Legal And Operational Duties Of The QP

Question 1

What are the operational duties of the QP

Answer 1

Manufacture and testing sites are consist with the MA

Manufacture and testing and certification completed as per MA

Source and specification of starting materials are as per MA and supplier management for control and supply in place

TSE status as per MA, where applicable

Finished product testing is completed in line with the specification listed in the MA

Audits of manufacturing and testing sites are completed and available to the QP

Self inspection schedule is active and current

Required technical agreements in place

Supply chain for the manufacturing train from API starting material through to release is known and available to the QP

Processes and testing remain in a validated state and personnel are trained and qualified

API is manufactured to GMP and distributed to GDP

Written confirmation of any API imported from a third country is available

Agreement for distribution are in place

Excipients manufactured to appropriate level of GMP

Safety features affixed to packaging

Manufacture and testing to GMP

Records are complete and endorsed by appropriate personnel, IPC checks complete

Any investigations completed to a level that does not negate certification

Changes assessed and any additional action complete

Complaints, investigations, recalls investigations do not negate release

Post market commitments completed and stability supports ongoing release

Question 2

Legal duties of a commercial QP

Answer 2

As per human medicine regulation 2012/1916 schedule 7 the QP must personally ensure a number of duties have been completed prior to release for sale:

Each batch of medicinal product inks manufactured to GMP, the marketing authorisation and any local and National legislation

Any imports from a third country should undergo full qualitative and quantitative analysis of at least the active substances

Any batch manufactured for import into the EU should have appropriate safety features affixed to the packaging

Each batch certified in a register

Question 3

Legal duties of an IMP QP

Answer 3

As per statutory instrument 2004/1031 part 6 the QP should personally ensure a number of duties are complete before a batch can be release for clinical evaluation:

Each batch manufactured to GMP, the CTA and the PSF

Each batch has been tested and complies to the specification detailed in the psf

Any batch (including comparators) sourced from a third country has been manufactured to GMP

Each batch certified in a register