14/15 June 2022
A manufacturer of medicinal products must meet Good Manufacturing Practice (GMP) standards. These standards are defined in various laws and regulations. In the EU the compliance with these regulations is checked and assessed by the national competent authorities. The overall goal is to have medicinal products of consistent high quality that meet the requirements of the marketing authorisation (MA) or product specification.
If a company supplies product to the USA, the U.S. Food and Drug Administration (FDA) might inspect the site assuring that drugs, medical devices, certain active pharmaceutical ingredients (APIs) and biological products manufactured in foreign countries and intended for U.S. distribution are in compliance with the applicable U.S. law and regulations.
GDP Inspections are carried out at Wholesale Dealer Licence Holders
Good Distribution Practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification. Many of the actors in the supply chain must implement GDP but are not under supervision. The competent authority for GDP will normally not carry out GDP inspections at transport companies (shipping companies) or at airport hubs.
You will also be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically, normally based on risk assessments. Overseas manufacturing sites are also inspected when medicinal products or certain APIs are imported to the EU.
Types of inspection
Inspections under a risk-based compliance programme
It is the aim of the competent authorities and inspectorates to prioritise regular inspections based on risk assessments. These inspections are generally announced in advance.
GMP inspections may sometimes be carried out with other inspections, such as with GDP, Good Clinical Practice (GCP) or Good Pharmacovigilance Practice (GPvP).
Product-related GMP inspections
Inspectorates may conduct product-related GMP inspections when assessing an application for a marketing authorisation. This inspection checks if the manufacturer complies with GMP. FDA may also carry out these pre-approval inspections. These inspections are generally announced in advance.
Product-related inspections can also be requested by the European Medicines Agency (EMA) for example by the Committee for Human Medicinal products (CHMp) during the pre-application of a centralised marketing authorisation application or the Co-ordination group for Mutual Recognition and Decentralised Procedures - human (CMDh). EMA uses inspectors from EU member states to ensure compliance with GMP principles.
Triggered or For Cause Inspections
Competent Authorities may inspect you if they are informed about possible GMP or GDP breaches for example by a whistle blower, the press/ media or another regulatory authority.
Here, only little or no notification of these inspections is given in advance.