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Module 13 | Slide 1 of 30 January 2006 Good Practices in Production and Quality Control Basic Principles of GMP Section 16 and 17.

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Presentation on theme: "Module 13 | Slide 1 of 30 January 2006 Good Practices in Production and Quality Control Basic Principles of GMP Section 16 and 17."— Presentation transcript:

1 Module 13 | Slide 1 of 30 January 2006 Good Practices in Production and Quality Control Basic Principles of GMP Section 16 and 17

2 Module 13 | Slide 2 of 30 January 2006 Good Practices Objectives Discuss aspects of good practices in production Discuss aspects of good practices in quality control Group session

3 Module 13 | Slide 3 of 30 January 2006 Good Practices Manufacture WHO Definition: All operations of purchase of materials and products, production, quality control, release, storage and distribution of pharmaceutical products, and the related controls Production and QC are parts of GMP Separate training module on QC Glossary

4 Module 13 | Slide 4 of 30 January 2006 Good Practices Design of Premises Design äWalls, floors, ceilings, ledges, drains, air supply, dust extraction Prevention of build-up of dirt and dust to avoid unnecessary risks of contamination äCleaning programme, appropriate cleaning, cleaning records Effective cleaning and disinfection ächoice of materials and chemicals, validation Drains – prevent backflow Protection from insects, birds, vermin and weather äfrom receipt of raw materials to dispatch of released product 12.2, 12.3, 12.7, 12.9, 12.29

5 Module 13 | Slide 5 of 30 January 2006 Basic Principles of GMP Walls, floors, ceilings – smooth and easy to clean No ledges or areas where dust can accumulate Prevention of build-up of dirt and dust to avoid unnecessary risks of contamination

6 Module 13 | Slide 6 of 30 January Good Practices Avoidance of Cross-Contamination I Special precautions should be taken to prevent generation and dissemination of dust Proper air control – supply and extraction, suitable quality Due to uncontrolled release of: ädust, gas, particles, vapours, sprays, organisms, residue, insects

7 Module 13 | Slide 7 of 30 January (a) Good Practices Avoidance of Cross-Contamination II Dedicated and self-contained areas for: äLive vaccines äLive bacterial preparations äCertain other biological materials äPenicillin products

8 Module 13 | Slide 8 of 30 January (b) Good Practices Avoidance of Cross-Contamination III Campaign production: äSeparation in time äFollowed by appropriate cleaning äValidated cleaning procedure

9 Module 13 | Slide 9 of 30 January (c and d) Good Practices Avoidance of Cross-Contamination IV Ventilation systems and airlocks äAppropriately designed ventilation system with air supply and extraction systems äSupply or incoming air should be filtered äRecirculation of air versus 100% fresh air supply äProper airflow patterns äPressure differentials äAppropriately designed airlocks

10 Module 13 | Slide 10 of 30 January (e) Good Practices Avoidance of Cross-Contamination V Clothing äProtection of operator and product äHighly potent products or those of particular risk - need for special protective clothing äPersonnel should not move between areas producing different products äGarments need to be cleaned

11 Module 13 | Slide 11 of 30 January (f, h and i) Good Practices Avoidance of Cross-Contamination VI Cleaning and decontamination äProcedure for removing soil and dirt äRemove all cleaning chemical residues or disinfectant residues äRemove and/or reduce micro-organisms äValidated (known effectiveness of the procedure) äUse cleanliness status labels äTest for residues

12 Module 13 | Slide 12 of 30 January (g) Good Practices Avoidance of Cross-Contamination -VII Closed processing systems äFor example: totally enclosed water purification systems äTanks fitted with appropriate filtration - without removable lids äPresent special cleaning difficulties, sometimes use clean-in-place (CIP)

13 Module 13 | Slide 13 of 30 January 2006 Good Practices Production Operations – Sanitation – I Work-flow ädesigned to avoid potential contamination Access äto production areas restricted to authorized personnel ädirect operators, QC staff, warehouse staff, maintenance personnel, cleaners äthe more critical the area - fewer number of persons there

14 Module 13 | Slide 14 of 30 January 2006 Good Practices Production Operations – Sanitation – II Simultaneous operations not permissible to process different products in different areas with a common ventilation system permissible to carry out secondary packaging activities for different products within a packing hall with adequate physical separation

15 Module 13 | Slide 15 of 30 January 2006 Good Practices Production Operations – Sanitation – III Area clearance checks Process of checking äall materials and documentation from the previous batch removed äall plant and equipment thoroughly cleaned and appropriate status labelling ächecklist useful

16 Module 13 | Slide 16 of 30 January 2006 Good Practices Production Operations – Sanitation – IV Area clearance checks The area clearance check should be carried out by two people äbetween batches of same product, acceptable for both checks to be carried out by production personnel äfor product changeover, second check carried out by QC staff äall checks carried out in accordance with written SOP and results recorded on the batch documentation.

17 Module 13 | Slide 17 of 30 January 2006 Basic Principles of GMP Line opening: Includes checks on materials and components Batch number Expiry date Printed packaging material including cartons, leaflets, foil...

18 Module 13 | Slide 18 of 30 January 2006 Good Practices Production Operations – Sanitation – V Cleaning and cleaning validation ädegree of cleaning depends on whether consecutive batches are of same or different product Check cleaning agent is fully removed If possible hot water alone used for cleaning äall cleaning and disinfecting solutions carefully prepared and expiry dated Final rinse with purified water, or water for injection (for sterile products) Full records kept

19 Module 13 | Slide 19 of 30 January 2006 Good Practices Production Operations – Sanitation – VI Water systems Water - major constituent of most products SOP for cleaning and sanitization of the water purification system should include distribution pipework Validation and removal of disinfectant before reuse

20 Module 13 | Slide 20 of 30 January 2006 Good Practices Production Operations – Sanitation – VII Maintenance and repair äactivities inevitable in manufacturing area äShould present no risk to product Whenever possible, all planned maintenance outside normal operating hours Emergency work in working area followed by thorough clean down and disinfection before manufacturing recommences Area clearance by QC

21 Module 13 | Slide 21 of 30 January Good Practices Good Practices in Quality Control (QC) Complete module on Quality Control Laboratories. This section only reflects some aspects of good practices in QC labs Each manufacturer should have a QC Department Independence from production and other departments is fundamental Under the authority of an appropriately qualified and experienced person with one or several control laboratories at his or her disposal

22 Module 13 | Slide 22 of 30 January (a) Good Practices Basic Requirements for Quality Control Resources Adequate facilities Trained personnel Approved procedures

23 Module 13 | Slide 23 of 30 January (a) Good Practices Basic Requirements for Quality Control Tasks Sampling Inspecting Testing Monitoring Releasing/rejecting

24 Module 13 | Slide 24 of 30 January (a) Good Practices Basic Requirements for Quality Control - I Objects Starting materials Packaging materials Intermediates Bulk products Finished products Environmental conditions

25 Module 13 | Slide 25 of 30 January b- e Good Practices Basic Requirements for Quality Control – II 1. Sampling: Methods and personnel approved by QC department 2. Qualification and validation done 3. Making records 4. Ensure ingredients and finished products are of the required quality and comply with marketing authorization, are in correct containers and have correct labels

26 Module 13 | Slide 26 of 30 January f- h Good Practices Basic Requirements for Quality Control – III 5. Records of tests made 6. Review production documentation 7. Assess deviations 8. Retain samples of starting materials and products 9. Release of batches together with the authorized person

27 Module 13 | Slide 27 of 30 January Good Practices Other Duties of the Quality Control Department 1. Establish, validate and implement QC procedures 2. Evaluate, store and maintain reference standards 3. Correct labelling of containers and materials and products 4. Monitor stability of APIs and products 5. Participate in complaint investigations 6. Participate in environmental monitoring

28 Module 13 | Slide 28 of 30 January Good Practices Assessment of Finished Products Should embrace all relevant factors, including: production conditions in-process test results manufacturing documentation compliance with finished product specification examination of the finished pack

29 Module 13 | Slide 29 of 30 January Good Practices QC Access QC Personnel must have access to production areas: äfor sampling äand investigation As appropriate

30 Module 13 | Slide 30 of 30 January 2006 Part One 3.1, 3.2 Good Practices Quality Control - summary QC is part of GMP - refer to the handout äsampling äspecifications ätesting ärelease procedures ärecalls and complaints ädecision-making in all quality matters ä authorization ä definition of product quality ä laboratory operations ä release decisions ä investigation and reporting


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