{tab Tartalom}
Továbbképző közlemények
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[item title=”Kőszeginé Szalai Hilda, Kósa Tibor: A gyógyszergyártás és gyógyszer-nagykereskedelem szabályozása az Európai Unióban és hazánkban – GYOGAI. 60. 643-651. 2016.”]
Irodalom
1. Bayer I.: Gyógyszerészet 51(10), 642 (2007).
2. Selmeczi Mária Teréz: A gyógyszergyártás hatósági ellenőrzésének kialakulása és szervezése Magyarországon, egyetemi doktori értekezés, Budapest 1987.
3. Draft Requirements for Good Manufacturing Practice in the Manufacture and Quality Control of Drugs and Pharmaceutical Specialities EB 41/38, 11, 01.(1968).
4. WHO Technical Report Series 418 Annex 2. Genf (1969)
5. Good Practice in the Manufacture and Quality Control of Drugs and Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce, Official Records of the World Health Organisation No.226 Twenty Eighth World Health Assembly Geneva, 13-30 May 1975 Annex 12 pps 88-96 (1975)
6. Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products, European Yearbook volume XVIII 1970 729-747
7. Az Elnöki Tanács 1976. évi 31. számú törvényerejű rendelete, Magyar Közlöny 1976. 94.szám és OGYI Közlemények 2.02, 23-27.
8. http://ec.europa.eu/health/documents/eudralex/vol-1
9. http://www.efta.int/legal-texts/eea
10. Mutual Recognition Agreements http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000248.jsp&mid=WC0b01ac058005f8ac
11. EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines http://ec.europa.eu/health/documents/eudralex/vol-4
12. Com-pi-lation of Community Procedures on Inspections and Exchange of Information http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf
13. Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:0014:EN:PDF
14. Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use. http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52015XC0321(01)
15. Quality Guidelines http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
16. Eudra GMDP http://eudragmdp.ema.europa.eu
17. Riccardo Luigetti, EMA, Emer Cooke, EMA, Brendan Cuddy, EMA, Sebastien Goux, European Commission, and Ian Rees, MHRA | Sep 25, 2015: GMP Oversight of Medicines Manufacturers in the European Union https://www.pda.org/pda-letter-portal/archives/full-article/gmp-oversight-of-medicines-manufacturers-in-the-european-union
18. MHRA GxP Data Integrity Definitions and Guidance for Industry https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/538871/MHRA_GxP_data_integrity_consultation.pdf
19. WHO Guidelines on validation 3 (May 2016) 4 Draft for comments http://www.who.int/medicines/areas/quality_safety/quality_assurance/validation-without_appendices_2016_05_17.pdf?ua=1
20. Elemental Impurities in Drug Products Guidance for Industry http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm509432.pdf
21. Data Integrity and Compliance With CGMP Guidance for Industry http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM495891.pdf
22. Annex 5 Guidance on good data and record management practices http://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex05.pdf?ua=1
23. Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52015XC0321%2802%29&from=EN
24. Request for Quality Metrics Guidance for Industry http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm455957.pdf
25. Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/04/WC500205447.pdf
26. Good Manufacturing Practice for Advanced Therapy Medicinal Products http://ec.europa.eu/health/files/advtherapies/2015_pc/publ_cons_doc_2015.pdf
27. WHO GMP for Biological Products, Proposed replacement of: TRS 822, Annex 1 © World Health Organization 2015 http://www.who.int/biologicals/GMP_For_Biologicals_version_Post_ECBS.pdf?ua=1
28. Questions and answers on production of water for injections by non-distillation methods
reverse osmosis and biofilms and control strategies Draft http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/08/WC500211657.pdf
29. Safety features for medicinal products for human use Question and Answers Version 5 http://ec.europa.eu/health/files/falsified_medicines/qa_safetyfeature_v5_0.pdf
30. http://ec.europa.eu/health/human-use/quality/developements/index_en.htm
H. Kőszeginé Szalai, T. Kósa: Regulation of the manufacture and wholesale distribution of medicines in the European Union and in Hungary
In the introductory part of the paper history of the supervision of drug manufacture including the implementation of GMP rules is Hungary is presented by the authors. In the further chapters the legal tools and the system of guidelines regulating the manufacture , importation and wholesale distribution of medicines as well as the manufacture, importation and distribution of active substances and excipients thereof in the EU are shown. This is followed by the discussion of the content of the law and other regulation including the role and responsibilities of the actors participating in the supply chain and of the supervisory authorities in ensuring the GMP/GDP compliance of the manufacture and distribution of medicines and their ingredients. The rules relating to the manufacturers and distributors acting within or outside the EU are equally covered, with reference to the respective paragraphs of the EU law and guidelines. The authors also outline the current forms of cooperation within the network of the European national supervisory authorities and the European Medicines Agency in building and maintaining an effective system of GMP/GDP compliance monitoring as well as the new tendencies in the GMP/GDP regulation in the EU and worldwide.
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[item title=”Détári Gabriella: Gyártói minőségbiztosítási feladatok hatóanyaggyártás és -forgalmazás esetén – GYOGAI. 60. 652-655. 2016.”]
Irodalom
1. Az Európai Parlament és Tanács emberi felhasználásra szánt gyógyszerekről szóló EC 2011/62 rendelettel módosított EC 2001/83 Közösségi Kódexe.
2. Eudralex Volume 4. the Rules Governing Medicinal Product in the EU, GMP for human and veterinay use, Part II: Active Substances used as a Starting Materials (2014. Sept. 1).
3. ICH Q7a. International Conference on Harmonisation of GMP guide for Active Pharmaceutical Ingredients. Version 8. 2015.
4. ICH Q9 guideline on Risk Management.
5. Az Európai Bizottság által 2015. március 19.-én kiadott (2015/C95/01) Iránymutatások az emberi felhasználásra szánt gyógyszerhatóanyagokra vonatkozó helyes forgalmazási gyakorlat elveiről
Détári G.: Quality Management System at manufacturer and distributor of Active Pharmaceutical Substances
Each manufacturer and distributor should maintain an effective Quality System to ensure the high quality of Active Substance, using for medicinal product. In the article the main element of Quality System is discussed e.g. Training of personnel, release system, documentation system, how to handles deviations or change control, emphasis the importance of process validation and internal audit as well
The aim of the article is to give some ideas for auditors for performing an effective audit at Active Substances manufacturer.
The article considers the European requirement for distribution of these types of products; give some idea on the principles of good distribution practices for active substances for medicinal products for human use
[/item]
[item title=”Hasznosné Sklánitz Lucia, Zambó Katinka: Citosztatikum szennyezettség visszaszorítása intézeti gyógyszertárban – GYOGAI. 60. 656-660. 2016.”]
Irodalom
1. Hon, C.Y., Teschke, K., Demers, P.A., Venners, S.: Ann Occup Hyg. 58(6), 761-70 (2014).
2. Rioufol, C., Ranchon, F., Schwiertz, V., Vantard, N., Joue, E., Gourc, C., Gauthier, N., Guedat, M.G., Salles, G., Souquet, P.J., Favier, B., Gilles, L., Freyer, G., You, B., Trillet-Lenoir, V., Guitton, J.: Clin Ther. 36(3), 401-7 (2014).
3. U.S. Pharmacopeial Convention: General chapter <800> hazardous drugs
handling in healthcare settings: http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings
4. Hon, C.Y., Teschke, K., Shen, H., Demers, P.A., Venners, S.: Antineoplastic drug contamination in the urine of Canadian healthcare workers. Int Arch Occup Environ Health. 2015 Jan 28. [Epub ahead of print]
5. Tompa A, Jakab M, Biró A, Magyar B, Fodor Z, Klupp T, Major J.: Ann N Y Acad Sci. 1076, 635-48 (2006).
6. Tompa A, Jakab M, Bíró A, Major J.: Orv Hetil. 156(2), 60-66 (2015).
7. Bouraoui, S., Brahem, A., Tabka, F., Mrizek, N., Saad, A., Elghezal, H.: Environ Toxicol Pharmacol. 31(1), 250-7 (2011).
8. ESOP. Monitoring of surfaces contamination with antineoplastic drugs in preparation and administration areas, 2015, http://www.esop.li/downloads/ESOP_project.pdf
Hasznos-Sklánitz L., Zambó K.: Reducing Cytostatic Pollution in the Institutional Pharmacy
The goal of the present experiment was to track the decay of cytostatic pollution in Budapest’s MHEK. The initial levels were ascertained during a 2013 national audit, and we accelerated the rate of decay using a series of decontamination measures during 2015. Such measures included the drafting of more effective cleaning protocols, implementing stricter security proceedings, and transitioning to the Tevadaptor closed system in the production of mixed infusions.
Our experience shows that a combination of good workflow management and the adaptation of closed systems pushes the levels of contamination below the threshold of detection.
We believe the main value of our experiment is that it proved in a methodologically sound manner that contamination can be reduced radically. However, we must also point out that the present experiment was limited in scope to the hospital’s pharmacy. If the hospital is to combat pollution effectively, they should also frequently re-evaluate other protocols, such as those applying to the nurses.
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Növényi szerek helye a mai gyógyszerkincsben
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[item title=”Kúsz Norbert: Podophyllum peltatum – podofillotoxin – GYOGAI 60. 661-663. 2016.”]
Irodalom
1. Moermann, D.E.: Medicinal plants of native America; University of Michigan, Museum of Anthropology, technical report No. 19, 1986.
2. Sackett, D.L.: Pharmacol Ther, 59, 163–228 (1993).
3. Lu W., Fu C., Zhao Y.: China J Chin Mater Med, 36, 1109–1114 (2011).
4. Filley, C.M., Graff-Radford, N.R., Lacy, R. et al.: Neurology, 32, 308–311 (1980).
5. Lund, O., Marstrander, J., Smedby, B. et al.: J Norw Med Assoc, 108, 1293 (1988).
6. Kaplan, I.W.: New Orleans Med Surg J, 14, 936–945 (1942).
7. Cortese, F., Bhattacharyya, B., Wolff, J.: J Biol Chem, 252, 1134–1140 (1977).
8. Podwyssotzki V.: Pharm J Trans, 12, 217–218 (1881).
9. Borsche, W., Niemann, J.: Justus Liebids Ann Chem, 494, 126–142 (1932).
10. Von Krogh, G.: Acta Dermatovenereol, 98(Suppl.), 1–48 (1991).
11. Stähelin, H., von Wartburg, A.: Prog Drug Res, 33, 169–267 (1989).
12. Canel, C., Moraes, R.M., Dayan, F.E. et al.: Phytochemistry, 54, 115–120 (2000).
Kúsz N.: Podophyllum peltatum – podophyllotoxin
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Gyógyszerészettörténeti közlemények
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[item title=”Takácsné Novák Krisztina: Brantner Antal, az elhivatott kutató és oktató munkássága (1929-2006) – GYOGAI 60. 664-669. 2016.”]
Irodalom
1. Önéletrajz. Forrás: SOTE Archívum.
2. Brantner A.: Gyógyszerészet 50, 428 (2006).
3. Brantner A.: Gyógyszerészet 2, 231 (1958).
4. Brantner A., Vámos J., Végh A., Simonyi I.: Acta Pharm. Hung. 37, 49 (1967).
5. Vámos J., Brantner A., Végh A., Simonyi I.: Acta Pharm. Hung. 37, 55 (1967).
6. Brantner A., Vámos J., Végh A., Simonyi I.: Acta Pharm. Hung. 39, 232 (1969).
7. Brantner A., Vámos J., Végh A., Simonyi I.: Acta Pharm. Hung. 39, 265 (1969).
8. Vámos J., Brantner A., Szász Gy., Végh A.: Acta Pharm. Hung. 38, 378 (1968).
9. Vámos J., Brantner A., Szász Gy., Végh A.: Acta Pharm. Hung. 40, 135 (1970).
Takács-Novák, K.: Brantner A. (1929-2006) dedicated researcher and teacher’s life-work
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Aktuális oldalak
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[item title=”Hankó Zoltán: Új képzési és kimeneti követelmények a gyógyszerészképzésben – GYOGAI 60. 673-678. 2016.”]
Irodalom
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Takács-Novák K., Hankó Z.: New funding and output requirements for education in pharmacy
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Hírek
Kórházi Gyógyszerészi Szimpózium; Balatonfüred, 2016. szeptember 29.-október 1. – Brantner-Lárencz Emléknap a Pécsi Tudományegyetem Gyógyszerésztudományi Karán – FIP World Congress 2016, Buenos Aires, Argentina – Folyamatos filmbevonás: A Gyógyszeripari Szervezet szakmai délutánja a Meditop Kft-vel – Húszéves a Gyógyszer-nagykereskedők Szövetsége – XVI. Román Nemzeti Gyógyszerészkongresszus; Bukarest, 2016. szeptember 28.-október 1. – Hírek Szegedről – Molnár Borbála PhD védése – In Memoriam
Tallózó
{tab Távoktatási cikkek}
Kúsz Norbert: Podophyllum peltatum – podofillotoxin
{/tabs}