YASWANTH ALLAMNENI1*, NAVYA ALLAMNENI2, P DAYANANDA CHARY1, G VIJAY KUMAR3, ARUN KUMAR KALEKAR1, PAVAN KUMAR POTTURI1
1Research and Development Department, Natco Pharma Limited, Kothur, Mahaboobnagar,Andhra Pradesh – 509228.
2Department of Pharmaceutical Technology, Narasaraopeta Institute of Pharmaceutical Sciences, Narasaraopeta, Guntur, India.
3Principal, A.K.R.G college of Pharmacy, Nallagerla, West Godavari, Andhra Pradesh.
Water is widely used as a raw material, ingredient, and solvent in the processing, formulation, and manufacture of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, compendial articles, and analytical reagents. This review discusses, primarily from a microbiological aspect, the review and evaluation of high purity water systems that are used for the manufacture of drug products and drug substances. It also includes a review of the design of the various types of systems and some of the problems that have been associated with these systems. As with other guides, it is not all-inclusive, but provides background and guidance for the review and evaluation of high purity water systems. The main objective of this review was to provide guidance to the industry on the pharmaceutical use of different grades of water in the manufacture of active pharmaceutical ingredients and medicinal products for human and veterinary use. This guidance is not intended to cover situations where, for example, medicinal products are prepared extemporaneously or where preparations are reconstituted or diluted with water prior to use by pharmacist (eg. Oral antibiotic mixtures) or in the case of veterinary products by the user (eg. Sheep dips).