Guidelines for Inspection of Contract Research Organizations

Mandated to grant marketing authorization in Kenya, the Pharmacy and Poisons Board (PPB) establishes applicable regulatory requirements, receives and assesses applications that meet the requirements and grants marketing authorizations for successful applicants. To do this, PPB has the responsibility for inspections of source-sites of all the product registration applications. It also has the responsibility of performing investigations in all Bioequivalence studies sites and data pertaining to generic products in Kenya.

As such PPB requires that all sites used for clinical trials and Bioequivalence studies as well as sponsors and/or contract research organisations (CRO) from where data submitted for registration of medicines in Kenya is generated comply with applicable Good practices (GxP) including Good Clinical Practice (GCP), Good Laboratory Practice (GLP) Good Documentation Practices. Based on risk assessment, PPB will determine Clinical trial/ Bioequivalence study site (GCP/ BESS) compliance with generally accepted GxP through inspections and where appropriate document reviews. In addition, the GCP/ BESS GxP inspections seeks to determine whether the Bioequivalence studies were conducted in accordance with applicable regulatory requirements. These includes ethical standards, whether the approved protocol was followed and to determine the credibility, integrity and accuracy of data submitted and whether the participants enrolled in BE study were not subjected to undue risks among other considerations.

For the purpose of marketing authorization, planned inspections of Clinical trials and Bioequivalence Study Sites are generally performed after the completion of the Bioequivalence studies, data generated and is submitted for medicine marketing authorisation in Kenya. The inspections may be initiated during the initial review of a product registration (e.g. inspection of studies conducted or completed as part of the condition of a product registration), but could arise post-registration (e.g. because of concerns arising about the studies previously submitted). This usually may be due to queries arising during the assessment of the dossier or by other information such as previous inspection experience. Unplanned inspections are often investigative and are initiated following a complaint or suspicion of serious non-compliance integrity issues and/or scientific/ethical misconduct among other reasons.

The Pharmacy and Poisons Board CRO inspections are conducted to ensure that the rights, safety, and welfare of the human study subjects have been protected, and to verify compliance with Bioavailability and Bioequivalence Requirements. Such processes assist in ensuring the integrity and reliability of the bioequivalence study data submitted to PPB towards multisource product registration.