PARAMETRIC RELEASE MODEL OF INJECTION PRODUCT X IN PHARMACEUTICAL INDUSTRY PT. XYZ

• Main Author: Martupa Bukit Leo M, Agung
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/40337
• Institution: Institut Teknologi Bandung

Parametric release is a sterility assurance release program based on effective control, monitoring, and documentation of a validated sterile product manufacturing process where sterility release is dependent upon demonstrated achievement of critical operational parameters in lieu of end product sterility testing. The absence of implementation parametric release in the Indonesian pharmaceutical industry is currently the basis for the development applicative designs of parametric release in the pharmaceutical industry. The research starts with searching the elements needed in parametric release, then arranges into a systematic model of parametric release, sets the basis of activity for each element in the model, furthermore identifies the existing system in the XYZ Pharmaceutical Industry, applied with selected X injection products. The research resulting model with 6 (sixs) basic elements of parametric release namely (1) quality risk management; (2) personnel; (3) product design; (4) process design; (5) utility and machines design; (6) on going control and monitoring. Model trials are performed by desk review by looking at concurrent procedures and retrospective data from 2017 to 2019. The results are 0, 0, 42, 64, 78, and 33% respectively as identified fullfilled activities of parametric release. Overall, the total activities identified has been met by PT.XYZ companies for X Injection product models is 69% or in other words this model is able to capture 31% of activities that still need to be prepared to implement parametric release.