Pharmaceutical Quality Assurance 13 ) Training of Employees: A person is called "a trained person", when he has appropriate knowledge, skill and attitude. Here, knowledge refers to the theoretieal background expected in a person regarding the job, which he is going to perform and also the knowledge about the principles of GMP, which may affect his area of work. Skill refers to the practical experience he has or in other words, his ability to use his theoretical knowledge to perform a particular task. Attitude is a behavioural trait of a person who is performing a task. He must have knowledge, skill and positive attitude towards performing work assigned to So in short a Trained Person is one, who has knowledge of his job and GMP, skill to use his knowledge and a very very positive attitude towards his work. Gi Sufficient number of people : Regulatory guidelines do use this phrase ‘there should be sufficient number of qualified personnel to carry out all the tasks for, which manufacturers are responsible’ ‘The sufficiency is to be defined based on the work load, e.g. how many activities in how many geographically diversed areas are to be supervised or carried out. In ease of supervisory responsibilities, time and efforts required for simultaneous documentation is also to be considered. Also how many people are reporting to one person at a time is also to be taken into account. How many shifts the plant is being operated has a direct relevance to the number of people required. ‘The numbers may vary from organisation to organisation but what is the underlying principle here is very clearly written in T, G, A. Australian guidelines, It clearly states that ~ "The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. The responsibilities placed on any one individual should not be so extensive as to present any risk to quality’. In short, the manufacturing plant should have sufficient number of people such that they are able to perform all the work assigned to them so that there is no risk of quality, because of overload of work to any person. (iv) Ability to perform given task at given level: In pharmaceutical manufacturing there are different levels of operation, they may start from operating a production equipment to formulating the top management policy of the organisation. Hence, the abilities required at different levels are different. People must be trained in all these levels to perform the designated jobs. In summary the three levels can be identified as : - Machine operators. ‘Shopfloor supervisors, + Junior/Senior managers. + Top managers and Directors. III O <