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IP 2 Unit 4 NABL, OOS, GLP.pdf

The National accreditation Board for Testing and Calibration laboratories (NABL) is an independent organization operating under the supervision of the Department of Science and Technology, Government of India. Its primary objective is to provide certification to clinical labs in India for their testing and calibration activities.

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NABL Accreditation
NATIONAL ACCREDITATION BOARD
FOR TESTING AND CALIBRATION
LABORATORIES (NABL),
& OOS, GLP
Dr. Kumara Swamy Samanthula
M. Pharm, Ph.D
A s s o c i a t e P r o f e s s o r
F a c u l t y o f P h a r m a c e u t i c a l S c i e n c e
A S S A M D O W N T O W N U N I V E R S I T Y
What is NABL ?
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an
autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India,
whose purpose is to supply accreditation to testing and calibration of clinical laboratories
within the country.
NABL specifies the general requirements for the competence to carry out tests and
calibrations, including sampling. It covers testing and calibration performed using
standard methods, non-standard methods, and laboratory-developed methods.
National Accreditation Board for Testing and Calibration Laboratories (NABL) is an
autonomous body under Department of Science & Technology, Government of India, and is
registered under the Societies Act.
NABL has been established with the objective to provide Government, Industry and Society
in general with a scheme for third- party assessment of the quality and technical
competence of testing and calibration laboratories.
Government of India has authorized NABL as the sole accreditation body for Testing and
Calibration laboratories.
In order to achieve this objective, NABL provides laboratory accreditation services to
laboratories that are performing tests / calibrations in accordance with NABL criteria based
on internationally accepted standard for laboratory accreditation ISO.
CONCEPT: The concept of Laboratory Accreditation was developed to
provide a means for third- party certification of the competence of
laboratories to perform specific type(s) of testing and calibration.
Laboratory Accreditation provides formal recognition of competent
laboratories, thus providing a ready means for customers to find reliable
testing and calibration services in order to meet their demands.
Laboratory Accreditation enhances customer confidence in accepting
testing / calibration reports issued by accredited laboratories.
The globalization of Indian economy and the liberalization policies initiated
by the Government in reducing trade barriers and providing greater thrust
to exports makes it imperative for Accredited.
Benefits of Accreditation:
⚫ Potential increase in business due to enhanced customer confidence and
satisfaction.
⚫ Savings in terms of time and money due to reduction or elimination of the need
for re- testing .
⚫ Better control of laboratory operations and feedback to laboratories as to
whether they have sound Quality Assurance System and
⚫ Increase of confidence in Testing / Calibration data and personnel performing
work.
⚫ Customers can search and identify the laboratories accredited by NABL for
their specific requirements from the directory of Accredited Laboratories.
⚫ Users of accredited laboratories will enjoy greater access for their products, in
both domestic and international markets, when tested by accredited
laboratories.
TYPES OF LABORATORY CAN SEEK ACCREDITATION:
⚫ Laboratories undertaking any sort of testing or calibration in the
specified fields.
⚫ Private or government laboratories.
⚫ Small operations to large multi-field laboratories.
⚫ Site facilities, temporary field operations and mobile
laboratories.
TESTING
LABORATORIES
CALIBRATION
LABORATORIES
MEDICAL
LABORATORIES
PROFICIENCY
TESTING
PROVIDERS
REFERENCE
MATERIAL
PRODUCERS
Biological Electro-Technical Clinical Biochemistry Testing Chemical Composition
Chemical Mechanical Clinical Pathology Calibration Biological & Clinical
Electrical Fluid Flow Thermal Hematology & Medical Properties
Electronics Fluid- & Optical Immunohematology Inspection Physical Properties
Flow Mechanical Radiological Microbiology & Engineering Properties
Non-Destructive Serology Miscellaneous
Testing Histopathology Properties
Photometry Cytopathology
Radiological Genetics
Thermal Nuclear Medicine (in-
Forensic vitro tests only)

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IP 2 Unit 4 NABL, OOS, GLP.pdf

  • 1. NABL Accreditation NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL), & OOS, GLP Dr. Kumara Swamy Samanthula M. Pharm, Ph.D A s s o c i a t e P r o f e s s o r F a c u l t y o f P h a r m a c e u t i c a l S c i e n c e A S S A M D O W N T O W N U N I V E R S I T Y
  • 2. What is NABL ? The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of the Dept. Of Science & Technology, Govt. of India, whose purpose is to supply accreditation to testing and calibration of clinical laboratories within the country. NABL specifies the general requirements for the competence to carry out tests and calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under Department of Science & Technology, Government of India, and is registered under the Societies Act. NABL has been established with the objective to provide Government, Industry and Society in general with a scheme for third- party assessment of the quality and technical competence of testing and calibration laboratories. Government of India has authorized NABL as the sole accreditation body for Testing and Calibration laboratories. In order to achieve this objective, NABL provides laboratory accreditation services to laboratories that are performing tests / calibrations in accordance with NABL criteria based on internationally accepted standard for laboratory accreditation ISO.
  • 3. CONCEPT: The concept of Laboratory Accreditation was developed to provide a means for third- party certification of the competence of laboratories to perform specific type(s) of testing and calibration. Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing / calibration reports issued by accredited laboratories. The globalization of Indian economy and the liberalization policies initiated by the Government in reducing trade barriers and providing greater thrust to exports makes it imperative for Accredited.
  • 4. Benefits of Accreditation: ⚫ Potential increase in business due to enhanced customer confidence and satisfaction. ⚫ Savings in terms of time and money due to reduction or elimination of the need for re- testing . ⚫ Better control of laboratory operations and feedback to laboratories as to whether they have sound Quality Assurance System and ⚫ Increase of confidence in Testing / Calibration data and personnel performing work. ⚫ Customers can search and identify the laboratories accredited by NABL for their specific requirements from the directory of Accredited Laboratories. ⚫ Users of accredited laboratories will enjoy greater access for their products, in both domestic and international markets, when tested by accredited laboratories.
  • 5. TYPES OF LABORATORY CAN SEEK ACCREDITATION: ⚫ Laboratories undertaking any sort of testing or calibration in the specified fields. ⚫ Private or government laboratories. ⚫ Small operations to large multi-field laboratories. ⚫ Site facilities, temporary field operations and mobile laboratories.
  • 6. TESTING LABORATORIES CALIBRATION LABORATORIES MEDICAL LABORATORIES PROFICIENCY TESTING PROVIDERS REFERENCE MATERIAL PRODUCERS Biological Electro-Technical Clinical Biochemistry Testing Chemical Composition Chemical Mechanical Clinical Pathology Calibration Biological & Clinical Electrical Fluid Flow Thermal Hematology & Medical Properties Electronics Fluid- & Optical Immunohematology Inspection Physical Properties Flow Mechanical Radiological Microbiology & Engineering Properties Non-Destructive Serology Miscellaneous Testing Histopathology Properties Photometry Cytopathology Radiological Genetics Thermal Nuclear Medicine (in- Forensic vitro tests only)
  • 7. 10 Step Approach To Accreditation ⚫ Awareness Training ⚫ Quality Policy & Objectives Finalization ⚫ Gap Analysis ⚫ Documentation / Process Design ⚫ Documentation / Process Implementation ⚫ Internal Audit ⚫ Management Review Meeting ⚫ Shadow Audit ⚫ Corrective –Preventive Actions ⚫ Final Certification Audit Step 1: Awareness Training ⚫ 100 Separate training sessions for top management, middle management and junior level management. ⚫ Creates a motivating environment throughout the organization for ISO 17025 implementation.
  • 8. Step 2: Quality Policy & Objectives ⚫ Work shop with top management on development of quality policy. ⚫ Work shop with top management and middle level functional management on development of quality objectives Step 3: Gap Analysis ⚫ Understanding of all the operations of the organization. ⚫ Development of process map for the activities of the organization. ⚫ Comparing existing operations with requirements of ISO 17025:2005 standard. Step 4: Documentation / Process Design ⚫ Quality Manual ⚫ Functional Procedures ⚫ Work Instructions ⚫ System Procedures ⚫ Formats
  • 9. Step 5: Documentation / Process Implementation ⚫ Work–shop on process / document implementation as per ISO 17025 requirements. ⚫ Departmental / Individual assistance in implementing the new processes / documents. Step 6: InternalAudit ⚫ InternalAudit Training & Examination (Optional). ⚫ Successful employees carry out internal audit of the organization covering all the departments and operations. ⚫ Suggest corrective and preventive actions for improvements in each of the audited departments. Step 7: Management Review Meeting ⚫ Quality Policy & Objectives ⚫ Results of internal audit ⚫ Results of supplier evaluation ⚫ Results of customer complaints ⚫ Results of customer feedback etc.
  • 10. Step 8: Shadow Audit of the final ⚫ It is a final certification audit. ⚫ Finds degree of compliance with ISO 17025 standard. ⚫ Gives an idea to the employees about the conduct certification audit. Step 9: Corrective – Preventive Actions ⚫ On the basis of shadow audit conducted in the last step, all the non- conformities will be assigned corrective and preventive actions. ⚫ A check will ensure that all the points are closed and the organization is ready for the final certification audit. Step 10: Final Certification Audit ⚫ Upon completion of various stages of accreditation audit, the audit, your organization will be awarded accreditation. ⚫
  • 11. Out of Specifications (OOS): Introduction:- When an analytical or test result of any batch or material is out of prescribed and predetermined limits or specifications, it is called as OOS. OOS may be raised in the case of stability testing, analysis of in-process, test of raw materials, intermediates and finished goods (API). Investigation for OOS may be performed while getting any unacceptable and questionable results.
  • 12. Identification of OOS: Reports of Laboratory Investigation:- This investigation is conducted when OOS is found in analysis. The main purpose of obtaining OOS reports is to find out the source of the results which fall outside the specifications. In this initial investigation, all the results should be recorded and well documented. The data should be conveyed and forwarded to quality control department, so that full scale analysis can be performed.
  • 13. Responsibility of Analyst and Supervisor:- An analyst has the primary responsibility for the laboratory testing results. He should have sound knowledge about the principle, primary requirements and process of the investigations. The accurate and precise results are expected, if any wrong results are found that should be informed to concern superior department and assessment should be initiated with immediate effect. The supervisor of the laboratory should discuss the problems and the malfunctioned result with the analyst. He should verify the followed correct procedure and knowledge of the analyst.
  • 14. He should overlook the following points: 1. Raw data of the result. 2. Calculations of the result. 3. Proper functioning of instruments. 4. Procedure performed by the analyst. 5.Quality parameters of solvent's, reagents, standard solutions. 6. Knowledge of the analyst regarding investigation. 7. Method validation and evaluation of performance. 8. Preservation of the results obtained.
  • 15. Identification of OOS: Reports of FuIl- Scale Investigation: When an initial analysis does not confirm the errors caused by OOS result from lab investigations, full scale investigations with proper design should be performed. The identification of the source of the errors and the action taken for the correctness are the main objectives of this investigation. The following are the important aspects of OOS results identification with respect to full scale investigation. 1. Review of manufacturing, production and sampling. 2. Review of lab investigation result. 3. Supplementary laboratory testing procedure.
  • 16. Review of Manufacturing, Production and Sampling:- T o find out the OOS results, review of manufacturing, production and sampling is very important. The errors and problems should be investigated and identified. The documents and records of manufacturing and production should be reviewed. The investigations should be reviewed through a well- documented manner.
  • 17. Review of Lab Investigation Results:- It contains the following information: ⚫ Cause of the investigation. ⚫ Review and summary of manufacturing process (which may have identified as malfunctioned or cause of OOS results). ⚫ Review of previous results to find out the possible causes of OOS results. ⚫ Review of documented records to analyze the possible factors of wrong results. ⚫ The actions taken to correct the process.
  • 18. Supplementary Laboratory Testing Procedure: To investigate OOS results in full scale, additional laboratory testing may be performed. This includes Re-testing and Re- sampling. In Re-testing, a portion of original samples are tested again according to the standard procedures. The results are kept in a well documented manner. This process helps to find out the problems encountered due to error in instruments, process, dilution or sample handling. In Re-sampling, a specimen is collected from any additional units from original sample or a new sample is prepared from the same batch and analyzed further.
  • 19. ANALYSIS OF INVESTIGATED RESULTS:- THE REPORTED RESULTS SHOULD BE ANALYZED AND INTERPRETED TO FIND OUT THE POSSIBLE, PROBABLE AND ACTUAL CAUSES OF OOS RESULTS. SOME POSSIBILITIES ARE DISCUSSED BELOW: Analysis of Investigated Results
  • 21. Change Control:- Introduction:- In pharmaceutical industry change control is an important part of quality assurance. The changes proposed and made in any procedure or process should be reviewed, established, documented and approved by the concerned authorities. Change control is the system to implement this approved change to confirm the regulatory requirements. Definition:- Change control can be defined as a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equipment or processes. The intent is to determine the need for action that would ensure and document that the system is maintained in a validated state.
  • 22. Function: Any change in manufacturing process. equipment, materials used that may cause alteration in product quality should be validated. The main functions of change control are: 1. Identification of the changes made. 2. Review of the change. 3. Approval of the change. 4.Validating the changes which can alter the product quality, regulatory or GMP requirements. 5. Analysis of the change and monitoring of the impact of change
  • 23. Area of Change: 1. Manufacture: Following changes are concerned: ⚫ Raw materials, ⚫ Equipment's, ⚫ Process/parameters, ⚫ Testing/validation procedures, ⚫ Packaging materials, ⚫ Cleaning process 2. Quality control and quality assurance: Following changes are considered: ⚫ Quality testing parameters, ⚫ Sampling size, ⚫ Validation process, ⚫ Specifications of raw materials, intermediates and final product, ⚫ Documentation, ⚫ Standard operating procedures (SOPs).
  • 24. 3. Research and development: It includes the change in:- ⚫ Manufacturing process (any addition of elimination of steps), ⚫ Raw materials (any addition of omission of the product ) ⚫ Specifications of raw materials, intermediates and final product, ⚫ Quantitative aspects of raw materials and finished products, ⚫ Manufacturing conditions and storage conditions, ⚫ Testing/validation procedures. 4. Engineering: ⚫ Equipment used, ⚫ Validation of the equipment, ⚫ Parts of equipment, ⚫ Working and design layout, ⚫ Software/ Hardware or Change in any program.
  • 25. 5.Marketing: Written Procedures & Documentation: Procedures in writing should be kept at the proper place to describe the changes made related to the materials, equipment and method of manufacturing or testing conditions or any other change that can affect the quality of the product. Standard operating procedure (SOP) and records of change control documents are required for the documentation. The Change Control Form (CCF) is an important documentation part of change control. It contains the form related to initiate department for the proposed change, proposed change details, comments from QA Head, category of the changes, supportive documents, management review form and assessment of CCF.
  • 26. GLP (Good Laboratory Practice) :- Introduction:- GLP was introduced for the non-clinical safety studies in 1976. In late 90's this practice along with OECD (Organization for Economic Co-operation and Development) was accepted as industry standards. GLP has been introduced due to the poor and dishonest practice in laboratory in the early 70's. The poor lab practices include wrong calibration of equipments, inaccurate test systems and accounts. In 1983, Industrial Bio Test Laboratory (1952-1978) of New York was found guilty as it provided wrong and inaccurate research data to the Government. The company provided fake, fabricated and concealed data of the tests on rodents involving Trichlorobanilide (deodorant soap additives), Naprosyn (arthritis drug), Sencor (Herbicide) and Nemacur (Pesticide).
  • 27. Definition:- According to Valcarcel M., GLP is a set of rules, operating procedures and practices established by an organization to ensure the quality and accurate results in a laboratory practice. In this practice, the given organization sets the principles and the laboratory works are planned, operated, overlooked and reported. Fundamentals of GLP: Resources: It includes the following: 1.Organization and Management: Management has the overall responsibility for the implementation of both good science and good organization within their institutions. Good science includes proper definition of experimental design, knowledge of scientific principles, documentation of experimental and environmental variables, complete evaluation of the results and reporting of results. Whereas, good organization should provide proper planning of studies, qualified skilled personnel, adequate facilities, infrastructures, proper conduction of studies and verification process for the study results
  • 28. 2.Personnel: The detailed records should be maintained for every individual staff of the institution. The records include the detail curriculum vitae, training records and their job descriptions. These records should meet the GLP requirements and these are maintained to establish that every staff has the competence, education, experience and training to perform the tests. 3.Availability of Facilities: Adequate facilities with state-of- the-art infrastructure should be provided by the institution and management to ensure the validation of the studies. The cleaning, maintenance and documents of the site plan should satisfy the guidelines. 4.Availability of Equipments: Adequate equipments must be available for the study in the organization. The suitability of the equipment and calibrated instruments should be provided by the management.
  • 29. C. Characterization:- It includes: 1.Test Items: It may be an active ingredient for a medicine, a pesticide, a food additive, a vaccine, an industrially used chemical, a biomass or an extraction from plants. These items are characterized by analytical profile like chemical identification test, solubility, stability etc. The test items should be stored properly to avoid the contamination. 2.Test Systems: The test systems could be the animals, bacteria, cells, organs and plants. Sometimes they may be analytical equipments also. The test systems should be handled in such a way that it must comply with the GLP guidelines and with the national animal welfare law.
  • 30. C. Rules:- 1.Study Protocols: The study plan or protocol describes how the study is designed and how it is to be conducted. The plan should include the expected time frame of the study. 2.Written Procedures: Written procedures are often known as SOPs (Standard Operating Procedures). SOPs provide the instructions how each technical procedure should be performed, how to ensure the sound organization of the study, environmental variables and data.
  • 31. D. Results :- It includes raw data, final reports and data archiving. 1.Raw Data: The original record and the data needed for the reconstruction should be recorded. The raw data should include 'what‘ was done, 'how' it was done, 'when’ the work was done and ’who’ performed the work. The recorded data should clarify the process by which it is generated and should confirm the process has been performed as per the guidelines and SOPs. 2.Final Results: Final results are the responsibility of the study director. These results should describe the study accurately and the scientific interpretation. The results should reflect accurately the raw data. The review and audit of these reports should be done. All accepted changes in the results approved by the reviewer should be incorporated before the finalization of the results.
  • 32. 3 Archives: Archiving is a safe depositing of all information. It is considered to be a center for the compilation and distribution of summary documents. The archiving of document helps the reconstruction of studies performed earlier. E. Quality Assurance: The requirement of the quality assurance is to validate the experimental results. Quality assurance unit (QAU) or simply QA must review all phases of preclinical research, organization framework, staff documents, study procedures and SOPs. The internal audits and inspections should be performed by the QA officers. The QA performs the study-based audit, facility and systems- based inspection and process-based inspections.
  • 33. GLP Principles:- GLP principles are set of organizational requirements. GLP is a regulation covering the quality management of non-clinical safety studies. The aim of the regulation is to encourage scientists to organize and perform their studies in a way which promotes the quality and validity of the test data. GLP deals with the following issues: ⚫ The facility provided by the organization. ⚫ Efficient and trained personnel. ⚫ Quality of validated equipment and reagents. ⚫ Predetermined study design. ⚫ SOPs, process validation and test procedures. ⚫ Correctness of the results. ⚫ Quality assurance laboratory (QAL) and Quality assurance program (QAP). ⚫ Recorded and documented results and their storage. The organizations should fulfill all the criteria to provide all the facilities for the good practice in laboratory. The personnel should have enough knowledge about the principles and working of the practices. In the elements of GLP, SOP is an important part with respect to quality assurance. T o maintain the productivity of the result, a well documented SOP is required; moreover, the personnel should have complete information mentioned in SOPs.
  • 34. SOPs define the complete process flow and work steps which help to achieve the accurate and precised results. Validated modern equipments and adequate facilities should be provided by the organization to maintain the good practice in laboratory. The complete specifications and storage of reagents and materials should be provided. QA laboratory should have the proper test procedures (physical, chemical and biological) and characterized data for both the test and reference materials. Quality assurance unit (QAU) bears the responsibility to assure the GLP and this unit is attached with QAL and QAP. The audit of the laboratory and verification of the quality parameters are the major responsibilities of the QAU. The reported study results should be stored and retained with well documented manner.
  • 35. Aim of GLP:- 1.GLP helps to reduce the number of false negatives arising from the studies. False negative result for a toxicity study falsely intimated that the test item is not toxic, but in real the item is toxic. 2.GLP also helps to reduce the chance of false positives. In the case of a non-clinical safety study, the results wrongly predict that the test item is toxic, when really it is not. 3.GLP promotes international recognition of study data. When studies are performed according to OECD GLP principles, then the acceptability and reliability of the data are recognized in the international level by the OECD member states.