Basic Principles of GMP Quality Management Section 1
Basic Principles of GMP Quality Management Section 1 and 2 Module 2 | Slide 1 of 19 January 2006 STOP
Quality Management Objectives l To understand key issues in quality assurance/good manufacturing practices/quality control. l To understand specific requirements on quality management and quality assurance including: äOrganization äProcedures, processes and resources. l To develop actions to resolve your current problems. Module 2 | Slide 2 of 19 January 2006 STOP
Quality Management Quality relationships Quality Management Quality Assurance GMP Section 1 and 2 Production and Quality Control Module 2 | Slide 3 of 19 January 2006 STOP
Quality Management Philosophy and essential elements l What is Quality Management? ä The aspect of management function that determines and implements the “quality policy” ä The overall intention and direction regarding quality, as formally expressed and authorized by top management Module 2 | Slide 4 of 19 January 2006 STOP
Quality Management l The basic elements are: ä An appropriate infrastructure or “quality system” encompassing the organization structure, 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” Module 2 | Slide 5 of 19 January 2006 STOP
Quality Management l Quality assurance is a management tool l In contractual situations, it also serves to generate confidence in a supplier l 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 Module 2 | Slide 6 of 19 January 2006 STOP
Quality Management Principles of Quality Assurance (QA) 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 1. 1 Module 2 | Slide 7 of 19 January 2006 STOP
Quality Management QA System should ensure: l Products are designed and developed correctly ä Complying with, e. g. GMP, GCP, GLP l Production and control operations are defined l Managerial responsibilities are defined ä In job descriptions l The manufacture, supply and use of correct starting and packaging materials 1. 1 a- d Module 2 | Slide 8 of 19 January 2006 STOP
Quality Management QA System should ensure (2): l Controls are performed, including intermediates, bulk, calibration and validation l Correct processing and checking of the finished product l Products are sold/supplied only after review by the authorized person ä Complying with marketing authorization, production and QC requirements l Proper storage, distribution and handling 1. 1 e - h Module 2 | Slide 9 of 19 January 2006 STOP
Quality Management QA System should ensure (3): l Procedures for self-inspection and/or quality audits l Reporting, investigation and recording of deviations l System for change control/approval l Regular evaluation of product quality to verify consistency and continued improvement 1. 1 i - l Module 2 | Slide 10 of 19 January 2006 STOP
Quality Management Quality Assurance l Manufacturer is responsible for the quality of the product ä Fit for intended use ä Comply with marketing authorization ä Safety, efficacy and quality l Senior management and commitment of all staff 1. 3 Module 2 | Slide 11 of 19 January 2006 STOP
Quality Management Quality Assurance l Requires a comprehensively designed and well implemented QA system l Fully documented, and effectiveness monitored l Competent personnel, sufficient premises, equipment and facilities 1. 3 Module 2 | Slide 12 of 19 January 2006 STOP
Quality Management Good Manufacturing Practices (GMP) l That part of QA that ensures that products are consistently produced and controlled ä Quality standards ä Marketing authorization l Aim: Diminishing risks that cannot be controlled by testing of product ä Contamination and cross-contamination ä Mix-ups (confusion) 2. 1 Module 2 | Slide 13 of 19 January 2006 STOP
Quality Management Basic Requirements for GMP – I l Clearly defined and systematically reviewed processes l Qualification and validation is performed l Appropriate resources are provided: ä Qualified and trained personnel ä Premises, space, equipment and services ä Materials, containers, labels ä Procedures, storage, transport ä Laboratories and in-process control 2. 1 a - c Module 2 | Slide 14 of 19 January 2006 STOP
Quality Management Basic Requirements for GMP – I l Clear, written instructions and procedures l Trained operators l Records of actions, deviations and investigations l Records for manufacture and distribution l Proper storage and distribution l Systems for complaints and recalls 2. 1 d - j Module 2 | Slide 15 of 19 January 2006 STOP
Quality Management Group session – I l How many GMP deficiencies can you find in the photographs in the handout? Module 2 | Slide 16 of 19 January 2006 STOP
Quality Management Group session II l Imagine you are inspecting a pharmaceutical company for compliance with GMP l Consider the situations in the next slides which may have impact on a company’s quality management programme l Describe the action to be taken in each case Module 2 | Slide 17 of 19 January 2006 STOP
Quality Management Issues – I l Quality Management manual not established in writing l Limited human resources l Lack of qualified people l Processes not properly validated l Poor SOPs or standard batch documentation l More consideration to cost than quality l Family members in key positions of authority Module 2 | Slide 18 of 19 January 2006 STOP
Quality Management Issues – II l Substandard materials deliberately purchased l Technical staff not involved in purchasing l Inability to re-export substandard materials l Owner insists on selling rejects l Corruption l No commitment to training Module 2 | Slide 19 of 19 January 2006 STOP
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