good Manufacturing Practice Part I Basic requirements for Medicinal Products Chapter IV Documentation [displayed 12 February 2010]. Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/pdfs-en/cap4en200408.pdfSearch in Google Scholar

EudraLex. The Rules Governing Medicinal Products in the European Union Volume - 4; Good Manufacturing Practice Part I Basic requirements for Medicinal Products Chapter V Production [displayed 12 February 2010]. Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/pdfs-en/cap5en.pdfSearch in Google Scholar

EudraLex. The Rules Governing Medicinal Products in the European Union Volume - 4; Good Manufacturing Practice Part I Basic requirements for Medicinal Products Chapter VI Quality Control [displayed 12 February 2010]. Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/pdfs-en/2005_10_chapter_6_en.pdfSearch in Google Scholar

EudraLex. The Rules Governing Medicinal Products in the European Union Volume - 4; Good Manufacturing Practice Part I Basic requirements for Medicinal Products Chapter VIII Complaints and Product Recall [displayed 12 February 2010]. Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/pdfs-en/2005_12_gmp_part1_chap8_en.pdfSearch in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; Procedure for handling rapid alerts and recalls arising from quality defects [displayed 12 February 2010]. Available at http://www.ema.europa.eu/Inspections/docs/CoCP/31351006enrev1.pdfSearch in Google Scholar

EudraLex. The Rules Governing Medicinal Products in the European Union Volume - 4; Good Manufacturing Practice Part I Basic requirements for Medicinal Products Chapter IX Self-Inspection [displayed 12 February 2010]. Available at http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol-4/pdfs-en/cap9_en.pdfSearch in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; The issue and update of GMP certificates [displayed 12 February 2010]. Available at http://www.ema.europa.eu/Inspections/docs/CoCP/CoCP_GMP_certificates_procedure.pdfSearch in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; Guideline on training and qualifications of GMP [displayed 12 February 2010]. Available at Inspectors http://www.ema.europa.eu/Inspections/docs/CoCP/CoCP_TrainingQualificationGMPInsp.pdfSearch in Google Scholar

Pravilnik o iskaznici farmaceutskog inspektora [Ordinance on pharmaceutical inspector's identity card, in Croatian]. Narodne novine 02/2005 [displayed 12 February 2010]. Available at http://narodne-novine.nn.hr/clanci/sluzbeni/2005_02_19_313.htmlSearch in Google Scholar

Directive 2001/82/EC on the Community code relating to veterinary medicinal products [displayed 8 December 2011]. Available at http://www.echamp.eu/fileadmin/user_upload/Regulation/Directive_2001-82-EC__-__Consolidated_Version_.pdfSearch in Google Scholar

Pravilnik o načinu praćenja neispravnosti u kakvoći lijeka [Ordinance on monitoring of quality defects, in Croatian]. Narodne novine 36/2010.Search in Google Scholar

Directive 2003/94/EC laying down principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use [displayed 7 December 2011]. Available at http://ec.europa.eu/health/files/eudralex/vol-1/dir_2003_94/dir_2003_94_en.pdfSearch in Google Scholar

Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [displayed 7 December 2011]. Available at http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdfSearch in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; Conduct of Inspections of Pharmaceutical Manufacturers [displayed 12 February 2010]. Available at http://www.ema.europa.eu/Inspections/docs/CoCP/CoCP_InspConduct.pdfSearch in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; Exchange of information on manufacturers and manufacturing or wholesale distribution authorisations between Competent Authorities in the European Economic Area [displayed 12 February 2010]. Available at http://www.ema.europa.eu/Inspections/docs/CoCP/CoCP_ExInfo.pdfSearch in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; Procedure for dealing with serious GMP noncompliance or voiding/suspension of CEPS thus requiring coordinated administrative action [displayed 12 February 2010]. Available at http://www.ema.europa.eu/Inspections/docs/CoCP/2356709en.pdfSearch in Google Scholar

Morénas J. PICS: un système de coopération en matière d'inspection des produits pharmaceutiques [PICS: Pharmaceutical inspection cooperation scheme, in French]. Ann Pharm Fr 2009;67:16-9.10.1016/j.pharma.2008.10.00519152846Search in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; Outline of a procedure for co-ordinating the verification of the GMP status of manufacturers in third countries [displayed 12 February 2010]. Available at http://www.ema.europa.eu/Inspections/docs/CoCP/CoCP_VerificationGMP3rdCountry.pdfSearch in Google Scholar

European Medicines Agency (EMA). Compilation of Community Procedures on Inspections and Exchange of Information; Guidance on the occasions when it is appropriate for competent authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials [displayed 12 February 2010]. Available at http://www.ema.europa.eu/Inspections/docs/CoCP/CoCP_APIGMPInspTriggers.pdfSearch in Google Scholar

Milstien J, Costa A, Jadhav S, Dhere R. Reaching international GMP standards for vaccine production: challenges for developing countries. Expert Rev Vaccines 2009;8:559-66.10.1586/erv.09.2319397413Search in Google Scholar

ISSN:
0004-1254
Langues:
Anglais, Slovenian
Périodicité:
4 fois par an
Sujets de la revue:
Medicine, Basic Medical Science, other