Abstract

A REVIEW ON PROCESS VALIDATION: STANDARDIZATION OF HERBAL TABLET FORMULATION

Anil M. Sawant*, Sultan A. Mulla, Devyani V. Pisal, Sachin S. Mali, Dipak P. Mali, Durgacharan A. Bhagwat

ABSTRACT

Validation is a concept that is fundamental to GMP and any quality assurance programme. Validation of the individual stage of the process is called process validation. Process is developed in such way that the required parameters achieved and it ensures that the output of process will consistently meet the required parameters during routing production. This concept is applied in pharmaceutical industry, but not that much deeply applied in herbal industry. The use of herbal medicine is the oldest form of healthcare. About 80% of the world‘s population has belief in traditional medicine, particularly herbal drugs for their primary healthcare. India has a rich tradition of herbal medicine as evident from Ayurveda. As growing public interest in use of herbal medicines, it is necessary to development of modern and objective standards for evaluating quality of herbal medicines. So that it is a need process validation in manufacturing of herbal drugs for control the quality of herbal drugs. The reasons for doing process validation in herbal manufacturing industry are manufacturers are required by law to confirm to GMP regulations, good business dictates that a manufacturer avoids the possibility of rejected or recalled batches, process validation helps to ensure product uniformity, reproducibility, quality and to make process economical.

Keywords: Process validation, Standardization, IPQC, Quality assurance, Herbal formulation, etc.