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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.

United kingdomNorthern irelandGood laboratory practicePrinciples of good laboratory practiceUnited kingdom is pfizerHuman medicine regulationsPfizer limitedManufacturing gmbhHuman medicines regulationsGood laboratoryEmergency use authorisationCrown dependencyCrown dependenciesMedicines actஒன்றுபட்டது கிஂக்டம்வடக்கு ஐயர்ல்யாஂட்