Good Laboratory Practice (GLP)

Slovak National Accreditation Services has launched electronical services for providing accreditation services. All processes, including  filling in the applications for providing accreditation services, its course, procesing results from testing of whole service, are solved electronically - directly by Accreditation information system - AIS.

It is necessary to have internet connection and web browser for AIS usage. Access to AIS is possible anytime on website AIS

New applicants for accreditation have to fill the registration form for their legal entity on website AIS

Application for accreditation services can be submit only through AIS. 

More information about working in AIS you can find in the User's Guide for the Subject, accessible after logging into the system by clicking on the name of the logged-in user at the top right of the screen.

The Slovak Good Laboratory Practice Monitoring Authority (SNAS) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme:

As part of our response to the coronavirus outbreak, we have decided to conduct only essential on-site Good Practice (GxP) inspections of Laboratories (renewing validity of the GLP Certificate), until further notice. Other inspections will be deferred to a later date.

If an remote office based inspection of your facility is conducted, once the inspection is closed a statement of compliance will be issued to provide your facility with a record of continued membership of the monitoring programme to perform GLP studies continually. An onsite facility inspection will then be scheduled after the end of the restrictive measures (paid hourly rate + in the case of foreign entities also travel costs).

This next requirement applies to all test facilities/test sites:

Any issues encountered due to COVID-19 that could potentially impact the GLP status of a study should be managed, fully assessed and documented via existing amendment and deviation procedures.
Maintaining an adequate QA programme is essential and it is recommended that QA activities are prioritised using a risk based approach. A risk assessment can be used to identify where to focus resource and adapt audit programmes.
If planned QA audits cannot be conducted or are delayed due to lack of available resource or travel restrictions, the impact this has on the study should be assessed and documented by the study director.
The use of remote technology (Skype, video calls, photos of the activities being performed with the date and time indicated...) as an alternative to physical presence would be considered acceptable provided there is enough detail within study records to reconstruct activities and that the method of observation can be identified. The use of remote observation methods should be fully risk-assessed to ensure they provide a similar level of oversight as a physical audit.
(We recommend you consult e.g. the MHRA guidance for GLP facilities on implementing and maintaining a risk-based quality assurance programme) which provides information on possible approaches for QA programmes).

SNAS should be informed, via email, of any significant changes that happen with regard to the premises, activities or management of a Test Facility to kvetoslava.forisekova@snas.sk

This situation remains under review and we will provide further information as it becomes available. If you have any questions on GLP-related issues, please email: kvetoslava.forisekova@snas.sk

For GLP Guidelines please visit web page : OECD Document Listing

12.05.2020

Number 21 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies

was published on the web page OECD.

Ing. Henrieta Bóriková, e-mail: henrieta.borikova(@)snas.sk; +421 940 982 186