IRCA launches Pharmaceutical Quality Management Systems Auditor certification scheme

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 which 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 quality management systems auditors who conduct audits of suppliers, service providers, contractors and their own operations.

Within this context, the IRCA Pharmaceutical Quality Management Systems (PQMS) Auditor certification scheme is designed to provide confidence that auditors in the pharmaceutical (and biotech) industry have the training and experience required to provide an accurate assessment of organizations’ ongoing capability to deliver products that meet the requirements of patients, healthcare professionals, regulatory authorities, and internal/external customers throughout the product lifecycle.

Simon Feary, IRCA director, says: ‘For many years IRCA has been at the forefront of the auditing industry, leading trends and adapting to new external environments. 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, plus:
    - 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 GxP prior knowledge, through the following certified training courses:

PQMS auditor certification

Once individuals have successfully completed the relevant course, they can apply for professional recognition as an IRCA certified PQMS auditor at the following grades:

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/business context(s) in which they audit, including 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 (eg 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).