GMP Compliance on Ophthalmics: Analysis of EMA and FDA inspections deviations

Sara Maria Mateus Coutinho

Key information

Authors:

Sara Maria Mateus Coutinho (Sara Maria Mateus Coutinho)

Supervisors:

Rui Miguel Dias Loureiro; José Monteiro Cardoso de Menezes (José Monteiro Cardoso de Menezes)

Published in

11/17/2021

Abstract

The pharmaceutical industry it is one of the most regulated industries worldwide. Regulatory authorities like the European Medicines Agency (EMA) and Federal Drug Administration (FDA) conduct regular inspections to assess sites and manufacturing process compliance with regulations. As ophthalmic preparations are particularly demanding as far as requirements are compared with other dosage forms, their manufacturing process is more complex and, therefore, shows a higher risk for deviations. To identify the industry's hurdles, as far as compliance with regulatory authorities in Europe and the United States, data was gathered from the FDA public database and the request made by the Freedom of Information Act (FOIA) and EMA's Good Manufacturing Practice report. Subsequently, it was analyzed, systematized by categories, and verified. The most common deficiency was related to the Procedures category in EMA's (31,1%) and the FDA's inspections (42%). In a more in-depth analysis of the FDA's inspections data, this mostly happened because there were no written Procedures 33% of the time, and 18% of those written were not followed. The Records category, 30% of all deviations in the FDA's inspections, is the second-highest from which 79% are of investigations not followed through. The systematic analysis enabled the identification of the main issues around Ophthalmic inspections. This way, Ophthalmic manufacturers can be more attentive to these aspects and be better prepared in the event of an inspection.