CENTRE FOR TISSUE ENGINEERING & REGENERATIVE MEDICINE, FACULTY OF MEDICINE
CURRENT GOOD MANUFACTURING PRACTICE (cGMP) LABORATORY
CTERM’s cGMP Laboratory is a state-of-the-art cleanroom which is located on the 12th Floor of HCTM UKM in Cheras, Kuala Lumpur. This facility consists of three Grade B cleanrooms which are supported by Grade C and D areas.
The cleanrooms are equipped with fully validated equipment including, but not limited to, CO2 incubators, biological safety cabinets, fridge/freezers, centrifuges, and microscopes and are capable of producing cell and gene therapy products (CGTPs) for clinical application. The facility is supplied with HEPA filtered clean air by 3 dedicated Air Handling Units (AHU).
The facility is staffed by dedicated personnel and has implemented a Quality Management System (QMS) to ensure conformance to Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guides to Good Manufacturing Practice for Medicinal Products. The facility also undergoes scheduled cleaning and environmental monitoring which include non-viable and viable airborne particles to ensure that it is compliant to ISO 14644-1 classifications of air cleanliness.
CTERM’s cGMP Laboratory is certified as an ISO 14644 compliant cleanroom by the National Environmental Balancing Bureau (NEBB) and is recertified on an annual basis. It has also been audited by the National Pharmaceutical Regulatory Agency (Malaysia) and has been confirmed that the facility conforms to the requirements of PIC/S GMP Guides and its relevant Annexes.
The construction of this facility was funded by Malaysian Technology Development Corporation (MTDC) and the National University of Malaysia.
Any inquiries on cGMP laboratory, equipment and services can be emailed to: ctermfper@ukm.edu.my
CENTRE FOR TISSUE ENGINEERING AND REGENERATIVE MEDICINE (CTERM)
Admin Office:
15th Floor, Pre-Clinical Building,
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, MALAYSIA.
Operational Office:
12th Floor, Blok Klinikal HCTM,
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Kuala Lumpur, MALAYSIA.
Phone: +6 03 9145 6239
Email: ctermfper@ukm.edu.my
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