Analytical Quality by Design; Design Space; Method Operable Design Region (MODR); Risk management; Pharmaceutical impurities; Separative analytical techniques
Abstract :
[en] The pharmaceutical industry is highly regulated by quality policies. The concept of risk management is strongly integrated into the quality assurance system to ensure pharmaceuticals’ quality and patients’ safety. In the context of quality control, the detection of impurities in raw materials and finished products is a major concern. It can be challenging for analytical scientists to meet specificity/selectivity and sensitivity requirements. Obviously, separation techniques are widely used for the detection of impurities but the method development required to achieve Analytical Target Profile (ATP) concerns is often challenging. Therefore, to ensure pragmatic and systematic methods development and simultaneously manage the risk associated with analytical methods, the principles of Quality by Design (QbD) should be applied. This paper provides an overview of QbD principles and statistical strategies (mainly DoE-DS approach) which can be applied to impurity detection methods, as well as a review of the literature where QbD has been applied to these types of analytical methods.
Research center :
CIRM - Centre Interdisciplinaire de Recherche sur le Médicament - ULiège
Disciplines :
Pharmacy, pharmacology & toxicology Chemistry
Author, co-author :
Dispas, Amandine ; Université de Liège - ULiège > Département de pharmacie > Analyse des médicaments
Avohou, Tonakpon Hermane ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Hubert, Cédric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Language :
English
Title :
‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances
Publication date :
April 2018
Journal title :
TrAC: Trends in Analytical Chemistry
ISSN :
0165-9936
eISSN :
1879-3142
Publisher :
Elsevier Science, London, United Kingdom
Special issue title :
The Last Decade in Regulation and Control of Impurities in Pharmaceuticals
Volume :
101
Pages :
24-33
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
FEDER - Fonds Européen de Développement Régional [BE] DGTRE - Région wallonne. Direction générale des Technologies, de la Recherche et de l'Énergie [BE]
Borman, P., Truman, K., Thompson, D., Nethercote, P., Chatfield, M., The application of quality by design to analytical methods. Pharm. Technol. 31:10 (2007), 142–152.
Maggio, R.M., Vignaduzzo, S.E., Kaufman, T.S., Practical and regulatory considerations for stability-indicating methods for the assay of bulk drugs and drug formulations. Trends Anal. Chem. 49 (2013), 57–70.
Hubert, C., Lebrun, P., Houari, S., Ziemons, E., Rozet, E., Hubert, Ph., Improvement of a stability-indicating method by Quality-by-Design versus Quality-by-Testing: a case of a learning process. J. Pharm. Biomed. Anal. 88 (2014), 401–409.
Peterson, J.J., A Bayesian approach to the ICH Q8 definition of design space. J. Biopharm. Stat. 18 (2008), 959–975.
U.S. Pharmacopeial Convention, New Chapter 1224, 1225, 1226, USP panel expert.
FDA, Code of Federal Regulations, Title 21, Section 211, Current Good Manufacturing Practice for Finished Pharmaceuticals (Rockville, MD, 2012).
ICH, Q10, Pharmaceutical Quality System. 2008.
EMA-FDA Pilot Program for Parallel Assessment of Quality-by-Design Applications: Lessons Learnt and Q&A Resulting from the First Parallel Assessment, 2013.
Quality by Design Approaches to Analytical Methods – FDA Perspective, 2011, AAPS.
Karmarkar, S., Garber, R., Genchanok, Y., George, S., Yang, X., Hammond, R., Quality by Design (QbD) based development of a stability indicating HPLC method for drug and impurities. J. Chromatogr. Sci. 49 (2011), 439–446.
Rafamantanana, M.H., Debrus, B., Raoelisen, G.E., Rozet, E., Lebrun, P., Uverg-Ratsimamanga, S., Hubert, Ph., Quentin-Leclercq, J., Application of design of experiments and design space methodology for the HPLC-UV separation optimization of aporphine alkaloids from leaves of Spirospermum penduliflorum Thouars. J. Pharm. Biomed. Anal. 62 (2012), 23–32.
Vogt, F.G., Kord, A.S., Development of quality-by-design analytical methods. J. Pharm. Sci. 100 (2011), 797–812.
Pohl, M., Smith, K., Schweitzer, M., Hanna-Brown, M., Larew, J., Hansen, G., Borman, P., Nethercote, P., Implications and opportunities of applying QbD principles to analytical measurements. Pharm. Tech. 34 (2010), 52–59.
Borman, P., Chatfield, M.J., Damjanov, I., Jackson, P., Method ruggedness studies incorporating a risked base approach: a tutorial. Anal. Chem. Acta 703 (2011), 101–113.
Bradley, J., Nachtsheim, C.J., A class of three-level designs for definitive screening in the presence of second-order effects. J. Qual. Technol. 43 (2011), 1–15.
Peterson, J.J., Altan, S., Overview of drug development and statistical tools for manufacturing and testing. Zhang, L., Kuhn, M., Peers, I., Altan, S., (eds.) Nonclinical Statistics for Pharmaceutical and Biotechnology Industries, 2016, Springer International Publishing AG, Cham, Switzerland, 383–414.
Goos, P., Bradley, J., Optimal Design of Experiments: a Case Study Approach. 2011, John Wiley & Sons, Chichester, United Kingdom, 287.
Del Castillo, E., Process Optimization: a Statistical Approach. 2007, Springer Science & Business Media, New York, USA, 459.
Myers, R.H., Montgomery, D.C., Anderson-Cook, C.M., Response Surface Methodology: Process and Product Optimization Using Designed Experiments. 2016, John Wiley & Sons Inc., New Jersey, USA, 825.
Peterson, J.J., Lief, K., The ICH Q8 definition of design space: a comparison of the overlapping means and the Bayesian predictive approaches. Stat. Biopharm. Res. 2 (2010), 249–259.
Lebrun, P., Boulanger, B., Debrus, B., Lambert, P., Hubert, Ph, A Bayesian design space for analytical methods based on multivariate models and predictions. J. Biopharm. Stat. 23 (2013), 1330–1351.
Furlanetto, S., Orlandini, S., Pasquani, B., Del Bubba, M., Pinzauti, S., Quality by Design approach in the development of a solvent-modified micellar electrokinetic chromatography method: finding the design space for the determination of amitriptyline and its impurities. Anal. Chim. Acta 802 (2013), 113–124.
Pasquani, B., Orlandini, S., Caprini, C., Del Bubba, M., Innocenti, M., Brusotti, G., Furlanetto, S., Cyclodextrin- and solvent-modified micellar electrokinetic chromatography for the determination of captopril hydrochlorothiazide and their impurities: a Quality by Design approach. Talanta 160 (2016), 332–339.
Orlandini, S., Pasquini, B., Gotti, R., Giuffrida, A., Paternostro, F., Furlanetto, S., Analytical quality by design in the development of a cyclodextrin-modified capillary electrophoresis method for the assay of metformin and its related substances. Electrophoresis 35 (2014), 2538–2545.
Furlanetto, S., Orlandini, S., Pasquani, B., Caprini, C., Mura, P., Pinzauti, S., Fast analysis of glibenclamide and its impurities: quality by design framework in capillary electrophoresis method development. Anal. Bioanal. Chem. 407 (2015), 7637–7646.
Orlandini, S., Pasquani, B., Stocchero, M., Pinzauti, S., Furlanetto, S., An integrated quality by design and mixture-process variable approach in the development of a capillary electrophoresis method for the analysis of almotriptan and its impurities. J. Chromatogr. A 1339 (2014), 200–209.
Orlandini, S., Pasquani, B., Caprini, C., Del Bubba, M., Pinzauti, S., Furlanetto, S., Analytical Quality by Design in pharmaceutical quality assurance: development of a capillary electrophoresis method for the analysis of zolmitriptan and its impurities. Electrophoresis 36 (2015), 2642–2649.
Orlandini, S., Pasquani, B., Caprini, C., Del Bubba, M., Squarcialupi, L., Colotta, V., Furlanetto, S., A comprehensive strategy in the development of a cyclodextrin-modified microemulsion electrokinetic chromatographic method for the assay of diclofenac and its impurities: mixture-process variable experiments and quality by design. J. Chromatogr. A 1466 (2016), 189–198.
Orlandini, S., Pasquani, B., Del Bubba, M., Pinzauti, S., Furlanetto, S., Quality by design in the chiral separation strategy for the determination of enantiomeric impurities: development of a capillary electrophoresis method based on dual cyclodextrin systems for the analysis of levosulpiride. J. Chromatogr. A 1380 (2015), 177–185.
Terzic, J., Popovic, I., Stajic, A., Tumpa, A., Jancic-Stojanovic, B., Application of Analytical Quality by Design concept for bilastine and its degradation impurities determination by hydrophilic interaction liquid chromatographic method. J. Pharm. Biomed. Anal. 125 (2016), 385–393.
Tumpa, A., Stajic, A., Jancic-Stojanovic, B., Medenica, M., Quality by Design in the development of hydrophilic interaction liquid chromatography method with gradient elution for the analysis of olanzapine. J. Pharm. Biomed. Anal. 134 (2017), 18–26.
Vemic, A., Rakic, T., Malenovic, A., Medecina, M., Chaotropic salts in liquid chromatography method development for the determination of pramipexole and its impurities following quality-by-design principles. J. Pharm. Biomed. Anal. 102 (2015), 314–320.
Pantovic, J., Malenovic, A., Vemix, A., Kostic, N., Medenica, M., Development of liquid chromatography method for the analysis of dabigatran etexilate mesilate and its ten impurities supported by quality-by-design methodology. J. Pharm. Biomed. Anal. 111 (2015), 7–13.
Patel, P.N., Karakam, V.S., Ragampeta, S., Quality-by-design based ultra high performance liquid chromatography related substances method development by establishing the proficient design space for sumatriptan and naproxen combination. J. Sep. Sci. 38 (2015), 3354–3362.
Tol, T., Kadam, N., Raotole, N., Desai, A., Samanta, G., A simultaneous determination of related substances by high performance liquid chromatography in a drug product using quality by design approach. J. Chromatogr. A 1432 (2016), 26–38.
Schmidt, A.H., Stanic, M., Molnar, I., In silico robustness testing of a compendial HPLC purity method by using a multidimensional design space build by chromatography modelling – case study pramipexole. J. Pharm. Biomed. Anal. 91 (2014), 97–107.
Kormany, R., Molnar, I., Feteke, J., Renewal of an old European Pharmacopeia method for terazosin using modelling with mass spectrometric peak tracking. J. Pharm. Biomed. Anal. 135 (2017), 8–15.
Andri, B., Lebrun, P., Dispas, A., Klinkenberg, R., Streel, B., Ziemons, E., Marini, R.D., Hubert, Ph, Optimization and validation of a fast supercritical fluid chromatography method for the quantitative determination of vitamin D3 and its related impurities. J. Chromatogr. A 1492 (2017), 171–181.
Dispas, A., Desfontaine, V., Andri, B., Lebrun, P., Kotoni, D., Clarke, A., Guillarme, D., Hubert, Ph, Quantitative determination of salbutamol sulfate using achiral supercritical fluid chromatography. J. Pharm. Biomed. Anal. 134 (2017), 170–180.
Lebrun, P., Govaerts, B., Ceccato, A., Caliaro, G., Hubert, Ph, Boulanger, B., Development of a new predictive modelling technique to find with confidence equivalence zone and design space of chromatographic analytical methods. Chemom. Intell. Lab. Syst. 91 (2008), 4–16.
Hubert, C., Houari, S., Rozet, E., Lebrun, P., Ph. Hubert, Towards a full integration of optimization and validation phases: an analytical-quality-by-design approach. J. Chromatogr. A 1395 (2015), 88–98.
Peterson, J.J., Yahyah, M., A Bayesian design space approach to robustness and system suitability for pharmaceutical assays and other processes. Stat. Biopharm. Res. 1:2009 (2009), 441–449.
Okafo, G., Laures, A., Jackson, P., Borman, P., Chatfield, M., Reduced method robustness testing of analytical methods driven by a risk-based approach. Pharm. Tech. 34 (2010), 72–86.
Hubert, Ph, Nguyen-Huu, J.J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.A., Dewé, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., Valat, L., Harmonization of strategies for the validation of quantitative analytical procedures – a SFSTP proposal – part I. J. Pharm. Biomed. Anal. 36 (2004), 579–586.
Hubert, Ph, Nguyen-Huu, J.J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.A., Dewé, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., Valat, L., Rozet, E., Harmonization of strategies for the validation of quantitative analytical procedures – a SFSTP proposal – part II. J. Pharm. Biomed. Anal. 45 (2007), 70–81.
Hubert, Ph, Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., Rozet, E., Harmonization of strategies for the validation of quantitative analytical procedures – a SFSTP proposal – part III. J. Pharm. Biomed. Anal. 45 (2007), 82–96.
Hubert, Ph, Nguyen-Huu, J.-J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P.-A., Dewé, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., Rozet, E., Harmonization of strategies for the validation of quantitative analytical procedures – a SFSTP proposal – part IV. J. Pharm. Biomed. Anal. 48 (2008), 760–771.
