PIC/S has published a "Letter of Agreement between the
EEA Heads of Medicines Agencies and the Pharmaceutical Inspection Co-operation
Scheme" on their website. The objective of the agreement is the exchange
of information after audits among authorities and joint trainings for GxP
inspectors.
The agreement has been signed by PIC/S
and the "Heads of Medicines Agencies" (HMA), a network of Heads of
European Medicines Agencies responsible for the authorization of human and
veterinary medicinal products in the European Economic Area.
The information is exchanged in
connection with the "EEA Joint Audit Programme" (JAP) and the
"PIC/S Joint Reassessment Programme" (JRP). Both programmes are
considered equivalent and will alternately accompany audits within the
programmes.
The exchange of auditing schedules,
also with other programmes - such as the WHO vaccination programme - is
important to avoid any duplication of audits. Another key point is the joint
training of inspectors and auditors. Here, the main focus is on GMP and GDP.
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Source: PIC/S GMP Compliance
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