LIFE CYCLE APPROACH TO CLEANING VALIDATIONAbstract
The regulatory expectations are changing day by day on the cleaning validation in Pharmaceutical industries, considering the patient safety and drug efficacy. Manufacturing of an Intermediate and Active Ingredient Pharmaceuticals involves many chemical syntheses and same equipment is being using for manufacturing of different product in multi-production facility. Equipment cleaning plays a key role in controlling the contamination, to control the potential carryover of the product, cleaning methods shall be designed effectively to reduce the previous product residue. The current good manufacturing practice regulations state that cleaning is a critical issue to ensure the product quality. Improper cleaning results the carryover of the previous product residue and leads to failure of the product, so adequate cleaning procedures should be in place to clean the equipment to provide the documented evidence. The established cleaning procedures and cleaning methods shall be validated, life cycle approach is considered for the cleaning validation process. The article discussed about the outlines of the life cycle approach for the cleaning validation.
Chandra Sekhar Gupta Penugonda
Quality Assurance, Dr. Reddy’s Laboratories Limited, Visakhapatnam, Andhra Pradesh, India.
04 October, 2016
28 November, 2016
01 December, 2016
01 April, 2017