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Introduction qa, qc and tqm



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quality assurance, quality control, total quality management UNIT 1, b pharma 6th sem
Quality management in the drug industry
Why quality is important in pharmaceuticals?
Impacts of ignorance on quality
Quality control
Role of quality control in pharmaceutical industry
Objectives of quality control
Components of quality control
Functions of qc in pharmaceutical industry
Quality assurance
Total quality management
Characteristics of tqm
Benefits of tqm:

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Introduction qa, qc and tqm

  2. 2. CONTENTS 1. Quality management in the drug industry 2. Why quality is important in pharmaceuticals? 3. Impacts of ignorance on quality 4. Quality control 5. Role of quality control in pharmaceutical industry 6. Objectives of quality control 7. Components of quality control 8. Functions of qc in pharmaceutical industry 9. Quality assurance 10. Total quality management 11. Characteristics of tqm 12. Benefits of tqm:
  3. 3. QUALITY MANAGEMENT IN THE DRUG INDUSTRY (WHO) In the drug industry at large, quality management is usually defined as the aspect of management function that determines and implements the “quality policy”, i.e. the overall intention and direction of an organization regarding quality, as formally expressed and authorized by top management. The basic elements of quality management are: an appropriate infrastructure or “quality system”, encompassing the organizational structure, procedures, processes and resources; 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. 4. Within an organization, quality assurance serves as a management tool. In contractual situations, quality assurance also serves to generate confidence in the supplier. The concepts of quality assurance, GMP and quality control are interrelated aspects of quality management. They are described here in order to emphasize their relationship and their fundamental importance to the production and control of pharmaceutical products
  5. 5. The pharmaceutical environment today is changing quickly due to globalization, increased competition, cost constraints, demands for efficiency, development of international regulation, supply chain complexity, and product/process complexity. In this fast-changing environment, the people and companies that learn to adapt will prosper. To manufacture & deliver consistently zero-defect products to the patients. The quality, efficacy and safety attributes of products must be ensured so that the consumer health is not compromised. Why Quality is important in pharmaceuticals?
  6. 6. Impacts of ignorance on Quality MEDICINE QUALITY  Manufacturing process  Packaging  Transportation  Storage condition  Lack of therapeutic effect:  Prolonged illness  Death  Toxic and adverse reaction  Waste of limited financial resources  Loss of credibility
  7. 7. Quality Assurance Quality Quality Control
  8. 8. QUALITY: A measure of excellence or a state of being free from defects, deficiencies and significant variations. Quality is “totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs”. The ability to make the same thing the same way, over and over again. QA GMP QC
  9. 9. QUALITY CONTROL: Part of GMP concerned with sampling, testing and specifications. OR Process concerned with medicine sampling, specifications, and testing, and with the organization’s release procedures that ensure that the necessary tests are carried out and that the materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. According to Broom, quality control is “systematic control of these variables encountered in manufacturing process which affect the excellence of the end product.” According to Alford and Beatty, quality control is “that technique or group of techniques of industrial management by means of which products of uniform acceptable quality are manufactured.”
  10. 10. ROLE OF QUALITY CONTROL IN PHARMACEUTICAL INDUSTRY • Quality control is an essential operation of the pharmaceutical industry. • Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. • New and better medicinal agents are being produced at an accelerated rate. At the same time more exacting and sophisticated analytical methods are being developed for their evaluation. • The 4 Main responsibilities of quality control in pharmaceutical industry include : Efficacy Safety Quality Compliance
  11. 11. OBJECTIVES OF QUALITY CONTROL Establishment of quality standard: Main motive of QC is the economical production of a high quality product at the quality level the customer wants. Locating quality deviations: It is necessary to analyze the trend and extent of quality deviations in a manufacturing process, which should be explained by statistical techniques. Evaluating methods and processes of production: It is a corrective measure to maintain the quality. Quick sale of quality goods: QC accelerates the sale of the goods by supplying only the quality goods. Production of standard quality goods: QC aim at manufacturing standard quality products and avoids producing inferior quality goods. Improvement in quality: Aims at creating quality consciousness at all levels in the organization.
  12. 12. COMPONENTS OF QUALITY CONTROL Adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting and testing of starting materials, packaging materials and intermediate bulk and finished products and where appropriate of monitoring environmental conditions for GMP purpose.
  13. 13. QC LABS 1. Chemical Testing Lab 2. Instrumental Analysis Lab 3.Microbioloy and Toxicology lab 4. Provision for retained samples and stability samples 5. Documentation Room 6. Relevant Books 7. SOPs 8. Trained Personnel
  14. 14. SAMPLING • Approved method for sampling • Well trained personnel and sampling tools • Records maintenance of all sampling • Checklist for every stage • Sops divided into – before, during and after VALIDATION • All the methods used by QC, say for sampling, testing and other activities must be validated. • Validation of testing method is particularly very important.
  15. 15. RECORDS • Records must be made (manually and/or by recording instrument) demonstrating that all the required sampling, inspecting, testing procedures have been actually carried out and that any deviation have been recorded and investigated. • Recording is the primary basis of any pharmaceutical activity and hence all regulations insist on recording of each and every activity carried out. This helps in tracing the history of a batch produced; this may be required in future if any investigation is to be made. • The basic concept of GMP is – Do as you have written (i.e. SOPs) and write what you have done
  16. 16. FINISHED PRODUCT The finished product must contain ingredients complying with qualitative and quantitative composition of the product described in the marketing authorization, the ingredients must be of required purity, in their proper containers and correctly labeled.
  17. 17. Preparation of specifications for testing of materials and products. Carrying out Sampling and testing of materials or products. Environment Monitoring Conducting stability studies. Investigating test failures such as OOS / OOT / OOAC / OOAL. Analytical method validation. Evaluation of complaint samples. All the quality control activities are performed adherence to the GLP . Functions of QC in pharmaceutical industry:
  18. 18. Quality Management (QM) • A quality management system is a management technique used to communicate to employees what is required to produce the desired quality of products and services and to influence employee actions to complete tasks according to the quality specifications. • In brief, quality management is not the responsibility of management alone. • Participation/involvement of both parties (management and employees) is essential for achievement of quality and other benefits.
  19. 19. QUALITY ASSURANCE: Obtaining confidence that, required quality of product or service is satisfactory for their intended use. OR Sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable to the patient. QA= GMP + QC+ Product design and development + Quality goal activities QA is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers.
  20. 20. Goals of QA Programs:- • To make certain that each medicine reaching a patient is safe, effective, and of standard quality. • Obtaining quality products that are safe and effective through structured selection and procurement methods • Maintaining quality products through the appropriate storage, distribution, monitoring, and use by prescribers, dispensers, and consumers • Characteristics of a QA Program o Medicines are selected on the basis of safety and efficacy, in an appropriate dosage form with the longest shelf life.
  21. 21. • Suppliers with acceptable quality standards are selected. o Medicines received from suppliers and donors are monitored to meet quality standards. • Medicine packaging meets contract specifications. • Repackaging activities and dispensing practices should maintain quality. • Adequate storage conditions in all pharmaceutical areas are maintained. • Transportation conditions are adequate. o Product quality concerns are reported and monitored.
  22. 22. ACTIVITIES IN QUALITY ASSURANCE: 1. Planning 2. Data collection 3. Quality control 4. Documentation 5. Evaluation 6. Reporting activities
  23. 23. Total Quality Management Total - made up of the whole Quality - degree of excellence a product or service provides Management - act, art or manner of planning, controlling, directing,…. Therefore, TQM is the art of managing the whole to achieve excellence. Total Quality Management TQM, also known as total productive maintenance, describes a management approach to long-term success through customer satisfaction. In a TQM effort, all members of an organization participate in improving processes, products, services, and the culture in which they work. Total quality management (TQM) has been defined as an integrated organizational effort designed to improve quality at every level.
  24. 24. The concept of TQM • Produce quality work the first time. • Focus on the customer. • Have a strategic approach to improvement. • Improve continuously. • Encourage mutual respect and teamwork.
  25. 25. Characteristics of TQM Committed management. Adopting and communicating about total quality management. Closer customer relations. Closer provider relations. Benchmarking. Increased training. Open organization Employee empowerment. Flexible production. Process improvements. Process measuring
  26. 26. Principles of TQM: Management Commitment 1. Plan (drive, direct) 2. Do (deploy, support, participate) 3. Check (review) 4. Act (recognize, communicate, revise) Employee Empowerment 1. Training 2. Suggestion scheme 3. Measurement and recognition 4. Excellence teams Fact Based Decision Making 1. SPC (statistical process control) 2. DOE, FMEA 3. The 7 statistical tools 4. TOPS (Ford 8D – team-oriented problem solving)
  27. 27. Continuous Improvement 1. Systematic measurement and focus on CONQ 2. Excellence teams 3. Cross-functional process management 4. Attain, maintain, improve standards Customer Focus 1. Supplier partnership 2. Service relationship with internal customers 3. Never compromise quality 4. Customer driven standards
  28. 28. BENEFITS OF TQM: a) attain higher profitability and increased market share b) improve customer satisfaction c) improve organizational productivity d) improve employee morale and job satisfaction e) create a positive work culture f) undertake systematic problem solving and decision making through project teams g) improve teamwork h) create a climate conducive to continuous improvement
  29. 29. THANK YOU