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Here are potential issues and actions to address them:
- Quality Management manual not established in writing: Cite deficiency and require written manual establishing QA, QC, and GMP responsibilities and procedures.
- Limited human resources: Note insufficient staffing and require hiring of additional qualified personnel or use of contractors.
- Lack of qualified people: Cite lack of qualified staff and require training and certification programs for existing employees.
- Processes not properly validated: Note validation deficiency and require validation protocols and studies for all critical processes.
- Poor SOPs or standard batch documentation: Cite deficiencies and require review and revision of all procedures and documentation.
Here are potential issues and actions to address them:
- Quality Management manual not established in writing: Cite deficiency and require written manual establishing QA, QC, and GMP responsibilities and procedures.
- Limited human resources: Note insufficient staffing and require hiring of additional qualified personnel or use of contractors.
- Lack of qualified people: Cite lack of qualified staff and require training and certification programs for existing employees.
- Processes not properly validated: Note validation deficiency and require validation protocols and studies for all critical processes.
- Poor SOPs or standard batch documentation: Cite deficiencies and require review and revision of all procedures and documentation.
Copyright:
Attribution Non-Commercial (BY-NC)
Verfügbare Formate
Als PPT, PDF, TXT herunterladen oder online auf Scribd lesen
Here are potential issues and actions to address them:
- Quality Management manual not established in writing: Cite deficiency and require written manual establishing QA, QC, and GMP responsibilities and procedures.
- Limited human resources: Note insufficient staffing and require hiring of additional qualified personnel or use of contractors.
- Lack of qualified people: Cite lack of qualified staff and require training and certification programs for existing employees.
- Processes not properly validated: Note validation deficiency and require validation protocols and studies for all critical processes.
- Poor SOPs or standard batch documentation: Cite deficiencies and require review and revision of all procedures and documentation.
Copyright:
Attribution Non-Commercial (BY-NC)
Verfügbare Formate
Als PPT, PDF, TXT herunterladen oder online auf Scribd lesen
Quality Management Objectives To understand key issues in quality assurance/quality control. To understand specific requirements on organization, procedures, processes and resources. To develop actions to resolve your current problems.
Module 2 Slide 2 of 26 WHO - EDM
Quality Management Quality Management Terminology may differ “Quality System” is said to be rarely used in drug manufacturing The concepts of QA, GMP and Quality Control are interrelated aspects of Quality Management. 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 Part One
Module 2 Slide 3 of 26 WHO - EDM
Quality Management Principles of Quality Assurance Wide-ranging concept covers all matters that individually or collectively influence the quality of a product Totality of the arrangements to ensure that the drug is of the right quality for the intended use Quality Assurance incorporates GMP and also product design and development which is Part One 1.1 outside the scope of this module
Module 2 Slide 4 of 26 WHO - EDM
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 Part One 1.2 a-j
Module 2 Slide 5 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
Module 2 Slide 6 of 26 WHO - EDM
Quality Management GMP Ensure that products are consistently produced and controlled Diminishes risks that cannot be controlled by testing of product Cross-contamination Mix-ups
Part One 2.1 a-j
Module 2 Slide 7 of 26 WHO - EDM
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 Part One 2.1 a-j
Module 2 Slide 8 of 26 WHO - EDM
Quality Management Basic Requirements for GMP – II 6. Complete records, failure investigations 7. Proper storage and distribution 8. Recall system 9. Complaint handling
Part One 2.1 a-j
Module 2 Slide 9 of 26 WHO - EDM
Quality Management Group session - I How many GMP deficiencies can you find in the photographs in the handout?
Module 2 Slide 10 of 26 WHO - EDM
Quality Management Quality relationships
Quality Management
Quality Assurance
GMP
Part One 1, 2 and 3
Quality Control Module 2 Slide 11 of 26 WHO - EDM Quality Management Quality Control (QC)
QC is part of GMP
Module 2 Slide 12 of 26 WHO - EDM
Quality Management Quality Control (QC) Department Each holder of a manufacturing authorization should have a QC Department Independence from production and other departments is considered to be fundamental Under the authority of an appropriately qualified and experienced person with one or several control laboratories at his or her disposal. Part One 3.2
Module 2 Slide 13 of 26 WHO - EDM
Quality Management Basic Requirements for Quality Control
Quality Management Basic Requirements for Quality Control Tasks Sampling Inspecting Testing Monitoring Releasing/rejecting Part One 3.2
Module 2 Slide 15 of 26 WHO - EDM
Quality Management Basic Requirements for Quality Control - I Objects Starting materials Packaging materials Intermediates Bulk products Finished products Environmental conditions Part One 3.2
Module 2 Slide 16 of 26 WHO - EDM
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 Part One 3.2 b – e authorization
Module 2 Slide 17 of 26 WHO - EDM
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
Part One 3.2 e – h
Module 2 Slide 18 of 26 WHO - EDM
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 Part One 3.3
Module 2 Slide 19 of 26 WHO - EDM
Quality Management Assessment of Finished Products Should embrace all relevant factors. For example: production conditions in-process test results manufacturing documentation compliance with finished product specification examination of the finished pack
Part One 3.4
Module 2 Slide 20 of 26 WHO - EDM
Quality Management QC Access QC Personnel MUST have access to production areas for sampling and investigation As appropriate!
Part One 3.5
Module 2 Slide 21 of 26 WHO - EDM
Quality Management Quality Control - summary QC is part of GMP - refer to the handout authorization sampling definition of product quality specifications laboratory operations testing release decisions release procedures investigation and reporting recalls and complaints decision-making in all quality matters Part One 3.1, 3.2
Module 2 Slide 22 of 26 WHO - EDM
Quality Management Group session II Imagine you are inspecting a pharmaceutical company for compliance with GMP Consider the situations in the next slides which may impact on a company’s quality management programme. Describe the action to be taken in each case
Module 2 Slide 23 of 26 WHO - EDM
Quality Management Issues – I Quality Management manual not established in writing Limited human resources Lack of qualified people Processes not properly validated Poor SOPs or standard batch documentation More consideration to cost than quality Family members in key positions of authority
Module 2 Slide 24 of 26 WHO - EDM
Quality Management Issues – II Substandard materials deliberately purchased Technical staff not involved in purchasing Inability to re-export substandard materials Owner insists on selling rejects Corruption No commitment to training