Abstract

PROSPECTIVE PROCESS VALIDATION FOR POLYHERBAL ORAL LIQUID PREPARATION

Sadia Shakeel*, Zeeshan Ahmed Sheikh and Khan Usmanghani

Abstract

Background: Process validation is an enduring progression indicating regulation of all aspects of the process. Pharmaceutical validation and process control are necessary to make sure that the drug product will congregate the specified standards for identity, quality, purity, safety and efficacy. Objective: Present work was carried out to validate the manufacturing procedure of oral liquid formulation and to provide assurance that it meets with predetermined specifications. Materials and Methods: In this prospective process validation, critical process parameters were identified, the protocol and report were made and results of critical parameters were checked for three consecutive batches to assure reproducibility of the results. Results: The identified critical process parameters were checked for their compliance and also for their reproducibility. The filling and sealing quality were also determined for each batch. Conclusion: The manufacturing process of polyherbal Entoban syrup was found to be reproducible for three batches and all parameters were complying with the specifications and validated as per the guidelines mentioned in prospective process validation.

Keywords: Process validation, Polyherbal formulation, Critical process parameters, Specifications.