Genesis of SUPAC

Scale-UP and Post Approval Changes (SUPAC) is an integral part of pharmaceutical product development but till a few years ago, no guidance was available, to assure a smooth scale-up operation. US FDA was the first regulatory body to address this issue.

Any pharmaceutical product developed by R&D team has to undergo various stages of scale-up from ‘laboratory-scale’ to ‘pilot-scale’ to ‘production-scale’ before it reaches the market. Scale-up process is an inherent part of overall product development activity and by virtue of variables involved poses a challenge to the product stability and performance. This makes scale-up a very critical component, which if not handled sensitively can undo all the R&D efforts.

Russo, in 1984 discussed the factors influencing the scale up process of various dosage forms. Factors such as variability of raw material, equipment differences, wet granulation effects, and compression press differences have been analysed for their role in scale-up process. The difficulties observed during scale-up of liquid formulations (sterilisation process) and for suppositories, which are quite dependent upon suppository making machines were also enumerated.

Pondell, in 1985 analysed the process variables involved in the film coating operation. Importance of factors like variation in supply of raw material and their response to processing and variation in instrumentation type. Problems crop up during scale up because at R&D scale the product is developed using fairly standard equipment and under controlled conditions compared to production level. The ultimate success of a product, to a great extent is determined by how easily and cost-effectively it can be commercialised.