For all test facilities established in OECD countries, you should contact the national GLP Monitoring Authority responsible for the scope of your studies.
For test facilities established in a non-OECD country you can contact us by phone (+32 2 6425230) or via e-mail: guido.jacobs@wiv-isp.be for more country specific information.
For test facilities established in Belgium you should address a letter to Dr.
Johan Peeters, General Director of the Scientific Institute of Public Health, J. Wytsmanstraat 14, 1050 Brussels.
as explained in our Belgian GLP Compliance Monitoring Programme Manual
What is the price of a GLP inspection ?
The price of a GLP inspection is fixed in the Royal Decree of March 6,
2002 (B.S. of 12/3/2002). This means about € 111,5 per hour (preparation, travelling, inspection, audit, draft report, verification of corrective actions
included) per inspector.
When inspectors need to travel more than 100 kilometers extra costs for logements can be asked.
For inspections abroad of Europe, € 1784 is asked a day per inspector. The fees for Visa and vaccinations should be refunded. Transport (in business class) and logement should be arranged by the test facility;
Which functions are required by the GLP principles ?
Four functions are required: management, QA, study director and archivist.
Can more functions be combined by one person?
The test facility manager has to ensure that for each function qualified personnel is designated. It should be avoided that the same person has to
do different functions, but, in small facilities the function of management, study director and archivist can be combined. Quality Assurance personnel may never be involved in any part of a study.
They must also avoid to do any facility related action (authorization of SOP, validation, archiving of study material,contact with sponsor, master schedule..
.) that has to be audited or verified by them.
How many people can fulfill the role of Test Facility Manager?
As many individuals as a facility wants can make up TF management as long as the management responsibilities (as defined in the Principles)
allocated to each individual is clearly defined.
Each individual may hold all or only some of these responsibilities depending on their role within the
facility.
Regardless of how test facility management is defined, QA must be appointed by, and report directly to, it
What is the function of the sponsor? Can he take an active role during the study as a scientific advisor or in the redaction of the study report? Is the Study director allowed to send an intermediate or draft report to the sponsor?
Sponsor means the identity which commisions, supports and/or submits a non-clinical study. It is not foreseen by the principles that the sponsor is involved at any moment during the study.
The sponsor should discuss therefore the protocol, study plan and SOPs before the study plan is signed. He should provide information about
any known potential risk of the test item to the study director. If the characterisation of the test item is conducted by the sponsor, this fact should be explicitely mentioned in the final report and
it should be written down before in the study plan how the characterisation of the test and reference item will be done.
A study director is allowed to contact the sponsor to receive agreement before important amendments to the studyplan due to unforeseen deviations or problems.
The study director is also allowed to send intermediate results on request of the sponsor to help him in the programming of future studies, but the sponsor should
avoid to comment any result or raw data observed. The sponsor is not allowed to ask the study director to make changes in the draft report other than typographic faults.
It is not acceptable that the signature of the final report is delayed by sending the draft report to the sponsor. Finally the sponsor is responsible for the integrity of the assembled package of unalterated final reports.
Can the testfacility manager be at the same time the sponsor?
The principles don't forbid it. The sponsor can include an entity who support, by provision of financial or other resources, non-clinical health and environmental safety studies.
However, the sponsor should understand the requirements of the principles of GLP, in particular those related to the responsibilities of the test facility management
and the study director/Principal investigator.
Can the QA have family relationships with study director or financial interest in the company?
The principles don't forbid this kind of relationship between the different responsibilities. But every function should be aware that during
an inspection attention is always given to separation of responsibilities.
Why is there a need for us to inspect our quality assurance (QA) activities?
All elements of a test facility’s quality system should be inspected; QA is a key part of the GLP quality system. The inspection of QA activities
should be used to determine the extent to which the QA programme meets the requirements of GLP and the extent to which it complies with
the requirements of the test facility’s own processes and procedures.
Who should conduct inspections of our QA activities?
Inspections should be performed by a person(s) independent of the work/activities they are assessing and who are accountable to test facility
management. Inspections should be undertaken by persons who are suitably trained and experienced and are familiar with the test facility’s
QA processes and procedures.
The GLP Regulations state that 'the quality assurance programme should be carried out by an individual or individuals designated by and
directly responsible to management and who are familiar with the test procedures'. Neither the GLPMA nor the sponsor is responsible to test
facility management. However, departures from GLP identified during such inspections should be considered by test facility management and
may contribute to the overall assessment of QA.
Are electronic signatures and electronic raw data accepted?
Electronic raw data are allowed, if a full reconstruction of the study is possible. But the laboratories should pay attention to the stability of the data carriers. Is the software / hardware needed for reading of the electronic raw data still available after 10 or 20 years? Electronic signatures are generally accepted in Europe.
What are short-term studies?
There's no general agreement about the definition of short-term studies in the OECD GLP panel. Some types of studies can be accepted as short term studies: acute toxicity (one single application, in vivo or in vitro) and physico-chemical studies. The Test facility should at least define in his SOP what is seen as a short term study in
the test facility.
The Principles state that all amendments to study plans must be approved by the Study Director.
What about multisite studies. Is it acceptable that the Study Director is only advised of these changes in the form of an amendment if the
Principal Investigator decides that these are "major" changes?
First of all it is important that the Study director and the principle investigators verify that the study plan clearly describes any step in the whole study. It is not possible to make an amendmend is not decribed before anyware in a study plan or SOP. Any change should be noted to the study director before bringing in practice. Minor modifications made to standard analytical methods performed at an analytical test site
do not need to be approved by the Study Director located at different facilty. This would include changes in the type of glassware, brand of analyser, reagents, extraction procedures etc.
It would be acceptable for only the analytical Principal Investigator to approve and document such changes.
Where changes made to critical components (eg solvent mix, column type etc.) there need to be records to demonstrate that the changes have been validated
or checked to show that the method is still satisfactory.
The final report must also fully describe the method used INCLUDING any changes made to the original method listed in the study plan!
How much information must we have on a test item and does it have to have been generated in a GLP (Good Laboratory Practice) environment?
To conduct a GLP study on a test item where no information has been provided is not acceptable. The GLP
Principles state that information relating to a test item’s identity (code, CAS number, name etc) and
characteristics (batch, purity, composition etc) should be known and that records relating to expiry date and
quantities received and used should be maintained (Schedule 1, Part VI 1.- and 2.-).
To conduct a GLP study on a test item where the study director and their facility take no responsibility for
verifying the identity and nature of the test item is not acceptable. For example, a claim in either the study
plan or the report that “The Sponsor is responsible for the characterisation of the test item” is not
acceptable. The GLP Principles state that the study director and their test facility management have a
responsibility to establish a mechanism by which the identity of the test item can be verified (Schedule 1,
Part VI, 2.-(3)). If the sponsor is determining the test item characteristics, this information should be made
available to the study director.
There is no requirement to characterise the test item in a GLP compliant test facility, unless the receiving authority is requesting it. However, the study
director should be satisfied that the information has been generated in a facility where the results obtained
are considered to be accurate and reliable.The Study director must mention it in his compliance statement.
Are electronic copies of SOPs and the electronic distribution of these documents allowed ?
Electronic SOPs are accepted. But they should always be available at the working place and should be approved by management.
What's the difference between a deviation and an amendment ?
Deviations are unplanned deviations from the study plan, like e.g. problems that occurred during the executing of certain experiments. After the deviation corrective actions should be taken to avoid repetition of the deviation. Deviations are noted and acknowledged in a timely manner to the study director and signed by him/her.
Planned deviations should be made under the form of an amendment of the study plan. Amendments are mostly active for a longer time during the study.
Who should maintain CV's, job descriptions and training files ?
There's no obligation in the GLP principles that states where these documents have to be retained. Old versions of these documents should be stored in the archives. It's the responsibility of the management to organize the maintenance of these documents. GLP inspectors should always have access to these documents.
Should reference standards like weights, thermometers, etc. be calibrated by ISO 17025 accredited laboratories ?
Yes, standards should be traceable to national standards, which can only be obtained by calibration of the standards by a national metreological institute or by an accredited laboratory.
Do we need to conduct formulations analysis where there is no specific requirement for it in the test guideline (OECD, ICH etc)?
The OECD (Organisation for Economic Co-operation and Development) Principles of GLP (Good Laboratory Practice) require that if a test
item is administered or applied in a vehicle the homogeneity, stability and concentration of the test item in the vehicle should be determined.
Consequently, this information should be generated as part of a GLP study if the study director intends to make a full claim of GLP
compliance, regardless of whether or not it is specifically required by a test guideline.
Can formulation analysis be performed in a GMP (Good Manufacturing Practice) compliant laboratory?
In some instances, and particularly when testing pharmaceuticals, a study director may receive a formulated test item that has been supplied
by a facility that works in compliance with the principles of GMP. In these cases it would be acceptable for the GMP facility’s own laboratory or
an associated GMP contract laboratory to determine the homogeneity, concentration and stability of the formulation. In such circumstances,
the study director has a responsibility to ensure that the laboratory used to perform the analysis has been subject to a GMP inspection by the
appropriate regulatory body. The study director must also indicate in their statement within the final report that the work was performed in
accordance with the principles of GMP.
How do we issue a final report amendment?
Part IX of Schedule 1 of the GLP Regulations 1999 requires that amendments to the final report of a study should clearly specify the reason
for the correction or addition to the final report and also requires that the amendment should be signed and dated by the study director. The
form of the amendment itself is not dictated by the Regulations.
The responsibilities of the study director and QA apply to a final report amendment in the same manner they would apply to a final report.
Consequently, any amendment to a final report should:
Be signed by the study director to indicate acceptance of responsibility for the validity of the data and to indicate the extent of
compliance with GLP (if the original study director is no longer available, this should be stated and the amendment signed by
management).
Be inspected by QA to confirm that the reported results reflect the raw data.
Contain a signed QA statement detailing the inspections conducted (for example, review of the amended final report and data pertinent
to it) and confirming that the amendment reflects the raw data. Be retained in the facility archive.
In deciding how best to deal with amendments to a final report , it is useful to consider the extent of the addition or correction, and whether it
affects a discrete part of the final report, or affects multiple parts of the final report requiring changes to be made to many of its pages.
Should the amendment affect only a discrete part of the final report it is possible to issue a short document detailing the following:
The correction to be made and/or the text to be added to a specific section.
The reason why the change is being made.
A signed statement by the study director.
A signed QA statement.
Should the amendment affect multiple sections of the final report (for example, where amendment of a data point affects derived data,
tabulated data and statistical analysis) it may be more appropriate to issue an amended final report that replaces the original final report in its
entirety. In this instance, the amended final report should clearly state that it replaces the original version and detail the reason why the
changes or additions have been made.
Sponsors should be informed as soon as possible that a final report amendment or amended final report is required to ensure that any
regulatory authorities that have received the original final report can be informed. Test facilities should request confirmation from the sponsor
that the amended final report has been received and circulated appropriately.
It is advisable to sequentially number final report amendments.
If a final report is to be reformatted to meet the specific requirements of a regulatory authority, this is not considered to constitute either a
correction or addition to the final report provided that:
No changes are made to the detailed information presented and the narrative text of the final report remains identical
Any changes in wording relate only to those required for formal statements (for example, addition of a statement of no data
confidentiality within a final report reformatted for submission to the United States Environmental Protection Agency).
If the issue of a final report amendment is required to correct information within the original final report, test facility management should
investigate the root cause of the error.
What is the recommended archive period for GLP (Good Laboratory Practice) study records and materials?
The GLP Principles specify the manner in which study materials should be archived but do not specify for how long these items should be
retained. For some types of test items, the legislation relating to
that type of chemical or product may specify a required archiving period and this should be complied with.
Supporting records should be retained for as long as they may be required in order to support study data.
Items that have a limited shelf-life are not expected to be retained beyond their likely usefulness.
