IRCA (International Register of Certified Auditors) has launched a revised scheme for auditing pharmaceutical GMP standards globally. The Pharmaceutical Auditing Scheme was established to provide a common benchmark for auditor competency within the industry to ensure that manufacturing and distribution operations and practices comply with GMP and GDP legislation and guidelines. To date, there is no common approach to GMP auditor training, or to auditor competence within the industry.
IRCA’s GMP Auditor Certification Scheme aims to ensure auditor competency for audits of GMP and the International standards ICHQ 7, 8, 9, and 10, across the pharmaceutical industry, covering all manufacturing processes, including production, hygiene, distribution and tracking. Supported by the UK’s MHRA, IRCA’s certification criteria are based on demonstration of appropriate work experience, the successful completion of IRCA auditor training and exam, demonstration of sector understanding, and the submission of audits and records of continuing professional development.
Max Linnemann, certification manager at IRCA, said, “With the increasing rise of the contract manufacturing organization, 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 ensure robust quality manufacturing practices. Currently, 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.”
An IRCA spokesman told Contract Pharma, “With the continued growth and increasing importance of the contract manufacturing sector, a clear benchmark for auditor competence and auditor training is a real necessity now, and IRCA is providing the solution.”
Mark Birse, group manager GMDP Inspections at MHRA, said, "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."