Comparability and quality of experimental data under different quality systems. S. Caroli Istituto Superiore di Sanità Rome

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1 Comparability and quality of experimental data under different quality systems S. Caroli Istituto Superiore di Sanità Rome

2 Programme of this presentation Part I. Background information Part II. Key aspects of a quality system based on the principles of good laboratory practice Part III. Key aspects of a quality system based on the accreditation criteria Part IV. Final remarks

3 Programme of this presentation Part I. Background information Part II. Key aspects of a quality system based on the principles of good laboratory practice Part III. Key aspects of a quality system based on the accreditation criteria Part IV. Final remarks

4 Background information (1/7) Important decisions are often taken on the basis of experimental data. Hence, it is crucial that such data be comparable, reliable and valid.

5 Background information (2/7) No laboratory can be run without a quality system in place. Quality systems are currently based either on the Good Laboratory Practice (GLP) principles or on the accreditation criteria.

6 Background information (3/7) Laboratory work may be of two different types: the outcome of the investigation are exact figures, for which precision and reproducibility are expected; the outcome of the investigation is, in a general sense, information to which credibility should be attached.

7 Background information (4/7) In the former case, what matters more are the experimental measurements. Quality is assessed in terms of precision and reproducibility of the numerical data obtained. The ability of the laboratory to generate such data is thus of primary importance. Quality systems based on accreditation criteria are ideal in this context.

8 Background information (5/7) In the latter case, the focus is on the study. Third parties should be enabled to reconstruct its whole course and check its integrity so that confidence can be gained in the way the study results have been obtained. Hence, quality systems based on the GLP principles do apply.

9 Background information (6/7) Which approach is to be preferred depends only on the scope of the activities performed in a laboratory. One major difference between the two systems is that accreditation is basically voluntary, whereas the GLP system is prescribed by law for those test facilities undertaking non-clinical safety studies.

10 Background information (7/7) There is some confusion surrounding the terms of accreditation and certification. Consensus has been reached on the following definitions: accreditation is a means used to identify competent testing laboratories; certification is the official approval granted by a given authority.

11 Programme of this presentation Part I. Background information Part II. Key aspects of a quality system based on the accreditation criteria Part III. Key aspects of a quality system based on the principles of good laboratory practice Part IV. Final remarks

12 The accreditation approach (1/7) Accreditation-based quality systems are governed by the international Standard ISO/IEC (General Requirements for the Competence of Testing and Calibration Laboratories). This standard exploits the extensive experience gained in implementing the ISO/IEC Guide 25 and EN norms and replaces them both.

13 The accreditation approach (2/7) The ISO/IEC Standard sets forth the requirements a laboratory has to meet to be recognized as competent to carry out tests and/or calibrations, including sampling.

14 The accreditation approach (3/7) The pillars of an accreditation system are: Service to the Client Policy for Complaints Control of Nonconformities Quality Manual Management of Records Internal Audits Management Reviews Motivation of Personnel Laboratory Setting Validation of Methods Equipment Measurement Traceability Test and Calibration Items Report of Results

15 The accreditation approach (4/7) Credibility of a laboratory The international scientific community recognizes that a laboratory must take appropriate measures to ensure that it is capable of providing data of the required quality. Such measures include: - validated methods of analysis; - internal quality control procedures; - participation in proficiency testing schemes; - accreditation to an international standard. (IUPAC Technical Report on Harmonized Guidelines for Single-Laboratory. Validation of Methods of Analysis)

16 The accreditation approach (5/7) The purpose of method validation Method validation is central to the accreditation process. Reliability and comparability of data are crucial to perform experimental meaningful studies and to achieve credible results which can be profitably used by the end-user.

17 The accreditation approach (6/7) Validation process Software Validation Hardware Validation/ Qualification System Suitability Method Validation

18 The accreditation approach approach (7/7) Applicability Selectivity Calibration and linearity Trueness Accuracy Precision Recovery Range Limit of detection Limit of quantification Sensitivity Ruggedness Robustness Fitness for purpose Matrix variation Measurement uncertainty

19 Programme of this presentation Part I. Background information Part III. Key aspects of a quality system based on the accreditation criteria Part III. Key aspects of a quality system based on the principles of good laboratory practice Part IV. Final remarks

20 The GLP approach (1/12) In the early 1960 s the US Food and Drug Administration (FDA) became aware that some studies on the safety of new chemicals performed by test facilities for regulatory purposes were basically unreliable. Evidence was in fact provided of major adverse effects of such substances. Such effects had not been reported at the time when the authorization to production and commerce was granted.

21 The GLP approach (2/12) In the early 1970 s the US Congress undertook the re-assessment of studies on new substances submitted by some Test Facilities to Regulatory Authorities and suspected to be fraudolent. Under such conditions thousands and thousands of safety studies on new industrial chemicals, pesticides, herbicides, drugs, cosmetics and food and feed additives were conducted for years (about % of all toxicological studies authorized in the USA in that period).

22 The GLP approach (3/12)

23 The GLP approach (4/12) Senator Edward Kennedy declared at the US Congress of January 20, 1976, that unreliable, undocumented and fraudolent research is the most frightening menace to the health and safety of people. That research be wrong because of technical problems or because of the lack of competence or even due to criminal negligence is less important than the very fact that it is wrong

24 The GLP approach (5/12) The principles of Good Laboratory Practice (GLP) were conceived to harmonise the conduct of non-clinical safety studies and to minimise the risk of fraud. According to OECD, the principles of GLP are a quality system concerned with the organisational process and the conditions under which safety studies are planned, conducted, controlled, recorded, reported and archived. In practice, they form a body of reciprocally dependent documented items that make the falsification of a study more time-consuming and expensive than its actual performance.

25 The GLP approach (6/12) The Organisation for Economic Co-operation and Development (OECD) has set up the GLP principles in order to promote and manage the mutual acceptance of non-clinical safety studies in the Member Countries.

26 The GLP approach (7/12) The three major acts of OECD in the field of GLP are as follows: Decision of the Council concerning the Mutual Acceptance of Data (MAD) in the Assessment of Chemicals [C(81)30(Final)] Council Decision- Recommendation on Compliance with Principles of Good Laboratory Practice [C(89)87(Final)] Council Decision concerning the Adherence of Nonmember Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals [C(97)114(Final)]

27 The GLP approach (8/12) Annexes to the MAD Decision of 1981 OECD Test Guidelines for Chemical Substances OECD GLP Principles Permanent activities in the framework of the Environment, Health and Safety Programme Updating Activities for the harmonisation of the compliance with the GLP principles and their interpretation

28 The GLP approach (9/12) Series on the GLP principles and compliance monitoring No. 1, OECD Principles of Good Laboratory Practice No. 2, Revised Guides for Compliance Monitoring Procedures for Good Laboratory Practice (1995) No. 3, Revised Guidance for the Conduct of Laboratory Inspections and Study Audits (1995) No. 4, Quality Assurance and GLP (as revised in 1999) No. 5, Compliance of Laboratory Suppliers with GLP Principles (as revised in 1999)

29 The GLP approach (10/12) Series on the GLP principles and compliance monitoring No. 6, The Application of the GLP Principles to Field Studies (as revised in 1999) No. 7, The Application of the GLP Principles to Short Term Studies (as revised in 1999) No. 8, The Role and Responsibilities of the Study Director in GLP Studies (as revised in 1999) No. 9, Guidance for the Preparation of GLP Inspection Reports (1995)

30 The GLP approach (11/12) Series on the GLP principles and compliance monitoring No. 10, The Application of the Principles of GLP to Computerised Systems (1995) No. 11, The Role and Responsibilities of the Sponsor in the Application of the Principles of GLP (1999) No. 12, Requesting and Carrying Out Inspections and Study Audits in Another Country (2000) No. 13, The Application of the OECD Principles of GLP to the Organisation and Management of Multisite Studies (2002) No. 14, The Application of the OECD GLP Principles to in vitro Studies (2004)

31 The GLP approach (12/12 12) The pillars of a GLP system are: Test Facility Director of the Test Facility Study Director Quality Assurance Unit Archivist Sponsor Test and Reference Items Study Plan Final Report Standard Operative Procedures Test Site (if applicable) Principal Investigator (if applicable) Monitoring Authority Receiving Authority

32 Programme of this presentation Part I. Background information Part II. Key aspects of a quality system based on the principles of good laboratory practice Part III. Key aspects of a quality system based on the accreditation criteria Part IV. Final remarks

33 OECD-GLP specific Overlapping subjects ISO/IEC specific Studies Master schedule Study director Archivist Quality Assurance Unit Study Plan Current training Test article and system Chain of custody Inspection monitoring Management Motivation Training Reference materials Equipment and maintenance Reports Sampling Sample reception Audits Corrective actions Method validation Quality control procedures Services Management of complaints Uncertainty of measurement Proficiency testing Preventive actions Service to the client

34 Examples of major differences between the two systems ISO GLP Independence of the Quality Assurance Unit No Yes Existence of the Quality Manual Yes No Existence of the Study Plan No Yes Need for a Study Director No Yes Management of Complaints Yes No Participation in Proficiency Tests Yes No Master Schedule Yes No

35 In recent years,, the OECD has established a dialogue group to verify where the two systems can actually interact, thus minimizing useless duplication of efforts.

36 The selection of the quality system to be adopted is made on the basis of the prevailing activities carried out in the laboratory. Quality is inescapable, but has a cost: : a wrong decision can only lead to failure.

37 MANY FOR THANKS BEING HERE TODAY

38 Examples of major differences between the two systems ISO GLP Independence of the Quality Assurance Unit No Yes Existence of the Quality Manual Yes No Existence of the Study Plan No Yes Need for a Study Director No Yes Management of Complaints Yes No Participation in Proficiency Tests Yes No Master Schedule Yes No

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