Scale-up and postapproval changes (SUPAC) guidelines for industry: A comprehensive review

Swati Pund; Mayuri Dhande; Suresh Jayatpal; Asmita Tupe; Sumit Deore; Harshal Tare

doi:10.31893/multirev.2024071

Keywords:

SUPAC

Postapproval changes

site transfer and stability

Abstract

The SUPAC approach enables either an increase or a decrease in production levels to be implemented in response to shifts in customer demand. The rules that apply to these SUPACs are different based on the regulatory agency that oversees the manufacture of the product. In this review, the rules for making USFDA SUPACs have been written out in detail. This study is being conducted with the intention of reducing the amount of time and money required to manage site migrations. More productive results, a faster deployment of tools and methods, and less time spent studying failures are all benefits of this approach. An increase in the pace of uptake, increased batch sizes, a decrease in the production of things that are not yet stable enough for commercial use, and a cost reduction for stability testing are all desirable outcomes.
References
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2. Ankit T, Shrikalp D, Maitreyi Z, Praveenkumar J, Kiran K (2021) Regulatory procedure of post approval changes and comparative requirements of EU and USA regulatory regions. Journal of Pharmaceutical Research International 33:304-317.https://doi.org/10.9734/jpri/2021/v33i46B32944
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7. Kamnoore K, Venkatesh M P, Kumar TM (2022) Study on post approval source change of active pharmaceutical ingredient in the finished product and its regulatory requirements in EU and US. The Thai Journal of Pharmaceutical Sciences 46:11-19.
8. Mali SM, Patil A, Saptal V, Phate N, Pathan F, Pawar P, Mali A (2022) An updated review on SUPAC-scale-up process and changes guidelines. Journal of Pharmaceutical Quality Assurance and Quality Control: 1-21.
9. Metry M, Polli JE (2022) Evaluation of excipient risk in BCS class I and III biowaivers. The AAPS journal 24:20. https://doi.org/10.1208/s12248-021-00670-1
10. Mounica NVN, Sharmila Reddy V, Anusha S, Evangeline L, Nagabhushanam MV, Nagarjunareddy D, Brahmaiah B (2017) Scale up and post approval changes (SUPAC) guidance for industry: a regulatory note. International Journal of Drug Regulatory Affairs 5:13-9.https://doi.org/10.22270/ijdra.v5i1.192
11. Mustafa G, Mujtaba MA, Kotta S, Habeeballah A, Alhakamy NA, Aldawsari HM, Md, S (2022) Drug product performance and scale-up process approval changes. In Regulatory Affairs in the Pharmaceutical Industry Academic Press:215-240.
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13. Sherman R (2015) Technology & product architectures. Business Intelligence Guidebook 143-169. https://doi.org/10.1016/B978-0-12-411461-6.00007-1
14. Vásquez AGT (2021) Risk based approach of postapproval changes in central America and Dominican republic, identifying opportunities for convergence with EMA and FDA.
15. Wu D, Sanghavi M, Kollipara S, Ahmed T, Saini AK, Heimbach T (2023) Physiologically based pharmacokinetics modelling in biopharmaceutics: case studies for establishing the bioequivalence safe space for innovator and generic drugs. Pharmaceutical Research 40:337-357. https://doi.org/10.1007/s11095-022-03319-6
16. Xiaowen L, Zhe H (2023) Present situation and enlightenment of postapproval change management of drugs in China, USA and EU 18:17-23.

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

How to cite

Pund, S., Dhande, M., Jayatpal, S., Tupe, A., Deore, S., & Tare, H. (2024). Scale-up and postapproval changes (SUPAC) guidelines for industry: A comprehensive review. Multidisciplinary Reviews, 7(4), 2024071. https://doi.org/10.31893/multirev.2024071

[1] Ahmed P (2022) A current review on pilot plant scale up techniques: focus on supac (scale up and post approval changes). J.Xi'anShiyou Uni 18:575-600.

[2] Ankit T, Shrikalp D, Maitreyi Z, Praveenkumar J, Kiran K (2021) Regulatory procedure of post approval changes and comparative requirements of EU and USA regulatory regions. Journal of Pharmaceutical Research International 33:304-317.https://doi.org/10.9734/jpri/2021/v33i46B32944

[3] Chowdhary Y, Kumar B (2023) SUPAC-Post approval changes suggested by FDA to industry. Asian Journal of Research in Pharmaceutical Science 13. https://doi.org/10.52711/2231-5659.2023.00005

[4] Dhobale A, Mahale A M, Shirsat M, Pethkar S, Chakote V (2018) Recent advances in pilot plant scale up techniques-a review. Indo Am J Pharm Res 8:1060-1068

[5] Jereb R, Kristl A, Mitra A (2020) Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modelling (PBBM). European Journal of Pharmaceutical Sciences 155:105554.

[6] https://doi.org/10.1016/j.ejps.2020.105554

[7] Kamnoore K, Venkatesh M P, Kumar TM (2022) Study on post approval source change of active pharmaceutical ingredient in the finished product and its regulatory requirements in EU and US. The Thai Journal of Pharmaceutical Sciences 46:11-19.

[8] Mali SM, Patil A, Saptal V, Phate N, Pathan F, Pawar P, Mali A (2022) An updated review on SUPAC-scale-up process and changes guidelines. Journal of Pharmaceutical Quality Assurance and Quality Control: 1-21.

[9] Metry M, Polli JE (2022) Evaluation of excipient risk in BCS class I and III biowaivers. The AAPS journal 24:20. https://doi.org/10.1208/s12248-021-00670-1

[10] Mounica NVN, Sharmila Reddy V, Anusha S, Evangeline L, Nagabhushanam MV, Nagarjunareddy D, Brahmaiah B (2017) Scale up and post approval changes (SUPAC) guidance for industry: a regulatory note. International Journal of Drug Regulatory Affairs 5:13-9.https://doi.org/10.22270/ijdra.v5i1.192

[11] Mustafa G, Mujtaba MA, Kotta S, Habeeballah A, Alhakamy NA, Aldawsari HM, Md, S (2022) Drug product performance and scale-up process approval changes. In Regulatory Affairs in the Pharmaceutical Industry Academic Press:215-240.

[12] https://doi.org/10.1016/B978-0-12-822211-9.00010-1

[13] Sherman R (2015) Technology & product architectures. Business Intelligence Guidebook 143-169. https://doi.org/10.1016/B978-0-12-411461-6.00007-1

[14] Vásquez AGT (2021) Risk based approach of postapproval changes in central America and Dominican republic, identifying opportunities for convergence with EMA and FDA.

[15] Wu D, Sanghavi M, Kollipara S, Ahmed T, Saini AK, Heimbach T (2023) Physiologically based pharmacokinetics modelling in biopharmaceutics: case studies for establishing the bioequivalence safe space for innovator and generic drugs. Pharmaceutical Research 40:337-357. https://doi.org/10.1007/s11095-022-03319-6

[16] Xiaowen L, Zhe H (2023) Present situation and enlightenment of postapproval change management of drugs in China, USA and EU 18:17-23.

Abstract

References

How to cite