WHO prequalification of medicines is a program by WHO to assess the quality, safety and efficacy of medicinal products. WHO inspectors verify any Contract Research Organization (CRO) that conducted any clinical studies relating to the submitted product complies with WHO guidelines.
PT Equilab International as the leader of bioequivalence study provider in South East Asia was inspected by WHO on 15 – 19 March 2021. The public inspection report (PIR) has recently published after WHO concluded a comprehensive product evaluation, including evaluating the bioequivalence study report of an injection product manufactured by one of our exceptional customer, a Indonesian pharmaceutical pioneer in the reproductive health.
The PIR demonstrates Equilab’s compliance with WHO good clinical practice and with WHO good laboratory practice in conducting the bioequivalence study based on the facilities inspected, the people met, and documents reviewed by WHO.
Facing pandemic since March 2020 has undeniably pushed us to reschedule the WHO inspection for numerous times. Considering the pandemic uncertainty on travel restriction, on February 2021 WHO decided to conduct the remote inspection which needs an immaculate preparation and coordination in order to ensure the online interaction will not be an issue during the assessment regardless of the time difference between Indonesia and Switzerland.
Dr Elham Kassary and Ms Stephanie Croft, the official inspectors, have lead the five days online inspection very delightful despite of the hectic interaction when inspecting our facilities, procedures and documentation. Their review includes our company history and background, clinical study performance, informed consent process, ethics committee approvals and correspondence, IMP accountability, dispensation and storage, processing and handling the biological samples collected during the study, equipment qualification and maintenance, employee training, computer controls, and a tour of the facility.
We are thankful inasmuch as getting meaningful support from Badan Pengawas Obat dan Makanan Republik Indonesia in preparing the execution of this big step for Indonesia. Now, Equilab International is officially the first CRO in ASEAN who accomplished the inspection in WHO Prequalification program. Becoming a global player, Equilab International is excited to sow our optimism as we are committed to provide high quality of bioequivalence study and clinical trials.