The EMA therefore recommends that inspection teams, with agreement from the Committee for Medicinal Products for Human Use (CHMP), should make the decision on the appropriateness of using remote inspection on a case-by-case basis while also taking into account existing procedures for GCP inspections and considering the potential limitations of using a remote process.
It notes that these remote processes should not be viewed as a replacement for on-site GCP inspections but are a necessary consideration in the current circumstances. The EMA further notes that while standard procedures apply in the case of remote inspection, preparation for them will be more complex and require an assessment of whether the necessary technical requirements can be met to provide remote access. It advises on early engagement with sponsors and sites. The guidance cautions: “Remote inspections require a more customised preparation by the inspectee and the inspection team as compared to on-site inspections.”
The guidance covers all phases of remote GCP inspections, with a particular focus on the more challenging aspects, such inspection initiation, feasibility assessment and preparation.
COREX Logistics is a supply and logistics company with headquarters in Ireland, working with pharma and patients to facilitate improved healthcare worldwide.
Our expert international team works across an 80-country network, specialising in the EMEA region, providing the latest in clinical trial logistics technology and systems, cold-chain delivery, temperature-controlled transportation and storage services. From sourcing, procurement and customs clearance, to labelling, returns and destruction, we cover every link in the supply chain. We also run an established Named Patient Programme and provide Patient-Oriented services. With extensive knowledge and on-the-ground insight into our markets, we create innovative solutions with the ultimate goal of improving the lives of patients.