INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy burdens in terms of morbidity and mortality, and economic losses, onto the populations and health systems of the country. 2. In order to address the disease burden, it is of paramount importance that safe and effective new drugs are developed and available for prevention and treatment of various diseases. 3. ...

Internal audit The manufacturer shall conduct internal audits at planned intervals to determine whether the quality management system— (a) conforms to the planned arrangements, to the requirements of this Schedule and to the quality management system requirements established by the manufacturer; and (b) is effectively implemented and maintained. An audit programme shall be planned, taking into con ...

General: Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. Number of personnel employed shall be adequate and in direct proportion to the: workload. Prior to employment, all personnel, shall undergo medica'i examination including eye examination, and shall, be free from communicable or contagious disease ...