equilab news event

UK-MHRA Inspected Equilab's Bioequivalence Study

On the 25th – 27th November 2014, PT Equilab International was inspected by United Kingdom’s Medicines and Healthcare Products Regulatory Agency (UK-MHRA). The MHRA is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The inspection was conducted in order to assess the bioequivalence study for one of our sponsor’s products which will be registered and marketed in the UK.

The UK-MHRA inspectors consisted of two persons, one inspector specializing in assessing the GCP aspect and the other was for the GLP aspect. The inspectors were accompanied by Ibu Marianata R.S and Ibu Shanti Milani from Indonesian’s National Agency for Drug and Food Control (BPOM) as observers.

The opening of the inspection took place in the 3rd floor meeting room in PT Equilab International, Jalan RS Fatmawati Kav. 33, South Jakarta. The attendees from Equilab’s side were Mr Wimala Widjaja as the Director, Ms. Effi Setiawati as the General Manager Operational, Ms. Lucia Rat Handayani as Quality Assurance Manager, clinical site team which was led by Danang Agung Yunaidi, MD and the analytical site team which was led by Ismail Dwi Saputro.

The inspection was divided into three main aspects: Clinical, Analytical, and Management Aspect of the BA/BE study. In three days, the inspectors audited and assessed all the processes and documents that are related to the BA/BE studies in Equilab, including facility, procedures, equipment, and documentations.

This inspection was an important occasion for PT Equilab International. Through this process, PT Equilab International was able to present its commitment to the quality of system, services, and its vision to become a global scale company in BA/BE and clinical trials.