The Q&A is based on the fundamentals of the EU GMP Guidelines, in particular those of Annex 16, and is applicable to EU/EEA QP certification or QP confirmation. It applies to the production and importation of human and veterinary medicinal products as well as investigational medicinal products. Following is a brief summary of the four Q&As:
Is remote batch certification / batch confirmation by the QP (i.e. when not at the authorised site address specified on the MIA) allowed on a routine basis?
This could be acceptable if a remote certification is accepted by the national authority at the site. The manufacturer and the qualified person should meet all valid local requirements.
Where remote QP certification / confirmation is allowed on a routine basis, what conditions should apply?
Broadly summarised, they include
Is the QP required to be a resident in the Member State where the authorised site is located?
Reference is made to the specific national requirements
What are the technical requirements for the remote access and the signature used for batch certification / confirmation?
In terms of IT security and data integrity, the risk for remote access is higher than for access within the controlled environment at the approved site. The minimum requirements are highly dependent on the state of the technology and should be consistent with the guidelines of Annex 11. For instance, among other things:
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