Report Gives Update on International API Inspections
A new report gives an overview of the work of the International API Inspection Program.
On April 12, 2018, the European Medicines Agency (EMA) announced the release of a report on the progress of the International API Inspection Program from 2011–2016. As part of the program, international regulators have collaborated to share information on good manufacturing (GMP) inspections of API manufacturers.
The program, which started as a pilot project in 2008, began in response to the growing outsourcing of APIs from international manufacturers. The objective of the program is to evaluate and coordinate inspections of the facilities of contract API manufacturers to ensure quality of the supply chain.
The report presents an overview of the activities by European authorities, the US Food and Drug Administration, Australia’s Therapeutic Goods Administration, and the World Health Organization between 2011 and 2016. During the six years covered in the report, 1333 inspections were performed at 458 manufacturing sites located in 18 different countries (49% in India and 36% in China).
The program is beneficial, authorities say, and it will continue. Plans to streamline the program and make improvements to the electronic information exchange platforms were proposed.
Source: EMA
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
