Knowledge - Legal Duties of the QP
What are the legal duties of a QP?
The legal duties of the Qualified person are listed out in Annex 16 of both UK GMP (in the orange guide) and EU GMP
There are non-delegable duties
1) Ensure certification is permitted under the terms of the MIA/ManA/CTA
2) Ensure any additional requirements of national law have been met
3) Certify in a register that is maintained and available for inspection and up to date
Annex 16 lists 21 additional points that QPs are responsible for ensuring are “secured” prior to certification. These are delegable duties, A QP may check these herself but they can be entrusted to suitably trained personnel.
Manufacturing and testing are in accordance with GMP.
Supply chain available
Manufacturing (packaging, starting and critical materials)
Preferably a diagram
Audit of all sites involved in manufacture and testing plus AS manufacture. Reports available to QP.
All sites comply with the MA for the intended territory.
All manufacturing and testing comply with the MA for the intended territory.
Starting material spec and source compliant to MA. Supplier QMS in place.
For products subject to 2001/83/EC or 2001/82/EC the AS have been manufactured and shipped in compliance with GMP and GDP
Importation in compliance with Art 46b for 2001/83/EC
For products subject to 2001/83/EC excipients manufactured in compliance with GMP in Art 46f
TSE status compliant to MA
All records complete and endorsed by appropriate personnel. All in process checks have been made.
All processes in validated state and personnel are trained.
QC data complies with specification in MA.
Post marketing commitments have been addressed. On going stability supports certification
Impact of any change assessed and additional checks if needed are complete.
All investigations (including OOS and OOT) have been completed to a sufficient level.
Ongoing complaints/recalls/issue do not stop certification.
Required technical agreements are in place.
Self-inspection programme is active and current.
Agreements for shipment and distribution are in place.
Safety features in place where appropriate (Article 54o of 2001/83/EC)
Its challenging to remember the 21 points while potentially under stress in a viva scenario – a stress that is not truly reflective of the day-to-day job when the orange guide/ Annex 16 can be within arm’s reach.
I think the following framework below is useful in giving an underlying structure that’s easier to memorise. There are several key documents that a QP needs to remember
The marketing authorisation (the MIA, ManA or CTA) -
Site licencing (think MIA, ManA)
The falsified medicines directive
The batch documentation pack – what the QP may actually see at the time of release
The 21 duties divide as evenly as possible along those lines. 5 Points relate to each of the first three with the remaining six related to the batch specific documentation.
1) The marketing authorisation (the MA or CTA)
o Sites comply with MA
o Processes comply with MA
o Materials comply with MA (Site and Spec) / Supplier QMS in place
o Batch in Specification to MA
o TSE compliant if in MA
2) Site licensing (think MIA, ManA)
o All sites (Manufacture/Test/AS) audited and reports available
o Self inspection is active and current
o All processes in validated state and personnel are trained.
o Supply chain available to QP
o Required technical agreements are in place
3) The falsified medicines directive
o AS complaint to GMP and GDP
o AS imported has written confirmation of GMP (if not on whitelist)
o Safety feature in place
o Agreement for dist and shipment in place.
o Excipients compliant to GMP
4) The batch documentation pack – what the qp will see at the time of release
o Manufacturing and testing are in accordance with GMP.
o All records complete and IP checks complete
o Post marketing commitments met, stability data supports investigation
o Any changes assessed and any needed checks completed
o All investigations complete to a sufficient level
o Nothing open that stops certification (complaint/recall etc)