Quality assurance and quality management concepts ppt.pptx

quality control tools, NABL, ISO 9000, ISO 14000 , total quality management, quality by design, ICH guidelines

1. Ms . Tilottama M. Gatkine Assistant Professor Nagpur College of Pharmacy, Wanadongari . Quality assurance and quality management concepts

2. Introduction Definations Good manufacturing practices (GMP) Total quality management(TQM) ICH guidelines Quality by design ( QbD ) ISO 9000 AND ISO14000 NABL accreditation Content 2

3. The word quality generally has different meanings, Quality can be defined as “fitness for use”, “customer satisfaction,” “doing things right the first time”, of “ zero defects”. Quality is defined as “ an inherent characteristics, property or attribute. A management technique used for communicating 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 is termed Quality Management system (QMS). A QMS Is a set of policies, processes, and procedures required for planning and execution (production, development, or service) in the core business area of an organisation (i.e., area that can impact the organisation’s ability to meet customer requirements). An example of a QMS is ISO 9001 3 introduction

4. Defination : Quality assurance : According to WHO, quality assurance is a wide- ranging concept covering all matters that individually or collectively influence the quality of a product. With regard to pharmaceuticals, quality assurance can be divided into major areas: development, quality control, production, distribution, and inspections. ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled B. Quality control : ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements". It is that part of GMP concerned with sampling, specification & testing, documentation & release procedures which ensure that the necessary & relevant tests are performed & the product is released for use only after ascertaining it’s quality. introduction 4

5. The term quality assurance and systematic activities required for assuring that a product or service will meet the specifications. T he difference between quality control and quality assurance is that the former makes quality product and the latter assures the same Q uality assurance function should represent the customers and should not depend on quality control function that forms and integral part of the manufacturing operation. The system of quality assurance appropriate to the manufacture of the pharmaceutical products should ensure that: Pharmaceutical products are designed and developed in a way that takes account of the GMP requirements and other associated codes such as those of Good   laboratory practices(GLP) and Good clinical practice (GCP). 5 Quality assurance

6. Production and control operations are clearly specified in a written form and GMP requirements are adopted Managerial responsibilities are clearly specified in job descriptions. Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials. All necessary controls on starting materials, intermediate products, and bulk products and other In process controls, calibration, and validations are carried out. The finished products is correctly processed and checked, according to the defined procedures. Pharmaceutical products are not sold or supplied before the authorised persons have certified that each productions batch has been produced and controlled in accordance with the requirements of marketing authorisation and any other regulations relevant to the production, control and release of pharmaceutical products. Deviations are reported investigated and recorded 6

7. 9. Satisfactory arrangements exist to ensure that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that the quality maintained throughout their shelf life 10. There is a procedure for self inspection and or quality audit that regularly appraises the effectiveness and applicability of the quality assurance system. 11. There is a system for approving changes that may impact product quality 12. Regular evaluations of quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement 7

8. The Term quality control includes various techniques and activities of an organisations that are involved in the monitoring and improving the business so that products, processes or services meet the standard specifications. It aims to identify and eliminate the causes of substandard performance by removing or reducing the variation sources. the quality control program works on the objective to define a system in which the products meet the design requirements and checks and feedback for corrective actions and process improvements. In manufacturing or service environment, quality of design and quality of conformance are the two major categories of quality. 8 Quality control

9. Quality of design H igh grade materials, tight tolerances, special features, and high performance are characteristics related to the high quality product. Quality of Conformance After determining the quality of design, the product characteristics are formed into drawings and specifications, which are used by the manufacturing engineer to develop manufacturing standards and design the operations as required for production. The quality and the manufacturing engineers of together to make the quality system and maintenance of conformance quality an integral part of the manufacturing process A ny product checks, process checks, or quality improvement activities are an inherent part of the process C onformance quality is the degree of adherence of the product characteristics to the design drawings and specifications. The objective of quality program is to have a system that economically measures the controls and degree of the product and process conformance. 9

10. 10 Good manufacturing practices

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12. GMP is a part of quality management that ensures that products are consistently manufactured and analysed as per the quality standards appropriate for use and as required by the marketing authorisation , clinical trial authorisation , or product specification. Personnel Buildings and Infrastructure Process equipment Documentation and records Materials management Production and in- process controls Packaging and identification labelling of APIs and intermediates Storage and distribution Laboratory controls Validation Change control Rejection and re-use of materials Complaints and recalls 12 introduction

13. 13 Total quality management (TQM) Definations An integrated organisational efforts to improve the product quality at every level is referred to as Total Quality Management (TQM) TQM involves the management methods used for improving the quality and productivity of business in an organisation . It is comprehensive management approach that works parallelly with the organisation , involving all departments and employees and extending backword and forward to include both suppliers and clients or customers.

14. Elements According to their function, the TQM elements can be categorised into : Foundation : It involves ethics, integrity and trust Ethics : It is the discipline related to good and bad deeds under any circumstances. It is a two faceted subject, including organisation ethics and individual ethics. Organisation ethics refers to a business code of that setup guidelines which the employees follow while performing their work individuals ethics refers to the personal rights or wrongs. Integrity : Some characteristic traits like honesty morals, values, fairness and adherence to the fact and sincerity. These characteristics define what internal or external customers expect and what they deserve to receive. the opposite of integrity is duplicity, and TQM does not work under duplicity conditions. 14

15. Trust : It is the by product of integrity and ethical conduct, and builds the framework of TQM. T rust results from about two features. T rust ensures participation of all the members and allows empowerment that influences Pride ownership and commitment for the task to be performed. 2. Building bricks : It involves training, teamwork, and leadership Training : I t makes employees more productive. T raining provided to the employees including interpersonal Skills, decision making, job management, performance analysis, problem solving ability, business economy, technical skills. T raining is generally provided by the supervisors so that they can implement TQM as per the requirements of their department and guide their subordinates. 15

16. Teamwork : For a successful business, teamwork is one of the important components and therefore is categorised as key element of TQM. T eamwork provides quicker and better solution to problems in business. A team also provides more permanent improvement in processes and operations. Quality improvement Teams (QITs) or excellence teams Problem solving teams (PSTs) Natural work teams (NWTs) Leadership : I t is the most important TQM element that can be seen everywhere in an organisation . In TQM, leadership requires the manager to provide an inspiring vision, to make strategic directions which can be understood by all, and to provide guidelines for the employees. 16

17. Binding mortar : Communication act as a buildings and other elements of TQM together starting from house everything is bound together strong mobile of communication does it can be said that its act as a vital between hall ticket elements. Following different ways of communication : Downward communication Upward communication Sideways communication 3. Roof (Recognition) It is the last element of TQM forms the roof of the entire system. It should be provided for the suggestions as well as for achievements for teams and for individuals. within an organisation , employees are striving to receive recognition for themselves and their team. I t is the responsibility of a supervisor to find and recognise the contributors. Such recognition significantly changes the self-esteem, productivity, quality and efforts of an employee. Ways Places Time 17

18. The main charateristic of TQM is to focus on determining the root causes of quality problems and overcoming them at the source, as opposed to inspecting the product after it has been made. Quality circle Customer focus Continuous improvement Quality tools 18 Philosophies

19. Use of quality circle is successfully implemented by some organisations as part of an on-going improvement programme . While some organisations experimented with the quality circles with the best intentions and faced many obstacles. B ut the fact is that this type of participatory management gives many benefits to all concerned. Objectives Improvement of the quality and productivity so that enterprise can be improved and developed. R eduction of the cost of the products or services by reducing the waste, by effective utilisation of resources, and by avoiding unnecessary errors and defects.   To develop a sense of security for human needs of recognition, achievement and self-development. 19 Quality circle

20. I dentification of the work related problems that hinder with production and their correction. O ptimum use of the human resources and identification of creative intelligence of the people working in the organisation . P roviding required training to the employees to develop and use greater amount of knowledge and skills. M otivating the employees for performing a wide range of challenging tasks. I mprovement of communications within the organisation . D eveloping within the employees the sentiment of loyalty and commitment towards the organisation and its goals.   R espect for humanity and building a happy workplae environment  I ncrease human capability, confidence, morale, attitude, and relationship. 20

21. Develops of high level of productivity and quality mindedness Self and mutual development of employees builds up teams spirit and unity of action . develops in the employees the sense of motivation, job satisfaction, and pride for their work Increases the work efficiency of employees Reduces the number of absentees and labour turnover Develops in the employees the sense of belongingness towards the organisation Redues waste and cost Improves communication Improves safety Increases the consciousness and morale of employees through recognition of their activities Develops leaderships skills, Trains the staff 21 Advantages

22. Understand customer needs and expectations for products, delivery, price, dependability, etc., ensure a balanced approach among customers and other stakeholders needs and expectations communicate these needs and expectations throughout the organisation Measure customer satisfaction and act on results and manage customer relationships 22 Customer focus

23. Make continual improvement of products, processes, and systems an objective for every individual in the organisations apply the basic improvement concept of incremental improvement and break through improvement use periodic assessments against established criteria of excellence to identify areas for potential improvement continually improve the efficiency and effectiveness of all processes promote prevention based activities provide every member of organisation with appropriate education and training on the methods and tools of continual improvement such as the plan-do-check act cycle, problem solving, process re-engineering, and process innovation, establish measures and goes to guide and track improvements and recognise improvements 23 Continuous improvement

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25. TQM puts a great deals of responsibility on all the employees. If they have been assigned the job to identify and overcome quality problems, they should be provided proper training, and should be made aware of how to evaluate quality by using various quality control tools, how to interpret findings, and how to rectify problems. 25 Quality tools

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27. It strengthens a competitive position It improves the adaptability to changing or emerging market conditions and to environmental and other government regulations It increases productivity It enhances the market image It eliminates defects and waste It reduces costs and better cost management It increases profitability It improves customer focus and satisfaction It increases customer loyalty and retention It increases job security It improves employee morale It enhances shareholder and stakeholder value It results in improved and innovative processes 27 Advantages

28. Initial introduction costs-training workers and disrupting current production whilst being implemented Benefits may not be seen for several years Workers may be resistant to change and may feel less secure in jobs It is a long-term process that shows results only after years have passed. 28 disadvantages

29. ICH stands for International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. ICH is a joint initiative in which regulators as well as research-based industry initiatives of Europe, Japan,and U.S. involve in scientific and technical discussions regarding the testing procedures and their evaluation to ensure safety, quality and efficacy of the medicines. ICH was originated in April 1990 at a meeting hosted by the EFPIA (European Federation of Pharmaceutical Industries and Association) in Brussels. 29 ICH Guidelines

30. It Monitors updates, and increases the international hormonization of technical requirements. I t ensures safety, efficacy and quality of medicines that should be developed and registered in an efficient and cost-effective manner It promotes and protects public health from an international perspective It prevents unnecessary duplication of clinical trials in humans  It reduces animal testing without compromising the safety of effectiveness It improves the efficiency of global drug development 30 purpose

31. The ICH steering committee and its subgroups comprise of representatives from six parties, representing the regulatory bodies and research based industries in the USA, Japan, European union. The European Free Trade association (EFTA), World Health Organisation (WHO), and Canada are these non-voting members of the ICH steering committee and its sub-group . 31 Participants Regions Regulatory Bodies Research based Industries Japan MHLW- Ministry of Health, Labour and Welfare JPMA- Japan Pharmaceutical Manufacturers Association Europe EU- European Union EFPIA – European Federation of Pharmaceutical Industries and Association USA FDA- Food and drug administration PhRMA - Pharmaceutical research an Manufacturer of America

32. Each of the six official ICH members (namely, EFPIA,EU, MHLW, JPMA , PhRMA AND FDA) and the ICH observers (namely, WHO, EFTA and Health Canada) appoint official representatives to each ICH working groups. The official membership of ICH expert working groups should comprise of a topic leader and a deputy topic leader for ICH members and one representative for each ICH observer.(EFTA, Health Canada and WHO) 32

33. The ICH steering committee is responsible for the ICH administration, including determining the adoption of every ICH project, whether a new issue, maintenance of an existing guidelines, of specific implementation work. E ach harmonization action is started with the concept paper which includes a short summary of the proposal. A business plan may also be needed as for the category of harmonization activity. any ICH member or observer can offer of proposal for a new ICH implementation activity. The ICH steering committee determines the adoption of every ICH task and supports the creation of a EWG/IWG. T he ICH harmonization activities are categorised into formal ICH procedure, questions and answers procedure, revision procedure and maintenance procedure. 33 Process harmonization

34. Formal ICH Procedure Step 1 : Consensus building Step 2a: Confirmation of six-party unanimity on the technical documents Step 2b : Espousal of the draft guideline Step 3 : Regulator consultation and discussion Stage 1 : Regional regulatory consultation Stage 2 : Discussion of regional consultation comments Stage 3 : Finalisation of step 3 experts draft guidelines Step 4 : Acceptance of an ICH Harmonised Tripartite guideline Step 5: Implementation Questions and answers procedure Revision procedure Maintenance procedure 34

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37. 37 S-series guidelines

38. 38 E-series guidelines

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40. Climatic zones for stability testing F or stability testing, the world has been divided into four zones depending on the environmental conditions to which the pharmaceutical products are subjected during storage. These conditions have been derived based on the mean annual temperature and relative humidity data and this data helps in deriving the long-term or real-time stability testing conditions and accelerated stability testing conditions. The stability conditions have also been harmonised and adjusted to enhance their practical use in industries. 40 ICH stability testing guidelines

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42. The protocol for stability testing is an essential requirement before starting stability testing and is a written document containing the key component of the regulated and well-controlled stability study T he protocol should represent the regions where the product is planned to the marketed; for example, the stability program should include I-III, IVa and IVb climatic zones if the product is proposed to be used in all these zones. Batches Containers and closures Orientation of storage of containers Sampling time points and sampling plan Test storage conditions Test parameters Test methodology Acceptance criteria 42 Protocol for stability testing

43. At Development of stages, a single batch is subjected to stability studies; first three production batches are subjected to studies proposed for registration of new product or unstable is establish product; and stable and well established batches are subjected to both the studies. The first three batches of drug product manufactured after approval should be subjected to long-term studies using the same protocol as in approved drug application. The laboratory scale batches data obtained during development of pharmaceuticals are not accepted as primary stability data but constitute supportive information. Selection of batches should be done by taking a random sample from the population of pilot or production batches. 43 Batches

44. The product is tested in immediate containers and closes intended for marketing. T he packaging materials including aluminium strip packs,Alu-Alu packs, HDPE bottles, secondary packs, etc. P roducts in different types of the containers/closures either meant for the distribution or for physician and promotional samples, should be separated tested. However, testing for bulk containers should be done in prototype containers if it stimulates the actual packaging 44 Containers and closures :

45. Samples collected from solutions, dispersed systems and semi solid drug products for conducting stability studies should be kept upright either inverted or on the side to allow interaction between the product and the container closer. through this orientation, it can be determined that the drug products or solvent and the closure in contact causes extraction of chemical substances from the closure components or adsorption of product components into the container-closure. 45 Orientation of storage of containers

46. Bracketing is a stability study schedule design in which only samples on the extremes of certain design factors are tested at all time points as in a full design. Matrixing on the contrary is stability schedule design in which of subset of the total number of possible samples for all combinations is tested at the specific time point. Sampling plan for stability testing involves planning for the samples to be the charged to the stability chambers and sampling out of the charged batch to cover the entire study. the entire process of sampling plan should involve development of sampling time points followed by the number of samples to be collected at each pull point for evaluation of all the test parameters and lastly summing up all the samples to get the total number. 46 Sampling time points and sampling plan

47. 47 Test storage conditions

48. The test parameters to be used for evaluating the stability samples should be describes in the stability test protocol. T he test monitoring the quality, purity, potency, and identity of the drug substance or product, which might change on storage, are selected as stability tests. Thus, the tests for appearance, assay, degradation, microbiological attributes and microbial count . 48 Test parameters

49. The procedures given in the official compendia should always be followed so that the result obtained from the official tests find better acceptance. If using alternate methods, they should be appropriately validated . However, the drug should assayed by the stability indicating method , established by carrying out stress test on the drug under force decomposition conditions. the specificity, accuracy, precision, and linearity in the range to which the drug is expected to fall during stability studies should be validited for this method the methods reported in literature should be used after confirming reproducibility and validating the linearity, range, etc. A standard test protocol(STP) for each test should always be prepared. 49 Test methodology

50. T he acceptance criteria for each stability test are fixed in the form of numerical limits for the results quantitative test, example, moisture pick up, viscosity, particle size, assay, degradation products, etc. and as pass or fail for the results of qualitative tests, example odour , colour , appearance, cracking, microbial growth, etc T he individual and total upper limits for the degradation production should also be included in this acceptance criteria ICH guidelines Q3B(R2) related to impurities in new drug products addresses degradation products in new drug formulations. 50 Acceptance criteria

51. The concept of QbD was developed by DR. Joseph M. Juran, who believed that quality should be designed into a product, and most quality problems are related to the way in which a product was designed. QbD involves designing and developing formulations and manufacturing processes that ensure predefined product specifications. It aims to shift from the concept of quality by testing to a development that improves the understanding of the processes and the products, and hence the product quality, process efficiency, and regulatory flexibility. 51 Quality by design ( qbd )

52. According to ICH Q8(R2) guideline, QTPP is described as a prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product. QTPP defines the properties of drug product that are essential to deliver therapeutic benefits mentioned in the label. Tablet characteristics Identity Assay and uniformity Purity and impurity Stability Dissolution 52 Quality target product profile (QTPP)

53. The next step after QTPP identification is the identification of relevant CQAs. A CQA is defined as a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality. 53 Critical quality attributes (CQA)

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55. According to FDA, risk management is a strategic safety program designed to reduce product risk by using one or more interventions or tools. QRM is a systematic process designed to assess, control, communicate, and review the risks related to the quality of the drug product during the product lifecycle. Failure Mode Effects Analysis (FMEA) Failure Mode, effects and critically Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Points (HACCP) 55 Quality risk management (QRM)

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57. According to the ICH Q8(R2) guideline, design space is defined as the multidimensional combination and interaction of input variables and process parameters established to provide quality assurance. Design space may be established for a single unit operation, multiple unit operations, or the entire process. But as per the FDA guideline defining design space is not an essential condition because the product and process understanding can be established without a formal design space; however, such an approach regarding the design space can be helpful for better understanding and overall control of a system. Design space can be determined by the following methods : One-variable-at-a-time experiments Statisitcally designed experiments Modelling approaches 57 Design space

58. According to the ICH Q10 guideline, a control strategy is defined as a planned set of control derived from current product and process understanding that assures process performance and product quality. 58 Control strategy

59. Prior knowledge : The term prior knowledge has been widely used in workshops, seminars, and presentations. Knowledge is defined as an awareness o f someone or something that can include information, facts, descriptions, and skills attained through experience or education. Design of Experiments (DOE) : I t is a structured and organised method od determining relationship between the factors influencing process outputs. When DoE is applied to a pharmaceutical process, factors like raw material attributes, process parameters and outputs are the CQAs such as blend uniformity, tablets hardness, thickness, and friability. Process Analytical Technology (PAT) : I t is defined as a system for designing, analysing , and controlling manufacturing through measurements, during processing of CQAs of raw and in-process materials and processes, to ensure the final product quality. 59 Tools for qbd

60. Design space is the key and critical process parameter identified from process characterisation studies and the acceptable ranges. NIR is a tool for PAT and is useful in Real Tie Release Testing (RTRT) as it monitors the particle size, blend uniformity, granulation, content uniformity, polymrophism , dissolution and monitoring the process online, at the time and offline, thus reducing the release testing of the product. 3) Risk Management Methodology : Quality risk management is defined as a systematic process for the assesment , control, communication and review of risks to the quality of the drug product across the product lifecycle. The pharmaceutical industry and regulators, with the help of the following risk management tools and internal procedure, such as basic risk management facilitation methods, evaluate and manage risks : 60

61. Failure Mode Effects Analysis (FMEA) Failure Mode, Effects and Criticality Analysis (FMECA) Fault Tree Analysis (FTA) Hazard Analysis and Critical Control Points (HACCP) Preliminary Hazard Analysis (PHA) Risk ranking and filtering 61

62. ISO refers to International Organisation for Standardisation . ISO 9000 is a set of International standards on quality management and quality assurance. ISO 9000 helps a company to satisfy its customers, meet regulatory requirements, and achieve constant improvement. ISO 9000 is widely recognised in the world. It aims to implant a quality management system in an organisation for increasing productivity, reducing unnecessary costs, and ensuring quality of processes and products . 62 ISO 9000 and iso 14000

63. The organisation gains customers’s confidence when it gets ISO certified. ISO 9000 requires a well-documented software production process that contributes to repeatable and higher quality of the developed software. ISO 9000 the development process focused, efficient,and cost effective. ISO 9000 certification recognises the weakness of an organisation and recommends corrective measures. ISO 9000 sets the basic framework for developing an optimal process and Total Quality Management (TQM). 63 Benefits

64. Management responsibility Quality system Contract review Design control Document control Purchasing Handling of purchaser supplied product Product identification and Traceability Process control Inspection and testing Inspection, Measuring and test equipment 64 Elements 12. Inspection and test status 13. Control of non- conforming product 14. Corrective action 15. Handling , storage, packaging and delivery 16. Quality records 17. Internal quality audits 18. Training 19.Servicing 20.Statistical techniques

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66. ISO 14000 is a series of international environmental management standards, guides, and technical reports. The requirements for establishing an environmental management policy, determining environmental impacts of products or services, planning environmental objectives, implementing programs to meet objectives, and conducting corrective action and management review. Since 1947, the ISO has been developing voluntary technical standards for all sectors of business, industry, and technology. ISO 14000 grew out of ISO’s commitment to support sustainable development as discussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992. The first standards, i.e., ISO 14004 and ISO 14001, were published in 1996 in the months of September and October . 66 Iso 14000

67. ISO 14000 certification is achieved either when a qualified auditor verifies that all the requirements have been fulfilled or when a company self-declares so. Companies and customers also play more for environmental friendly products. If the ISO 14000 standards are met, the product cost is reduces, as it encourges the efficient use of resources and waste limitation. This leads to ways of recycling products of new uses for previously disposed by-products. It also results in better conformance to environmental regulations, greater marketability, better use of resources, higher quality goods and services, increased levels of safety, improves image and increased profits. Certification and documentation also assist a company in gaining funds, in guarding itself during environmental litigtion , and in receiving insurance or permits. 67 Benefits

68. The producers of consumer goods will realise that many consumers purchase goods from environment friendly companies, and also spend more if they feel they are helping the environment. For acquiring this benefits, a company makes their environmental efforts acknowledged through advertisements and labelling . Finding ways to capture emissions or recycle the products any reduce the amount of raw materials and utilities used. If the amount of potentially dangerous substances in an end product is redues , dangerous chemicals will be less used in a plant, thus leading to a safer internal environment for empolyees and reducing insurance premiums. The employee morale improves when they feel their workplace is safe and their work contributes to the environmental effort. 68

69. Environmental policy Planning Implementation Study and correct Management review Continuous improvement 69 elements

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71. NABL stands for NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES Accreditation is the formal recognition, authorisation and registration of a laboratory that has demonstrated its capability, competence and credibility to perform the tasks it claims to be able to do. NABL has been authorised by the Indian Government as the accreditation body for testing and calibration laboratories. It aims to provide third-party assessment of quality and technical competence. Years ago, NABL accrediated laboratories linked with international bodies, like Asia Pacific Laboratory Accreditation Cooperation and International Laboratory Accreditation Cooperation, and thus got international recognition. The inetrnational standard currently followed by NABL is ISO 15189, which is specific for medical laboratories. 71 NABL accreditation

72. Due to accreditation status, customer confidence in testing and calibration reports issued by the laboratory has increased. Due to enhanced customer confidence and satisfaction, the business of laboratory has also increased. Accreditation provides better control over the laboratory operations. Laboratories get feedback about their technical capability and quality assurance system. Database or directory of NABL accredited laboratories is made available both online and offline. NABL accreditation results in time and money saving as the need for retesting of the products is reduced or eliminated. 72 Benefits

73. NABL provides accreditation : Testing laboratories medical laboratories Calibration laboratories Proficiency testing providers Reference material producers Drugs and pharmaceuticals Cosmetics and essential oils Ayush products Plants and plant materials Cell culture Molecular analysis Resistance to microbial attack 73 Scope of NABL accreditation Toxicology Veterinary testing Biologicals derived pharmaceutials Nutraceuticals Medical accessories and surgical products Medical laboratories Inorganic and organic reference materials.

74. Application for NABL Accreditation Acknowledgment of application Review by Lead Assessor Pre – assessment Assessment Scrutiny of Assessment report Accreditation committee Issue of Accreditation certificate 74 procedures

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