PIC/S looks to adopt EU Annex on qualified persons, batch release

Regulatory NewsRegulatory News | 16 June 2021 |  By 

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) this week announced plans to incorporate the EU good manufacturing practice (GMP) Annex 16 on batch release by a qualified person (QP) into a PIC/S guideline. The aim is to have non-EU/European Economic Area (EEA) members incorporate Annex 16 into their regulatory systems.
The EU’s Annex 16 covers the certification of a QP that can release product batches for marketing authorization holders in the EU or labeled for export, and also covers investigational drugs. The QP certifies that a drug has been manufactured in accordance with the marketing authorization and adheres to good manufacturing practices. The annex went into effect on 15 April 2016.
The decision to incorporate Annex 16 stems from a memorandum of understanding signed between the European Medicines Agency and PIC/S following the revision of Annex 16 in 2016, said a PIC/S announcement. The transposition effort was led by PIC/S subcommittee on GMDP harmonization, led by Health Canada’s Paul Gustafon.
The purpose of the incorporation is aligned with PIC/s mission to “lead the international development, implementation and maintenance of harmonized GMP standards and quality systems of inspectorates in the field of medicinal products.”
The stakeholder consultation follows several rounds of internal consultations and “extensive discussion” between PIC/S members on draft versions of PIC/S Annex 16. The PIC/S Committee recently agreed to proceed to Step 2 of the PIC/S consultation process, which “enables an opportunity for PIC/S participating authorities to consult with stakeholders.”
The consultation focuses on non-EU/EEA members of PIC/S, considering that EU/EEA members already follow Annex 16. The consultation is also open to the public.
PIC/S said that comments from stakeholders “will be considered carefully while working toward a general objective of ensuring continued harmonization and equivalence between the EU and PIC/S GMP guides.”
The public consultation period will end on 15 September.
For more information, contact info@picscheme.org
EU Annex 16
PIC/S announcement


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