QP check sheets and Pfizer/BioNTech provide these to the
MHRA for each batch along with the
QP certificates of conformance.
QP certification must take into NIBSC
certification process, as this in itself does not imply release to market.
QP certification declares: (i) compliance with all stages of EU
GMP (where non-compliant, a gap analysis must be performed, and captured on the
QP checksheet), and (ii) that the batch has been manufactured as per the dossier supplied (currently Emergency Use Authorisation).
A certificate of conformance with
GMP and the conditions of this authorization must be generated by the releasing
QP and supplied to the onward supply chain.
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