Decree of the Ministry of Environment No. 305 / 1998 Coll.
Ordinance of the Ministry of the Environment laying down the principles of good laboratory practice, the procedure for verifying compliance, the certification procedure and the procedure for checking compliance with good laboratory practice (principles of good laboratory practice)
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Order
Effective from 01.01.1999
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01.01.1999
31.12.1998
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305
DECLARATION
Ministry of Environment
of 10 December 1998
laying down the principles of good laboratory practice, the procedure for verifying compliance with them, the procedure for issuing certificates and the procedure for checking compliance with the principles of good laboratory practice (principles of good laboratory practice)
The Ministry of the Environment provides pursuant to Section 5 (10) of Act No. 157 / 1998 Coll., on Chemicals and Chemicals and on the amendment of certain other laws (hereinafter referred to as "the Act"):
The principles of good laboratory practice (hereinafter referred to as "the principles') are set out in Annex 1.
(1) A legal person or a natural person authorised to do business (hereinafter referred to as "applicant") who requests the Ministry of the Environment (hereinafter referred to as "Ministry") to issue a certificate of compliance (hereinafter referred to as "certificate") shall submit a written quality system security programme in the testing facility in accordance with the principles (hereinafter referred to as "programme"). The test equipment is a legal or natural person authorised to do business who has the necessary equipment for carrying out studies.
(2) The applicant shall submit in the programme:
(a) evidence of the readiness of the test equipment to plan, implement, document and archive a study on the influence of the test item on the test system;
(b) evidence of the establishment of a quality assurance unit in the test equipment;
(c) the name and surname of the person responsible for managing the quality assurance function;
(d) proof of the scope of the quality assurance service's activities and the method of monitoring compliance with them;
(e) a description of the organisational integration of the quality assurance unit in the test equipment;
(f) establishing qualification assumptions for all test equipment personnel;
(g) details of the documentation management system in the test equipment;
(h) a description of the internal control system and study audits of the test equipment carried out by the quality assurance unit;
(i) evidence of the way in which the personnel in the test equipment are informed of all the circumstances relating to the quality assurance system.
(3) The model of the application for verification of compliance with the principles is set out in Annex 2.
Verification of compliance with the principles shall be carried out by checking the test equipment or by the Ministry through the legal person established by it.
The model of the certificate to be issued to the applicant is set out in Annex 3.
(1) Control of compliance with the principles is ensured by the Ministry in testing facilities through the legal person established by it in the form of periodic inspections of the test equipment or studies.
(2) The report on the outcome of periodic checks on the test equipment or studies shall include:
(a) the name, address and identification number of the test facility;
(b) the dates on which the check was carried out;
(c) the names and surnames of the staff involved in the inspection;
(d) the subject matter of the check;
(e) conclusions and recommendations concerning the granting, maintenance or withdrawal of certificates;
(f) the opinion of the test equipment on the conclusions of the inspection.
This Decree shall take effect on 1 January 1999.
Minister:
RNDr. Kužvart v. r.
Příloha č. 1
Annex No. 1 to Decree No. 305 / 1998 Coll.
PRINCIPLES OF CORRECT LABORATORY PRACTICE
The principles of good laboratory practice are used for testing chemicals and chemical products in which data on their properties and safety are obtained with regard to human health or the environment. Studies carried out according to principles include field work.
For the purposes of these principles:
1.1. Test site - part of a test facility in which a study or part thereof is carried out.
1.2. Study - a non-clinical study aimed at protecting human health and the environment, which represents an experiment or series of experiments in which the test item is examined in laboratory conditions or in the field to obtain data on its properties or safety.
1.3. By the contracting authority - the person who orders and finances the study.
1.4. A study leader - a worker who is responsible for the overall conduct of a non-clinical study. This responsibility shall include the approval of the study plan and its possible extension, the approval of the final report and ensuring that the study is carried out in accordance with the principles.
1.5. Senior scientist - a person who is responsible for a specific phase of the study in the case of a multi-site study. The responsibility of the study leader in the conduct of the whole study cannot be transferred to the senior scientist.
1.6. Quality assurance programme - system designed to ensure compliance of working procedures used with principles.
1.7. Short-term studies - studies conducted over a short period of time using widely used routine procedures.
1.8. The study plan - a document that defines the objective and experiments planned in the study.
1.9. Addition of the study plan - the necessary and documented amendment of the study plan after the start of the study.
1.10. Derogation from the study plan - unexpected and documented deviation from the study plan after the start of the study.
1.11. Test system - biological, chemical or physical system or combinations thereof used in the study.
1.12. Primary data - all initial records and documentation or certified copies thereof resulting from initial observations and other activities during the study. Primary data may be stored on magnetic media, photographs, microfilms, microfiche or may be put on sound media.
1.13. Test sample - material obtained from the test system for examination, analysis or storage.
1.14. The starting date of the study experiments - the day when the first data from the study began to be collected.
1.15. End day of study experiments - last day when data from the study were still collected.
1.16. The day the study started - the day the study manager approved the study plan.
1.17. The day of study completion - the day on which the study leader approved the final report.
1.18. Test item - chemical or preparation subject to study.
1.19. Reference item - item used for comparison with the tested item.
1.20. Batch - a specific quantity or part of a test or reference item prepared during a defined production cycle in such a way that it can be assumed that they have uniform characteristics.
1.21. Vehicle - a substance which serves as a carrier with which it is mixed or in which the test item is dispersed or dissolved to facilitate its application in the test system.
Organisation of test equipment
2.1. In test equipment
(a) records of qualifications, training, experience and job descriptions shall be kept for each university and technical worker participating in the study;
(b) appropriate and valid standard working procedures are in place and approved by all original and amended standard working procedures;
(c) a quality assurance programme is implemented, including the designation of the persons responsible for the programme, in order to ensure that quality assurance is carried out in accordance with the principles;
(d) be appointed as a senior officer with appropriate education, training and experience for each study; the appointment shall take place before the beginning of the study;
(e) in the case of a study carried out in several places, a senior scientist is appointed who has the appropriate education and experience to conduct a particular stage of the study.
2.2. The study leader is the highest degree of study management responsible for overall study management and for the final report on study results.
2.2.1. Study Manager:
(a) approve the study plan and any additions thereto by signing the study plan, indicating the date of signature;
(b) ensure that a copy of the study plan, including its additions, is available to the quality assurance service in good time;
(c) ensure that the study plan and standard working procedures are accessible to all persons participating in the study;
(d) ensure that a senior scientist is appointed in a multi-site study plan and that all test facilities and test sites in which the study is conducted are identified;
(e) ensure that the procedures specified in the study plan are followed, that any deviations from the study plan are assessed and documented on the quality and integrity of the study and that any deviations from the standard working procedures are confirmed;
(f) ensure that all primary data obtained are fully documented and recorded;
(g) sign the final report on the results of the study and thus assume responsibility for the validity of all these data;
(h) ensure that the study plan, the final report on the study results, the primary data and other supporting material are archived immediately after completion or suspension of the study.
2.3. The senior scientist shall ensure that the identified parts of the study for which he is responsible are kept in accordance with the principles.
2.4. The study staff shall comply with the safety rules and notify the study leader of any change in their health or use of medicines that might affect the results of the study.
Quality assurance programme
3.1. The test equipment has a documented quality assurance programme to ensure compliance with the principles of the conduct of the study.
3.2 The quality assurance programme shall be drawn up by persons who do not participate in the conduct of the study.
3.3. Unit ensuring compliance with the quality assurance programme
(a) maintain copies of all approved study plans, standard working procedures used in the test facility and have access to the timetable for the studies carried out;
(b) verify and document that all the data necessary to comply with the principles are included in the study plan;
(c) carry out checks on whether the studies are conducted in accordance with the principles. These checks are also intended to determine whether the study plans and standard working procedures have been made available to other workers and whether they are respected. The checks shall be divided into three categories, as specified in the standard working procedure of the quality assurance unit:
- study checks
- checking the test equipment
- checking methods and procedures,
(d) checks the final reports to verify that the methods, procedures and observations are correctly and fully described and that the results of the study reported in the report are consistent with the primary data;
(e) submit a written report to the statutory representative of the test facility and to the study leader or, where appropriate, to the lead scientist on the results of the check;
(f) draw up and sign a declaration accompanying the final report on the results of the study, specifying the date and type of control carried out and the date on which the results of the check were submitted to the head of the test facility and to the head of the study. The statement also confirms that the results of the study in the final report correspond to the data originally obtained.
Test equipment
4.1. The test equipment shall have an appropriate size, design and location to meet the requirements of the study and to avoid adverse effects that would impair the validity of the study; it has a sufficient number of rooms or spaces to ensure the separation of test systems and the separation of individual projects in which substances or organisms known or suspected to be biologically hazardous are handled.
4.2. Storage rooms or premises shall be separated from the rooms or spaces in which the test systems are located and shall ensure appropriate protection against contamination by living organisms, contamination or other disturbances of the environment. Suitable rooms or spaces are available for diagnosis, treatment and control of biological test systems.
4.3. The rooms or compartments for the reception and storage of the test items and reference items shall be separated from those intended for the preparation of mixtures of these substances with vehicle to prevent contamination or confusion.
4.4. The storage rooms or spaces for the test items are separated from those in which the test systems are located. They are suitable for maintaining the identity, concentration, purity and stability of test and reference substances and ensure safe storage of hazardous substances.
4.5. For the safe storage and searching of data, reports of study results, samples of test and reference items and substances, a archive is available in each test facility.
Instruments, materials and reagents
5.1. Apparatus, including validated computer systems, used for the creation, storage and searching of data, as well as equipment for the control and management of environmental factors relevant to the study, shall be appropriately placed, of the appropriate type and performance.
5.2. The apparatus used in the study shall be regularly checked, cleaned, maintained and calibrated according to standard working procedures. Records of such activities shall be kept. Calibration, if possible, has a link to national or international etalones.
5.3. The apparatus and materials used in the study shall not interfere with the test system.
5.4. Chemicals, reagents and solutions are properly identified in order to identify their name (including concentration and preparation), the date of the consumption period and the specific storage instructions. Data on the source, date of preparation and stability are also available. The consumption period may be extended on the basis of a documented evaluation or analysis.
Test systems
6.1. Apparatus used for measuring physical and chemical data are suitably located, of an appropriate type and of adequate performance; In doing so, the integrity of physical and chemical test systems should be ensured.
6.2. Appropriate conditions shall be established, maintained and documented for the location, handling and care of biological test systems.
6.3. The newly obtained animal and plant test systems shall be separated until their health status has been assessed. In the event of any unusual mortality or morbidity, the relevant delivery shall not be used for the study and in such a case the test system shall be handled in accordance with specific provisions. 1) At the beginning of the study experiments, test systems are in a disease-free state or conditions that would adversely affect the conduct of the study. Test systems that become ill or injured during the course of the study shall be separated and treated if necessary for the undisturbed course of the study. Any diagnosis or treatment performed prior to or during the study shall be documented.
6.4. Records of the source, date and condition of the accepted test system are archived.
6.5. Biological test systems must be adapted to the conditions of the test equipment environment within a reasonable period of time prior to the beginning of the study experiments.
6.6. The data necessary for the appropriate identification of biological test systems shall be provided in the boxes in which they are kept (cages, containers, packaging, etc.). Individual test systems shall be marked separately when removed from the boxes, where possible.
6.7. Containers for test systems are regularly cleaned and subjected to sanitation. Any material that comes into contact with the test system shall not be contaminated at a degree that would adversely affect the outcome of the study. The litter for animals changes according to breeding practice. The use of pest control devices shall be documented.
6.8. Test systems used in field studies shall be placed in a way that prevents adverse effects on the study by spraying and prior use of pesticides.
Test and reference items
7.1. The test equipment shall keep and maintain records of the characterisation of the test and reference item, the date of receipt, the guarantee period, the quantity obtained and the quantity used in the study.
7.2. The test equipment shall maintain and maintain procedures for the handling and sampling and storage of test and reference items in order to ensure their homogeneity and stability and to prevent their possible contamination or confusion.
7.3. Packaging with stock items tested and reference items shall bear identification data, consumption period and specific storage conditions.
7.4. Each test and reference item is identified by e.g. code, CAS registration number (Chemical Abstracts Service Registry Number), name, biological parameters, etc.
7.5. For each study, the identity of the test or reference item, including the batch number, purity, composition, concentrations or other parameters defined by each batch, is known.
7.6. In cases where the test item is supplied by the contracting authority, a procedure drawn up jointly by the contracting authority and the test equipment to verify the identity of the test item used in the study shall be established.
7.7. For all studies the stability of test and reference items under storage conditions shall be known.
7.8. If the test item is administered or administered in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle shall be determined. For test items used in field studies (e.g. in tanks), these parameters can be determined using separate laboratory experiments.
7.9. For all studies, a sample for analytical purposes shall be retained from each batch of the test item.
Standard working procedures
8.1. The test equipment shall have its own written standard working procedures that describe quality assurance and guarantee the integrity of the data obtained by that equipment.
8.2. In each separate unit or area of the test equipment, valid standard operating procedures relating to the activities carried out therein are available. Published book texts, articles and manuals can be used as additions to these standard working procedures.
8.3. Derogations from the standard working procedures for the study shall be documented and approved by the study leader or by a senior scientific officer.
8.4. Standard operating procedures are available in particular for these types of test equipment activities.
8.4.1. Test and reference items receiving, identifying, marking, handling, sampling and storage.
8.4.2. Instruments, materials and reagents
(a) instruments, use, maintenance, cleaning and calibration;
(b) computer systems and programmes, validation, operation, maintenance, safety, change management and backup;
(c) materials, reagents and solutions, preparation and labelling, storage, identity verification.
8.4.3. Workers: required expertise, training and education.
8.4.4. Maintaining records, preparing reports on study results, storing and searching data, identifying studies using coded characters, collecting data, preparing study reports, registering test systems, handling data, including using computer systems.
8.4.5. Test system
(a) preparation of areas and environmental conditions in areas for the test system;
(b) procedures for the reception, transport, location, characterisation, identification and care of test systems;
(c) preparation, observation and examination of test systems before, during and after the completion of the study;
(d) the treatment of subjects of the test system who have been diagnosed with disease or death during the study;
(e) the collection, identification and treatment of laboratory samples, including necropsy and histopathology.
8.4.6. Quality assurance procedures
Activities of the quality assurance service in the planning, implementation and documentation of checks and reports on those activities.
8.4.7. Archiving: what is to be archived, who is the responsible person where the archive is located, the archiving order.
Study execution
9.1. A study plan shall be drawn up in writing before each study begins. The study plan shall be approved by signature of the study manager and compliance with the principles shall be verified by the head of the quality assurance service. The study plan shall be approved by signing the statutory representative of the test equipment and the study contracting entity.
9.2. (a) Complements to the study plan shall be approved by the study leader by signing the date and archived together with the study plan.
(b) Derogations from the study plan shall be documented and approved without delay by the study leader or, where appropriate, by the senior scientific officer by signing the date and the relevant documentation shall be kept together with the primary data.
9.3. For short-term studies, a general study plan with addenda specific to the study may be used.
9.4. The study plan shall include the following data:
9.4.1. Name of study, identification of test and reference item
(a) the descriptive name;
(b) clarification of the nature and purpose of the study;
(c) identification of the test item by code or name (IUPAC nomenclature, CAS registration number, biological parameters, etc.),
(d) the reference item used.
9.4.2. Data on the sponsor of the study and test equipment
(a) the name and address of the contracting authority;
(b) the name and address of the test equipment and test sites involved in the study;
(c) the name of the study director;
(d) the name and address of the senior scientist and part of the study for which the senior scientist has been appointed as Head of the study and thus gained responsibility for the conduct of that part of the study.
9.4.3. Time data
(a) the date of approval of the study plan by signature of the study manager. Date of approval of the study plan by signing the head of the test facility and the study sponsor,
(b) the estimated dates for starting and ending the experimental part of the study.
9.4.4. Test methods
Reference to documented test procedures.
9.4.5.
(a) justification for the selection of the test system;
(b) the characteristics of the test system, e.g. species, strain, substrain, source, lot, number and weight range of individuals, sex, age and other appropriate data;
(c) the route of administration and the justification for its choice;
(d) dose or concentration, frequency and duration of administration or administration,
(e) details of the experimental plan, including a description of the time schedule of the study, all methods, materials and conditions, type and frequency of analyses, measurements, observations and examinations to be carried out and, where appropriate, a description of the statistical methods to be used to evaluate the data.
9.5. Study management.
9.5.1. Each study is clearly identified. All materials which are study items shall bear the same marking. The test samples of the study shall be identified to demonstrate their origin. Such identification allows the follow-up of the sample and the study.
9.5.2. The study shall be conducted as planned.
9.5.3. All data obtained during the study shall be recorded. These records shall be signed by the full name or initials of the worker, including the date.
9.5.4. Any change in the original data shall be made with an indication of the reason for such change in a manner which does not invalidate the previous data. This information shall be signed in full by the name or initials of the worker who made the changes, including the date.
9.5.5. Data directly entered into the computer shall be identified by the worker responsible for this activity. The design of the computer system allows for all audits or checks to show that all changes in the data did not interfere with the original data.
Report on study results
10.1. The final report on the results shall be drawn up for each study. In the case of short-term studies, a standardised final report with the study-specific accompanying supplement may be prepared.
10.2. Reports drawn up by senior scientists or other staff shall be signed by those involved in the study.
10.3. The study director signs and dates the final report on the study results, thereby assuming responsibility for the validity of the data. The extent of compliance with the principles shall be indicated.
10.4. The corrections and additions to the final report are in the form of additions. The supplements clearly state the reason for such corrections or additions and are signed and dated by the study leader.
10.5. The revision of the final report on the results into the form required by the registration or legislative authorities does not imply a correction, supplement or supplement to the final report, provided that the revised report contains the reason for the revision and a reference to the final report.
10.6. The final report shall include in particular the following information:
10.6.1. Name of study, identification of test and reference item
(a) the descriptive name;
(b) identification of the test item by code or name (IUPAC nomenclature, CAS registration number, biological parameters, etc.),
(c) identification of the reference item by name;
(d) characterisation of the test item, including purity, stability and homogeneity data.
10.6.2. Data on the sponsor of the study and test equipment
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Regulation Information
| Citation | Decree of the Ministry of the Environment No. 305 / 1998 Coll., laying down the principles of good laboratory practice, the procedure for verifying compliance with them, the certification procedure and the procedure for checking compliance with the principles of good laboratory practice (principles of good laboratory practice) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.1998 |
|---|---|
| Effective from | 01.01.1999 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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