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 diseases. Thereafter, they should be medically Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India examined periodically, at least once a year. Records shall be maintained thereof. 6.2.2 Competence, awareness and training: The manufacturer shall— (a) determine the necessary competence for personnel performing work affecting product quality, (b) provide training or take other actions to satisfy these needs, (c) evaluate the effectiveness of the actions taken, (d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, (e) maintain appropriate records of education, training, skills and experience, and (f) establish documented procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.