Comparison of Quality Requirements for Sterile Product Manufacture as per International Regulatory Agencies

The present study deals with a brief overview of the quality requirements for sterile pharmaceutical product manufacture as per international regulatory requirements. The pharmaceutical companies are required to follow the quality management specifications as per different guidelines such as Indian GMP (Schedule M), WHO, US cGMP and MHRA. Parenteral products are intended to be non-pyrogenic too, additionally to the requirement to be sterile. Medicinal drug products that do not meet the requirement to be sterile, non-pyrogenic can otherwise cause severe harm to life, threatening health risk to patient. It is necessary to know the differences in the requirements of guidelines given by different international agencies. Knowledge of the differences in the requirements is important to guarantee the quality products and their supply in due time for the designated market.The main aim is to study the quality requirements for sterile pharmaceutical product manufacture and to list down the similarities and differences as per the international regulatory requirements. The aspects that are taken into consideration are environmental parameters, buildings and premises, personnel, sanitation, equipment and sterilization.These guidelines focus on the parameters to be stressed on while manufacturing sterile pharmaceutical product and when these guidelines were compared, certain similarities and differences were observed. The requirements were broadly similar, and the differences found are detailed in this study.