Cabinet of Ministers Regulations No. 398 in Riga 2002 (September 3. No 37) requirements for laboratories and laboratory quality inspection Issued in accordance with the chemicals and chemical products Act article 6 and the second paragraph of the law "on conformity assessment" 7. the first paragraph of article i. General questions 1. determines: 1.1. requirements to the quality of work of laboratory chemicals and chemical products, physical, chemical, toxicological or ecotoxicological properties determination or studies on this substance and product exposure to the environment or human health;
1.2. the conditions for the inspection of laboratories, laboratories for the quality (good laboratory practice) evaluation, monitoring, study audits (to provide research data that can be compared with other countries, the studies carried out and prevent technical barriers to trade) and laboratory monitoring (to avoid duplication of tests, save time and resources, as well as to improve protection of human health and the environment).
2. the rules apply to research checks (excluding clinical) and tests (hereinafter study) carried out for news on biocides, chemicals and chemical characteristics of the products, as well as on the preparation of biological origin or characteristics of a living organism, which are intended for use in medicinal products, plant protection products, cosmetic products, veterinary drugs, food additives and animal feed additives (hereinafter referred to as the test substance or organism), and the hazards to human health and the environment. Studies intended for submission to the Ministry of Welfare, the environment and regional development Ministry and the Ministry of agriculture, as well as in the institutions subordinated to the Ministry (hereinafter referred to as competent authorities).
3. Test substance and body properties, as well as the dangers of exploring the laboratory, in greenhouses or environment using biological, chemical or physical system, or combinations thereof (hereinafter referred to as the system under test). Through research, take into account the Organisation for economic cooperation and development (OECD) recommendations on principles of good laboratory practice.
4. in Latvia it is recognised in the European Union, the European Free Trade Association and the Organization for economic cooperation and development Member States appropriate in Latvia or in the European Union norms issued receipts, or confirmation, which affirms that the studies are carried out and monitored according to the requirements of good laboratory practice.
5. the studies will be carried out in laboratories that monitor the Latvian National Accreditation Bureau according to the requirements of this regulation.
 
 
II. Requirements for the quality of work of laboratories 6. Where studies are conducted in several places (hereinafter study), compliance with the requirements of this Regulation shall ensure all research sites.
7. a Person who arranges all the research management and responsible and owning a laboratory or a laboratory wire (hereinafter referred to as the responsible person), supports the work of the laboratory quality supervision and control. Responsible person: 7.1. study Director is appointed and controlled by it;
7.2. ensure adequate laboratory staff numbers and qualifications, premises, equipment and materials for the timely and proper research.
7.3. the seconded employee providing archive and storage of such information: 7.3.1. of approved study plan;
7.3.2. the qualifications of the laboratory (including the job description and details of the training and experience of staff);
7.3.3. the work schedule;
7.4. checks whether the laboratory staff must clearly understand the functions and to ensure the training of staff;
7.5. designate one or more persons who are responsible for quality assurance (quality assurance staff);
7.6. designate a person responsible for each specific study (hereinafter responsible);
7.7. Approves the work of the laboratory quality assurance program and check whether the head of the laboratory of studies of the quality of work provided pursuant to these rules;
7.8. evaluate and approve appropriate and technically based research methods and amendments, as well as ensure their implementation.
8. in order to carry out the study plans and documents, unregulated transactions, use confirmed by the person responsible for carrying out the studies. Simple, common studies used laboratory practice widely used methods.
9. to assess and schedule employee workload and implement the research sequential execution, research manager of the approved schedule, as well as the research plan research proposed documentary captures. Study plan aligned with the quality assurance personnel who check compliance with the requirements of this regulation. Short-term studies used in the study plan, which covers the basic questions of the study and the relevant explanatory notes.
10. the observations and readings obtained in direct observations and activities and fixed documentation of research protocols, or original, or study Director approved copies of such documents, is the original data. The original data can also be photographs, microfilm or microfiche copies of a fragment of information in electronic form, tapes, recorded data from automated instruments, as well as other media, which are able to provide information.
11. study initiation date is considered the date the study Director will approve the study plan.
12. If, after the start of the study, the study plan required revisions, it confirms the study Director and stored together with the study plan.
13. If after the study initiation date occurs in unexpected deviations from the study plan the study and description of the performer explains, but as the study Director the study plan deviation and stored together with the original data.
14. study completion date is considered the date the study Director approves the final report.
15. the start date of the experiment shall be deemed the date for the first specific research.
16. Experimental completion date is considered the date when the results of the study are summarized.
17. Research Manager is responsible for research management, compliance with these regulations, the reliability of research results and merits, as well as the following: 17.1. studies provide appropriate premises, equipment and equipment design and deploy it to minimize interference, which could affect the credibility of the study;
17.2. the study plan the actions that guarantee the right of each study;
17.3. the study provides sufficient space, or the area to guarantee the insulation of the individual studies, taking into account the test substance or organism that is unknown or there is a possibility that they are the biological hazard;
17.4. the signature and date approve the study plan and any amendments;
17.5. works closely with the quality assurance personnel, as well as to ensure that the quality assurance personnel timely issued study plan and a copy of all corrections;
2.7. ensure that the laboratory personnel have access to the study plan and its revisions, as well as the approved research methods;
17.7. ensure that complex study plan and the final report should specify the role of each specialist;
11.1. provides all of the procedure provided for in the study plan are followed, and assess and document the impact of deviations study plan on the quality and reliability of the study;
11.1. approved research the amendments made during the research methods;
17.10. ensure that all the original documentation of the data obtained and recorded in the minutes;
17.11. provides research information systems applied to safety and compliance;
17.12. Approves closing statements, indicating the date and the deviations permitted from the requirements of this regulation;
17.13. ensure that after completion of the study, the study plan, the final report, the original data and materials that justify the data be passed on to the archives.
18. Employees, performing research, has the following responsibilities: 18.1. learn the work of the laboratory quality assurance, which are needed for the activities of the research staff;
18.2. to get acquainted with the study plan and research methods to work the trials follow the study plan and methods under certain conditions;
18.3. to document deviations from the study plan or research methods and to submit relevant information to the study Director or responsible officer;
18.4. to immediately and accurately to record the original data and be responsible for their quality;
18.5. to comply with health and safety measures to minimize the risk and report to the study Director, on the necessary safety or health conditions.
19. the quality assurance personnel have the following responsibilities: 19.1 consult the approved research plan, schedule, and methods of carrying out the study;

19.2. to check that the study plan contains the information required in accordance with the requirements of this regulation, document, and store the results of the inspection reports;
19.3. check studies, work processes, machinery and equipment, to determine if all studies are consistent with the requirements of this regulation, evaluation, or research performers are available in the study plan and the approved research methods and whether they are observed;
19.4. check closing statements and confirm that observations, methods and procedures are described and the reported results accurately reflect the original data;
19.5. immediately report in writing to the person responsible, and research managers for any inspection results;
12.2. to draw up a report (for inclusion in the final report), indicating the types of inspections and their dates, check the phase of the study, as well as the dates when the results of the reported the person responsible, and Research Manager.
20. Materials and equipment shall be provided with separate storage premises or areas of the field are separated from those rooms or areas containing the test substance and organism to ensure protection from contamination, cross-contamination, failure or foreign body invasion.
21. Test substance or organism storage space or area of the equipment in the field so as to keep the test substance or organism identity, strength, purity and stability as well as guarantee safe storage of dangerous substances.
22. to prevent the test substance and the reference substance or organism (or the test substance in the body that are used as a basis for comparison with the test substance or organism) infection, poisoning or contamination, equipment or certain areas of the field and storage.
23. The test organism for disease diagnosis and treatment equipment of suitable rooms or areas that prevent infection or disease.
24. The study plan, the original data, closing statements, sample (all materials obtained from the test systems and for the investigation, analysis, or retention) and a sample of the substance to be tested for safe storage of the equipment of suitable archive and sample storage room.
25. Transactions with those wastes generated by the laboratory shall be carried out in a way that does not endanger human life and health, the environment, as well as to not influence the quality of the work of the laboratory.
26. Studies of the used hardware periodically check, clean, serviced and calibrated according to regulations or studies approved driving instructions (if the question is not regulated in legislation).
27. Studies in hardware and materials used must not cause any adverse effects to the test substances or organisms that are not specified in the study plan.
28. Chemical reagents and solutions marked with labels indicating name, expiry date, storage conditions and, if possible, the concentration. Staff must have access to information about the origin, date of manufacture and stability.
29. the solution of chemical reagent and the validity of the study Director may be extended only on the basis of documented results.
30. Physical and chemical studies of the system to use hardware should be appropriately located, constructed and powerful to ensure the test substance or organism wholeness (integrity).
31. in order to guarantee the quality of data, provide suitable conditions for the storage of biological systems for keeping, care and activities, as well as to comply with the following conditions: 31.1. newly received animal and plant test systems be isolated until their health status has been evaluated. If a non-specific death case that tested the animals and other biological studies of the system must not be used. If necessary, animals are euthanased;
31.2. study initiation date of the system under test must not be ill or infected. If you want to maintain the integrity of the study, isolated and treated individuals who becomes ill or is injured in the course of the study. Studies and research both before all of the diagnosis and treatment of each disease is recorded;
31.3. stores information about the origin of the system, the date and condition at the time of receipt;
19.5. the test systems before biological treatment or use the time to Acclimate in the same environment;
31.5. the construction rooms, cages or containers shall provide all information needed to properly identify the test systems (including information about the studies carried out);
19.6. experiment with appropriate intervals during the test system holding space, cages or containers clean and litter animals altered laws that govern the experiments and scientific purposes of animals used, use, trade and killing procedures and methods, as well as the welfare of these animals;
19.7. any material that comes into contact with the test system must not contain any substance in such a degree that could interfere with the research;
19.8. the use of plant protection products and biocides indicated in the Protocol;
19.8. the test system by exploring the outdoors, located so as to avoid distortions which could lead to aerosol spray or use of pesticides before carrying out the studies.
32. Research Manager provides storage for all the protocols, which provide a test substance and the reference description, date, expiration date and quantity as received and spent on research.
33. action to test substances or organisms and reference substances or organisms as well as the reference, sampling, and storage procedures organised in such a way as to ensure the homogeneity and stability of these substances, prevent poisoning, contamination or mingling.
34. Storage container specifies information about substances or organisms in the product name, expiry date and specific storage conditions.
35. Each test substance or organism and a reference or a reference organism identified by name according to the international theoretical and practical chemistry associations (hereinafter referred to as the IUPAC) nomenclature code or Chemical Abstracts Service registry number of the journal Chemical Abstracts (CAS number) and biological parameters.
36. each Document of the test substance and the reference substance or organism or reference the name of the body series (including the serial number), purity, composition, concentrations and other special characteristics.
37. If the test substance or organism in the transportform testsistēm, previously determined the homogeneity, concentration of solution and the test substance or stability of the organism. The test substances and organisms used, these parameters are determined by the individual lab experiments.
38. From each test substance or organism series retains the control sample analyses.
39. each trial the persons responsible for the use of approved research methods relating to action to be taken on this site.
40. If research results in deviations from research methods, it specifies the Protocol and, if the changes are valid, the study confirms the study Director.
41. The approved research methods used: 25.5. test substance or organism, a reference or a reference body, identification, labelling, handling, sampling and storage;
41.2. hardware use, cleaning and calibration;
41.3. the use of information systems, security, change control and information for backup;
25.7. materials, reagents and solutions for the manufacture and labelling;
25.8. Protocol for the preparation, storage and editing (including surveys for encoding), data collection, reporting, system indexing, data processing, as well as the use of information systems;
25.8. transactions with test systems, including: the preparation of the premises, 41.6.1. microclimate and air cleanliness of the room;
41.6.2. the test system, transfer, deployment, characterisation, identification and care;
41.6.3. test system preparation, as well as observations and tests before the start of the study, research and study in the final;
41.6.4. handling of test system individuals that research found moribund or dead;
41.6.5. sampling, identification and handling (including autopsy and histopathological);
41.6.6. test system insertion and deployment research schemes;
25.9. quality assurance procedures (including quality assurance personnel in inspection planning, scheduling and execution, writing documents and reporting).
42. study plan indicates the following: 42.1. name of the study of the test substance and the reference substance or organism or organisms 42.1.1. reference: the brief description of the study;
42.1.2. nature and purpose of the study;
42.1.3. the test substance or organism name in the IUPAC nomenclature, the code number of the Chemical Abstracts Service registry or journal Chemical Abstracts (CAS number), biological parameters;

42.1.4. reference substances used or reference organisms;
26.2. study the customer's name and address;
26.3. the name and address of the controller;
26.3. the study Director's name, surname and address;
26.4. the specialist's name and address, the study phase, which the responsible specialist assigned by the study Director;
26.5. date of approval of the study plan;
26.5. date when the study plan agreed with the client;
26.6. the experiment envisaged start and completion dates;
26.7. the reference to generally accepted research methods;
42.10. selection of the test system;
42.11. characteristics of test systems (e.g., species, family, Antelope, the number, origin, age, sex and body weight);
42.12. route of Administration (e.g., oral, inhalation entering) and justification of its choice;
42.13. the size of the dose or concentration, entry or going rate, duration of use;
42.14. detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations to be performed, and statistical methods to be used;
store protocol list 42.15..
43. Studies carried out in accordance with the study plan, subject to the following conditions: 43.1. special name for each study and for each substance or organism, related to this research;
43.2. each sample marking indicates the origin of the samples;
43.3. the minutes of all the data, accurate and legible records of each reading and observation. These records, including date, research artist confirms with his signature;
43.4. corrections to the original data, indicating the reason for the correction shall be made so as to be readable on the previous record. Each correction, including date, research artist confirms with his signature.
44. entering study data in the information system initial data, all data changes and their causes, as well as information on the date, time and details of the person who made the record information system.
45. For each study, prepare a final report. For short-term studies prepare audited statutory that adds the appropriate explanations.
46. The final report shall be accompanied by a responsible specialist signed statements, indicating the date.
47. Closing statements, as well as corrections to the study Director of the signature, specifying a date (correction – also repair reasons).
48. The final report shall contain the following information: the name of the study, 48.1. the test substance or organism, substance or organism of reference: the brief study description 48.1.1.;
48.1.2. test substance or organism name in the IUPAC nomenclature, the code number of the Chemical Abstracts Service registry or journal Chemical Abstracts (CAS number), biological parameters;
48.1.3. reference standard;
48.1.4. the test substance or organism (including purity, stability and homogeneity);
48.2. information on the Subscriber and research performers: 48.2.1. name and address of the Subscriber;
48.2.2. all studies of place names and addresses;
48.2.3. study the driver's name, surname and address;
48.2.4. the specialist's name and address, as well as the research phase, which he delegated;
48.2.5. the study of names and addresses, which made the final review reports;
48.3. experimental starting and completion dates;
30.1. the quality assurance program the person responsible for the report, which outlines the quality assurance program related inspections and their dates, and the dates inspection results for inspection reported the person responsible and informed by the study Director or responsible, confirming that the final report reflects the original data;
30.1. materials and methods the study description: 48.5.1. methods and materials used;
48.5.2. references to relevant approved study methods;
30.2. the results of the study: 48.6.1. Summary of results;
48.6.2. information and data required by the study plan;
48.6.3. statement of results, showing the statistical methods used;
48.6.4. evaluation of the results and conclusions;
30.3. the location stored in the study plan, the test substance or organism and a reference or a reference body, the original data and the final report.
49. the archive stores the following materials: 30.5. study plans, work schedules, the original data, the test substance or organism and a reference or a reference organism samples and final review of each study;
30.6. inspection reports relating to the quality assurance program;
30.6. information on staff qualifications, training, experience and job descriptions of personnel;
49. records and reports on the operation and calibration of the equipment;
30.8. news about the information systems;
30.8. documentation associated with the research methods;
49.7. environmental monitoring protocols.
50. If the test substance or organism, a reference or a reference organism and experimental product samples are destroyed before the end of the storage period, justified and shall draw up a document.
51. the test substance or organism, a reference or a reference organism and experimental product samples shall be kept only as long as the quality of these products allow evaluation.
 
 
III. the quality of the work of the laboratory surveillance and laboratory assessment 52. when assessing the quality of work of laboratory monitoring, Latvian National Accreditation Bureau periodically controlled laboratory studies of collateral (whether the laboratory has the necessary staff, equipment and other material resources for carrying out the study), procedures, and practices for the spot, asked the leading technical staff and the persons responsible for the assessment of management systems and processes, as well as assess the quality of the data obtained in the laboratory and set and these rules. Test and evaluation of the Latvian National Accreditation Bureau employees can call in experts.
53. The Latvian National Accreditation Bureau prepares written inspection report (in duplicate) for each test. The Protocol specifies the detected inconsistencies and anomalies, as well as guidance on the necessary modifications.
54. The Latvian National Accreditation Bureau provides your employees ' knowledge and practical training, as well as information on the requirements and methodology used in the laboratory for the assessment of the quality of work.
55. The Latvian National Accreditation Bureau employees have the right to access the restricted access information (including trade secrets), relating to the studies carried out in the laboratory, and refer to them in their reports. Latvian National Accreditation Bureau ensures the preservation of secrecy restricted access information (including trade secrets), produced by the laboratory for the monitoring of the quality of work.
56. The Latvian National Accreditation Bureau employees do not participate in the study and interpretation of the study results.
57. The Latvian National Accreditation Bureau employees have the right, with prior coordination with the laboratory control or a responsible person, to get into the laboratory and get the information you need. If the data access is essential to protect human health or the environment, authorised personnel shall have the right, by the study Director, or other representative of the laboratory management, to get into the laboratory and obtain necessary information without prior coordination with the laboratory control or responsible person.
58. If the laboratory is restricted access information (including trade secrets), the Latvian National Accreditation Bureau guarantees that reports on laboratory testing and study audits are made available only to the competent authorities.
59. The Latvian National Accreditation Bureau developed in laboratory performance evaluation (inspection) program, which includes: 59.1. conditions for testing laboratories (including general laboratory testing), as well as study audits (data, research methods, process and outcome evaluation) of one or more ongoing or completed studies;
59.2. the conditions for laboratory testing and study audits at the request of the competent institution;
59.3. authorized employee rights and duties of the laboratory test and data acquisition, test, a sample of approved research methods and other documentation;
59.4. laboratory inspection and study audit procedures;
59.5. validation of laboratory and research audit descriptions.
60. study audits will be carried out in order to assess ongoing or completed research and obtain additional information that is not specified in the final report. The audit of research, compare the original data with closing statements and other information, whether data or is not used in processing methods that could reduce the reliability of the results, and assess whether the checks carried out in accordance with the study plan and the approved research methods.
61. before the laboratory tests or study audit of Latvian National Accreditation Bureau staff:

61.1. plan your work and coordinate visits and slices in the selection with the study Director;
61.2. familiarize yourself with the test substance or organism, management structure, physical layout of buildings and research;
38.1. the previous inspection reports, the location of the laboratory, work organisation, reports on studies, reports and staff life descriptions (curriculum vitae).
62. During the evaluation, with particular emphasis on the previous examination or assessment courtofauditorsin, violations and the measures taken to eliminate such deviations or irregularities.
63. The Latvian National Accreditation Bureau shall inform the employee of the laboratory on the arrival date and time of visit, purpose and length of the test to ensure that the Latvian National Accreditation Bureau employees are available for the relevant staff and documentation. If you want to search the individual documents or statements, the trustee an employee indicates before the visit.
64. Entering the laboratory inspection or study audit, Latvian National Accreditation Bureau shall inform the employee of the laboratory's management and staff for inspections or study audits, nature areas and laboratory departments, auditing, selected studies, documents and staff need to engage, as well as discussing with the management of the laboratory, laboratory tests or study the progress of the audit, including: 64.1. agree on access to the documentation and, if necessary, the relevant copy documents;
64.2. request information about lab management structure, organization of work and employees;
64.3. requests information about the studies which are not covered by these rules, the laboratory rooms where the inspection or study audit;
64.4. what documents and samples necessary for the chosen study ongoing or completed audit;
64.5. agree on separate rooms provide a verification of documents and other activities;
64.6. in discussions with the quality assurance personnel.
65. in order to assess whether the laboratory has sufficient qualified personnel, staff position and fixed assets to study diversity and quantity, or organizational structure is appropriate and whether management has developed a staff training and health policies to be carried out in laboratory studies, the Latvian National Accreditation Bureau staff will check the following: 65.1. building floor plans;
65.2. the documents on the Organization of work in administrative and scientific matters;
65.3. the studies chosen for audit personnel life descriptions (curriculum vitae);
65.4. the on-going and completed studies with information on the list of study types, start and completion dates, test system, use of the substance and the study Director's name;
65.5. the staff health plans;
65.6. staff position descriptions, instructions, personnel training programs and protocols;
65.7. the approved laboratory studies the methods list.
65.8. approved research methods or inspect audited research.
66. in order to assess the quality of the mechanism provided for in the programme are adequately controlled studies under laboratory performance requirements, the Latvian National Accreditation Bureau staff person responsible for the quality, require quality play and study of the control systems and methods, as well as to produce quality time prepare protocols.
67. The Latvian National Accreditation Office, verify the following information about the quality assurance personnel: 67.1. quality assurance Manager and staff qualifications of personnel documents;
67.2. quality assurance personnel independence of research;
67.3. the quality assurance personnel in planning and conducting inspections, monitoring in certain critical phases of the study, as well as the resources available the following;
41.9. procedures, using samples, controls the short-term studies, where it is not possible for each study control;
67.5. quality assurance monitoring volume study;
67.6. quality assurance procedures, examining the statutory compliance with original data;
67.7. quality assurance staff reports on issues that may affect the quality or reliability of the study;
mm. measures to make the quality assurance personnel where derogations from the requirements of this regulation;
67.9. role of the quality assurance personnel, if studies or parts of studies are done in other laboratories;
67.10. quality assurance staff membership validation studies the methods of checking, editing and refinement.
68. the laboratory testing, the Latvian National Accreditation Bureau employee checks: 68.1. a separate study of the test substance, animals, food, and other materials posted in such a way that they cannot be mixed with other substances, research samples, animals and feed;
68.2. is made suitable for environmental control and monitoring of test substance storage areas, laboratory space, animal and other biological systems in the premises;
68.3. performing the necessary pest extermination procedures.
69. In assessing the biological systems of care and living conditions in the laboratory, check whether they comply with the laws and regulations that govern the experiments and scientific purposes of animals used, and trade policy and welfare of these animals, the killing procedures and methods.
70. If such is made in the laboratory studies, which require animal or plant species diversity as well as microbial or other cell or cells similar to the systems control regarding care, living conditions and the maintenance is determined depending on the test systems.
71. with regard to biological systems, the Latvian National Accreditation Bureau employee checks: 71.1. used in study plans under specified system;
study of the test system of 71.2. has been identified or is appropriate protocol or journals for the records system, or is completely received, registered, used or destroyed system;
71.3. test system facilities, pens, cages or tanks are accurately identified and supplied all the necessary information;
71.4. such separated enough studies that are conducted with the same animal species or the same biological test systems, but with different substances;
71.5. animal species and other biological test systems are adequately separated;
71.6. biological test system environment temperature, light and dark cycle corresponds to the study plan or in the standardised research methods;
71.7. records journals for the system, living conditions, maintenance, care and health evaluation meets the test systems;
44.6. performing records journals for the animal and plant quarantine system investigation, morbidity, mortality, behaviour, diagnosis and treatment, or other similar aspects appropriate to each biological system;
are the conditions suitable for 71.9. the removal or destruction of the system of inspection at the end.
72. Biological systems, the Latvian National Accreditation Bureau employees check: 72.1. space, hardware, the suitability of the equipment and material test systems and research needs;
72.2. measures to quarantine animals and plants that are introduced into the laboratory, and the operation of those arrangements;
72.3. procedures for isolating the animals or other elements of a test system, for which it is known or there is a possibility that they are ill or are disease vectors;
72.4. or each test system is adequate, and whether the Control Protocol (on health, behavior, and other aspects);
72.5. animal cage, feed tables, ūdenstvertņ, enhancement of other tanks and purity;
72.6 at. environmental analysis, environmental conditions, maintenance of equipment suitability and effectiveness;
72.7. animal faeces and waste removal and disposal operations with those of-or occurs to minimize odors, spread of diseases and pollution of the environment;
72.8. storage areas for animal feed or equivalent materials for all test systems-whether these areas are not used for the storage of objectionable material (for example, test substances, pest extermination chemical, disinfectants) and whether those materials is separate from the areas where the animals are kept or in other biological test system;
45.3. the stored feed and bedding for protection from the deterioration of adverse environmental conditions, infestation or contamination.

73. In assessing the equipment, materials, chemical reagents and samples, check whether the laboratory premises and equipment are suitable for carrying out the study, used equipment is enough, fast enough, according to a laboratory study requirements, or materials, chemical reagents and specimens are properly labelled, used and stored, as well as check: 73.1. hardware purity and agenda;
73.2. entries in journals and the instrument hardware, including information systems, operation, servicing, inspection, calibration, verification and certification;
73.3. material and labelling of chemical reagents, storage temperature consistency, compliance with the term of validity, the data on the labels of chemical reagents;
45.6. the compliance system to be tested, the type of study and the acquisition date;
73.5. apparatus and materials used on the system.
74. Physical and chemical systems to see whether there is a specific test and reference substances, where this is required by the study plan, or are used in the study plan contains the reference, or automatic systems for the graphic, pašrakstoš equipment, prints and computer printouts are documented in the logs as the original data and transferred to the archives.
75. In assessing the test substance or organism and a reference or a reference body, assess, define and guarantee the identity, potency of these substances, the quantities and composition of the conformity marking, and the receipt and storage of the substance, as well as check that: 75.1. the Protocol on a written test and reference substances, all activities, sampling, usage and storage, as well as is specified in the Protocol or responsible employee;
75.2. the test and reference substances are labelled according to regulations;
75.3. the test and reference substances containers, vessels, containers are properly labelled;
75.4. storage conditions are appropriate to preserve the test and reference substances concentration, purity and stability;
75.5. written protocols or record in journals for the test substance and the reference substance identity, purity, composition, stability, and, if necessary, for the prevention of infection;
75.6. are the procedures of the test substance and the reference substance mixture containing homogeneity and stability;
47.0. containers, receptacles and containers containing test and reference substances, mixtures or solutions are highlighted, as well as records or journals for the homogeneity and stability of their contents;
75.8. is the analysis of control samples from each of the test and the reference series the research. Study of duration of not more than four weeks, these samples are stored in the appropriate period of time;
75.9. the substance of the blending methods ensure the avoidance of errors in identification of the substance or the unwanted mixing between;
75.10. detailed quantitative and qualitative information about the test organism and reference-microbiological purity of the body, nature, identity, properties, content of impurities and extraneous organisms.
76. In assessing research methods, check that: 76.1. in each of the studies are available in place of the approved research methods;
76.2. provides research methods supplement;
76.3. is approved in all studies the methods of correction or changes and indicates date of approval;
76.4. is stored in the research methods of documentation;
76.5. There are certain research methods: 76.5.1. test and reference substances, identity, purity, composition, stability detection, marking, sampling, usage and storage;
76.5.2. measuring apparatus, information systems and environmental control equipment, crew, cleaning, calibration and validation;
76.5.3. preparation of the reagent and dose;
76.5.4. data recording magazines, reporting, reporting, record keeping and reporting;
76.5.5. the test system containing space, distance and area preparation and environmental control;
76.5.6. the test system to receive, transfer, deployment, characterisation, identification and care;
76.5.7. transactions with test systems prior to research, study and after their completion;
76.5.8. the removal or destruction of the system;
76.5.9. destruction of parasites and cleaning products;
47.6. is available for a quality assurance program.
77. In assessing the performance of studies, check that: 77.1. the study plan was signed by the study Director;
77.2. any amendments to the study plan, including date, was signed by the study Director;
77.3. date when the agreement to the study plan by the study of the customer;
77.4. measurements, observations and examinations correspond to the study plan and the approved research methods;
77.5. measurements, observations and results of the right, correct, accurate and legible is recorded in the logs and signed, indicating the date.
77.6. after the original data (including data stored in computers) are saved in previous entries, the changes in the grounds, the person responsible for the change and the date when the change is made;
77.7. from your computer or obtained the data stored on your computer are identified and protected against unauthorised amendments or loss;
77.8. studies-information systems are reliable, accurate and tested;
all cases not provided for 77.9. original data is researched and evaluated;
77.10. the results include research reports, is relevant, complete and properly reflect the original data.
78. In assessing the closing statements, the Latvian National Accreditation Bureau staff will make sure that: 78.1. report is signed by the study Director to indicate date, thereby accepting the responsibility for reliability of the study and confirming that the study has been conducted in accordance with the requirements of this regulation;
78.2. reports are signed by the employee stating the date, if you include reports on research undertaken in other laboratories;
78.3. the report includes the quality assurance staff report, and that it is signed, including date;
78.4. are signed corrections if the staff responsible for the committed;
is a list of all 78.5. sample models and the original location of the data in the archive and storage space.
79. In assessing the reports, Protocol and storing messages, check: 79.1. is designated as the person responsible for archives;
79.2. archive security research plan, the original data, closing statements, samples and models, staff training and practice protocol protocol for storage;
79.3. in the receipt of material the archive;
49.3. procedures governing only authorized personnel access to the archives, as well as employee registration procedures, which allow access to the original data and other documents;
49.4. entries in the journal or index of materials taken from archives or returned;
79.6. or reports and materials stored in the specified time, or they are protected from damage by fire, adverse environmental conditions, or other factors.
80. the laboratory test may also include a study audit, which examines ongoing or completed studies.
81. The Latvian National Accreditation Bureau (apart from the provision of research tests) take specific, specific study audits if they required public authorities to assess applications for test substances or organisms or determine their risk to human health and the environment.
82. The Latvian National Accreditation Bureau staff and external experts participating in the study, the audit has the right to decide about the type of verification and inspection. Study audits carried out in order to assess the progress of the study, comparing the closing statements of research plans, research methods, the original data and other archive material.
83. the audit of research, the Latvian National Accreditation Bureau employee: 83.1. familiar with the research manager and the responsible specialist job description, description of life (curriculum vitae) and work experience;
51.7. check that there is enough relevant studies to be carried out by trained personnel in the sectors;
83.3. identifies the hardware used in the trials or special equipment to individual items and check the calibration of the equipment, operation and maintenance of journal entries;
83.4. test reports on the stability of the test substance, the substance to be tested and used for analysis, food analysis;
83.5. check (if possible, interrogating employees) work tasks selected study participants to see if they have had sufficient time to complete the study plan or report specified tasks;
83.6. compile all the copies of documents concerning the control procedures or important stages of the study, including: 83.6.1. research plan;
83.6.2. approved research methods at the time when the study was carried out;

83.6.3. Journal, laboratory notebooks, files, logs, schedules, computers, data to be retained of the calculations, if one is used;
83.6.4. closing statements;
83.7. surveys used by mammals, check a certain percentage of individual animals from their arrival to the study for autopsy, paying special attention to protocols relating to: 83.7.1. animal body weight, food and water intake, dose formulation and dosing;
83.7.2. clinical observations and autopsy findings;
83.7.3. Clinical Biochemistry;
83.7.4. pathology.
84. After laboratory examination or study audit completion the Latvian National Accreditation Bureau employees closed the meeting discusses the findings with laboratories and research institutions whom management representatives and prepares written inspection report.
85. If the assessment and audit of studies found only negligible laboratories quality requirements, all of which can affect the results of the Latvian National Accreditation Bureau employee requests to correct the violations and report shall specify the period within which the violations to be rectified. After the end of the period set out again.
86. If laboratory work quality violations is not open or if they are insignificant, the Latvian National Accreditation Bureau: 86.1. a receipt that the laboratory is evaluated and operate in accordance with laboratory performance requirements. The acknowledgement shall state the date and verified test studies;
86.2. a copy of the receipt along with the test report shall be submitted to the competent institution which requested a study audit.
87. If the assessment and audit of studies found significant laboratory work quality, which can affect the results of the Latvian National Accreditation Bureau: 87.1. the test report shall specify the details of the inadequacies or errors that could affect the credibility of the studies conducted in the laboratory;
87.2. notify the competent institution which requested that the study of laboratory test is invalid;
101.8. withdraw a statement that the laboratory is evaluated according to the requirements of this regulation;
87.4. indicates that the closing statements needs a report describing the work of the laboratory's quality requirements.
88. If a study audit has been carried out at the request of another institution, the Latvian National Accreditation Bureau responsible for preparing opinions and sends it to the competent institution, which commissioned the study.
 
 
IV. concluding issues 89. paragraph 4 of the rules shall enter into force with special cabinet rules.
90. the regulations shall enter into force by January 1, 2004.
 
 
Informative reference to European Union directives, the regulations include provisions arising from the Directive 88/320/EEC and 1999/12/EC Appendix and of Directive 87/18/EEC and 1999/11/EC Appendix.
Prime Minister a. Smith of environmental protection and regional development Minister, traffic Minister a. Gorbunov Editorial Note: regulations shall enter into force by January 1, 2004.