Application of near infrared conformance trending for material quality, container consistency and minimisation of process risk

Journal of Near Infrared Spectroscopy

Volumn 22, Issue 3, 2014, Pages 169-178

  Grout, Bronwyn ^a  

^a PFIZER INC   (United States)

Author keywords

Material conformance; Near infrared spectroscopy; Pharmaceutical industry; Process analytical technology; Qualification

Indexed keywords

CHEMICAL ANALYSIS; NEAR INFRARED SPECTROSCOPY; PRINCIPAL COMPONENT ANALYSIS; PRODUCT DESIGN; QUALITY CONTROL;

ACTIVE PHARMACEUTICAL INGREDIENTS; MATERIAL QUALIFICATION; PHARMACEUTICAL INDUSTRY; PHARMACEUTICAL MANUFACTURING PROCESS; PHARMACEUTICAL PROCESS; PROCESS ANALYTICAL TECHNOLOGY; QUALIFICATION; STATISTICAL PROCESSING;

INFRARED DEVICES;

EID: 84907187477     PISSN: 09670335     EISSN: 17516552     Source Type: Journal    
DOI: 10.1255/jnirs.1118     Document Type: Article

References (13)

1. US Food and Drug Administration, Process Analytical Technology. US Food and Drug Administration, Rockville, MD (2004).
2. W. Plugge and C. Van Der Vlies, "Near-infrared spectroscopy as a tool to improve quality", J. Pharm. Biomed. Anal., 14, 891-898 (1996). doi: http://dx.doi.org/10.1016/S0731-7085(96)01782-7
3. K.A. Bakeev (Ed.), Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries. John Wiley & Sons, Chichester (2010). doi: http://dx.doi.org/10.1002/9780470689592
4. M. Jamrogiewicz, "Application of the near-infrared spectroscopy in the pharmaceutical technology", J. Pharm. Biomed. Anal. 66, 1-10 (2012). doi: http://dx.doi.org/10.1016/j.jpba.2012.03.009
5. M. Blanco and M.A. Romero, "Near-infrared libraries in the pharmaceutical industry: a solution for identity confirmation", Analyst 126, 2212-2217 (2001). doi: http://dx.doi.org/10.1039/b105012p
6. Y. Roggo, "A review of near infrared spectroscopy and chemometrics in pharmaceutical technologies", J. Pharm. Biomed. Anal. 44, 683-700 (2007). doi: http://dx.doi.org/10.1016/j.jpba.2007.03.023
7. G. Reich, "Near-infrared spectroscopy and imaging: Basic principles and pharmaceutical applications", Adv Drug Deliv. Rev. 57, 1109-1143 (2005). doi: http://dx.doi.org/10.1016/j.addr.2005.01.020
8. J. Luypaert, D.L. Massart and Y. Vander Heyden, "Nearinfrared spectroscopy applications in pharmaceutical analysis", Talanta 72, 865-883 (2007). doi: http://dx.doi.org/10.1016/j.talanta.2006.12.023
9. P. Chalus, Y. Roggo, S. Walter and M. Ulmschneider, "Near-infrared determination of active substance content in intact low-dosage tablets", Talanta 66, 1294-1302 (2005). doi: http://dx.doi.org/10.1016/j.talanta.2005.01.051
10. N. Chieng, T. Rades and J. Aaltonen, "An overview of recent studies on the analysis of pharmaceutical polymorphs", J. Pharm. Biomed. Anal. 55, 618-644 (2011). doi: http://dx.doi.org/10.1016/j.jpba.2010.12.020
11. B. Swarbrick, B. Grout and J. Noss, "The rapid, at-line determination of starch content in sucrose-starch blends using near-infrared reflectance spectroscopy; a process analytical technology initiative", J. Near Infrared Spectrosc. 13, 1-8 (2005). doi: http://dx.doi.org/10.1255/jnirs.451
12. J.A. Lopes, P.F. Costa, T.P. Alves and J.C. Menezes, "Chemometrics in bioprocess engineering: process analytical technology (PAT) applications", Chemometr. Intell. Lab. Syst. 74, 269-275 (2004). doi: http://dx.doi.org/10.1016/j.chemolab.2004.07.006
13. R.V. Haware, I. Tho and A. Bauer-Brandl, "Multivariate analysis of relationships between material properties, process parameters and tablet tensile strength for a-lactose monohydrates", Eur. J. Pharm. Biopharm. 73, 424-431 (2009). doi: http://dx.doi.org/10.1016/j.ejpb.2009.08.005