Scale Up and Postapproval Changes (Supac) Guidance for Industry: A Regulatory Note

N.V.N., Mounica; V, Sharmila Reddy; Anusha, S.; L, Evangeline; Nagabhushanam, Manasa; Nagarjunareddy, D.; Brahmaiah, Bezawada

doi:10.22270/ijdra.v5i1.192

Cited by 4 publications

(1 citation statement)

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“…If a sponsor wants information on testing and application documentation for modifications that are not included in this guideline or if numerous changes are submitted concurrently or in a short period of time, they can contact the relevant CDER review division or look at other CDER guidelines. Additionally, if a sponsor requires information on changes that are not included in this guideline, they can look at other CDER guidelines (Mounica et al 2017).…”

Section: Purpose Of Supac Guidancementioning

confidence: 99%

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

Pund,

Dhande,

Jayatpal

et al. 2024

Multidiscip. Rev.

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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.

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Section: Purpose Of Supac Guidancementioning

confidence: 99%