QP Quality release certification

The QP is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the EU Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP).

PharmaConsult have a comprehensive network of experienced QP’s in UK , EU and USA so we can supply GMP compliance for materials and finished product produced in UK , EU and USA to allow final QP assessment and release certification to be made in the intended market.

Where importation is required from a third country manufacturing site, the QP is responsible for ensuring that a  technical justification should include a formal Quality Risk Management process to identify and manage any risks associated with obtaining materials of product from such a source. This should be fully documented and include at least the following elements:

  • Audit of the manufacturing activity including any sampling activity at the third country site and evaluation of subsequent transportation steps of both the batch and samples to ensure that the samples are representative of the imported batch.
  •   A review of any unexpected result or confirmed out of specification result. These may have implications for reliance on sampling performed at the third country manufacturing site and should be notified to the Supervisory Authority for the site where certification is performed. Such an occurrence should be regarded as a potential quality defect and investigated in line with the guidance in Chapter 8 of EudraLex, Volume 4, Part I.

The QP must personally ensure that the following operational responsibilities are fulfilled prior to certification of a batch for release to market or for export:

  • Certification is permitted under the terms of the MIA.
  • Any additional duties and requirements of national legislation are complied with.
 

Certification is recorded in a register or equivalent document.

PharmaConsult will provide the QPPV services as may be required;
for further details please contact,admin@pharmaconsult.co.uk