Guidelines for National

1 WHO/CDS/WHOPES/ quality control OF. PESTICIDE PRODUCTS. Guidelines for National Laboratories Collaborative International Pesticide Analytical Council Food and Agriculture Organization of the United Nations Department of control of Neglected Tropical Diseases WHO Pesticide Evaluation Scheme (WHOPES). World Health Organization 2005. World All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

2 All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Contents Contents Ackowledgements .. v 1. Introduction .. 1. 2. Organization and managment .. 2. Structure, responsibilities and authority of individuals in the laboratory .. 2. quality assurance schemes .. 2. Management review .. 2. quality system .. 3. Customer orders and contracts .. 3. Document and data recording .. 3. Internal quality audits .. 4. Participation in international ring and collaborative studies .. 5. 3. Staff qualifications and training .. 6. 4. Facillities .. 7. Library and access to electronic databases.

3 7. Laboratory facilities and safety provisions .. 7. Areas for storage of data, samples, standards and reagents .. 8. 5. Equipment .. 8. Range and type of equipment .. 8. Procurement of equipment .. 9. 6. Chemicals .. 9. quality and type used .. 9. Analytical standards .. 9. Procurement of chemicals .. 10. Safe handling and storage .. 10. Waste disposal .. 10. 7. Operational procedures for quality control .. 11. Procurement of materials and services .. 11. Sample registration and traceability .. 11. Analytical and physical test method and validation .. 12. Product specifications .. 12. Special laboratory procedures .. 12. 8. References .. 14. iii Acknowledgements Acknowledgements The Collaborative International Pesticide Analytical Council (CIPAC), the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) wish to thank the following for their valuable contributions to the development of this document: Dr L.

4 Bura, Department of quality control of Pesticides, Budapest, Hungary Dr V. Chmil, Medved's Institute of Ecohygiene and Toxicology, Kiev, Ukraine Dr C. Cook, Department of Primary Industries, Werribee, Victoria, Australia Mr A. Hill, Huntington, York, UK. Dr A. Hourdakis, Benaki Phytopathological Institute, Athens, Greece Ms T. Iurascu, Central Laboratory for Phytosanitary Quarantine, Bucharest, Romania Dr M. D. Muller, Swiss Federal Research Station, W denswil, Switzerland Dr R. Parker, Staplehurst, Kent, UK. Ms J. Schlosserova, Central control and Testing Institute in Agriculture, Bratislava, Slovak Republic Dr G. Vaagt, Food and Agriculture Organization of the United Nations, Rome, Italy Dr M. Zaim, World Health Organization, Geneva, Switzerland. This publication has been funded by the Global Collaboration for Development of Pesticides for Public Health. v Guidelines for National Laboratories 1. Introduction The aim of this document is to provide a general guidance for the establishment or strengthening of National pesticide quality control activities, irrespective of the use of the product, whether public health or agricultural.

5 Though the end- use of a product may differ, the quality control schemes are very similar, and a laboratory combining products of both areas may prove synergistic and allow a rational use of resources. This document focuses on laboratories involved in the post-registration analysis of pesticide products to ensure that the data generated are of a sufficiently high standard to stand external scrutiny. Reference is also made to laboratories engaged in pre-registration testing of products. The scope of the Guidelines is not restricted to the control of quality in conducting specific analyses, but extends to the full range of management activities related to the operation of the laboratory, including organization, staff, procedures, and the facilities involved. This is a guidance document with quality assurance requirements for laboratories involved in product testing. In general, accreditation according to ISO/IEC 170251 through a National body seems to respond better to the specific needs of an official quality control laboratory than the quality assurance scheme under Good Laboratory Practice (OECD Series on the Principles of Good Laboratory Practice and Compliance Monitoring2), which is mandatory for the elaboration of studies necessary for National registration in countries of the Oganisation of Economic Co-operation and Development.

6 The emphasis of accreditation is on quality management and competency, while offering more flexibility with respect to the analysis of samples arriving at short notice a situation often seen in official quality control laboratories. The outline of the document and the points covered refer very often to the requirements of the Standard ISO/IEC 17025. In order to maintain a simple wording, the assumption was made that samples are submitted to the control laboratory by a body outside the lab organization. The term customer is used in that context. 1. quality control of pesticide products 2. Organization and management Structure, responsibilities and authority of individuals in the laboratory It is essential that official laboratories engaged in the quality control of public health and agricultural pesticides possess an awareness of the National and international regulatory framework within which both the pesticide industry and the National registration authorities operate.

7 The pesticide manufacturers have to comply with National pesticide standards and, depending on National legislation, also the FAO and WHO specifications for pesticides. It is essential, therefore, that laboratories engaged in the development and use of methods of analysis of pesticides must possess up-to-date test equipment and have trained and competent staff. It is also important that laboratory staff are able to hold a pragmatic dialogue with technical staff among regulators and manufacturers, to deal with disputes and promote beneficial change. This section of these Guidelines deals in more detail with some of the key aspects. All staff in the laboratory will impact on the quality of the data generated, and must therefore have clear and agreed job descriptions. These must cover all the accountabilities that the jobholder takes on, together with a clear description of the purpose of each one. Each job must be captured within the organization chart for the laboratory, providing an instant overview of key areas of responsibility, and a clear structure for the organization.

8 Thus, the overall purpose of one job will become a key accountability for the person who manages that jobholder. In particular, this will allow all aspects of dealing with non-conformance to be defined, together with appropriate corrective and preventative actions. Specified staff will have accountability for quality assurance within the facility, and for quality auditing. quality assurance schemes Management review It is recommended that a management review of all systems and procedures should be carried out at an agreed frequency, usually once a year. Each review should identify any improvements needed, whether in terms of organization, training, or changes to any particular procedures or analytical methods. These requirements should be documented in an agreed improvement programme, with action dates. To facilitate this review, it is useful to identify some key points which might include: 2. Guidelines for National Laboratories a judgement of available resources (staff, rooms, sample capacity, etc.)

9 Adherence to calibration protocols adherence to maintenance schedules results of proficiency testing programmes, if available results from collaborative testing programmes. quality system It is essential that the key elements of the operation of the laboratory, which impinge on quality , are captured in the Laboratory quality Manual. This will refer to key procedures, quality planning, and record keeping. quality planning should ensure that all buildings, equipment, resources, skills, processes, etc. are available and up to date, in order to meet customer expectations, with the ability to change as requirements change. Important aspects of the quality system are traceability of results (archiving of raw data, electronic files, etc.). and documentation of standard operation procedures, including reference material and instrumentation (see below). Customer orders and contracts Procedures must be established to cover contract and order agreements with key customers.

10 These must include: a process for ensuring customers requirements are properly checked and clear before acceptance;. a process for amending contracts;. procedures to cover receipt, storage, and disposal of samples;. systems for recording contracts and orders, and for filing. Document and data recording Procedures are needed to define how all key documents and laboratory results and other data are controlled and archived for a specified period of time. Documents will include: all analytical and physical test methods all product specifications all laboratory operating procedures all safety health and environmental control procedures. There must also be a documented system, with associated operating procedures, to ensure that all documents are written consistently, issued to where they are to be used, readily available when the method described is being carried out, and removed or replaced when they are out of date. Nevertheless, systems should be kept as simple as possible, and documents may be kept as hard 3.