Decree No. 163 / 2012 Coll.
Order on the principles of good laboratory practice
Valid
Effective from 14.06.2012
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163
DECLARATION
of 4 May 2012
on the principles of good laboratory practice
According to Articles 17 (2) and 20 (6) of Act No. 350 / 2011 Coll., on Chemicals and Chemical Mixtures and on the amendment of certain laws (Chemical Act), the Ministry of the Environment provides:
Subject matter
This decree implements the relevant provisions of the European Union1), following the directly applicable regulations of the European Union2) and provides for
(a) principles of good laboratory practice (hereinafter referred to as "principles");
(b) the follow-up and periodic review and audit of the study;
(c) the scope of the information to be provided during the entry and periodic review and audit of the study;
(d) details of the report on the follow-up and periodic audit of the study;
(e) a model certificate.
Principles
(1) The principles set out in Part A of the Annex to Decree No 86 / 2008 Coll., on the establishment of principles of good laboratory practice in the field of pharmaceuticals apply to the testing of hazardous properties of chemicals and mixtures for the purposes of chemical law and directly applicable European Union2.
(2) The model certificate issued under the Chemical Act is set out in Annex 1 to this Decree.
Entry and periodic check and audit of the study
(1) Prior to the commencement of the entry control, each employee by the Ministry of the Environment of the established legal person for the verification of the principles (hereinafter referred to as "the validator ') shall be proved by a document of the staff member of the validator.
(2) The entry check shall determine whether the testing equipment (3) has an established quality assurance programme3) guaranteeing that the studies carried out (3) comply with the principles.
(3) The report on the process of initial control of the test equipment contains:
(a) the name, registered office and identification number of the testing facility;
(b) the date on which the check was carried out;
(c) the names and surnames of the senior staff involved in the inspection;
(d) the subject matter of the check;
(e) conclusions and recommendations concerning the certification;
(f) a statement of the management of the test equipment on the report on the conduct of the entry control.
(1) Before commencing the periodic check, each staff member of the certifying officer (hereinafter referred to as "the inspector ') shall be proved by an inspector's card.
(2) Periodic inspections shall examine the procedures and practices of the on-site testing equipment to assess the degree of compliance with the principles. Periodic checks shall be carried out at least every two years; where, for serious reasons, a check cannot be carried out within that period, the check shall be carried out within the earliest possible time, by mutual agreement of the certificate holder with the verifier.
(3) The audit of the study shall compare the primary data (3) and the related records with the interim or final report on the results of the study in order to determine whether the primary data have been properly reported and whether the testing is carried out in accordance with the study plan (3) and standard operating procedures (3); The audit of the study is used to obtain further information not included in the final report on the results of the study and to determine whether procedures have been used in the processing of the data that could reduce their validity.
(4) The report on the conduct of periodic inspection of the testing equipment contains:
(a) the name, registered office and identification number of the testing facility;
(b) the date on which the check was carried out;
(c) the names and surnames of the senior staff of the testing facility participating in the inspection;
(d) the subject matter of the check;
(e) conclusions and recommendations concerning the maintenance or withdrawal of certificates;
(f) the statement of the conduct of the testing equipment on the periodic inspection report.
(5) The audit report contains:
(a) name of the study;
(b) the name, registered office and identification number of the test facility;
(c) the date on which the audit took place;
(d) the names and surnames of the senior staff of the testing facility participating in the audit;
(e) the subject matter of the audit;
(f) conclusions and recommendations on the degree of compliance of the study with the principles;
(g) the statement of the management of the testing equipment on the audit progress report.
The course of entry and periodic control and audit of the study, including the extent of the information provided, is set out in Annex 2.
Efficacy
This Decree shall take effect on the 15th day following its publication.
Minister:
Mgr. Chalupa v. r.
Příloha č. 1
Annex No 1 to Decree No. 163 / 2012 Coll.
MODEL
Příloha č. 2
Annex No 2 to Decree No. 163 / 2012 Coll.
The course of entry and periodic control and audit of the study and extent of information4)
1. Verifying Person
The verifier shall ensure that an adequate number of inspectors is available, depending on:
(a) the number of test equipment included in the compliance programme;
(b) the frequency with which the degree of compliance of testing equipment with the principles is to be assessed;
(c) the number and complexity of studies carried out by such testing facilities;
(d) the number of special checks or audits required by the Ministry of the Environment and the Ministry of Health.
The verifier shall ensure the training of inspectors taking into account their individual qualifications and experience and shall participate in mutual consultations, including, where appropriate, training with the staff of the verifier in other OECD Member States.
2. Conformity programmes
The compliance programme shall be a detailed plan for monitoring compliance with the principles of testing facilities through study checks and audits. The purpose of monitoring compliance with the principles is to determine whether the test equipment has established principles in the conduct of studies and whether it is able to ensure that the resulting data are of appropriate quality.
3. Control of test equipment
Checks carried out on land, objects and workplaces used for testing to establish compliance with the principles may take place in any test facility which receives and has a certificate or application for health and environmental safety data for regulatory purposes. The inspector may audit data relating to the physical, chemical, toxicological and ecotoxicological properties of substances and mixtures. During the inspection, the management structure and the standard operating procedures of the test equipment shall be reviewed, interviews with the technical staff leaders shall be conducted, quality and integrity of data obtained by the equipment shall be assessed and reported.
3.1. Control procedures
Preliminary inspection
Before carrying out the examination of the test equipment or the audit of the study, the inspector shall familiarise himself with the test equipment to be visited. The inspector shall study all reports on previous inspections, plans of the testing facilities, organisational rules, study results reports and a list of staff.
The inspector focuses mainly on information on:
(a) the type, size and arrangement of the test equipment;
(b) the scope of the studies to be addressed during the inspection;
(c) the structure of the control of the test equipment.
The inspector shall focus in particular on deficiencies identified during previous inspections of the testing facility. Where no prior checks have been carried out, the preliminary checks shall serve to obtain the basic information.
3.2. Opening meeting
Inspector at the opening meeting
(a) clarify the purpose and scope of the visit;
(b) describe documentation such as in particular lists of ongoing and completed studies, study plans, standard operating procedures, reports on the results of the studies required for checking the testing equipment; agree also on access to relevant documents and, where necessary, copy them, clarify the structure of the test equipment or request information on the structure of the test equipment and its staff;
(c) request information on studies not covered by the principles carried out in parts of the testing facility where studies are carried out according to the principles;
(d) determine provisionally which parts of the test equipment are to be checked;
(e) describe the documents and samples required for the audit of selected ongoing or completed studies;
(f) notify that a final meeting shall be held after completion of the inspection.
The inspector shall establish contact with his quality assurance service before checking the test equipment.
When carrying out the inspection, the inspector shall be accompanied by a staff member of the quality assurance service.
3.3. Organisations and staff
The test equipment manager (3) shall submit, on request, in particular:
(a) floor plans;
(b) the organisational structure of management and expert sections;
(c) a list of staff involved in the studies selected for the audit, specifying their qualifications;
(d) a list of ongoing and completed studies with information on the type of studies, start-and-end data (3), testing system3), the method of application of test items (3) and the name of the study leader (3);
(e) health surveillance programmes;
(f) staff work, training programmes and records thereof;
(g) an overview of the standard operating procedures in the testing facility;
(h) specific standard operating procedures related to studies or procedures to be checked or audited;
(i) a list of study leaders and procuring entities (3) audited.
The inspector shall check in particular:
(a) the conduct of ongoing and completed studies to determine the level of work carried out by the testing equipment;
(b) the qualifications of the study manager, the head of the quality assurance service and other staff;
(c) the existence of standard operating procedures for all relevant areas of testing.
3.4. Quality assurance programme and quality assurance department
The head of the quality assurance service shall, upon request, clarify the systems and methods for checking and monitoring the quality assurance of studies and the system for recording observations made during quality assurance monitoring.
The inspector checks
(a) the qualifications of the head of the quality assurance service and of all staff of that department;
(b) whether the quality assurance service operates independently of the staff involved in the studies;
(c) how the quality assurance service proposes and performs checks, how it monitors the identified critical stages of the study and what means it has for quality assurance checks and monitoring;
(d) whether, in the case of short-term studies (3), where it is not practical to monitor each study, random sampling is used;
(e) the scope and depth of quality assurance monitoring during the implementation of the practical stages of the study;
(f) the scope and depth of monitoring of the quality assurance of the normal activities of the test equipment;
(g) the quality assurance procedure for checking the report on the results of the study to confirm its compliance with primary data;
(h) whether the management receives reports from the quality assurance function concerning problems that may affect the quality and integrity of the study;
(i) the measures taken by the quality assurance service in order to detect derogations;
(j) the possible role of the quality assurance function where studies or parts thereof are carried out in contractual laboratories;
(k) the possible role of the quality assurance function in reviewing, reviewing or amending standard operating procedures.
3.5. Space
The inspector shall verify that:
(a) the arrangements allow, in particular, tested items, animals, feed and pathological samples to be sufficiently separated so that they cannot be confused with these objects from another study;
(b) there are procedures for maintaining and monitoring environmental conditions and operating effectively in critical places such as rooms for animals and other biological systems, storage facilities for tested items and laboratories;
(c) the total cleaning in different areas is sufficient and whether pest control is carried out if necessary.
3.6. Care of biological testing systems, their location and isolation
The inspector shall check according to the testing systems that:
(a) the premises correspond to the test systems used and the testing needs;
(b) conditions are established for the quarantine of animals and plants which have been admitted to the testing facility and whether those conditions are properly applied;
(c) conditions are created for the isolation of animals and, where appropriate, other elements of the testing system known or suspected to be sick or carrying diseases;
(d) there is adequate control and registration of the health status, behaviour or other aspects of the testing system;
(e) there is adequate, well-maintained and efficient equipment for maintaining the environmental conditions required for each test system;
(f) cages for animals, nets, tanks and other containers and their accessories are kept clean;
(g) analyses to check environmental conditions and auxiliary systems are carried out in accordance with standard operating procedures;
(h) there are areas for the disposal of animal waste and waste from testing systems and whether they are handled in such a way as to minimise insect infestations, odour, disease hazards and environmental contamination;
(i) storage facilities for feed or similar material are available for all test systems; whether these premises are not used for storage of other materials such as test items, pest control chemicals or disinfectants, and whether they are separated from the premises where animals or other biological testing systems are located;
(j) the stored feed and litter are protected against deterioration caused by adverse environmental conditions, contamination or contamination.
3.7. Instruments, materials, reagents and samples
The inspector shall verify that:
(a) the instruments are clean and operational;
(b) records are kept of the operation, maintenance, verification, calibration and validation of the measuring apparatus and apparatus, including computer systems;
(c) the materials and chemical agents are properly identified and stored at appropriate temperature, and the duration of exspiration is respected; whether labels on agents indicate their origin, identity and concentration or other relevant information;
(d) the samples are correctly marked according to the test system, study, origin and date of collection;
(e) the instruments and materials used do not significantly affect the test systems.
3.8. Test Systems
3.8.1. Physical and chemical systems
The inspector shall verify that:
(a) stability of test and reference positions has been established (3) if the study plan so requires, and whether the reference entries in the study plan have been used;
(b) data from automatic systems obtained in the form of graphs, recordings or outputs from a computer are documented as primary data and are archived.
3.8.2. Biological Test Systems
The inspector shall, taking into account the aspects relating to the treatment, location and isolation of biological testing systems, check that:
(a) the test systems comply with the specifications set out in the study plans;
(b) test systems are identified, where necessary unambiguously, during the study, and there are records of the reception of test systems fully documenting the number of accepted, used, replaced and discarded test systems;
(c) the cages or containers for testing systems are properly labelled with all the necessary data;
(d) studies carried out on the same species or bioassay system but with different substances are adequately separated;
(e) the species or other biological testing systems in space and time are adequately separated;
(f) the environment of the biological testing system is in accordance with the study plan or standard operating procedures, such as temperature or light mode;
(g) records of reception, handling, location or isolation, treatment and medical evaluation relate to the relevant test systems;
(h) written records of examinations, quarantine, disease, mortality, behaviour, diagnosis and treatment of animal and plant testing systems or other similar aspects corresponding to each biological testing system are kept;
(i) appropriate measures are taken to remove test systems after completion of the tests.
3.9. Test and reference items
The inspector shall check that:
(a) there are written records of the receipt of the tested and reference items, including the designation of the responsible person, and of the handling, sampling, use and storage of the tested and reference items;
(b) the packaging of the tested and reference items is properly marked;
(c) the storage conditions are suitable for maintaining the concentration, purity and stability of the tested and reference items;
(d) there are written records of identity, purity, composition, stability of the tested and reference items and, where appropriate, of their protection against contamination;
(e) where appropriate, procedures exist for determining homogeneity and stability of mixtures containing test and reference items;
(f) containers containing mixtures or solutions of the tested and reference items, if necessary, and whether records of homogeneity and stability of their contents are kept;
(g) in the case of a test lasting more than four weeks, samples have been taken for analytical purposes from each lot (3) of the tested and reference items and have been kept for the relevant period;
(h) procedures for mixing substances are designed to prevent confusion or contamination.
3.10. Standard operating procedures
The inspector shall check that:
(a) each part of the test equipment is immediately available to the relevant approved version of the standard operating procedures;
(b) there are procedures for the revision and updating of standard operational procedures;
(c) all additions and amendments to standard operating procedures are approved and dated;
(d) old versions of standard operating procedures are kept;
(e) standard operating procedures are available in particular for these activities:
(i) reception, identification, purity, composition and stability, labelling, handling, sampling, use and storage of tested and reference items;
(ii) use, maintenance, cleaning, calibration and validation of measuring instruments, computer systems and environmental control equipment;
(iii) preparation of reagents and batch forms;
(iv) registration, notification, retention and searching of records and reports of study results;
(v) preparing and checking the environment in areas where testing systems are located;
(vi) reception, transmission, location, characterisation, identification and care of test systems;
(vii) handling of test systems before, during and after the study,
(viii) removal of test systems,
(ix) use of pest control and cleaning products;
(x) the activities of the quality assurance service.
3.11. Implementation of studies
The inspector shall verify that:
(a) the study plan is signed by the study manager;
(b) all additions to the study plan have been signed and dated by the study manager;
(c) the date of the contracting authority's consent to the study plan has been recorded where necessary;
(d) the measurements, observations and tests are in accordance with the study plan and the corresponding standard operating procedures;
(e) the results of these measurements, observations and tests have been recorded directly, immediately, correctly and legibly and have been signed or initialled and dated;
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Regulation Information
| Citation | Decree No. 163 / 2012 Coll., on the Principles of Good Laboratory Practice |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.05.2012 |
|---|---|
| Effective from | 14.06.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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