MOH Approved Facility Certification Body and Certifier
Find out more about the requirements for Ministry of Health Approved Facility Certification Body and Certifier.
On this page
General
Ministry of Health-Approved Facility Certification Body (MOH-AFCB) is a company with independent facility certifiers approved by the Ministry of Health (MOH). The certifiers are assessed to have the necessary experience and are credible to provide certification/auditing services for biocontainment facilities (e.g. high containment facility, maximum containment facility, BSL2 facility and biomanufacturing facility) using the relevant reference materials.
Criteria/eligibility
MOH-AFCB must have a minimum of two certifying members or approved facility certifiers (AFCs) and shall comprise of at least one lead biorisk management professional and one lead biocontainment engineering professional, wherein:
Lead Biorisk Management Professional is a person having expertise in microbiology, biosafety, biosecurity, general laboratory safety, laboratory practices and knowledge in relevant local legislations, and is familiar with the relevant biocontainment standards.
Lead Biocontainment Engineering Professional is a person who is professionally trained and engaged in a branch of engineering (e.g. mechanical, civil, electrical, chemical, industrial, etc), has knowledge in the principles of biocontainment, expertise and technical experience in biocontainment engineering (e.g. facility and biocontainment equipment) and is familiar with the relevant local legislation and biocontainment standards.
The MOH-AFCB and the members of the certification team (AFCs) shall have experience in certifying and/or commissioning the type/level of biocontainment facilities that they are providing services to and are required to be accredited under the Singapore Accreditation Council's (SAC's) Accreditation Scheme for Bio-Risk Management Audits (in accordance with CT 17 SAC Criteria for Accreditation of Auditing Organisations).
Application procedure
Applicants interested to apply as MOH-AFCB and MOH-AFC may apply online via the Biosafety E-services portal (HALP-BS or Healthcare Application and Licensing Portal-Biosafety Module) with all the relevant documents to the Ministry of Health.
Requirements
The following documents are to be attached to the application for MOH-AFCB and MOH-AFC.
Facility Certification Body (the company/organisation)
Indicate the level of biocontainment certification or auditing service to be provided
Background and history
Experience in certifying, commissioning and/or auditing of any biocontainment facilities
Internal standard operating procedure detailing methods to ascertain that the biocontainment facility under certification has the necessary engineering and administrative control, biorisk management system that meet the requirements specified in the relevant MOH facility certification/audit checklist and/or the biosafety or biorisk management standards, to ensure that the facility can be operated safely and securely
Singapore Accreditation Council (SAC)’s accreditation certificate for Bio-Risk Management Audits with date of validity
SAC’s latest Schedule of Accreditation for Bio-Risk Management Audits
Facility certifier
Indicate the level of biocontainment certification services to be provided
Submit
Curriculum vitae of the team members
Academic and professional certificates of the team members
At least three (3) testimonials from previous clients stating that the individual applicant (the biorisk management professional as well as the biocontainment engineering professional) had certified, commissioned/audited the biocontainment facility (the containment level shall be equivalent or higher than the containment level of facility that the applicant applies to provide services)
SAC’s accreditation certificate for Bio-Risk Management Audits with date of validity
SAC’s latest Schedule of Accreditation for Bio-Risk Management Audits
Submit your application via the HALP-BS or Healthcare Application and Licensing Portal-Biosafety Module.
Fees
Currently, the Ministry of Health does not charge any fees for the application as MOH-AFCB or MOH-AFC.
Processing time
The processing time for an application as MOH-AFCB and MOH-AFC will depend on the completeness and accuracy of the data in the application form and supporting documents submitted which is necessary in the processing of the application.
The application generally takes up to 30 working days to process, if and only if all the criteria and/or requirements for the application have been satisfied.
Validity of MOH-Approved Facility Certification Body and Certifier (MOH-AFCB and MOH-AFC)
The validity of registration as an MOH-AFCB and MOH-AFC is up to 5 years depending upon the discretion of MOH and is subject to renewal.
MOH has the right to revoke the approval if the MOH-AFCB and/or MOH-AFC refuses to accept new requirements or fails to comply with the requirements given by the MOH.
Reference materials for facility certification/audit
High Containment (Biosafety Level 3) Facility
Maximum Containment (Biosafety Level 4) Facility
Biomanufacturing or Large-scale Production Facility
Instructions to MOH-AFCB and Facility Owner (to be made available in future)
Biorisk Management Standard for Large-Scale Work With Biological Agents
Containment (Biosafety Level 2) Facility
MOH-Approved Facility Certification Body and Certifier (MOH-AFCB and MOH-AFC)
The facility certification bodies and certifiers included in this list are approved by the Ministry of Health to have the necessary experience and are credible in certifying/auditing biocontainment facilities.
View the List of MOH-Approved Facility Certification Bodies and Certifiers (MOH-AFCBs and MOH-AFCs).
FAQ
Read our FAQs for answers on commonly asked questions on biosafety.
