Sterile facility is required for Realizing the crucial importance of quality, safety and efficacy of sterile pharmaceutical preparations such as eye drops, intravenous admixtures, parenteral nutrition and cytotoxic drug reconstitutions (CDR) in hospitals. There is an urgent need for better clean room facilities, water supply system and sterilization facilities in new as well as existing hospitals. To assist those in the planning and development of such facilities, the FDA, WHO, ISO and Good Manufacturing Practices has established the “Guides to the Development of Sterile Pharmaceutical Preparation Facilities for Healthcare Establishments”.
This document addresses several important aspects including policies, design, layout and specifi cations, management and quality control as well as storage, distribution and ancillary areas. It also provides recommendations for the layout of CDR and non-CDR preparation facilities and also lays down the specific requirements during the construction process of such facilities. To ensure quality, safety and efficacy of products and also protect personnel, the document is intended to promote awareness amongst healthcare planners and developers of the stringent regulatory requirements for such facilities. It is our fervent hope that relevant stakeholders involved will find this guide useful and applicable. Finally, I would like to honor and thank each and every one of you that have played important role and made remarkable contributions towards the success of the project of this guideline.