The International Register of Certified Auditors (IRCA), located in London, UK has launched a revised scheme to ensure the highest auditing standards in pharmaceutical GMP (good manufacturing practice) globally.
The pharmaceutical auditing scheme has been set up to provide a common benchmark for auditor competency within the pharmaceutical industry. The primary legal responsibility of a GMP auditor in the pharmaceutical sector is to ensure that manufacturing and distribution operations comply with GMP and GDP legislation and guidelines and to ensure that practices do not put users of human and veterinary medicinal products at risk. While auditors are trained to audit, to date there has been no commonality in the approach to GMP auditor training, or to auditor competence within the industry internationally.
IRCA’s Pharmaceutical GMP Auditor Certification Scheme aims to ensure competency of auditors auditing against GMP and the International standards ICHQ 7, 8, 9, and 10, across the pharmaceutical industry. The areas cover all aspects of the manufacturing processes, including production, hygiene, distribution and tracking.
IRCA says the scheme gives auditors a mechanism for demonstrating their competency through the organisation's certification criteria based on: demonstration of appropriate work experience; the successful completion of the IRCA auditor training and exam; demonstration of sector understanding; and the submission of audits and records of continuing professional development.
The UK’s MHRA supports the scheme and AstraZeneca has already certified 20 of its international audit team.
Effective auditing is vital in ensuring patient safety, through helping to ensure robust quality manufacturing practices
Max Linnemann, Certification Manager at IRCA, said: 'With the increasing rise of the contract manufacturing organisation, more and more pharmaceutical manufacturing is being outsourced globally. While this can provide significant economic advantages to companies, ensuring the quality of pharmaceuticals can be challenging due to the lack of a single global standard.
'Effective auditing is vital in ensuring patient safety, through helping to ensure robust quality manufacturing practices. Currently, the industry appreciates quality management skills (as recognised by individuals being registered as QPs), however, auditing skills are not a criteria for QPs, and thus there is a real and worrying lack of clarity about “what is an effective auditor”. This scheme aims to provide that clarity, help raise standards in industry, and help individuals gain recognition for their auditing skills.'
Mark Birse, Group Manager GMDP Inspections at the MHRA, added: 'Pharmaceutical manufacturing and distribution supply chains have grown more complex and diversified over recent years and key to enabling companies to have satisfactory governance over these is the quality of the auditing performed. MHRA and IRCA share the desire to see an increase in auditing skill within the pharmaceutical supply chain and greater consistency in the approach taken to auditor training. Schemes of this nature have the potential to make a significant contribution in this regard.'