Working with GMMs
If you are considering to carry out research work which involves the use of GMMs at the University of Malta, please read carefully through the information on this website, including linked documents. The following points represent a summary of the main procedures that need to be carried out with respect to GMM work. Full details are provided in SOP ZRH-006-02. [PDF]
Prior checks
- Check carefully whether the GMMs you will be working with require Containment Level 1 or 2. The University is currently only licenced for these levels of containment. Work which requires higher levels of containment cannot be carried out at the University of Malta.
- Ensure that the laboratory you will be working in is registered with the Environment and Resources Authority as an approved laboratory for the Containment Level that is necessary for your work. If you are unsure, please email the Biosafety Committee and provide the room number and building of the laboratory you are enquiring about.
- Ensure that both yourself as well as any scientists working with you have received adequate training on the proper use of GMMs, including maintenance, use and disposal.
The process of registration
- Complete SOP ZRH-006-02 - Appendix 2 [Word] of SOP ZRH-006-02 [PDF], ensuring that you include correct details of the lab/s you will be using, as well as obtain signed approval of your Head of Department. If you will be using laboratories which fall under another University entity, you also need to obtain signed approval of the Head/Director of the respective entity. Each application requires a fee of €30 payable to ERA. Please indicate on this Appendix, the UM vote number from which this fee is to be debited. Use the ACRONYM field to provide this number.
- It is your responsibility to ensure that all researchers that will be using GMMs as part of your project, are adequately trained. Please complete one copy of SOP ZRH-006-02 - Appendix 3 [Word] for each researcher who will be handling GMMs. Specify also when the researcher obtained training for each of the listed items. Each form has to be signed by both the trainee as well as the trainer.
- Complete the risk assessment form in SOP ZRH-006-02 - Appendix 6 [Word], and take care to specify the names and details of every host and vector to be used in the project, as well as provide all the other information required. This is the most important part of the registration process, and needs to contain sufficient details in order to be able to provide a full risk assessment that is associated with the GMM related research work you will undertake. If you require more space in order to provide information for any section of this form, please attach additional sheet/s and refer to the respective sheet information within the relevant form fields. Appendix 5 contains full instructions on how to fill in this form.
- Go through the checklist in SOP ZRH-006-02 - Appendix 7 [Word], and ensure that you have included all required documentation in your registration application. Please also include this completed checklist with your registration application.
- Send all documents by email to the Biosafety Committee. Your application will be given a registration number and will be reviewed by the Biosafety Committee, normally within a period not exceeding 2 weeks from receipt of the application.
- Following the review, you will be provided with any relevant feedback in writing, if any additional information or changes are recommended by the Committee.
- Once the Committee is satisfied that the application fulfills the necessary requirements, it will be approved and signed by the Chairperson of the Biosafety Committee as well as the Biosafety Officer. You will be notified in writing of such approval.
- While the project is ongoing, you are required to inform the Biosafety Committee of any updates to your original application. Please refer to SOP ZRH-006-02 - Appendix 9 [Word]. Please send these updates to the Biosafety Committee by the 7th of March of every year, in order to allow the committee to compile a global report and forward it to ERA by the 31st March deadline. As long as your project updates require Containment Level 1, you may proceed to work during the year and include updates with your March report. However if any project update requires Containment Level 2, you are required to submit a full updated application, and need to await official confirmation from ERA before work commences.
- Ensure that throughout the course of your project, you also follow the requirements listed in SOP ZRH-006-02 - Appendix 7 [Word]. You need to maintain regular updated logbooks for the following:
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- quantity of GMM stock material and storage location/s
- every GMM inactivation event
- every periodical control check of the inactivation procedure
- any accidents, incidents and major spillages
If the GMM inactivation procedure being used is an in-house method, this requires at least a yearly validation process to ensure its efficacy, with validation records being kept accordingly. Alternatively, the GMM inactivation process can be carried out using commercially established kits such as the Bacillus stearothermophilus biological indicator procedure, or equivalent.
Training Records of all persons working on the project have to be maintained and updated. If additional persons at added during the course of the project, then training records for these have to be filled in too.
Note: Work with Containment Level 1 GMMs only requires the University to provide a notification of registration to ERA, meaning that you can start working on your project as soon as the University Biosafety Committee approves your registration application. However work which requires Containment Level 2, needs prior approval by ERA before any work can commence. The Biosafety Committee will review your application, provide any feedback and then seek approval from ERA on your behalf.
If you require any further information or clarification, please do not hesitate to email the Biosafety Committee.
