September 26, 2016
Improper product quality inspection and GMP certification
A manufacturer may bribe an inspector to amend the evidence from a failed inspection so they maintain their manufacturing license. In an attempt to maximise profit, a manufacturer may use: a lower quantity of the active ingredient; poorer quality components; or cut other corners in the manufacturing process, making a product less effective.
In particular, the Good Manufacturing Practices (GMP) are international guidelines that apply to manufacturers and related groups, to ensure the production of safe and high-quality products. If these practices are subverted through conflicts of interest or bribery there is a risk that products may harm patients. In order for countries to be able to export their medicines GMP standards must be met.
Weaknesses and opportunities for corruption in this area of the regulatory system increase the risk of falsified and substandard products entering the health system.