GMP Inspectors Working Group is considering which actions will be required after an inspection concludes that a manufacturing site does not comply with GMP, especially in cases in which a statement of noncompliance could lead to a shortage of critical medicines.
When a facility is deemed noncompliant, the concerned EU member states must decide how to manage the risk, using tactics that may include recall, prohibition of supply, or suspension of a manufacturing and importation authorization. However, in cases in which any those actions could lead to a drug shortage of life-saving drugs, national authorities might decide to “mitigate and accept” the risk posed by the site’s conditions, even though the site will remain noncompliant until corrective actions have been completed.
The EMA proposes to revise its Compilation of Community Procedures on Inspections and Exchange of Information to separate the processes of risk assessment and risk control, accelerate public release of noncompliance statement, avoid giving conditional GMP certificates together with noncompliance statements, and provide specific guidance to facilitate the release of critical drug products.
The newly announced consultation seeks to collect relevant information from stakeholders to help the working group to develop harmonized, risk-based approach to dealing with the supply of medicines in cases of serious noncompliance, and the EMA will accept comments on its proposed updates until May 15, 2018.