Safety-Critical Model for Process Validation in Paracetamol 500mg Tablet Manufacturing

摘要

Analyses show that processes at critical levels could easily result in process drifts. Process validation however ensures that critical parameters are under a state of control, and that the outcome of the process is proper, correct, and acceptable. In drug manufacturing, process validation relies on sampling of at least three consecutive batches to confirm if the process meets current good manufacturing practice. Drifts in process parameter values can introduce hazard in the quality of the product.This paper presents synthesis and analysis of critical process parameters for monitoring process validation in Paracetamol 500mg tablet manufacturing that ensures that safety-critical systems for process validation in Paracetamol 500mg tablet manufacturing are better controlled. A framework is proposed for the design of a safety critical system for Paracetamol drug manufacturing processes and simulated using Yunzhong model for fuzzy pattern recognition.Analyses show that processes at critical value-set (i.e. at maximum and minimum datasets) and optimum dataset exhibit exclusivity properties with safety score set of (0, 0.75). While process at critical dataset yields Highly Unacceptable outcome, that at optimum yields Highly Acceptable outcomes. Processes at varying random datasets yield generally acceptable outcomes with least Poor quality, whereas the outcome is Bad with higher degree of Poor quality. It is therefore concluded that critical systems performance is best at optimal levels and generally yield average results at values varying within the peaks. Results of the simulation show that the framework is feasible and could be quite efficient.