ORGANISATION and PERSONNEL

A detailed study of the organisation and personnel involved in the pharmaceutical industry. These are involved in the guidelines of Good Manufacturing Practices.

1. UNIT II – CHAPT 1 Ms. TENY SARA THOMAS MOUNT ZION COLLEGE OF PHARMACEUTICAL SCIENCES AND RESEARCH, ADOOR, KERALA ASSISTANT PROFESSOR B.PHARM SIXTH SEMESTER PHARMACEUTICAL QUALITY ASSURANCE ORGANISATION & PERSONNEL

2. INTRODUCTION In the complex field of pharmaceutical manufacturing, it is important to have a sound quality system in place to make sure that products manufactured have the desired quality, safety and efficacy. At the same time, it is vital to recognise that even the best quality system is only as good as the people who make it work. Personnel are the backbone of the manufacturing unit, and there must be a sufficient number of adequately qualified and trained staff to ensure one achieves the desired quality product.

3. It is important to lay out individual responsibilities in a manner that is clear enough to be understood by the personnel who are to perform the respective tasks. Written job descriptions must be available and an organisational chart must be prepared to show the hierarchical organisation of employees. All personnel should be aware of the principles of Good Manufacturing Practice that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs. People in responsible positions should have specific duties recorded in written job descriptions and adequate authority to carry out their responsibilities. There should be no gaps or unexplained overlaps in the responsibilities of those personnel concerned with the application of Good Manufacturing Practice

4. HIERARCHICAL ORGANISATION OF EMPLOYEES

5. KEY PERSONNEL

6. KEY PERSONNEL Key Personnel of an Organisation include:- Head of Production ( HoP ) Head of Quality Control ( HoQC ) Authorized Person The Head of Production and Head of Quality Control should be independent of each other. Key personnel responsible for supervising the manufacturing and quality control of pharmaceutical products should possess qualifications of a scientific education and practical experience required by national legislation. Their education should include any degree in a scientific field or pharmaceutical field.

7. The HoP and HoD share or jointly exercise responsibilities:- A uthorization of written procedures and other documents. Monitoring and control of manufacturing environment. Plant hygiene. Process validation and calibration of analytical instruments Training. Approval and monitoring of suppliers of materials and contact manufacturers. Retention of records. Designation and monitoring of storage conditions. Monitoring of compliance with GMP. Inspection, investigation, and taking of samples in order to monitor facts that may affect product quality.

8. HEAD of PRODUCTION ( HoP ) To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. To approve the instructions relating to production operations and to ensure their strict implementation. To ensure that the production records are evaluated and signed by an designated person before they are sent to the Quality Control Department. T o ch e ck t he m a i n t en a nce of h i s d epa r t m en t , p r e m i s e s a n d equipment. To ensure that appropriate process validations and calibrations of control equipment are performed and recorded and reports are made available. To ensure that the required initial and continuing training of production personnel is carried out.

9. HEAD of QUALITY CONTROL ( HoQC ) To approve or reject, as he sees fit, starting materials, p ac k a g i ng materials and intermediate , bulk and finished products To evaluate batch records Ensure all testing is carried out Approve sampling instructions, specifications, test methods, and other quality control procedures. Approve and monitor analyses carried out Check the maintenance of the department, premises and equipment. Ensure that the appropriate validations and calibrations of control equipment Ensure that required initial and continuing training of quality control personnel is carried out.

10. AUTHORIZED PERSON Responsible for compliance with technical and regulatory requirements related to quality of finished products Implementation of the quality system Participation in the development of company's quality manual Supervision of regular internal audits Oversight of QC department Participation in external audit Participation in validation programmes

11. APPROVAL & RELEASE OF FINISHED PRODUCT Personnel responsible, should have appropriate qualifications and experience Marketing and manufacturing authorization requirements should be met by the finished product. Ensure that principles and guidelines of GMP are followed. The principal manufacturing and testing processes have been validated. Ensures all necessary checks and tests have been performed Any planned changes in manufacturing or quality control have been notified Any additional sampling, inspection, tests and checks have been carried out. Ensure appropriate audits, self inspections and spot checks are carried out by experienced and trained staff.

12. RESPONSIBILITIES OF A PERSONNEL The guidelines for personnel responsibilities in the work area: - Personnel involved in aseptic manufacturing, processing, packaging, and handling of drug products should wear clean clothing or uniform. They should wear protective apparels, such as coverings for head, face, hands, and arms to prevent contamination of the drug products. The company should provide appropriate uniforms or protective clothing to the personnel. If protective clothing needed, personnel should be trained in donning and removing the protective clothing. Personnel should follow good sanitation and healthy habits.

13. Should not wear jewellery or make up in production / QC areas because it can result in safety hazard and a contamination issue. Eating, drinking, chewing, smoking should be restricted in production and storage areas. Only authorized and trained personnel should be allowed to enter the production and other areas. Also the entry should be limited. A personnel should be physically fit to work, routine medical check up and physical fitness test should be done by the company. If an individual found to have an illness or open lesions that may adversely effect the safety of quality of drug product , report to the supervisor regarding any health issues.

14. PERSONNEL TRAINING

15. The manufacturer should provide training for all the personnel whose duties take them into production areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product. Newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given. Training records should be kept.

16. Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitizing materials are handled, should be given specific training. Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given. Information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.

17. Job Description Training R e qu ire m e n t Individual training plan Appropriate Training events Documentation Approved and Accurate Training Material Evaluation Qualified trainer Knowledgeable training designer

18. TRAINING SYSTEM An accurate description of the Job or role. Specific training of job or role Training plan to be completed. Training material Qualified trainers Post training evaluation to measure the effectiveness of the training. Documentation and book keeping system.

19. TRAINING PLAN T raining plan should be designed and implemented in such a way that each individual receives right training at right time. Training plan should include the following- Training topic Mode of Training Sequence of training Approximate time of training Indication when the individual is trained.

20. PERSONNEL HYGIENE

21. All personnel should undergo health examinations Undergo periodic eye examinations Trained in practice of personal hygiene Instructed to wash hands before entering production areas. If an individual found to have an illness or open lesions that may adversely effect the safety of quality of drug product , should not be allowed to handle starting, packaging, in-process materials or drug products. All employees should be instructed to report to the immediate supervisor. To ensure protection form contamination, wear clean body coverings, appropriate to their duties.

22. Reusable clothes should be stored in separate closed containers until properly laundered, and if necessary disinfected and sterilized. Personnel should be instructed to use the hand washing facilities. Direct contact should be avoided between the operators hands and exposed products as well as with any part of the equipment that comes into contact with the products. Avoid cosmetics such as face powder, hair sprays, perfumes and aftershave .

23. PERSONNEL RECORDS

24. Personnel records are records pertaining to employees of an organisation. These records are accumulated, factual, and comprehensive information related to concern records and detained. All information with effect to human resources in the organisation is kept in a systematic order. Such records are helpful to a manager in various decision making areas. Keep an update record of leaves, transfers, turnover etc Helps researchers to carry in-depth study with respect to industrial relations and goodwill of the firm in the market. Personal Records include:- employment records, training records, health records, miscellaneous etc.,