​IRCA Pharmaceutical Quality Management Systems Certification Scheme

To be certified to this scheme, you'll need to demonstrate your ability to accurately assess the ability of pharmaceutical product suppliers to meet stakeholder needs.

For further information on the Pharmaceutical Quality Group's supplier standards for packaging materials please see the PQG's website.

Requirements

It is the responsibility of auditor to ensure that they have knowledge of the required GxP in which they will audit. For example:

• An auditor who is responsible for assessing the conformance of suppliers of active pharmaceutical ingredients must be familiar with ICH Q11: Development and manufacture of drug substances.
• An auditor performing internal audits on behalf of a biotech company must be familiar with Eudralex Volume 4 (Good manufacturing practice quidelines) Annex 2: Manufacture of biological medicinal products for human use.
• An auditor who is responsible for the assessment of an organisation's global supply chain, including suppliers who also supply to other industries, must be familiar with the PQG's Guide to supply chain risk management and ISO 9001.

Please note: All IRCA Certificated PQMS Auditors are required to have completed IRCA Certified ISO 9001:2015 initial auditor training or transition training .

Specific (additional) requirements

Auditors are required to demonstrate the following knowledge and competencies:

• Understanding of the lifecycle of a pharmaceutical medicinal product
• Knowledge and understanding of pharmaceutical GMPs and the relevant pharmaceutical legislation, e.g. EudraLex – Volume 4 or the 21 CRF standards and PIC/S GMP guidelines associated with them. This should be supported by: 
  • Evidence of successful completion of a GMP awareness training course, or
  • Two years’ demonstrable work experience in a GMP environment
•  Knowledge and understanding of the pharmaceutical supply chain and the context of individual suppliers within the globalization of the pharmaceutical supply chain, and the associated storage and distribution requirements
• Knowledge of ICH Q8 (current edition) and the interaction of ICH Q9 Quality risk management (current edition) and ICH Q10 Pharmaceutical quality system (current edition). This should be supported by:
  • Evidence of successful completion of a GMP awareness training course, or
  • Two years’ demonstrable work experience in a GMP environment
• Understanding of patient risk and general risk management to establish the control strategy that can include parameters and attributes related to drug substance, finished product, starting materials and components. This should embody a working relationship with applicable GMP
• Understanding the requirements of a Pharmaceutical Quality Management System, and the importance of this in maintaining control and facilitating continual improvement throughout the product lifecycle
• Understanding of the required GMPs for the processes that the auditor is intending to audit, for example:
  • an auditor who is responsible for assessing the conformance of suppliers of active pharmaceutical ingredients must be familiar with EudraLex – Volume 4 Part 2: ICH Q7 Manufacture of drug substances, and ICH Q11 if the drug substances are being developed as well
  • an auditor performing internal audits on behalf of a biotech company must be familiar with EudraLex – Volume 4 (Good manufacturing practice guidelines) and with Annex 2: Manufacture of biological medicinal products for human use.
  • an auditor who is responsible for auditing service providers (e.g.: delivery, warehousing, cleaning, etc.) must be familiar with supply chain risk management, such as Good Distribution Practice (GDP) guidelines and ISO 9001 (current version).

Audit requirements

For Internal Auditor grade, for initial certification and renewal of certification, all GMP audits will be accepted, including those that are not full management system audits.

For Auditor/Lead Auditor grades, for initial certification and renewal of certification, only full management system GMP audits will be accepted.

Note: Please indicate on the audit log any audits that are full management system audits.

The Pharmaceutical GMP Auditor Scheme is based on the auditing key standards:

• In Europe – The GMP Directive 2003/94/EC and EudraLex – Volume 4
• In the USA – CFRs Title 21, Parts 210 and 211
• PIC/S GMP guidelines
• ICH Q10: Pharmaceutical quality system (current edition) ICH Q9: Quality risk management (current edition)
• ICH Q8: Pharmaceutical development (current edition)
• ICH Q7: Good manufacturing practice guide for active pharmaceutical ingredients
• ISO 19011: Guidelines for auditing management systems (current edition)
• ISO 17021: Requirements for bodies providing audit and certification of management systems (current version). 

Guidance on who this scheme is intended for:

• Internal auditors who conduct full or partial GMP and pharmaceutical quality management system audits within their own organisation.
• Pharmaceutical auditors conducting audits of:
  • suppliers of starting materials and packing components
  • contract service providers
  • manufacturing operations
  • packing operations
  • testing laboratories
  • warehouse and distribution operations
• Third-party pharmaceutical auditors working for clients within the pharmaceutical industry
• Pharmaceutical  quality practitioners –   consultants, audit programme managers and other related personnel
• Audits of pharmaceutical operations performed by regulators to ensure compliance
• Pharmaceutical auditors working for third-party certification bodies/registrars who complete full GMP and pharmaceutical quality management system audits of suppliers, including:
  • audits of raw material and component suppliers
  • audits of different phases of the product lifecycle (i.e. research and development, clinical trial manufacture, commercial manufacture, distribution and supply, and product discontinuation).

Acceptable alternative standards

We may accept audits to alternative standards not listed on the IRCA certification scheme. To find out more please visit the Acceptable Alternative Standards page.