813.112.1 — OGLP
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
of 18 May 2005 (Status as of 1 December 2012)
The Federal Council
based on Article 5 paragraph 2 letter a of the Chemicals Act of 15 December 2000 1 (ChemA),
Articles 26 paragraph 3, 38 paragraph 3 and 39 paragraph 1 of the Environmental Protection Act of 7 October 1983 2 (EPA)
and Article 11 paragraph 2 letter a of the Federal Act of 15 December 2000 3 on Therapeutic Products (TPA)
decrees:
This Ordinance lays down the Principles of Good Laboratory Practice (GLP) as the quality standard for studies, and regulates compliance monitoring.
The Ordinance aims to:
The Ordinance applies to non-clinical studies of substances, preparations and articles (test items) that:
In this Ordinance:
Further terms relevant to GLP are defined in Annex 1.
The principles of GLP are listed in Annex 2.
The Federal Office of Public Health (FOPH) 5 , the Federal Office for the Environment (FOEN) and Swissmedic (Swiss Agency for Therapeutic Products) may issue joint guidelines on the interpretation of GLP Principles. In doing so they must take account of internationally recognised regulations.
Establishments that wish to have their test facilities listed in the register (Art. 14) must apply to the notification authority (Art. 8).
For each test facility, the application must include the following information:
On request from the competent authority, the establishments must submit other information.
If conditions in a test facility are substantially modified, the establishment must submit a new application without delay. In this case the list pursuant to paragraph 2 letter i must include all studies since the last inspection. In the event of any doubt, the establishment must refer without delay to the notification authority to determine whether the modification is substantial. The notification authority gives its decision in agreement with the competent authorities concerned.
After receiving an application, the competent authority shall inspect the test facilities on site. During this inspection, the authority checks in particular whether the procedures, operating procedures and data obtained respect the principles of GLP.
Thereafter, the authority shall inspect the test facilities again every two to three years. Prior to each inspection the authority shall request information pursuant to Article 5 paragraph 2. The list pursuant to Article 5 paragraph 2 letter i must include all studies conducted since the last inspection. The competent authority may request further data.
If there is sufficient reason to assume that a test facility does not comply with the GLP Principles, the competent authority may conduct an inspection without delay.
The competent authority shall produce a report on each inspection.
The competent authority shall conduct a study audit on its own initiative or at the request of another competent Swiss or foreign authority if:
If after completion of the study audit the competent authority concludes that the audited study did not comply with GLP Principles, it may carry out an inspection.
The competent authority may also carry out a study audit as part of an inspection.
The competent authority shall produce a report on each inspection.
The notification authority in accordance with Article 4 paragraph 1 letter h of the ChemA shall coordinate the conduct of inspections and of study audits and, in agreement with the competent authorities, produce decisions on conformity with the principles of GLP.
The following authorities are competent to carry out inspections and study audits:
Where necessary the authorities may delegate tasks to each other, or call in specialists. They may delegate all or part of the tasks and competences with which they are entrusted by virtue of this Ordinance to appropriate public corporations or individuals. The FOPH and Swissmedic may only delegate the conduct of inspections and study audits.
The authority shall carry out inspections and study audits according to the guidelines in Sections A and B of Annex I of European Directive 2004/9/EC of the Parliament and of the Council of 11 February 2004 6 .
On request, the establishment must submit to the authorities all documents and all other evidence required to assess its compliance with GLP Principles.
The authorities must be allowed to access the test facilities at all times.
If an establishment with test facilities has been accredited by the Swiss Accreditation Service pursuant to Article 14 of the Ordinance of 17 June 1996 7 on Accreditation and Identification, the authority shall take these results into account.
The competent authority shall provide the establishment with the draft of the inspection report and allow it an appropriate period in which to state its position thereon. On receipt of a response from the establishment or on expiry of the period, the authority shall pass the inspection report to the notification authority.
The competent authority shall pass the report on the study audit to the notification authority.
The notification authority shall decide:
The provisions on study audits also apply to studies audited during an inspection.
The notification authority shall inform the competent authorities of planned inspections and study audits, and of decisions pursuant to Article 10.
An establishment must immediately notify the notification authority if:
For any study that must be carried out according to the principles of GLP, it is necessary in the procedure of notification or authorisation:
If the study was carried out in a country other than Switzerland, in addition to the study report, an extract from the foreign register or a confirmation from the foreign authority must be submitted proving that the test facility was included in the official monitoring programme at the time the study was carried out. In the case of countries that are not members of the Organisation for Economic Co-operation and Development (OECD), the notification authority may request other documents that it considers necessary to evaluate compliance with the principles of GLP.
If justified by the circumstances, and in particular if the results of the study are very important, or if there is doubt whether the principles of GLP have been respected, a federal executive authority may ask the notification authority to have a study audit carried out.
The notification authority shall maintain a register of all establishments with their inspected test facilities and their audited studies.
The notification authority shall enter the data in the register as soon as the formal decision has been made confirming conformity of the test facility with the principles of GLP.
The notification authority shall provide the establishment with a confirmation stating, in one of the official Swiss languages or in English, that its test facilities are listed in the register.
The notification authority shall regularly publish, in an appropriate way, a list of the test facilities that work according to the principles of GLP.
If the principles of GLP are no longer respected, the test facility shall be removed from the list mentioned in paragraph 4.
The register shall specify:
If in the course of an inspection, the competent authority ascertains that a test facility fails to comply with GLP Principles to the extent that the reliability of study results is no longer guaranteed, and that in consequence these results may generate erroneous conclusions relating to human and environmental safety, it must immediately inform the notification authority.
The notification authority must inform the federal executive authorities responsible for evaluating notifications or authorisations for substances and preparations.
The competent authorities may transmit confidential data only to:
Under no circumstances are the entries in the register pursuant to Article 15 confidential.
Depending on the area of competence (Art. 8), the FOPH, the FOEN and Swissmedic shall represent Switzerland on GLP-related issues in dealings with authorities and institutions abroad, and with international organisations.
The FOEN shall co-ordinate dealings with the Organisation for Economic Co-operation and Development (OECD) at national level. Each year it shall supply the OECD and the OECD member states with a list of inspected establishments with their test facilities and conducted study audits, and notify them of establishments that are guilty of serious non-compliance with GLP Principles.
Decisions made and confirmations delivered before this Ordinance comes into force remain valid until they are replaced by documents after the next inspection.
Requests made according to the previous legislation and still being processed by the GLP authorities shall be passed on to the notification authority when this Ordinance comes into force.
This Ordinance comes into force on 1 August 2005.
(Art.3 para. 2)
(Art. 4 para. 1)
Each test facility management should ensure that these Principles of Good Laboratory Practice are complied with, in its test facility.
2 As a minimum it should:
3 When a phase(s) of a study is conducted at a test site, test site management (if appointed) will have the responsibilities as defined above with the following exceptions: point 1.1, paragraph 2, letters g., i., j. and o.
The Study Director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.
2 These responsibilities should include, but not be limited to, the following functions. The Study Director should:
The Principal Investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable Principles of Good Laboratory Practice.
All personnel involved in the conduct of the study must be knowledgeable in those parts of the Principles of Good Laboratory Practice which are applicable to their involvement in the study.
2 Study personnel will have access to the study plan and appropriate Standard Operating Procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the Study Director, and/or if appropriate, the Principal Investigator(s).
3 All study personnel are responsible for recording raw data promptly and accurately and in compliance with these Principles of Good Laboratory Practice, and are responsible for the quality of their data.
4 Study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.
The test facility should have a documented Quality Assurance Programme to assure that studies performed are in compliance with these Principles of Good Laboratory Practice.
2 The Quality Assurance Programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.
3 This/these individual/s should not be involved in the conduct of the study being assured.
The responsibilities of the Quality Assurance personnel include, but are not limited to, the following functions. They should:
The test facility should be of suitable size, construction and location to meet the requirements of the study and to minimise disturbance that would interfere with the validity of the study.
2 The design of the test facility should provide an adequate degree of separation of the different activities to assure the proper conduct of each study.
The test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances or organisms known to be or suspected of being biohazardous.
2 Suitable rooms or areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.
3 There should be storage rooms or areas as needed for supplies and equipment. Storage rooms or areas should be separated from rooms or areas housing the test systems and should provide adequate protection against infestation, contamination, and/or deterioration.
To prevent contamination or mix-ups, there should be separate rooms or areas for receipt and storage of the test and reference items, and mixing of the test items with a vehicle.
2 Storage rooms or areas for the test items should be separate from rooms or areas containing the test systems. They should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.
Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.
Handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures.
Apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate capacity.
2 Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to Standard Operating Procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to national or international standards of measurement.
3 Apparatus and materials used in a study should not interfere adversely with the test systems.
4 Chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions. Information concerning source, preparation date and stability should be available. The expiry date may be extended on the basis of documented evaluation or analysis.
Apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and adequate capacity.
2 The integrity of the physical/chemical test systems should be ensured.
Proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data.
2 Newly received animal and plant test systems should be isolated until their health status has been evaluated. If any unusual mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. At the experimental starting date of a study, test systems should be free of any disease or condition that might interfere with the purpose or conduct of the study. Test systems that become diseased or injured during the course of a study should be isolated and treated, if necessary to maintain the integrity of the study. Any diagnosis and treatment of any disease before or during a study should be recorded.
3 Records of source, date of arrival, and arrival condition of test systems should be maintained.
4 Biological test systems should be acclimatised to the test environment for an adequate period before the first administration/application of the test or reference item.
5 All information needed to properly identify the test systems should appear on their housing or containers. Individual test systems that are to be removed from their housing or containers during the conduct of the study should bear appropriate identification, wherever possible.
6 During use, housing or containers for test systems should be cleaned and sanitised at appropriate intervals. Any material that comes into contact with the test system should be free of contaminants at levels that would interfere with the study. Bedding for animals should be changed as required by sound husbandry practice. Use of pest control agents should be documented.
7 Test systems used in field studies should be located so as to avoid interference in the study from spray drift and from past usage of pesticides.
Records including test item and reference item characterisation, date of receipt, expiry date, quantities received and used in studies should be maintained.
2 Handling, sampling, and storage procedures should be identified in order that the homogeneity and stability are assured to the degree possible and contamination or mix-up are precluded.
3 Storage container(s) should carry identification information, expiry date, and specific storage instructions.
Each test and reference item should be appropriately identified (e.g. code, Chemical Abstracts Service Registry Number [CAS number], name, biological parameters).
2 For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.
3 In cases where the test item is supplied by the sponsor, there should be a mechanism, developed in co-operation between the sponsor and the test facility, to verify the identity of the test item subject to the study.
4 The stability of test and reference items under storage and test conditions should be known for all studies.
5 If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For test items used in field studies (e.g. tank mixes) these may be determined through separate laboratory experiments.
6 A sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies.
A test facility should have written Standard Operating Procedures approved by test facility management that are intended to ensure the quality and integrity of the data generated by that test facility. Revisions to Standard Operating Procedures should be approved by test facility management.
2 Each separate test facility unit or area should have immediately available current Standard Operating Procedures relevant to the activities being performed therein. Published text, books, analytical methods, articles and manuals may be used as supplements to these Standard Operating Procedures.
3 Deviations from Standard Operating Procedures related to the study should be documented and should be acknowledged by the Study Director and the Principal Investigator(s), as applicable.
4 Standard Operating Procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples:
For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the Study Director and verified for GLP compliance by Quality Assurance personnel as specified at point 2.2 letter b. The study plan should also be approved by the test facility management.
2 Study plan amendments and deviations should be treated as follows:
3 For short-term studies, a general study plan accompanied by a study specific supplement may be used.
The study plan should contain, but not be limited to the following information:
A unique identification should be given to each study. All items concerning this study should carry this identification. Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study.
2 The study should be conducted in accordance with the study plan.
3 All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated.
4 Any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change.
5 Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given.
A final report should be prepared for each study. In the case of short term studies, a standardised final report accompanied by a study specific extension may be prepared.
2 Reports of Principal Investigators or scientists involved in the study should be signed and dated by them.
3 The final report should be signed and dated by the Study Director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these Principles of Good Laboratory Practice should be indicated.
4 Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the Study Director.
5 Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.
The final report should include, but not be limited to, the following information:
1 The following should be retained in the archives for at least ten years after study completion:
2 In the absence of a required retention period, the final disposal of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.
3 Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval.
4 Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded.
5 If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).