GCP remote check ingons followed BY GMP

, June 15 (UPI) -- The European Medicines Agency (EMA) on Wednesday issued new guidelines explaining how to conduct a long-range test of Good Clinical Practice (GCP) during the COVID-19 pandemicThe EMA said GCP checks were "essential" to assess listing permit applications, especially during public health crisesPreviously, EU authorities had provided GMP-related guidance that allowed for remote assessment of GMP facilities during the pandemicThe EMA said that on-site inspections "may not be possible due to travel restrictions and health risks for inspectors and inspectors" during the pandemicThe EMA said that with the consent of the Human Drug Commission (CHMP), the inspection team "should decide on a case-by-case basis whether remote inspection scans are appropriate and feasible in accordance with existing procedures for GCP inspections and restrictions imposed by remote processes"The EMA also acknowledged that the remote process "cannot completely replace on-site GCP inspections" and said the limitations of remote inspections at research sites were restricted"It is critical that any additional burden on research sites be avoided at this time," the EMA saidIn addition, local legal requirements for patient data protection may prevent access to the original documentAlthough the EMA indicated that the standard procedures for preparing gCP inspections apply to remote processes, it noted that preparation was "much more rigorous than on-site inspections" and that the initiator or applicant needed to be contacted as early as possible to determine the feasibility of the remote inspection"It is critical to assess whether the person being examined meets technical requirements to provide remote access to electronic systems and maintains communication and support with the inspector" and further states that the person under inspection should provide all required information and ensure remote technical support for the inspector during the preparation phase, for their computer systemIf remote inspection is not feasible, the EMA says the rapporteur should notify the EMA "immediately" so that the Rapporteur, the EMA and CHMP can decide on the next course of actionOnce remote inspections are considered feasible, the EMA indicates that inspectors should enter the preparatory phase, which should be carried out in accordance with standard proceduresBut the EMAadded that"remote inspections require more personalized preparation than site inspections and inspection teams" and"the fact that remote inspections take longer than on-site inspections due to the particularnature of such inspections and the fact that inspectors may need to control multiple systems at the same time when inspecting them."The EMA also stresses that inspectors and subjects should be in the same location as far as possible during inspections, although local guidelines for remote work should be followed 　　The guide also provides recommendations on the conduct of the inspection itself and notes that inspectors must be able to review electronic master file (eTMF) audit records, activity logs and metadata, and be able to use the electronic pilot master file (electronic pilot master file, eCRF) system 　　Ref.: "EMA" (EMA) 2020-06-10" Guidance on remote GCP inspections the COVID-19