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Total quality management (TQM), and current Good Manufacturing Practice (cGMP) for pharmacy students

TQM, cGMP, Introduction, Definition, Importance, TQM frame work, Key concepts (Principles) of TQM, specific steps in the cycle, Benefits of TQM, cGMP, principles of GMP, Improtance of GMP, why GMP established?, difference between GMP and cGMP, GMP and cGMP regulations, code of federal regulations.

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Total quality management (TQM), and current Good Manufacturing Practice (cGMP) for pharmacy students

  1. 1. Dr. P. Ravisankar M. pharm., Ph.D. Professor and HOD Department of PAQA Vignan pharmacy college, Vadlamudi B. Sindhura Total Quality Management (TQM) and current Good Manufacturing Practice (cGMP) For Pharmacy students (B. Pharm, M.Pharm and Pharm D)
  2. 2. Introduction  To the better understanding the meaning of the total quality management we should firstly understand the meaning of the “Quality”.  “Quality is customer satisfaction” ,“Quality is Fitness for Use.”  Loss of quality means loss of customer satisfaction , public health and loss of organization resource. Vignan Pharmacy College, Vadlamudi. 2
  3. 3. Definition  Total quality management (TQM) is a modern approach to the management of the whole organization that emphasizes the role of quality in meeting the needs and expectations of its customers.  TQM stresses the need for the whole company to manage quality at every stage of production and interaction with the customer Vignan Pharmacy College, Vadlamudi. 3
  4. 4. TQM can also be defined as 1. Total : Every employ of the organization is involved. 2. Quality : Customer requirements are continuously satisfied. The quality here focuses in 3 perspectives: Quality of the products and services aligned with customer specifications Quality or amount of returns to satisfy the stakeholder needs Quality of working conditions internal to the organization. Vignan Pharmacy College, Vadlamudi. 4
  5. 5. TQM can also be defined as 3. Management : Senior management is fully committed toward the goals of total quality (customer satisfaction, effective employee participation, doing things right first time, eliminating the wastes and defects, increasing the efficiency and effectiveness of the work) TQM ensures that the management adopts a strategic overview of the quality & focuses on prevention rather than inspection. Vignan Pharmacy College, Vadlamudi. 5
  6. 6. Importance  Quality culture means prevention and elimination of errors, waste, reworks. So, the concept of TQM has been developed from inspection of quality control and quality assurence.  TQM is extremely important to business because it keeps a company competitive and productive.  It not only focuses on quality but also on the continuous improvement of process capabilities. Vignan Pharmacy College, Vadlamudi. 6
  7. 7. TQM framework  It covers all aspects of an organization and the way it operates.  Performance is achieved by planning the involvement of people in improving the processes.  All this can be implemented by an effective leadership, communication and commitment. Excellent performance of TQM Vignan Pharmacy College, Vadlamudi. 7
  8. 8. Key concepts Vignan Pharmacy College, Vadlamudi. 8 TQM Systematic approach Integrated system Continuous improvement Effective communication trainingProcess thinking Customer satisfaction Total employee commitment Team work and quality chain
  9. 9. Vignan Pharmacy College, Vadlamudi. 9  There are number of key principles that can be identified and associated with the definition of the TQM, including: TQM principles Quality oriented management Satisfy the customer Satisfy the supplier Continuous improvement
  10. 10. Quality oriented management Vignan Pharmacy College, Vadlamudi. 10  Management should inspire and motivate the entire workforce  Communication strategy, method and timeliness must be well defined to be followed by the entire workforce.  The mission and vision should balance the needs of the company and customers.  Top management should act as the main driver for TQM and create an environment that ensures its success.
  11. 11. Satisfy the customer Vignan Pharmacy College, Vadlamudi. 11  Satisfaction is basically physiological state,  Satisfaction is a function of total experience with organization. The research gives ten domains of satisfaction includes: Quality, value, timeliness, efficiency, ease of access, environment, inter-departmental team work, commitment to the customer and innovation.
  12. 12. Satisfy the supplier Vignan Pharmacy College, Vadlamudi. 12  External suppliers: A company must look to satisfy their external suppliers by providing them with clear instructions and requirements and then paying them fairly on time.  Internal suppliers: A supervisor must try to keep his or her workers happy and productive by providing good task instructions, the tools they need to do their job and good working conditions. The supervisor must also reward the workers with praise and good pay.
  13. 13. Continuous improvement Vignan Pharmacy College, Vadlamudi. 13  It’s a never-ending improvement.  Continuous improvement, called kaizen by the Japanese, requires that the company continually strive to be better through learning and problem solving.  Now let’s look at two approaches that can help companies with continuous improvement: the plan–do–study–act (PDSA) cycle and benchmarking.
  14. 14. Continuous improvement Vignan Pharmacy College, Vadlamudi. 14  The Plan–Do–Study–Act Cycle The plan–do–study–act (PDSA) cycle describes the activities a company needs to perform in order to incorporate continuous improvement in its operation. Continuous improvement plan Do Study Act
  15. 15. Specific steps in the cycle Vignan Pharmacy College, Vadlamudi. 15 1. PLAN:  Managers must evaluate the current process and make plans based on any problems they find  They need to document all current procedures, collect data, and identify problems. 2. DO (implementing the plan) :  During the implementation process managers should document all changes made and collect data for evaluation.
  16. 16. Steps in the cycle Vignan Pharmacy College, Vadlamudi. 16 3. STUDY:  The data are evaluated to see whether the plan is achieving the goals established in the plan phase. 4. ACT:  The best way is to communicate the results to other members in the company and then implement the new procedure if it has been successful.  Note that this is a cycle; the next step is to plan again, we need to continue evaluating the process, planning, and repeating the cycle again.
  17. 17. Stone work of TQM Vignan Pharmacy College, Vadlamudi. 17 will focus on explaining the main steps (stages) that help in paving the way for the organizational transition to TQM…
  18. 18. Benefits of TQM Vignan Pharmacy College, Vadlamudi. 18  Customer’s confidence.  Improvement of organization's reputations.  Increase in productivity.  Reduction in product cost.  Increase in profits.  Employ motivation.  Team spirit.  Improvement in attitude.
  19. 19. Vignan Pharmacy College, Vadlamudi. 19
  20. 20. Current good manufacturing practice Vignan Pharmacy College, Vadlamudi. 20 What is good manufacturing practice (GMP) ?......... GMP is a part of quality assurence, which ensure that product are consistently produced and controlled to the quality standards.  Every product should be manufactured pure, safe, effective…  FDA is also having this responsibility and one of the FDI work and inspect, food , drug manufactured by the factories and other health care organizations.  These controls & practices established in government regulations called GMP.
  21. 21. Principles of GMP Vignan Pharmacy College, Vadlamudi. 21 1. Writing step by step operating procedures and work instructions. 2. Following written procedures and instructions. 3. Properly and accurately documenting our work. 4. Validating our work. 5. Designing & constructing facilities and equipment 6. Maintaining facilities and equipment.
  22. 22. Principles of GMP Vignan Pharmacy College, Vadlamudi. 22 7. Clearly defining, developing and demonstrating job competence. 8. Protecting our products against contamination. 9. Building the quality in to the product by system quality controlling components and product related process. Such as manufacturing, packing, labeling, testing, distribution, marketing. 10. Conducting planed and periodic audits.
  23. 23. why are GMP’s requirement? Vignan Pharmacy College, Vadlamudi. 23 Government requirement. Ensure quality products. Reduced rejects and recalls. Satisfied customers. Maintain manufacturing consistency. Company image and reputation.
  24. 24. Importance of GMP Vignan Pharmacy College, Vadlamudi. 24  In the United States the Center for Drug Evaluation and Research (CDER) promotes and protects public health by assuring that safe and effective drugs.  There exits different types of risk with medicines..  one of which is a preventable adverse event, which can be caused by different reasons.  One of the reasons for this event can be a product quality defect.  This risk can be avoided by effective implementation of GMP.
  25. 25. why good manufacturing practices (GMPs) established?... Vignan Pharmacy College, Vadlamudi. 25 GMP regulations were originally established over time after three tragedies. They are as follows: 1. Elixir sulfanilamide disaster. 2. Sulfathiazole calamity. 3. Thalidomide disaster.
  26. 26. Elixir sulfanilamide disaster Vignan Pharmacy College, Vadlamudi. 26  In mid 1937 S.E Massengill company, a pharmaceutical manufacturer has been selling, treatment for streptococcal infections in tablets and powder form.  So, in 1937 the company’s chief pharmacist and chemist created the liquid form by dissolving in the active ingredient.  By Diethylene glycol (CH2OH)2O as a solvent a new product was formed. The preparation is called as “elixir sulfanilamide” by the addition of raspberry as a flavoring agent
  27. 27. Vignan Pharmacy College, Vadlamudi. 27  The company chemist who designed the cough syrup by mixing a sulfa drug into the poisonous sweetener.  FDA scientists would quickly realize, the syrup was toxic because it was sweetened by a compound known as DEG which kills by causing acute kidney damage.  The first case of a death from ethylene glycol occurred in 1930 and studies had been published in medical journals stating DEG could cause kidney damage or failure.  Although animal testing should have been routine in most drug company operations, Massengill performed none .
  28. 28. Vignan Pharmacy College, Vadlamudi. 28  As FDA scientists would quickly realize, the syrup was lethal because it was sweetened by a compound known as diethylene glycol.  The company started selling and distributing the medication in September 1937. By October 11, the American Medical Association received a report of several deaths caused by the medication.  Watkins, the chemist, committed suicide while awaiting trial.  Congress responded to public outrage by passing the 1938 Food, Drug, and Cosmetic Act, which required companies to perform animal safety tests on their proposed new drugs.
  29. 29. Sulfathiazole calamity Vignan Pharmacy College, Vadlamudi. 29  In 1940, a cross-contamination from equipment sharing resulted in Winthrop chemical producing contaminated sulfathiazole tablets contaminated with sedative phenobarbital.  An investigation by US Food and Drug Administration and the findings resulted in actions. Therefore the agencies retrieve the drug remaining on the market.  The incident was powerful in the introduction of GMP for drugs.  This results in more than 300 deaths and injuries.
  30. 30. Vignan Pharmacy College, Vadlamudi. 30  Thalidomide was first developed by a German pharmaceutical company called Grunenthal in Stolberg.  Thalidomide, this first enter the German market in 1957 over the counter as OTC for nausea.  The drug was marketed under the name Grippex, which contained a combination of thalidomide, vitamin C, acetylsalicylic acid, quinine and phenactin.  Researchers at Grunenthal also discovered that thalidomide could relieve morning sickness in pregnant women
  31. 31. Vignan Pharmacy College, Vadlamudi. 31  Thalidomide was found to cause deformity in children born to mothers who took the drug and affected over 10,000 babies.  These babies were born with missing or abnormal limbs, feet or hands. Other defects included abnormal or absent ears, heart and kidney problems, cleft palate, spinal cord defects and digestive system disorders.
  32. 32. Vignan Pharmacy College, Vadlamudi. 32  In march 1962 the drug was banned in most countries where previously sold. In July 1962 president Kennedy presented “federal civilian service medal” to FDA inspector Frances Kelsy who prevented drug approval in the U.S.  These three tragedies were responsible for the establishment of the Good manufacturing practices (GMP’s).
  33. 33. GMP Vs cGMPs Vignan Pharmacy College, Vadlamudi. 33  GMP’s have been accepted and followed by most of the countries to attain global standards, and to assist in giving people healthcare and pharmaceutical products that are of similar quality.  GMP’s have become a necessary to export healthcare products between more than 100 countries of the world. It has become a trend to refer to GMP as cGMPs.  Here, c refers to current rules and regulations that serve strictly follow the guidelines and manufacturing procedures that are current and most up to date.
  34. 34. Vignan Pharmacy College, Vadlamudi. 34  The use of c as a prefix to GMP is a an attempt.  Regulating authorities especially manufacturers who agree to follow the guidelines but still use 20-25 year old machinery and equipment to produce healthcare products.  GMP forced many manufacturers to give up on old practices and switch over to latest production processes.  It has also helped in avoiding contamination, errors and mix ups while at the same time helping in production of highest quality healthcare and pharmaceutical products.
  35. 35. Current good manufacturing practices Vignan Pharmacy College, Vadlamudi. 35  The WHO drafted its good manufacturing practices for the manufacture and quality control of drugs in 1967.  QA & QC departments develop and follow standard internal operating procedures directed towards assuring the quality, safety, purity, and effectiveness of drug product.  GMP is also sometimes referred to as "cGMPs".  The FDA has issued a primary regulations to the industry entitled current good manufacturing practice.
  36. 36. cGMPs follows Vignan Pharmacy College, Vadlamudi. 36  cGMPs are followed by pharmaceutical and biotechnology companies to ensure that their items are manufactured to specific requirements including identity, strength, quality, and purity.  There are a number of federal regulations that relate to cGMPs which, if not followed, can lead to criminal penalties.  Two specific regulations that relate to pharmaceutical manufacturers.1.biological products, 2. Regulations that regulates of electronic records and electronic signatures.
  37. 37. Good manufacturing practice Current good manufacturing practices Vignan Pharmacy College, Vadlamudi.  GMP refers to Goods Manufacturing Practices that are guidelines followed by over 100 countries  GMP applies to pharmaceutical and healthcare products and help to maintain high standards in these products.  cGMPs is current goods manufacturing practices that need to be followed by participating countries.  cGMPs is to remind accepting countries that all guidelines must be followed with latest and current production processes. 37 Difference between GMP and cGMPs
  38. 38. Vignan Pharmacy College, Vadlamudi. 38 Components of cGMPs The components of cGMPs are as the following- 1. Quality management. 2. Quality control. 3. Sanitation and Hygiene. 4. Validation. 5. Complaints. 6. Self-inspection and Quality audit. 7. Personnel. 8. Premises. 9. Equipment. 10. Documentation.
  39. 39. GMP (OR) cGMPs regulations Vignan Pharmacy College, Vadlamudi. 39  In March 1979, the FDA issued revised GMP regulations.  The federal Food, Drug, and cosmetic act states that a drug is deemed to be adulterated during the production.  FDA ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (CGMP) regulations.  FDA can issue a warning letter against a company that fails to comply with Current Good Manufacturing Practice regulations.
  40. 40. Code of federal regulations Vignan Pharmacy College, Vadlamudi. 40 The regulations document the actions of drug sponsors that are required under Federal law.  21 Code of Federal Regulations Part 210. Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs.  21 Code of Federal Regulations Part 211. Current Good Manufacturing Practice for Finished Pharmaceuticals.
  41. 41. Vignan Pharmacy College, Vadlamudi. 41 Some of federal regulations  211.42 design and construction features  211.46 ventilation, air filtration, air heating, and cooling  211.56 sanitation  211.58 maintenance  211.65 equipment construction  211.67 equipment cleaning and maintenance  211.87 retesting of approved components, drug product containers, and closures.  211.111 time limitations on production
  42. 42. References Vignan Pharmacy College, Vadlamudi. 42  The science & practices of pharmacy volume-2 – Remington. (pg. no. 1018-1024)  Advanced pharmaceutical analysis – Dr. G. Devala Rao. (pg.no. 270- 272).  http://www.fda.gov/Drugs/DevelopmentApprovalProcess.  www.intechopen.com.  https://www.youtube.com/watch?v=GVyooqOYS7a  http://pharma.about.com/od/C/g/Current-Good- Manufacturing-Practices-Cgmps.htm
  43. 43. Vignan Pharmacy College, Vadlamudi. 43