QP12 Roles & Duties

Question 1

Operational duties - MA Related (3)

Answer 1

1) All sites of Manufacture, Testing and Certification are compliant with the terms of MA
2) All Manufacturing & Testing activities are consistent with those described in the MA

3) The source and specifications of SMs and PMs used in the batch are compliant with the MA
AND
A supplier quality management system is in place to ensure that only materials of the required quality are supplied.

Question 2

Operational duties - Quality System (5)

Answer 2

1) All activities associated with the Manufacture & Testing of the batch have been conducted in accordance with the principles and guidelines of GMP
2) All INVESTIGATIONS pertaining to the batch being certified (including OOS/OOT) have been completed to a level sufficient to support certification.
3) Any ongoing COMPLAINTS, INVESTIGATIONS, RECALLS do not negate the conditions for certification of the batch in question.
4) The required QTAs are in place
5) The SELF INSPECTION program is active and current

Question 3

Operational duties - Manufacture & Testing related (5)

Answer 3

1) All RECORDS are complete and endorsed by appropriate personnel. All required in process controls and checks have been made.
2) All FP quality control test data complies with the FPS (or RTR TP)
3) All M and T process remain on the VALIDATED state. Personnel are TRAINED and qualified as appropriate.
3) Any regulatory Post Market COMMITMENTS relating to Manufacture or Testing have been addressed AND Ongoing STABILITY DATA continues to support certification.
4) The impact of any CHANGE to Manufacture or Testing has been evaluated and any additional checks and tests are complete.

Question 4

Operational duties - Supply Chain related (4)

Answer 4

1) The entire supply chain of the AS and MP up to the stage of certification is documented and available to the QP
Should include mnf sites of SMs, PMs and any other material deemed critical through process risk assessment.
Preferably in the format of a comprehensive diagram, with each party including subcontractors of critical steps included.

2) All AUDITS of sites involved in M/T of MP and M of AS have been carried out and the audit reports are available to the certifying QP.
3) Appropriate arrangements for DISTRIBUTION and SHIPMENT are in place
4) In the case of MPs intended to be placed on the market in the Union, the SAFETY FEATURES referred to in A54 (o) have been affixed.

Question 5

Operational duties - Active and Excipient related (4)

Answer 5

1) Active substances* have been manufactured in accordance with GMP and where required distributed in accordance with GDP for active substances (used for medicinal products in the scope of 2001/83/EC)
2) Importation of the AS should comply with A46(b)
3) Excipients have been manufactured in accordance with the ascertained GMP referred to in A46(f)
4) When relevant, the TSE status of all materials used in the batch manufacture is compliant with the terms in the MA

Question 6

A54 - The following shall appear on the outer packaging;

Point (o) - Safety Features (3)

Answer 6

For medicinal products other than radiopharmaceuticals, Safety features enabling wholesale distributors and persons authorized to supply to the public to;

verify the authenticity of the medicinal product

identify individual packs,

as well as a device allowing verification of whether the outer packaging has been tampered with.