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International Register of Certificated Auditors

FDA Compliance

New Pharmaceutical Quality Management Systems Auditor Certification Scheme

IRCA’s latest supports global supply-chain integrity

Published: Tuesday, August 30, 2011 - 11:34

(IRCA: London) -- The International Register of Certificated Auditors (IRCA) has launched a new Pharmaceutical Quality Management Systems (PQMS) Auditor certification scheme (ICH Q10), to support the assurance of global supply-chain integrity.

In a sector that has seen an increase in the contracting out of operations, and increasingly complex global-supply chains, companies and regulators are asking for evidence of relevant training and experience for pharmaceutical QMS auditors who conduct audits of suppliers, service providers, contractors, and their own operations.

Within this context the IRCA PQMS Auditor certification scheme is designed to provide confidence that auditors in the pharmaceutical and biotech industries have the training and experience required to provide an accurate assessment of organizations’ ongoing capability to deliver products that meet the requirements of patients, health care professionals, regulatory authorities, and internal and external customers throughout the product life cycle.

“For many years IRCA has been at the forefront of the auditing industry, leading trends and adapting to new external environments,” says Simon Feary, IRCA director. “The new pharmaceutical auditor scheme shows that IRCA is still at the forefront in providing reassurance to companies, regulators, and consumers alike, and that auditors are competent to perform rigorous audits.”

The IRCA PQMS auditor scheme was developed after consultation with a range of stakeholders within the industry, including regulatory, training, special-interest, academia and auditing representatives, and is based on:
• ICH Q10 (current edition), Pharmaceutical Quality System
• ICH Q9 (current edition), Quality Risk Management
• ICH Q8 (current edition), Pharmaceutical Development
• ISO 19011 (current edition), Guidelines on Quality and/or Environmental Management Systems Auditing

PQMS auditor training

The IRCA PQMS scheme provides auditor training for individuals who have the required technical good X practice (GxP) prior knowledge, through the following certified training courses:
• IRCA PQMS Auditor/Lead Auditor course—five days plus examination
• IRCA PQMS Auditor Conversion course—three days plus examination
• IRCA Internal PQMS Auditor course—two days
• IRCA PQMS Foundation course—one day

PQMS Auditor certification

Once individuals have successfully completed the relevant course, they can apply for profession recognition as an IRCA-certified PQMS auditor at the following grades:
• PQMS Principal Auditor
• PQMS Lead Auditor
• PQMS Auditor
• PQMS Provisional Auditor
• PQMS Internal Auditor
• PQMS Provisional Internal Auditor

Depending on the grade, certification indicates that PQMS auditors have the combination of education, technical experience, work experience, auditor training, and audit experience that indicate the following abilities:

Pharmaceutical GxP-related

• Understand the regulations and guidelines and current issues affecting the GxP discipline(s) in which they audit
• Understand scientific and technical aspects of processes and products within the industrial or business context(s) in which they audit, including and GxP-specific processes and practices

Pharmaceutical management systems-related

• Understand from the auditee’s point of view the role of a pharmaceutical management system in achieving and improving pharmaceutical quality requirements (ICH Q10), and relevant quality terminology and techniques (e.g. statistical process control, failure mode effects analysis)
• Understand from the auditee’s point of view the application of risk management (ICH Q9)
• Understand application and regulatory requirements associated with pharmaceutical development throughout the product life cycle (ICH Q8)

Management systems audit-related

• Apply audit principles, procedures, and techniques to ensure pharmaceutical management system audits are planned, conducted, reported, and followed up as appropriate to different audit situations and in a consistent and systematic manner
• Facilitate the efficient and effective conduct of an audit (team leaders)

View more information about accessing IRCA-certified auditor training courses or applying for certification as a PQMS auditor.


About The Author

International Register of Certificated Auditors

The International Register of Certificated Auditors (IRCA)
is the world’s original and largest international certification
body for auditors of management systems. IRCA provides auditors, business and industry with two main
services: certification  of auditors of management systems, and approval of training organizations and
certification of their auditor training courses.
IRCA offers certification programs that recognize the competence
of auditors who audit quality, environmental, occupational health
and safety, software development, information security, and food
safety management systems.