PPT ON ORGANIZATION,PERSONNEL, PREMISES.pptx

Organization,personnel,premises

1. Glass Plastics Rubbers Paper/card boards Metals Organization and personnel: Personnel responsibilities, training, hygiene and personal records. Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination. Equipment's and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials. UNIT II

2. Structure of the Organization Structure of the organization

3. PERSONNEL Objectives of Personnel management are as follows

4. General Personnel Requirements: The number of personnel should be adequate along with essential qualifications and practical work experience. The personnel should be given appropriate work load and responsibilities of the personnel should not be so extensive to compromise the mechanism of quality. The duties of all responsible staff should be well described in the job letters and staff should be provided adequate authority to perform the responsibilities. The personnel should have scope to delegate the responsibility to designated deputies with qualifications . There should not be any gaps or unexplained overlaps in the process.

5. Key Personnel : "Key personnels are considered those persons in the organization, who have direct impact on the working of the organization and quality of the product produced" There are six different key personnel : Head of production department. Head of Quality Control department. Head of Quality Assurance Department. Head of sales and distribution department. Authorized person. Managing director.

6. Personnel Qualification: Initial screening should select only those individuals who have such basic skills as reading, writing, and numeracy . Training should be imparted for current good manufacturing practice and this training shall be conducted by qualified individuals on regular basis. • Each person responsible for any operation in the manufacturing, processing or packing should be well educated and trained to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess. • There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

7. Training: Training, although essential, is more effective in a supportive environment management • Training should be in accordance with written, approved programs for all personnel w are involved into production areas or into control laboratories; and those person: whose activities could affect the quality of the product including technical, maintenance and cleaning personnel. The training should be: 1. INDUCTION AND CONTINUING TRAINING: • It is based upon the theoretical concepts and practice of GMP. • Practical effectiveness of the training module should be checked. • Training should be imparted before undertaking any new task. 2. SPECIFIC TRAINING FOR STAFF IN SPECIAL AREAS: • Specific training should be imparted to the persons where contamination can po hazard like clean areas or in case of areas where highly active, toxic, infection, sensitizing materials are handled.

8. Types of Training:

9. Personnel Hygiene: All personnel, prior to as well as during the period of employment, should undergo health checkups e.g. eye examinations regularly. All personnel should be trained in the practices of personal hygiene. Person showing any symptoms of illness or open lesions should be kept out of the process of handling of starting material, manufacturing as well as packing. The illness may affect the quality of the products. Employees should be instructed to report to their immediate supervisor in any conditions which may adversely affect the products. Proper handling care should be maintained particularly in case of starting material, intermediate or bulk products as well as primary packing material. Direct touch (uncovered hands of operators) should be avoided between the operator's hands and the exposed product as well as with any part of the equipment that comes into contact with the products.

10. Personnel Hygiene: 6. Personnel should wear clean body coverings appropriate to avoid contamination of the products. 7. Head should be covered along with the clean or sterilized clothing . Used clothes, if reusable, should be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized. 8. Eating, drinking, smoking should be avoided in the production area. Keeping plants and personal medicines also should not be allowed in laboratory, production and storage area or in any other areas where they might adversely influence product quality. 9. The protocols of personnel hygiene should be applied to all persons entering production areas, whether they are temporary or full-time employees or non-employees, e.g. contractors' employees, visitors, senior managers, and inspectors. 10. Personnel should be instructed to use the hand-washing facilities .

11. Personnel Records: Personnel records are records related to employees of an organization and accumulated, factual and comprehensive information. Purposes of Personnel Records: • It provides important information to managers regarding the employee. • To keep an update record of leaves, lockouts, transfers, turnover , etc. of the employees. It helps the managers to make salary revisions, allowances and other benefits related to salaries. • It helps the managers in designing the training modules and development programs on the basis of information available. • It also helps the researchers to carry in-depth study with respect to industrial relations and goodwill of the firm in the market.

12. Personnel Records: Consultants and contract staff: This regulation is brief and concise regarding the requirements of qualifications for a consultant and what records need to be kept. Qualifications: Qualification requirements for consultants are the same as those for the facility's employees. The consultant must have the education, training, experience, or a combination of them in the subject or area for which they are advising. Records: If a company has used a consultant, then a record of this consultant and services provided must be kept. The record must contain, at a minimum, the consultant's name, address, qualifications and type of service provided. Records should prove qualifications. Training records maintained. Consultants and contract staff: Types of training GMP/GLP related training. Job specific training. Behavioural training Training manual records contains: Attendance record. Training evaluation record.

13. Personnel Records:

14. Premises:

15. Premises:

16. Premises:

17. Premises:

18. Premises:

19. Premises:

20. Premises:

21. Premises:

22. Premises:

23. Premises:

24. Premises:

25. Premises:

26. Premises:

27. Premises:

28. Premises:

29. Premises:

30. Premises:

31. Premises:

32. Premises:

33. Premises:

34. Premises:

35. Premises:

36. Premises:

37. Premises:

38. Premises:

39. Premises:

40. Premises:

41. Premises:

42. Premises:

43. COMPLETED: Organization and personnel: Personnel responsibilities, training, hygiene and personal records. Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination