Chapter 1... 1.0 INTRODUCTION Managements basic job is the effective utilization of people, which they have, to achieve from the organisational objectives. It is through the combined efforts of personnel that technological, financial, physical and other resources are utilized. Without human efforts, no organisation can achieve their objectives. Therefore, motivation of people is of utmost importance everywhere Pharmaceutical manufacturers, manufacture quality medicines using various resources, in this, human resource is the most important. The quality of medicine depends upon the quality of people who produce them, ‘The regulatory guidelines talks about many things, about people, Some of these are as follows: (People must be qualified, experienced and trained. (ii) They must be sufficient in number. (iii) Their job responsibilities must be well explained to them and monitored. (iv) They must follow hygienic practices and finally, (v) They must be highly motivated. All the above points will be discussed in this chapter. Document required Nil 1.1 QUALIFICATION, EXPERIENCE AND TRAINING Once I had an opportunity to speak to Dr. M. Venkashwaralu, the Dy. Drug controller of India, Mumbai, about why organisations fail in regulatory inspections ? He laughed and said, "Potdar, people fee! that: gaod buildings, costly equipment and a few cleverly designed formats is the key to success in regulatory inspections, but they forget the most important factor of success, and that is the people. The people behind every thing is the only one important factor in any suecess story. And I can tell you, assuredly, that any organisation who has well qualified, experienced, trained and motivated people, will never fail ‘any regulatory inspections, I only wish that, organisations realise this thing and work on it" I still remember his words. They were just engraved in my mind forever. All regulatory requirements talk about the importance of right people, who are appropriately qualified, experienced and trained. Let us go little more in this and see what itis. ‘The W.H,O. guidelines on G.M.P. opens the chapter on "Personnel", saying — ‘The establishment and maintenance of a satisfactory system of quality assurance and the correct ua III O <