In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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First Revised Edition
March 2000
DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
Reliable cause specic mortality statistics are the cornerstone of national health information
systems. They are essential for evidence-based decision making for monitoring health of
populations, health services planning and delivery, programme implementation, policy development
and epidemiolog...ical research.
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(7th Version)
20, March 2020
An Evidence-Based Treatment Guide for Clinicians