18 Near-Infrared Spectroscopy in the Pharmaceutical Industry
409
quantitative and qualitative methods as much of the variance has to be captured by
the model prior to validation to avoid repeated method updates. Other techniques (i.e.,
Raman and Infrared spectroscopy) are also complementing and sometimes replacing
NIRS when better suited. Nevertheless, its flexibility of implementation, hardware
ruggedness, and wide range of applicability make it a tool of choice for process
understanding, monitoring, and control.
References
1. E.W. Ciurczak, Uses of near-infrared spectroscopy in pharmaceutical analysis. Appl. Spectros.
Rev. 23(1–2), 147–163 (1987)
2. USFDA, PAT—A framework for innovative pharmaceutical development, manufacturing, and
quality assurance, 2004
3. A. Chanda, A.M. Daly, D.A. Foley, M.A. Lapack, S. Mukherjee, J.D. Orr, G.L. Reid, D.R.
Thompson, H.W. Ward, Industry perspectives on process analytical technology: Tools and
applications in API development. Org. Process Res. Dev. 19(1), 63–83 (2015)
4. L.L. Simon, H. Pataki, G. Marosi, F. Meemken, K. Hungerbühler, A. Baiker, S. Tummala, B.
Glennon, M. Kuentz, G. Steele, H.J.M. Kramer, J.W. Rydzak, Z. Chen, J. Morris, F. Kjell, R.
Singh, R. Gani, K.V. Gernaey, M. Louhi-Kultanen, J. Oreilly, N. Sandler, O. Antikainen, J.
Yliruusi, P. Frohberg, J. Ulrich, R.D. Braatz, T. Leyssens, M. Von Stosch, R. Oliveira, R.B.H.
Tan, H. Wu, M. Khan, D. Ogrady, A. Pandey, R. Westra, E. Delle-Case, D. Pape, D. Angelosante,
Y. Maret, O. Steiger, M. Lenner, K. Abbou-Oucherif, Z.K. Nagy, J.D. Litster, V.K. Kamaraju,
M.S. Chiu, Assessment of recent process analytical technology (PAT) trends: a multiauthor
review. Org. Process Res. Dev. 19(1), 3–62 (2015)
5. E. Ciurczak, B. Igne, Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy
(CRC Press, Boca Raton, 2015)
6. C.C. Corredor, D. Bu, G. McGeorge, Chapter 9—Applications of MVDA and PAT for drug
product development and manufacturing, in Multivariate Analysis in the Pharmaceutical
Industry, ed. by A.P. Ferreira, J.C. Menezes, M. Tobyn (Academic Press, 2018), pp. 211–234
7. B. Igne, R.W. Bondi, C. Airiau, Chapter 8—Multivariate data analysis for enhancing process
understanding, monitoring, and control—active pharmaceutical ingredient manufacturing case
studies, in Multivariate Analysis in the Pharmaceutical Industry, ed. by A.P. Ferreira, J.C.
Menezes, M. Tobyn (Academic Press, 2018), pp. 185–210
8. ICH, Points to Consider for ICH Q8/Q9/Q10 Implementation. 2011
9. ICH, Validation of Analytical Procedures Q2(R1). 1996
10. G.E. Ritchie, R.W. Roller, E.W. Ciurczak, H. Mark, C. Tso, S.A. MacDonald, Validation of
a near-infrared transmission spectroscopic procedure: part B: application to alternate content
uniformity and release assay methods for pharmaceutical solid dosage forms. J. Pharm. Biomed.
Anal. 29(1–2), 159–171 (2002)
11. F. De Leersnyder, E. Peeters, H. Djalabi, V. Vanhoorne, B. Van Snick, K. Hong, S. Hammond,
A.Y. Liu, E. Ziemons, C. Vervaet, T. De Beer, Development and validation of an in-line NIR
spectroscopic method for continuous blend potency determination in the feed frame of a tablet
press. J. Pharm. Biomed. Anal. 151, 274–283 (2018)
12. G.L. Reid, J. Morgado, K. Barnett, B. Harrington, J. Wang, J. Harwood, D. Fortin, Analytical
quality by design (AQbD) in pharmaceutical development. Am. Pharm. Rev. 2013
13. American Society for Testing and Materials, E2476–16—Guide for risk assessment and
risk control as it impacts the design, development, and operation of PAT processes for
pharmaceutical manufacture. 2016
14. United States Pharmacopoeia, USP 1119—Near-infrared spectrophotometry. 2003
409
quantitative and qualitative methods as much of the variance has to be captured by
the model prior to validation to avoid repeated method updates. Other techniques (i.e.,
Raman and Infrared spectroscopy) are also complementing and sometimes replacing
NIRS when better suited. Nevertheless, its flexibility of implementation, hardware
ruggedness, and wide range of applicability make it a tool of choice for process
understanding, monitoring, and control.
References
1. E.W. Ciurczak, Uses of near-infrared spectroscopy in pharmaceutical analysis. Appl. Spectros.
Rev. 23(1–2), 147–163 (1987)
2. USFDA, PAT—A framework for innovative pharmaceutical development, manufacturing, and
quality assurance, 2004
3. A. Chanda, A.M. Daly, D.A. Foley, M.A. Lapack, S. Mukherjee, J.D. Orr, G.L. Reid, D.R.
Thompson, H.W. Ward, Industry perspectives on process analytical technology: Tools and
applications in API development. Org. Process Res. Dev. 19(1), 63–83 (2015)
4. L.L. Simon, H. Pataki, G. Marosi, F. Meemken, K. Hungerbühler, A. Baiker, S. Tummala, B.
Glennon, M. Kuentz, G. Steele, H.J.M. Kramer, J.W. Rydzak, Z. Chen, J. Morris, F. Kjell, R.
Singh, R. Gani, K.V. Gernaey, M. Louhi-Kultanen, J. Oreilly, N. Sandler, O. Antikainen, J.
Yliruusi, P. Frohberg, J. Ulrich, R.D. Braatz, T. Leyssens, M. Von Stosch, R. Oliveira, R.B.H.
Tan, H. Wu, M. Khan, D. Ogrady, A. Pandey, R. Westra, E. Delle-Case, D. Pape, D. Angelosante,
Y. Maret, O. Steiger, M. Lenner, K. Abbou-Oucherif, Z.K. Nagy, J.D. Litster, V.K. Kamaraju,
M.S. Chiu, Assessment of recent process analytical technology (PAT) trends: a multiauthor
review. Org. Process Res. Dev. 19(1), 3–62 (2015)
5. E. Ciurczak, B. Igne, Pharmaceutical and Medical Applications of Near-Infrared Spectroscopy
(CRC Press, Boca Raton, 2015)
6. C.C. Corredor, D. Bu, G. McGeorge, Chapter 9—Applications of MVDA and PAT for drug
product development and manufacturing, in Multivariate Analysis in the Pharmaceutical
Industry, ed. by A.P. Ferreira, J.C. Menezes, M. Tobyn (Academic Press, 2018), pp. 211–234
7. B. Igne, R.W. Bondi, C. Airiau, Chapter 8—Multivariate data analysis for enhancing process
understanding, monitoring, and control—active pharmaceutical ingredient manufacturing case
studies, in Multivariate Analysis in the Pharmaceutical Industry, ed. by A.P. Ferreira, J.C.
Menezes, M. Tobyn (Academic Press, 2018), pp. 185–210
8. ICH, Points to Consider for ICH Q8/Q9/Q10 Implementation. 2011
9. ICH, Validation of Analytical Procedures Q2(R1). 1996
10. G.E. Ritchie, R.W. Roller, E.W. Ciurczak, H. Mark, C. Tso, S.A. MacDonald, Validation of
a near-infrared transmission spectroscopic procedure: part B: application to alternate content
uniformity and release assay methods for pharmaceutical solid dosage forms. J. Pharm. Biomed.
Anal. 29(1–2), 159–171 (2002)
11. F. De Leersnyder, E. Peeters, H. Djalabi, V. Vanhoorne, B. Van Snick, K. Hong, S. Hammond,
A.Y. Liu, E. Ziemons, C. Vervaet, T. De Beer, Development and validation of an in-line NIR
spectroscopic method for continuous blend potency determination in the feed frame of a tablet
press. J. Pharm. Biomed. Anal. 151, 274–283 (2018)
12. G.L. Reid, J. Morgado, K. Barnett, B. Harrington, J. Wang, J. Harwood, D. Fortin, Analytical
quality by design (AQbD) in pharmaceutical development. Am. Pharm. Rev. 2013
13. American Society for Testing and Materials, E2476–16—Guide for risk assessment and
risk control as it impacts the design, development, and operation of PAT processes for
pharmaceutical manufacture. 2016
14. United States Pharmacopoeia, USP 1119—Near-infrared spectrophotometry. 2003