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  1. TOTAL QUALITY MANGMENT By: Radhika soni(48) Industrial Pharmacognostical Technology Faculty of Pharmacy M.Pharm (pharmacognosy) sem-I 1
  2. Contents: • Introduction OF TQM • Key elements of TQM • Advantages of TQM • TQM in drug industry • Quality by design 2
  3. Introduction • Quality: The degree to which a set of inherent characteristics fulfills the requirements • Quality is a term that is widely used when talking about how good or poor a product or service is. • What is TQM? ‘‘TQM is a structured approach to organizational management with a process focused on improving the quality of outputs of an organization, including services and goods, by the constant improvement of its internal practices.’’ or ‘‘TQM is an organizational management philosophy seeking to continuously improve the quality of processes and products.’’ • Using a set of management and quality tools, TQM approach seeks to increase business even as it reduces loss due to improper practices. Being a highly adaptable concept, it has been widely applied in several industries in the production and service sectors. 3
  4. • The main components of TQM include: Focus on consumer Analysis of process Work in quality teams Systematic analysis of problems Implement planned changes and evaluate results Use data to identify problems and solutions Implement changes • TQM is also based on the main principle that mistakes are often a result of faulty processes and systems. By identifying the causes of such mistakes, it is possible to eliminate them through three mechanisms:  Prevent errors from occurring. Where prevention is not possible, early detection to prevent the mistake causing damage down the chain. Immediate correction of process if mistakes recur. 4
  5. Key elements of TQM • There are eight key elements on which an organization must focus to implement TQM with success: (a) Ethics (b) Integrity (c) Trust (d) Training (e) Teamwork (f) Leadership (g) Recognition (h) Communication • These eight elements are further clubbed into four groups as based on their function. (a)Group I – Foundation (c) Group III – Binding Mortar (b)Group II – Building Bricks (d) Group IV – Roof 5
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  7. 1. Foundation: ‐ A foundation of ethics, integrity and trust helps to create an open and fair environment that fosters involvement by everyone in the organization. ‐ Ethics deals with what is good and bad in a given situation, both at the individual and the organizational levels. ‐ Integrity refers to the honesty with which one adheres to facts. ‐ When ethics are followed with integrity, it leads to development of trust, the third element of the ‘foundation’, which creates an environment of cooperativeness. 2. Building Bricks: ‐ Employees need to be trained in performing their duties right and in problem solving. ‐ They must also be trained in interacting with others, to do their job better through teamwork. ‐ Any team is only as good as its leader and so here has to be inspirational leadership by someone who understands TQM and is committed to it in daily practice. 7
  8. 3. Binding Mortar: ‐ The link which binds all elements of TQM is communication which refers to a common understanding of the message by both the sender and receiver. ‐ Openness in communication between members of an organization and with vendors and customers is key to the success of TQM. 4. Roof: ‐ Recognizing the contributions of people in an organization, whether for teams or for individuals, is the final element in TQM. ‐ When employees receive recognition, it brings about a leap in their self-esteem and such employees are more motivated which ultimately leads to better productivity and quality of work they do. 8
  9. Advantages of TQM: • Innovation in processes • Greater productivity • Reduced defects in product • Increased customer satisfaction • Higher profitability and reduced costs • Higher employee morale • Better adaptability to changing market conditions • Increased competitiveness 9
  10. TQM in drug industry: • As time evolved pharmaceutical processes grew more complex, it gradually came to be realized that no process is perfect all the time, and there are drifts from the normal functioning. • According to regulatory bodies across the world, high quality drug products are those that can be relied upon to deliver the desired clinical effects with consistency. • Consumers of medicines need to know for sure that the drug product they are consuming are of good quality, safe for consumption, and will be effective in relieving them of their ailment. • This quality can be guaranteed only if the products have it built into them right from the very first stage of design of the product and process. • Realization of this basic principle led to the International Conference on Harmonization (ICH) in 2002, introducing a unheard term in the drug processing field – the concept of ‘Quality by Design’ or QbD. 10
  11. Quality By Design • The ICH guideline Q8 Pharmaceutical Development defines QbD as, “A systematic approach to development that begins with predefined objectives, emphasizes product, process understanding and process control based on sound science and quality risk management.” • To achieve the objective of QbD, it is important to understand product characteristics and study process characteristics using a combination of prior knowledge and experimental studies. • From this data generated during product development, it becomes possible to decide which quality parameters in starting materials are the most important and which critical processing factors need to be controlled to achieve a product with all the desired quality attributes. • Developing such pharmaceutical quality systems is the key to meeting patient requirements in an efficient manner. Because they deliver consistent quality, these systems also serve to increase the confidence of regulatory bodies about the organization’s commitment to quality. 11
  13. Elements of QbD : 13
  14. Applications: 14
  15. References: • A. R. Kashi, B. Sukumaran, P. Venna ; A Text Book of Pharmaceutical Quality Assurance; Nirali Prakashan; 1st Edition; 2020: 2.1-2.6. • D. Ranjan, R. B. Bodla; QbD: Key To Quality Pharmaceuticals; Scholars Academic Journal Of Pharmacy; 260-265. 15
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