Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment
Abstract
Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbDbased submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especia...lly regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented.
Keywords:
Quality by design / Mathematical modeling / Design space / Control strategy / Pharmaceutical manufacturing / Real-time releaseSource:
International Journal of Pharmaceutics, 2017, 533, 2, 346-356Publisher:
- Elsevier Science BV, Amsterdam
Funding / projects:
DOI: 10.1016/j.ijpharm.2017.05.070
ISSN: 0378-5173
PubMed: 28579542
WoS: 000414188500004
Scopus: 2-s2.0-85020452915
Collections
Institution/Community
PharmacyTY - JOUR AU - Đuriš, Jelena AU - Đurić, Zorica PY - 2017 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2884 AB - Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbDbased submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented. PB - Elsevier Science BV, Amsterdam T2 - International Journal of Pharmaceutics T1 - Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment VL - 533 IS - 2 SP - 346 EP - 356 DO - 10.1016/j.ijpharm.2017.05.070 ER -
@article{ author = "Đuriš, Jelena and Đurić, Zorica", year = "2017", abstract = "Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbDbased submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented.", publisher = "Elsevier Science BV, Amsterdam", journal = "International Journal of Pharmaceutics", title = "Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment", volume = "533", number = "2", pages = "346-356", doi = "10.1016/j.ijpharm.2017.05.070" }
Đuriš, J.,& Đurić, Z.. (2017). Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment. in International Journal of Pharmaceutics Elsevier Science BV, Amsterdam., 533(2), 346-356. https://doi.org/10.1016/j.ijpharm.2017.05.070
Đuriš J, Đurić Z. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment. in International Journal of Pharmaceutics. 2017;533(2):346-356. doi:10.1016/j.ijpharm.2017.05.070 .
Đuriš, Jelena, Đurić, Zorica, "Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment" in International Journal of Pharmaceutics, 533, no. 2 (2017):346-356, https://doi.org/10.1016/j.ijpharm.2017.05.070 . .