NSF-DBA has launched an international training course for pharmaceutical quality management system (QMS) auditors with the certification imprimatur of UK’s International Register of Certificated Auditors (IRCA).
The course will deliver certified auditor training covering GMPs and the pharma QMS as outlined in ICH Q10 and is tailored specifically for auditors in the pharma industry that perform either internal self-inspections or external audits of suppliers and contractors.
UK-based IRCA is the world’s largest international certification body for auditors. It was formed in 1984 as part of the UK government’s “enterprise initiative,” with a mission of making industry and business more competitive through the implementation of quality principles and practices.
IRCA certification programs recognize the competence of auditors who audit quality, environmental, occupational health and safety, software development, information security, food safety management systems, and now pharmaceutical quality management systems.
Commenting on the certification, IRCA Deputy Director Vincent Desmond noted that “the pharmaceutical industry faces serious challenges such as contaminated or counterfeit products making their way into legitimate pharmaceutical supply chains. Regulatory agencies in the US, Europe and worldwide have put a hard focus on supply chain assurance.”
The NSF-DBA course on “Effective Pharmaceutical Audits and Self-Inspections” is the first training course certified under IRCA’s new “pharmaceutical quality management systems auditor scheme,” he pointed out, and “will supply the level of training and competency the industry needs to overcome these challenges.”
NSF-DBA Partner Mike Halliday emphasized that “prior to NSF-DBA’s IRCA-certified course, the pharmaceutical industry relied on general ISO 9000 auditor quality training, which provided little training specific to pharmaceutical quality and GMPs.”
Another NSF-DBA Partner – former AstraZeneca quality official Neil Wilkinson, who is based in the firm’s Boston office – echoed Halliday’s comments.
“While the ISO auditing approach gives you a solid background on the mechanics,” he said, “this course starts digging into the actual specifics that are related to the pharma environment.”
Wilkinson also pointed to the complementary nature of NSF-DBA’s course with work done by Rx-360 and the International Pharmaceutical Excipients Council (IPEC), all of which recognize the need for auditors that are qualified relevant to the areas that they are going to be auditing.
IPEC’s “EXiPACT” standard launched in early February (IPQ “Updates in Brief – Feb. 8, 2012) is a new, voluntary international certification scheme designed and developed to assure that current GMP and GDP standards are being used in the manufacture and supply of pharmaceutical excipients.
Wilkinson also stressed the need for auditors to keep current after the training and to continue to hone their skills.
Participants need to exhibit “an appropriate level of knowledge to take the course,” he said, “and then pass an exam set up by IRCA to become a certified auditor.” That will be followed by a “program of continual professional development meant to keep people current,” Wilkinson explained.
NSF-DBA has also developed and is conducting the second round of a course series for quality professionals outside the EU that closely parallels the training Qualified Persons (QPs) receive in Europe. Successful completion of the 12 established modules in the series results in a masters degree in pharmaceutical quality and good manufacturing practice from Scotland’s University of Strathclyde.
NSF-DBA, which has provided pharmaceutical industry training for more than 25 years, is part of NSF International’s Health Sciences Division. The division also includes NSF Reference Standards and NSF Pharmalytica, a GLP/GMP contract analytical laboratory based in the U.S.
Seven NSF-DBA IRCA-certified audit and self-inspection courses are planned for this year throughout South Africa, the UK, US, Germany and the Netherlands.