1. Module 8 | Slide 1 0f 30 2012 Personnel Basic Principles of GMP 9

2. Module 8 | Slide 2 0f 30 2012 Personnel Objectives To review general issues related to personnel To review requirements for key personnel To review the training of personnel To consider some specific issues

3. Module 8 | Slide 3 0f 30 2012 9.1 Personnel Principle A satisfactory system of QA, manufacture and control of products and APIs rely on people. Must be sufficient qualified personnel to carry out tasks Individual responsibilities must be clearly defined and understood by individuals concerned Written job descriptions All personnel should be aware of the principles of GMP that affect them

4. Module 8 | Slide 4 0f 30 2012 9.2 Personnel General (1) Personnel requirements: Adequate number of persons With necessary qualifications With practical experience An individual’s responsibilities should not be so extensive as to present a risk to quality

5. Module 8 | Slide 5 0f 30 2012 9.3 Personnel General (2) Specific duties in written job descriptions Adequate authority to carry out responsibilities May delegate to designated deputies with qualifications No gaps or unexplained overlaps Authorized organization chart

6. Module 8 | Slide 6 0f 30 2012 Basic Principles of GMP Organization chart This is NOT what it should look like

7. Module 8 | Slide 7 0f 30 2012 9.4 Personnel General (3) All personnel should be aware of GMP Must receive training in GMP: äinitial training äcontinuing training äincluding hygiene standards Motivated to äsupport the establishment ämaintain high-quality standards

8. Module 8 | Slide 8 0f 30 2012 9.5 Personnel General (4) Prevent unauthorized access to: äProduction areas äStorage areas äQuality control Stop personnel who do not work in these areas using them as passageways

9. Module 8 | Slide 9 0f 30 2012 Basic Principles of GMP

10. Module 8 | Slide 10 0f 30 2012 9.6 Personnel Key Personnel (1) Key personnel (which normally should be full-time) positions and include: Authorized person Head of Production Head of Quality Unit –Quality Assurance and Quality Control May delegate functions – not responsibility Heads of Production and Quality Unit should be independent of each other

11. Module 8 | Slide 11 0f 30 2012 9.7 Personnel Key Personnel (2) Should have appropriate qualifications Scientific education such as: ächemistry or biochemistry ächemical engineering ämicrobiology äpharmaceutical sciences and technology äpharmacology and toxicology äphysiology; or äother related science subjects relevant to the responsibilities to be undertaken

12. Module 8 | Slide 12 0f 30 2012 9.7 Personnel Key Personnel (3) Should have appropriate experience Practical experience äManufacture and quality assurance äPreparatory period under professional guidance sometimes needed Education and experience should enable personnel to take difficult decisions in an independent, professional and scientific way äresolve the problems encountered in manufacturing and QC

13. Module 8 | Slide 13 0f 30 2012 Personnel Shared Responsibilities (1) Heads of Production and Quality Unit may share/jointly exercise some responsibilities relating to quality e.g.: authorization of written procedures (SOPs) and other documents monitoring and control of manufacturing environment hygiene process validation and calibration training, including application and principles of QA approval and monitoring of suppliers and contract acceptors 9.8

14. Module 8 | Slide 14 0f 30 2012 Personnel Shared Responsibilities (2) Designation and monitoring of storage conditions for materials and products Performing and evaluating in-process controls Retention of records Monitoring compliance with GMP Inspection, investigation, and taking of samples to monitor factors which may affect quality 9.8

15. Module 8 | Slide 15 0f 30 2012 Personnel Head of Production: Responsibilities (1) Product production and storage according to appropriate documentation Approval and implementation of production instructions, in-process QC and ensure strict implementation Ensures that production records are evaluated and signed by designated person 9.9

16. Module 8 | Slide 16 0f 30 2012 Personnel Head of Production: Responsibilities (2) Checks maintenance of production department, premises and equipment Ensures process validation and calibration performed, recorded, and reports are made available Ensures initial and continuous training of production personnel 9.9

17. Module 8 | Slide 17 0f 30 2012 Personnel Head of Quality Unit: Responsibilities (1) Approve or reject starting materials, packaging materials, and intermediate, bulk and finished products in relation with their specifications Evaluate batch records Ensure that all necessary testing is carried out Approve sampling instructions, specifications, test methods and other QC procedures 9.10

18. Module 8 | Slide 18 0f 30 2012 Personnel Head of Quality Unit: Responsibilities (2) Approve and monitor analyses carried out under contract Maintenance of the department, premises and equipment Validations (including analytical procedures) and calibrations of control equipment are carried out Initial and continuing training of quality unit personnel 9.10

19. Module 8 | Slide 19 0f 30 2012 Personnel Head of Quality Unit: Responsibilities (3) Establishment, implementation and maintenance of the quality system Supervision of the regular internal audits or self- inspections Participation in external audit (vendor audit) Participation in validation programmes (See also other duties of QC later) 9.10

20. Module 8 | Slide 20 0f 30 2012 Personnel Authorized person: Responsibilities (1) Compliance with technical and regulatory requirements Approval of the release of finished product for sale Function may be delegated to another person (e.g. QA) In some countries, overall responsibility including –The establishment and implementation of quality system –Development of quality manual –Supervision of self-inspections and quality audits 9.11, 9.15

21. Module 8 | Slide 21 0f 30 2012 Personnel Authorized person: Responsibilities (2) No batch of product is to be released for sale or supply prior to certification by the authorized person(s). Assessment of finished product include: –Review of production conditions –Results of in-process testing –Manufacturing (including packaging) documentation –Compliance with specifications –Examination of the finished pack 9.12, 9.13

22. Module 8 | Slide 22 0f 30 2012 Personnel Person releasing the batch should ensure: (1) Each batch meets manufacturing and marketing authorization requirements Principles and requirements of GMP are met All checks and tests have been performed Production conditions and manufacturing records Planned changes and deviations reported - including where necessary to drug regulatory authority 9.14 a - e

23. Module 8 | Slide 23 0f 30 2012 Personnel Person releasing the batch should ensure: (2) Additional sampling, inspection, checks and tests had been done when required All production and control documents are completed and endorsed Audits, inspections and spot-checks were done QC approval has been given All other relevant factors have been considered 9.14 f - j

24. Module 8 | Slide 24 0f 30 2012 Personnel Training (1) Training, in accordance with a written, approved programme äall personnel whose duties take them into production areas; äinto control laboratories; and äfor others whose activities could affect the quality of the product including technical, maintenance and cleaning personnel Induction and continuing training äon theory and practice of GMP and their duties ätraining records should be kept äpractical effectiveness checked ätraining before undertaking any new task 10.1, 10.2

25. Module 8 | Slide 25 0f 30 2012 Personnel Training (2) Specific training for staff in special areas, e.g. äWhere contamination is a hazard äClean areas äAreas where highly active, toxic, infectious, sensitizing materials are handled The concept of QA - ensure understanding and its implementation 10.3, 10.4

26. Module 8 | Slide 26 0f 30 2012 10.5 Personnel Visitors or Untrained Personnel Should not to enter production and control areas. If this is unavoidable then: They must be given information in advance: äGMP äpersonal hygiene äprotective clothing requirements äBehaviour (no samples to be taken, touching etc.) Must be accompanied and closely supervised at all times

27. Module 8 | Slide 27 0f 30 2012 10.6 Personnel Consultants and contract staff Should be qualified for the services provided Training records maintained Records should prove qualifications

28. Module 8 | Slide 28 0f 30 2012 Personnel Group Session What do you think will be the key personnel issues to arise during an inspection? What sort of responses do you think you should give to these issues when they become apparent?

29. Module 8 | Slide 29 0f 30 2012 Personnel Possible Issues – I Limited number of staff Inadequate qualifications Inadequate experience Owner interferes in quality decisions Lack of means to develop training materials

30. Module 8 | Slide 30 0f 30 2012 Personnel Possible Issues – II Company procedures take precedence over local legislation Unclear organization diagram Staff movement Inadequate training records Illness