Decree No. 219 / 2004 Coll.
Order on the principles of good laboratory practice
Valid
Order
Effective from 01.05.2004
Zobrazeno prvních 200 z celkem 514 ustanovení tohoto předpisu.
Zobrazit celý předpis →
Pro stažení celého znění použijte tlačítko Stáhnout výše.
219
DECLARATION
of 14 April 2004
on the principles of good laboratory practice
The Ministry of the Environment (hereinafter referred to as "the Ministry ') provides, pursuant to § 9 (10) of Act No. 356 / 2003 Coll., on Chemicals and Chemical Products and amending certain acts (hereinafter referred to as" the Act'):
For the purposes of this decree:
(a) principles of good laboratory practice (hereinafter referred to as "principles") - a set of rules constituting a system of work for testing equipment in the conduct of non-clinical studies on the safety of chemicals and preparations (hereinafter referred to as "studies"); these rules concern the conditions under which such studies are planned, carried out, checked, recorded, submitted and archived,
(b) testing equipment - a legal person or an undertaking natural person carrying out the testing of dangerous properties and the premises and equipment in which he conducts studies; in the case of multiple-site studies, the site of the test facility is the place where the study leader works and all individual test points which may be considered as test equipment individually or as a whole;
(c) testing site - place where the individual parts of the study are carried out;
(d) the head of the testing facility - a natural person who is responsible for the organisation and operation of the test plant in accordance with this Decree and has the necessary powers to ensure the activities referred to in point 1, point 1.1 of Annex 1 to this Decree;
(e) the head of the test site - a natural person who ensures that part of the study for which he is responsible is carried out in accordance with this Decree; the head of the test site shall be appointed if the study is conducted in several locations;
(f) by the contracting authority - the person ordering, providing and submitting the study financially;
(g) study leader - the natural person responsible for the overall conduct of the study at the testing facility,
(h) the head of the partial examination - a natural person who, if parts of the study are in multiple places, acts on behalf of the study leader and is responsible for the specified parts of the study;
(i) the programme - the quality assurance programme, which is independent of the internal system of carrying out the study, which is used to ensure compliance with the principles for the head of the testing facility and which includes staff; the system is documented in writing,
(j) standard operating procedures - documented procedures describing how to perform tests or activities not detailed in the study plan or in the test instructions;
(k) a list of studies - the information collected to plan the activities and to monitor the studies in the testing facility;
(l) studies - test or set of tests which, under specified laboratory conditions or natural conditions, test an item tested in order to obtain data on its properties and safety under the law;
(m) short-term studies - studies carried out within a short period of time using routine and widely used methods,
(n) study plan - a document defining the objective of the study and the design of its experimental implementation, including additions;
(o) complement the study plan - the document on the intended change of the study plan after the date of commencement of the study,
(p) deviation from the study plan - unintended change from the study plan after the start of the study,
(q) testing system - any biological, chemical or physical object or combination thereof used in the study,
(r) primary data - any original records and documentation or certified copies thereof obtained in the testing facility as a result of observations and activities during the study; the primary data may be photographs, microfilms or copies of microlabels, records on electronic media, dictated observations, automatic instrument records or records on any other media storing data which are normally considered safe for the retention of information for the period referred to in point 10 of Annex 1;
(s) sample of the test system - any material obtained from the test system for testing, evaluation or storage;
t) start date of the study - date on which the study leader signed the study plan,
(u) date of experimental initiation of the study - the date on which the first data related to the study were obtained;
(v) the date of experimental completion of the study - the last day on which data related to the study were obtained,
(w) the date of completion of the study - the date on which the study leader signed the final report,
(x) test item - chemical or chemical preparation which are the subject of the study,
(y) reference item - chemical or chemical preparation to be used for comparison with the tested item;
(z) batches - specific quantity or part of the tested or reference item, prepared in a defined production cycle in such a way that its uniform characteristics can be assumed and appropriately identified,
(aa) vehicle - any substance with which the test or reference item is mixed or in which it is dissolved or dispersed to facilitate its application to the test system.
(1) Laboratory tests for testing the hazardous properties of chemicals and chemical products shall be carried out according to the principles set out in Annex 1 to this Decree.
(2) The details of the programme are contained in Part A, point 2 of Annex 1 to this Decree.
(3) The Ministry will publish in the Ministry of the Environment Bulletin documents detailing the programme, including information on the legal framework in which the programme is implemented, with references to legislation, inspection manuals and guidelines, the frequency of checks and the criteria for their planning.
(1) A legal person or an undertaking natural person requesting a certificate of compliance (hereinafter referred to as "applicant") shall submit an application in accordance with the model set out in Annex 2 to this Decree.
(2) The application for certification is sent by the applicant to the Ministry and to the legal person referred to in Section 4 (1).
(3) The applicant shall accompany the application with an affidavit declaring that he has an established and functional programme and indicating the name and, where appropriate, the names and surnames of the person responsible for the programme.
(4) Tests on animals shall be carried out by testing equipment in accordance with specific legislation (1)
(1) For the purposes of deciding on the issue of a certificate, compliance with the Principles shall be verified by means of an initial check of the testing equipment at the applicant's request. This verification is provided by the Ministry through the legal entity established by it (the inspection body), which carries out monitoring of compliance with good laboratory practice in testing facilities in the Czech Republic.
(2) Prior to the start of the inspection, the staff of the inspection body shall be proved by written authority of the Ministry.
(3) The report on the outcome of the test equipment inspection contains:
(a) the name, registered office and identification number of the testing facility;
(b) the dates on which the check was carried out;
(c) the names and surnames of the managers involved in the inspection;
(d) the subject matter of the check;
(e) conclusions and recommendations concerning the certification;
(f) the statement of the head of the test facility on the control result report.
(4) The model certificate to be issued to the applicant is set out in Annex 3 to this Decree.
(5) When checking the testing equipment, the staff of the inspection body shall proceed in accordance with the procedures set out in Annex 4 to this Regulation. The control procedure of the inspection authority is subject to the general rules on state control1a).
(1) Compliance with the Principles for holders of certificates is checked by the Ministry through the inspection body in the form of periodic checks on testing equipment or studies audits. Periodic inspections shall examine the procedures and practices of the on-the-spot 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 as soon as possible by mutual agreement of the certificate holder with the inspection authority. The audit of studies shall compare primary data and related records with an interim or final report to determine whether the primary data have been properly reported and whether the testing is carried out in accordance with the study plan and standard operating procedures; to obtain further information not included in the final report and to determine whether procedures have been used in the processing of data that could reduce their validity.
(2) The report on the outcome of the periodic inspection of the test equipment contains:
(a) the name, registered office and identification number of the testing facility;
(b) the dates on which the check was carried out;
(c) the names and surnames of the test facility managers involved 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 head of the test facility on the periodic review report.
(3) The audit report contains:
(a) name of the study;
(b) the name, registered office and identification number of the test facility;
(c) the dates on which the audit was carried out;
(d) the names and surnames of the test facility managers involved in the audit;
(e) the subject matter of the audit;
(f) conclusions and recommendations on the degree of compliance with the principles, conservation or withdrawal of certificates;
(g) the statement of the head of the testing facility on the audit result report.
(4) During the periodic examination of the test equipment or the audit of the study, the staff of the inspection body shall proceed in accordance with the procedures set out in Annex 4 to this Regulation. The procedure of the inspection authority for periodic checks is subject to general state control rules (1a).
In the event of non-compliance with the Principles, the Ministry shall, on the basis of a recommendation from the inspection authority, withdraw a certificate from the testing establishment.
Decree No 283 / 2001 Coll., on the principles of good laboratory practice, the procedure for verifying compliance with them, the procedure for issuing and withdrawing certificates and the procedure for checking compliance with the principles of good laboratory practice for testing the properties of chemicals and chemicals (principles of good laboratory practice) is hereby repealed.
This decree shall take effect on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Minister:
RNDr. Ambrozek v. r.
Příloha č. 1
Annex No. 1 to Decree No. 219 / 2004 Coll.
PRINCIPLES (2)
1. Organisations and staff of the testing facility
1.1. Head of Test Device
1.1.1. The head of the testing facility shall ensure compliance with this Principles in the relevant testing facility.
1.1.2. The head of the testing facility shall, in particular, ensure within its competence:
(a) that a document designating it as the person responsible for conducting the test equipment is available in accordance with this Principles;
(b) qualified staff, premises, equipment and materials are available to enable the study to be carried out in a timely and orderly manner;
(c) keeping documentation on the qualifications, training and experience of all professional and technical staff, including descriptions of their work;
(d) staff members shall mean the activities to be carried out and, where necessary, trained staff members;
(e) that the technical standard operating procedures in force are developed and followed and approved, whether original or revised;
(f) the implementation of the programme, including the identification of the persons responsible for the programme, and ensuring that quality assurance is carried out in accordance with this principle;
(g) prior to the start of each study, the appointment of a study leader who has the appropriate qualifications, training and experience; the replacement of the study leader shall be carried out according to the procedures laid down and documented;
(h) in the case of multi-site studies, the appointment of a head of sub-examination who has the appropriate qualifications, training and experience to supervise the studies entrusted to him; the replacement of the head of the subtest shall be carried out according to the procedures laid down and documented;
(i) documented approval of the study plan by the study leader;
(j) that the study manager has made available an approved study plan to the staff of the quality assurance service;
(k) keeping all valid and invalid versions of standard operating procedures in at least one specimen;
(l) the appointment of the staff responsible for keeping the archive,
(m) the registration of studies and the retention of their list;
(n) that supplies to the testing facility meet the requirements for their use in the study;
(o) that there are clear ways of exchanging information between the study leader, the study leader, the quality assurance programme manager and other staff involved in the study;
(p) characterisation of the tested and reference items.
1.1.3. The head of the testing facility shall, within its scope, establish procedures to ensure that computer systems are suitable for the intended purpose and are validated, used and maintained in accordance with this Guideline.
1.1.4. The head of the test site shall assume responsibility at the test site for the provision of the activities of the head of the test facility, with the exception of those referred to in point 1.1.2. (g), (i), (j) and (o).
1.2. Study Manager
1.2.1. The study leader is the only study manager and is responsible to the study leader for the overall implementation and final study report.
1.2.2. The study leader shall approve the study plan and any additions to the study plan within the scope of his or her competence and shall bear his or her signature and date.
1.2.3. In particular, the study director shall ensure, within his or her competence, that:
(a) the staff of the quality assurance service shall have a copy of the study plan and any additions thereto and effective cooperation with the staff of the quality assurance service during the study;
(b) staff involved in the study have a study plan at their disposal prior to its experimental initiation, all its supplements and standard operating procedures;
(c) the multi-site study plan and its final report identify and define the roles of all subtesting leaders, all test facilities and test points where the study is conducted;
(d) comply with the procedures set out in the study plan, assess and document the impact of any deviations from the study plan on the quality and integrity of the study and, where necessary, implement corrective actions; evaluate and confirm deviations from standard operating procedures during the study;
(e) all primary data obtained are fully documented and recorded;
(f) computer systems used in the study are validated;
(g) a study plan, final report, primary data and supporting material are archived after completion of the study.
1.2.4. The study leader shall confirm the final report by signing it, indicating its date, thereby assuming responsibility for the validity of the data and indicating the extent to which the study complies with this Principles.
1.3. Head of Substudy
The head of the partial examination shall ensure that the parts of the study entrusted to him are carried out in accordance with this Principles. The responsibility of the study leader for the overall conduct of the study cannot be transferred to the study leader; in particular, the responsibility for approving the study plan and its additions, approving the final report and stating that this principle has been complied with cannot be delegated.
1.4. Studies staff
1.4.1. Other study staff must be familiar with those parts of the Principles that relate to their study tasks.
1.4.2. The study staff shall have access to the study plan and the relevant standard operating procedures they use when carrying out the study. They are responsible for following these documents. Any deviation from these documents shall be recorded and reported to the study leader or, where appropriate, to the study director.
1.4.3. The study staff shall be responsible for the accurate recording of primary data without delay, for the quality of such data and for compliance with this Principles.
1.4.4. The study staff shall follow measures to minimise the risk to their health and to ensure the integrity of the study. Staff members shall notify changes to their health to the relevant person, who shall decide to exclude staff from those activities in which the changed health may affect the study.
2. Programme
2.1. General
2.1.1. The testing equipment has a documented programme guaranteeing that studies are carried out in accordance with this Principles.
2.1.2. The programme shall be implemented by an employee or staff directly subordinate to the head of the testing facility and shall be well aware of the testing procedures.
2.1.3. Staff who ensure the quality of the study cannot participate in its implementation.
2.2. Quality assurance staff
2.2.1. Quality assurance staff within their competence:
(a) keep copies of any agreed study plans and standard operating procedures used in the testing facility and have access to a simultaneously valid copy of the study list;
(b) verify that the study plan contains the information required to comply with this principle; the verification shall be documented;
(c) carry out inspections to determine whether all studies are carried out in accordance with this principle; inspections shall also examine whether the study staff are available and follow study plans and standard operating procedures;
inspections shall be divided into three categories to be described in the standard operational procedures of the quality assurance programme:
(i) inspection of studies;
(ii) inspection of premises and facilities;
(iii) process inspections; records of such inspections shall be kept;
d) check the final reports and confirm that the methods, procedures and observations are described faithfully and accurately and that the recorded results accurately and fully reflect the primary study data;
(e) report without delay all results of inspections to the head of the testing facility and to the head of the study, and, where appropriate, to the head of the partial testing and to the head of the test site,
(f) issue and validate a declaration attached to the final report indicating the categories of inspections and the dates of their implementation, including the parts of the study checked, the date of notification of the results of the inspections to the head of the testing establishment and to the head of the study, as well as to the head of the partial testing, where appropriate; This statement also confirms that the final report reflects primary data.
3. Space
3.1.
3.1.1. The test equipment shall have spaces of such size, design and location as to meet the requirements of the study and to minimise disruptive factors which may adversely affect the validity of the study.
3.1.2. The premises are arranged in such a way that the degree of separation of different activities ensures that each study is properly carried out.
3.2. Space for test systems
3.2.1. The areas for testing systems have a number of rooms or sections to ensure separation of test systems and individual projects using materials or organisms known or suspected to be biologically hazardous.
3.2.2. There are rooms or sections for diagnosis, treatment and control of the disease to ensure that testing systems are not unduly impaired.
3.2.3. Storage facilities for supplies and facilities are available. The storage facilities shall be separated from the rooms or sections in which the test systems are located and shall ensure appropriate protection against pest infestation, contamination and degradation.
3.3. Spaces for handling tested and reference items
3.3.1. Separate spaces for receiving and storing tested and reference items and for mixing tested items with vehicle are set aside to prevent contamination or confusion.
3.3.2. The storage facilities for the tested items are separate from those for the test systems so as to maintain the identity, concentration, purity and stability of the tested items and ensure safe storage of hazardous substances.
3.4. Archive spaces
The archive rooms shall be equipped to ensure the safe storage and searching of study plans, primary data, final reports, samples of tested items and samples of test systems. Archive design and archival conditions are designed to protect archived material from premature deterioration.
3.5. Waste disposal 3)
Waste management and disposal are carried out in such a way as not to jeopardise the integrity of studies; This includes ensuring space for collection, storage and disposal of waste and procedures for decontamination and transport.
4. Instruments, materials and reagents
4.1. Apparatus, including validated computer systems, used for the acquisition, storage and generation of data and for monitoring of study-related environments shall have design and capacity commensurate with the needs of the study.
4.2. The apparatus used in the study is regularly checked, cleaned, maintained and calibrated according to standard operating procedures. Records of such activities shall be kept. Calibration, if possible, shall be linked to national or international standards of measure.4)
4.3. Instruments and materials used in the study will not adversely affect test systems.
4.4. Chemicals, reagents and solutions shall be identified by name or concentration, where appropriate, by indication of the shelf life and instructions on specific storage conditions. Data on origin, dates of preparation and stability are also available. The period of application may be extended on the basis of documented testing or analysis.
5. Test Systems
5.1. Physical and Chemical
5.1.1. The location and characteristics of the instruments used to obtain chemical and physical data are consistent with the needs of the study; their design and capacity are proportionate to the purpose of their use.
5.1.2. The integrity of physical and chemical testing systems shall be ensured.
5.2. Biological
5.2.1. Good conditions shall be established and maintained for the location, housing, treatment and handling of biological testing systems to ensure the quality of the data.
5.2.2. Newly acquired animal and plant testing systems shall be isolated until their health status has been assessed. If an unusual mortality or disease occurs, the supply shall not be used for studies and, where appropriate, test systems for killing in accordance with specific legislation. 1) In the experimental initiation of the study, test systems are free from any disease or condition that could adversely affect the purpose or course of the study. Test systems that become ill or injured during the study shall be isolated or treated if necessary to maintain the integrity of the study, in accordance with specific legislation. 1) All diagnoses and treatments for any disease prior to or during the study are reported.
5.2.3. Records of the source, date and conditions of supply of test systems shall be kept.
5.2.4. Biological test systems shall be adapted to test conditions for a reasonable period prior to the first administration (application) of the tested or reference item.
5.2.5. Any information necessary to properly identify the test systems shall be provided on their cages or containers. Individual test systems that are removed from cages or containers during the study shall be marked as far as possible.
5.2.6. The use of bedding and the cleaning of cages and containers for test systems shall comply with specific legislation. 5)
5.2.7. Test systems used in field studies shall be located in such a way as to avoid disrupting the study with spray and prior use of plant protection products. 6)
6. Test and reference items
6.1. Reception, handling, sampling, storage
6.1.1. Data shall be recorded and stored characterising the test and reference items, their intake dates, shelf life, the quantities received and the quantities used in the studies.
6.1.2 Handling, sampling and storage shall be carried out in such a way as to avoid any confusion and contamination and ensure an acceptable degree of homogeneity and stability.
6.1.3. The storage containers shall bear identification information, shelf life and specific storage instructions.
6.2. Characterisation
6.2.1. Each test and reference item is identified accordingly, e.g. by code, CAS (Chemical Abstracts Service Registry Number), name, biological parameters, etc.
6.2.2. For each study, the identity of the tested or reference item, including batch number, purity, concentration or other parameters that define each batch accordingly, shall be known.
6.2.3. In cases where the tested item is supplied by the contracting authority, the procedure developed jointly by the contracting authority and the testing facility to verify the identity of the tested item subject to the study shall be established.
6.2.4. The stability of the tested and reference items under storage and testing conditions is known for all studies.
6.2.5. If the tested item is administered or administered in a vehicle, the homogeneity, concentration and stability of the tested item in that vehicle shall be determined; for test items used in field studies, e.g. mixtures in tanks these parameters may be determined by means of separate laboratory tests.
6.2.6. For all studies except short-term studies, samples from each batch of tested items shall be kept for analytical purposes.
7. Standard operating procedures
7.1. The test equipment shall have written standard operating procedures approved by the test leader to ensure the quality and completeness of the data generated in the test equipment. Revision of standard operational procedures shall be approved by the head of the testing facility.
7.2. Each part of the test equipment has a valid version of the standard operating procedures applicable to the activities carried out here for immediate use. The Annexes to these standard operating procedures may include published textbooks, analytical methods, publications and manuals.
7.3. Derogations from standard operating procedures relating to the study shall be documented and confirmed by the study leader or, where appropriate, by the study supervisor.
7.4. Standard operating procedures are available in particular for the following activities in the test equipment:
7.4.1. Test and reference items
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 219 / 2004 Coll., on the Principles of Good Laboratory Practice |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.04.2004 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0