1. Module 2Slide 1 of 26 WHO - EDM Quality Management Basic Principles of GMP Part One

2. Module 2Slide 2 of 26 WHO - EDM Quality Management Objectives l To understand key issues in quality assurance/quality control. l To understand specific requirements on organization, procedures, processes and resources.

3. Module 2Slide 3 of 26 WHO - EDM Part One Quality Management l Determines and implements the “quality policy” l The basic elements are: ä an appropriate infrastructure or “quality system” encompassing the Procedures, Processes, and Resources ä the systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality” The totality of these actions is termed “Quality Assurance”

4. Module 2Slide 4 of 26 WHO - EDM Part One Quality Management l Terminology may differ ä “Quality System” is said to be rarely used in drug manufacturing l The concepts of QA, GMP and Quality Control are interrelated aspects of Quality Management. ä They are described on the following slides in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products

5. Module 2Slide 5 of 26 WHO - EDM Part One 1.1 Quality Management Principles of Quality Assurance l Wide-ranging concept ä covers all matters that individually or collectively influence the quality of a product l Totality of the arrangements ä to ensure that the drug is of the right quality for the intended use l Quality Assurance incorporates GMP ä and also product design and development which is outside the scope of this module

6. Module 2Slide 6 of 26 WHO - EDM Part One 1.2 a-j Quality Management Requirements for QA Systems – I 1.Ensure products are developed correctly 2.Identify managerial responsibilities 3.Provide SOPs for production and control 4.Organize supply and use of correct starting materials 5.Define controls for all stages of manufacture and packaging

7. Module 2Slide 7 of 26 WHO - EDM Quality Management Requirements for QA Systems – II 6. Ensure finished product correctly processed and checked before release 7. Ensure products are released after review by authorized person 8. Provide storage and distribution 9. Organize self-inspection Part One 1.2 a-j

8. Module 2Slide 8 of 26 WHO - EDM Part One 2.1 a-j Quality Management GMP l Ensure that products are consistently produced and controlled l Diminishes risks that cannot be controlled by testing of product ä Cross-contamination ä Mix-ups

9. Module 2Slide 9 of 26 WHO - EDM Part One 2.1 a-j Quality Management Basic Requirements for GMP – I 1. Clearly defined and systematically reviewed processes 2. Critical steps validated 3. Appropriate resources: personnel, buildings, equipment, materials 4. Clearly written procedures 5. Trained operators

10. Module 2Slide 10 of 26 WHO - EDM Part One 2.1 a-j Quality Management Basic Requirements for GMP – II 6. Complete records, failure investigations 7. Proper storage and distribution 8. Recall system 9. Complaint handling

11. Module 2Slide 11 of 26 WHO - EDM Quality Management Group session - I l How many GMP deficiencies can you find in the photographs in the handout?

12. Module 2Slide 12 of 26 WHO - EDM Part One 1, 2 and 3 Quality Management Quality relationships Quality Management Quality Assurance GMP Quality Control

13. Module 2Slide 13 of 26 WHO - EDM Quality Management Quality Control (QC) l QC is part of GMP

14. Module 2Slide 14 of 26 WHO - EDM Part One 3.2 Quality Management Quality Control (QC) Department l Each holder of a manufacturing authorization should have a QC Department l Independence from production and other departments is considered to be fundamental l Under the authority of an appropriately qualified and experienced person with one or several control laboratories at his or her disposal.

15. Module 2Slide 15 of 26 WHO - EDM Part One 3.2 Quality Management Basic Requirements for Quality Control Resources l Adequate facilities l Trained personnel l Approved procedures

16. Module 2Slide 16 of 26 WHO - EDM Part One 3.2 Quality Management Basic Requirements for Quality Control Tasks l Sampling l Inspecting l Testing l Monitoring l Releasing/rejecting

17. Module 2Slide 17 of 26 WHO - EDM Part One 3.2 Quality Management Basic Requirements for Quality Control - I Objects l Starting materials l Packaging materials l Intermediates l Bulk products l Finished products l Environmental conditions

18. Module 2Slide 18 of 26 WHO - EDM Part One 3.2 b – e Quality Management Basic Requirements for Quality Control – II 1. Sampling approved by QC department 2. Validated test methods 3. Records 4. Review and evaluation of production documentation 5. Failure investigations for all deviations 6. Ingredients comply with the marketing authorization

19. Module 2Slide 19 of 26 WHO - EDM Part One 3.2 e – h Quality Management Basic Requirements for Quality Control – III 7. Ingredients are of the required purity 8. Proper containers 9. Correct labelling 10. Release of batches by the authorized person 11. Retained samples of starting materials and products

20. Module 2Slide 20 of 26 WHO - EDM Part One 3.3 Quality Management Other Duties of the Quality Control Department 1. Establish QC procedures 2. Reference standards 3. Correct labelling 4. Stability testing 5. Complaint investigations 6. Environmental monitoring

21. Module 2Slide 21 of 26 WHO - EDM Part One 3.4 Quality Management Assessment of Finished Products Should embrace all relevant factors. For example: l production conditions l in-process test results l manufacturing documentation l compliance with finished product specification l examination of the finished pack

22. Module 2Slide 22 of 26 WHO - EDM Part One 3.5 Quality Management QC Access l QC Personnel MUST have access to production areas for sampling and investigation l As appropriate!

23. Module 2Slide 23 of 26 WHO - EDM Part One 3.1, 3.2 Quality Management Quality Control - summary l QC is part of GMP - refer to the handout ä sampling ä specifications ä testing ä release procedures ä recalls and complaints ä decision-making in all quality matters ä authorization ä definition of product quality ä laboratory operations ä release decisions ä investigation and reporting