PHARMACEUTICAL QUALITY ASSURANCE
QUALITY and EXCELLENCE
Pharmaceutical Quality Management Systems (QMSs) are comprehensive systems including the control of every „corner”, every little detail of the production.
Current Good Manufacturing Practice (cGMP) rules are the collection of recommendations that oblige the producers – by the force of law! – to take proactive steps in order to maintain consumers’ safety. That means GMP is aimed primarily to reduce the risk inherent in any pharmaceutical production by assuring that the product is free from cross-contamination or any hazardous error of the production. Thus, cGMP is the part of QA activities in order to ensure that products are consistently produced and controlled to the quality standards and are appropriate to their intended use as required by the drug regulatory authorities. Validation is a tool of QA.
In the recent decade I specialized myself for quality assurance problems of the pharmaceutical industry. My main speciality is process and cleaning validation in the production of Active Pharmaceutical Ingredients (APIs), and the application of Quality Risk Management, with special emphasis on the risk assessment of possible cross-contamination.
Pharmaceutical Quality Assurance (QA), in general, is the complex entirety of all activities, arrangements and responsibilities required to ensure that the medicine reaching the patients is safe, effective and of standard quality. In the industrial practice, QA is a wide-ranging-concept covering all factors those individually or collectively influences the final quality of any product.
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Invited lecture in 2020:
2nd Annual Highly Potent APIs Summit
was held in Prague, Czech Republic on 19th-21st February, 2020. (Qepler)
was held in Novotel Praha Wenceslas Square Hotel. A presentaion was given as an invited lecture. entitled "Mitigation of cross contamination risk" by Ildikó Ziegler. This was the first invited lecture that I presented as a member of Vanessa Research.
Highly Potent APIs Summit
was held in Berlin, Germany on 20th-21st February, 2019. (Qepler)
in Hotel Riu Plaza Berlin. Lecture was presented entitled "Risk-based handling of highly potent APIs: cross-contamination and transportation parameters" as an invited speach by Ildikó Ziegler, B. Lugosi-Czangár, A. Balázs, B. Luczek, Z. Szabó.
SMi's 3rd Annual Highly Potent Active Pharmaceutical Ingredients
was organized in London, United Kingdom, 13th and 14th May, 2019. (SMi Group)
in Copthorne Tara Kensington Hotel. Another - hopefully informative - presentation was shown entitled "Risk-based handling of highly potent APIs: cross-contamination and transportation parameters" by Ildikó Ziegler, B. Lugosi-Czangár, A. Balázs, B. Luczek, Z. Szabó.
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Invited lectures in 2019:
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Invited lectures in 2018:
4th Annual Highly Potent Active Pharmaceutical Ingredients
was organized in Milan, Italy, 17th-19th October, 2018. (Vonlanthen Group)
in Leonardo Hotel Milan City Center. Our invited lecture on the following topic was presented: "Cross contamination risk assessment in parenteral product and HPAPI manufacturing" by Ildikó Ziegler, B. Lugosi-Czangár, A. Balázs, A. Boda-Szécsi, Cs. Bálint.
6th Annual HPAPI Congress
- as annually - took place in Basel, Switzerland on 30th-31st October, 2018.
in Congress Center, Basel. This broad-scaled event hosted the presentation entitled "Pre-reconstruction in an API pilot plant based on containment/ cross contamination risk evaluation" by Ildikó Ziegler, Ivonn Schenker, Zoltán A. Barna, Attila Baráth, Gábor Feczkó as an invited lecture.
2nd Annual High potent Medicines Conference
was held in Frankfurt, Germany on 29th and 30th May, 2018. (MarketsandMarkets)
in Dorint Main Taunus Zentrum Hotel Frankfurt /Sulzbach. As an invited lecture the following speach was presented, entitled "Cross contamination risk at production areas for active substances exhibiting hormonal activity" by Ildikó Ziegler, István Szabó, Gábor Szabó and Beáta Lugosi-Czangár.
Cleanroom Technology Summit and Exhibition
took place in Prague, Czech Republic, 26-
27th Febr., 2018. (Curtis & Wyss Group)
in Majestic Plaza Hotel. As an invited lecture the following presentation was shown, entitled "Quality risk evaluation in clean rooms: cross-contamination and environmental monitoring" by Ildikó Ziegler, Beáta Lugosi-Czangár and Réka Judit Kovács.
SMi's 2nd Highly Potent Active Pharmaceutical Ingredients
was organized in London, United Kingdom, 21st and 22nd May, 2018. (SMi Group)
in Holiday Inn Kensington Forum Hotel. As an invited lecture the following topic was presented, entitled "Pre-reconstruction risk evaluation for an active substance development pilot plant: a cross-contamination / containment assessment" by Ildikó Ziegler, Ivonn Schenker, Zoltán A. Barna, Attila Baráth and Gábor Feczkó.
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Invited lectures in 2017:
Aseptic Processing Summit
was organized in Berlin, Germany on 24th-25th October, 2017. (Vonlanthen Group)
in Crowne Plaza Berlin City Centre. As an invited speaker the following lecture was presented, entitled "Cross contamination risk assessment in aseptic manufacturing" by Ildikó Ziegler, Anikó Boda-Szécsi, Andrea Nagy, Csilla Bálint and Lajos Klein.
Pharma Congress Production & Technology 2017
was held in Düsseldorf, Germany on 28th and 29th March, 2017.
in Swissôtel Hotel /Neuss. As an invited lecture the following speach was presented, entitled "Case Study Gedeon Richter: Toxicology-based risk assessment program for the evaluation of possible cross-contamination" by Ildikó Ziegler, Anikó Boda-Szécsi, Csilla Bálint and Kitti Petrezselyem.
5th Annual HPAPI Congress
took place in Basel, Switzerland on 1st-2nd November, 2017.
in Congress Center, Basel. Ildikó presented the invited lecture entitled "Evaluation of cross contamination risk in shared facilities: case studies on steroid hormone API endproducts and cytotoxic drugs" by Ildikó Ziegler, Anikó Szécsi-Boda, Gyöngyvér Kovács, Éva Bánszegi and Csilla Bálint.
SMi's 1st Highly Potent Active Pharmaceutical Ingredients
took place in London, United Kingdom, 22nd and 23rd May, 2017.
in Copthorne Tara Kensington Hotel. Ildikó served as a chairperson and the lecture, "Cross contamination risk assessment in multi-product facilities: case studies on steroid hormones and cytotoxic products" by Ildikó Ziegler, Anikó Szécsi-Boda, Gábor Szabó, Beáta Lugosi-Czangár, Éva Bánszegi and Csilla Bálint was presented.
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The 11th Annual Quality & OpEx in Pharma & Biotech Conference
was held in Barcelona, Spain on 5th and 6th November, 2015
in the Barceló Atenea Mar Hotel. As an invited lecture the following speach was presented, entitled "Cross-contamination in the focus: toxicology-based risk identification" by Ildikó Ziegler, Beáta Lugosi-Czangár, Anikó Boda-Szécsi and Eszter Mecsnóbel.
To download the slides, please, click here:
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My publications concerning pharmaceutical quality assurance are listed below:
I. Book chapters:
1. MOHAMMEDNÉ ZIEGLER ILDIKÓ: A kvalifikálás és a validálás helye a gyógyszeripari minőségbiztosításban, valamint ezek kockázatkezelési szempontjai (6.3.6. fejezet) / Role of qualification and validation in pharmaceutical quality assurance and the aspects of their risk management (Chapt. 6.3.6.), in Róth A. (Ed): A minőségfejlesztés új útjai / New ways of the development of quality (gyűrűskönyv), 18. aktualizálás, Verlag Dashöfer Kft., Budapest, July 2012, pp. 1-48. (ISBN szám: ISSN 2060-016X) (in Hungarian).
2. ZIEGLER I., LUGOSI-CZANGÁR B.: A practical approach to chemical cleaning validation planing of active pharmaceutical ingredients: establishing a safe cleaning limit – present and future in ZIEGLER I., FEJES I. (Eds) Bilingual lecturebook on spectroscopy - on the 80th birthday of professor Dr. Ferenc Billes, Esztergom: private edition, June 2014. pp. 47-56. (ISBN: 978-963-08-9474-6).
For the (almost) full text of this book go to :
3. ZIEGLER I.: Szintézisreakció optimalizálása ipari méretben folyamatvalidálás életciklus-modellje és a tervezett minőség közötti kapcsolat / Optimization of a synthesis reaction in industrial scale based on the QbD approach, in ZIEGLER I., FEJES I. (Eds) Bilingual lecturebook on spectroscopy - on the 80th birthday of professor Dr. Ferenc Billes, Esztergom: private edition, June 2014. pp. 133-148. (ISBN: 978-963-08-9474-6), (in Hungarian).
II. Articles:
1. MOHAMMED-ZIEGLER I., MEDGYESI I.: Increased Importance of Documented Development Stage in Process Validation, Saudi Pharm. J., 20(3), 283-285 (2012). to see the manuscript...
2. MOHAMMED-ZIEGLER I., STEFF I., HALMAI-VARÉNYI, M.: Importance of Quality Risk Management in Pharmaceutical Quality System: Recent Trends and Harmonization, Saudi Pharm. J. (in press) (2014). to see the (in press) manuscript ...
3. ZIEGLER I., BORBÉLY-JAKAB J., SUGÓ L., KOVÁCS R. J.: Revision of Viable Environmental Monitoring in a Development Pilot Plant based on Quality Risk Assessment: A Case Study, PDA J. Pharm. Sci. Technol., 71(3), 234-244 (2017).
4. ZIEGLER I.: Gyártói minőségbiztosítási feladatok készítménygyártás esetén I. rész (Pharmaceutical quality system requirements for the manufacturers of medicinal products, Part I.) (továbbképző közlemény/ educational publication), Gyógyszerészet, 61(5), 259-265 (2017). (in Hungarian)
5. ZIEGLER I.: Gyártói minőségbiztosítási feladatok készítménygyártás esetén II. rész (Pharmaceutical quality system requirements for the manufacturers of medicinal products, Part II.) (továbbképző közlemény/ educational publication), Gyógyszerészet, 61(6), 331-335 (2017). (in Hungarian)
III. Proceedings:
1. MOHAMMED-ZIEGLER , I., WINKLER, R., KREITNER-KÜTSÖN, K.: Separation of a Salt Type Drug Molecule from its Structural Isomer and Oxidation Product by OPLC, Planar Chromatography 2004, Visegrád, (Eds. Sz. Nyiredy, A. Kakuk, Res. Inst. for Medical Plants, Budakalász) 2004, p. 465.
2. ZIEGLER I., CSIPOR I., BILLES F.: A NIR spektroszkópia európai szabályozásának változásai és gyakorlati alkalmazásának lehetőségei (Changes of the European regulations of NIR spectroscopic methods and some applications), Richter Innovációs Tudásalap (RITA) pályázat , Oct. 11(09), 2012, p. 1-9. (RITA elismeréssel jutalmazott pályázati alkotás) (RITA Certificate (lowest level of RITA Award) (in Hungarian).
3. ZIEGLER I., TUZA ZS., HALMAINÉ VARÉNYI M.: Az európai minőségügyi szabályozások aktuális változásai – a kiválóság kihívása (Actual changes of the European quality regulations - the challenge of excellence), Richter Innovációs Tudásalap (RITA) pályázat, Oct. 11(10), 2012, p. 1-9. (RITA elismeréssel jutalmazott pályázati alkotás) (RITA Certificate (lowest level of RITA Award) (in Hungarian).
4. ZIEGLER I., ZAJÁCZ M., ERDŐS E.: A felszabadítás és a meghatalmazott személy felelőssége a változó európai szabályozások tükrében (Batch release and the responsibility of the Qualified Person in the light of the changing European regulations), Richter Innovációs Tudásalap (RITA) pályázat, Sept. 10, 2013, p. 1-10. (RITA elismeréssel jutalmazott pályázati alkotás) (RITA elismeréssel jutalmazott pályázati alkotás) (RITA Certificate (lowest level of RITA Award) (in Hungarian).
5. ZIEGLER I., VÁNDOR K.: Különböző vízminőségek gyógyszerkönyvi specifikációi (Pharmacopoeial specifications for water of different qualities), I. Vízkémiai és Technológiai Konferencia és 57. Magyar Spektrokémiai Vándorgyűlés (First Conference on Water Chemistry and Technology and the 57th Hungarian Annual Meeting on Spectrochemistry), Veszprém, Pannon Egyetem (Pannon University), (Ed: B. Zsirka) July 7-9, 2014, Paper MM4. (ISBN:978-963-396-011-0) (in Hungarian).
6. ZIEGLER I.: Várható változások spektroszkópiai mérések területén (Expected changes in the field of spectroscopic measurements), GMP-hírlevél(GMP Newsletter), published by Quality Management Directorate of Gedeon Richter Plc, (Ed.: Diána Lantos) 2(6), 8-10, 2014 (in Hungarian).
IV. Oral presentations:
1. MOHAMMEDNÉ ZIEGLER I.: Ipari nyersanyagok minősítésének gyorsítása: 1,2,4-triazol-nátrium nedvességtartalmának meghatározása NIR spektroszkópiával (Acceleration of the testing of raw materials: determination of the humidity of 1,2,4-triazolyl sodium), 49. Magyar Spektrokémiai Vándorgyűlés (49th Hungarian Annual Meeting on Spectrochemistry), Miskolc, MKE (Hungarian Chemical Sociaty) (Ed.: G. Galbács) July 10-12, 2006, p. 73. (in Hungarian, oral).
2. MOHAMMEDNÉ ZIEGLER I., BERTHÁNÉ SOMODI ZS., VARGA Z.: A Spironolakton polimorfiája (Polymorphysm of Spironolactone), Molekulaspektroszkópiai Ankét Billes Ferenc professzor 75. születésnapja alkalmából (Molecular Spectroscopic Symposium on the 75th birthday of professor Dr. Ferenc Billes), Budapest, 11th Dec., 2009 (in Hungarian, oral).
3. MOHAMMEDNÉ ZIEGLER I.: NIR spektroszkópiai módszerek alkalmazása és validálása a gyógyszeriparban - a módszer validásának európai szabályozása (Application and validation of NIR spectroscopic methods in the pharmaceutical industry - European regulation of method validation), Vegyészkonferencia 2010 és 53. Magyar Spektrokémiai Vándorgyűlés (Chemical Conference 2010 and 53rd Hungarian Annual Meeting on Spectrochemistry), Hajdúszoboszló, MKE (Hungarian Chemical Sociaty), June 30 – July 2, 2010 (O-54, oral) (in Hungarian, oral).
4. ZIEGLER I., TÓTH ZS., MAGYARI P.: Tisztítási eljárás detergensek felhasználásával: környezetvédelmi szempontok, analitikai kontrol és tisztításvalidálás (Cleaning procedure using detergents: environmental aspects, analytical control and cleaning validation), “Mobilitás és környezet: járműipar, energetika és környezetvédelem” Konferencia és 55. Magyar Spektrokémiai Vándorgyűlés ("Mobility and Environment: Automotive,Energetics and Environmental Protection” Conference and 55th Hungarian Annual Meeting on Spectrochemistry), Veszprém, (Eds: G. Galbács, J. Kristóf) July 9-11, 2012 (oral) (in Hungarian, oral).
5. ZIEGLER I., VAD P.: Az ellátórendszerek és a környezeti monitorozás szerepe a gyógyszeripari minőségbiztosításban (Role of supply systems and environmental monitoring in pharmaceutical quality assurance), “Mobilitás és környezet: járműipar, energetika és környezetvédelem” Konferencia és 55. Magyar Spektrokémiai Vándorgyűlés ("Mobility and Environment: Automotive, Energetics and Environmental Protection” Conference and 55th Hungarian Annual Meeting on Spectrochemistry), Veszprém, (Eds: G. Galbács, J. Kristóf) July 9-11, 2012 (oral) (in Hungarian, oral).
6. ZIEGLER I., HARASZTI I.: Az infravörös spektroszkópia és a standardok szerepe a hatóanyagok minősítésében (Role of IR spectroscopy and standards in the testing of the active pharmaceutical ingredients), “Környezetbarát anyagok és technológiák" konferencia és 56. Magyar Spektrokémiai Vándorgyűlés ("Eco-friendly Materials and Technologies" Conference and 56th Hungarian Annual Meeting on Spectrochemistry), Veszprém, (Eds: G. Galbács, J. Kristóf). July 1-3, 2013 (oral) (in Hungarian, oral).
7. ZIEGLER I., VÁNDOR K.: Különböző vízminőségek gyógyszerkönyvi specifikációi (Pharmacopoeial specifications for water of different qualities), I. Vízkémiai és Technológiai Konferencia és 57. Magyar Spektrokémiai Vándorgyűlés (First Conference on Water Chemistry and Technology and the 57th Hungarian Annual Meeting on Spectrochemistry), Veszprém, Pannon Egyetem (Pannon University), (Ed: B. Zsirka) July 7-9, 2014 (oral) (in Hungarian, oral).
8. ZIEGLER I., LUGOSI-CZANGÁR B., BODA-SZÉCSI A. and MECSNÓBEL E.: Cross-contamination in the focus: toxicology-based risk identification, 11th Annual Quality & OpEx in Pharma & Biotech Conference, Barcelona, Spain, Nov. 5-6, 2015 (in English, as invited speaker, see above).
9. ZIEGLER I.: Cross-contamination risk analysis, Subsidiaries' GMP Meeting 2016, Total Quality Management Directorate of Gedeon Richter, Budapest, Febr. 23, 2016 (in English, invited oral). see more in "NEWS".
10. ZIEGLER I.: Az új toxikológiai alapú tisztítási határérték képzésére vonatkozó előírások gyakorlati vonatkozásai / Practical implications of new regulations regarding the determination of toxicology-based cleaning limit (Richter Gedeon tematika szerinti GMP oktatás / thematic GMP education of Gedeon Richter) , Total Quality Management Directorate of Gedeon Richter, Budapest, Febr. 23, 2016 (in English, invited oral). Budapest: 2016. March. 16., 30., May. 18., 25., 26., June. 10, July. 25./ Dorog: 2016. Oct. 19. (in Hungarian, oral).
V. Poster presentations:
1. ZIEGLER I., SUGO, L.: Implemetation of EMA’s new toxicology-based regulation on setting cleaning limit – some practical aspects of cross-contamination, IAQ World Quality Forum, Budapest, Oct. 26-27., 2015., P-1.
2. ZIEGLER I., BILLES F.: Evaluating the polyphenol content as quality attribute in green tea by NIR spectroscopy – selected examples, IAQ World Quality Forum, Budapest, Oct. 26-27., 2015., P-10.
3. ZIEGLER I., BILLES F.: Orientation dependence of molecule-molecule interactions between two piceatannol molecules, Athene’s Chemistry – Conference of outstanding women scientists for the 70th birthday of Magdolna Hargittai, Budapest University of Technlogy and Economics, Budapest, Nov 27., 2015., P16.
VI. Miscellanous in pharma topic:
1. ZIEGLER I.: Technológiai fejlesztések a gyógyszeriparban – és néhány érdekes adat a fejlesztésekkel összefüggésben / Technologial development in the pharma industry and some selected data (adminisztratív dolgozók GMP oktatása / GMP educational material for the administrative staff) (in Hungarian), Gedeon Richter, 23rd Nov., 2015, Dorog. To download the slides, please
2. ZIEGLER I.: Keresztszennyezés kockázatának elemzése / Analysis of the risk of cross-contamination (tréning oktatója / as instructor), Gedeon Richter-RUS, Yegoryevsk, Russia, 2nd and 3rd March, 2016. (in Hungarian with translation to Russian).
3. ZIEGLER I.: Újdonságok a törzskönyvezési szabályozásokban - Szemelvények az elmúlt évben kiadott dokumentumokból / What's new in the regulations of registration - Excerpts from documents released in the past year, (Richter Gedeon tematika szerinti GMP oktatás a Termékfejlesztési Igazgatóság részére / thematic GMP education for the Product Development Directorate of Gedeon Richter), 2016. Oct. 12. (in Hungarian, oral).
4. ZIEGLER I.: Technológiai fejlesztések a gyógyszeriparban – és egy kis kitekintés a biotechnológia felé /Technologial development in the pharma industry and an outlook to biotechnology (adminisztratív dolgozók GMP oktatása / GMP educational material for the administrative staff) (in Hungarian), Gedeon Richter, 17th Nov., 2016, Dorog.
5. ZIEGLER I.: Áttekintés a 2016-ban kiadott 483-asokról (belső anyag/ internal material) (in Hungarian), Gedeon Richter, 2nd Febr., 2017, Budapest and Dorog.
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For the full list of publications go to :
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