The challenges for a
pharmaceutical auditor in a
changing industry
looks at the changing role of the pharmaceutical auditor
Pharmaceutical companies have always been involved in the discovery, design, development, manufacture and commercial supply of life-saving and life-enhancing medicines. Today, the pharmaceutical industry is a global, complex and changing business. The role of pharmaceutical auditors has consequently become global and complex; it is also changing to ensure the industry’s future compliance and success.
There have been vast changes in the pharmaceutical industry over the past few decades that have directly impacted the auditor:
- Globalization - Many medicines are now manufactured in developing countries with emerging markets and varying regulatory frameworks. Auditors have to deal with differing cultural standards of working practice and regulatory interpretations.
- Change in government policy - Many governments now favour the purchase of generic medicines as they are much less expensive than patented equivalents. Auditors must adopt a pragmatic approach to the differences in production operations used to manufacture generic and patented medicines (eg shared production lines rather than dedicated ones where there is more potential for cross-contamination).
- Acquisitions and mergers - An increasing number of market leaders are merging or acquiring other companies eg GlaxoSmithKline, AstraZeneca, Sanofi-Aventis. The larger companies that dominate the market often train auditors internally and auditors may miss the benefit of differing opinions and experiences during their training.
- Rising numbers of small companies - Many entrepreneurial academics involved in drug discovery and innovative technology are establishing small venture capital companies. Auditors may find that such companies will encounter a very steep learning curve regarding knowledge and appreciation of quality management and compliance.
- Increasingly complex supply chains - The same medicine can be handled throughout its lifecycle of development, manufacture, labelling, packaging, storage, distribution, marketing and sale, by numerous companies in many locations circumnavigating the globe before it reaches the pharmacist’s shelf. Auditors must ensure that there is adequate traceability, interface and compliance of each stakeholder’s information about the medicine.
- Rising unregulated and illegal activities - Regulators and industry professionals are concerned at the unrestricted availability of medicines over the internet and the increase in international counterfeiting activities. Auditors must now be ready to verify simple evidence that used to be taken at face value, eg independently verifying the address of a manufacturing site.
Furthermore, changes to the industry highlighted above have been associated with a dramatic increase in legislation, regulatory publications, standards, guidance documents and expected best practice. Auditors must be up to date in their knowledge of a plethora of technical documentation to perform effective audits.
The role of the pharmaceutical auditor
Even though the industry is still undergoing dramatic change, the role of pharmaceutical auditors has not changed and should never change. Auditors must always obtain sufficient evidence to assure that a medicine will be pure, safe, correctly labelled and efficacious (ie does exactly what it is supposed to do, without doing anything that it isn’t supposed to do) when it is needed to preserve or enhance life. Patient protection must be at the forefront of the auditor’s mind at all times and any evidence that the medicine may not be of the appropriate quality should be ranked in terms of the threat to patient safety. Accordingly, pharmaceutical auditors should be trained to focus on evidence sampling that pertains to patient protection. Typically, auditors check to ensure there is evidence that a medicine has been:
- developed and tested comprehensively
- protected from contamination during manufacturing
- tested throughout manufacturing to approved specifications
- manufactured consistently in accordance with approved procedures and records
- labelled correctly with clear instructions for its use
- stored in a manner that prevents degradation
- handled appropriately and is always traceable during transport, particularly if temperature control has to be maintained
- only delivered to bona fide customers, eg doctors and pharmacists
- taken out of distribution for routine use once its shelf-life has expired.
Certificated schemes for pharmaceutical auditors
In August 2011, IRCA launched a certification scheme specifically for pharmaceutical auditors. The scheme has been received with much interest from influential industry stakeholders. It will ensure that pharmaceutical auditors can now:
- undertake consistent training with IRCA-approved providers that will equip them with a balanced combination of quality and technical knowledge and auditing skills
- learn how to apply the audit management process outlined in ISO 19011 to maximize the effectiveness of the audits they perform including compliant closure of findings pertinent to patient protection
- acquire and maintain certificated status, adhere to a code of conduct and pursue active professional development
- professionalize and engender respect for the auditing function with senior industry professionals.
Another certification scheme is available from the CQI’s, Pharmaceutical Quality Group (PQG) that is specifically for auditors engaged in the inspection of pharmaceutical packaging operations. The packaging guideline (PS9000:2011) has recently been updated to provide these auditors with current technical and quality information to help them continue to perform effective audits.
Continuing compliance and success
Auditors have a pivotal role in protecting the compliance and success of the pharmaceutical industry by assuring appropriate systems and controls are in place to protect the patient who takes a medicine trusting that it is what it is supposed to be and will do what it is supposed to do. Thus, the auditor’s role begins with a professional duty of care and an appreciation that an audit finding could be the difference between the supply of life-saving and enhancing medicines or medicines that are potentially harmful to patients.
The opportunity for pharmaceutical auditors to train, provide evidence of competency, adhere to a code of conduct and pursue active professional development in accordance with approved certification schemes will further equip them to contribute to protect patients and improve the compliance of this changing industry in challenging times.
About the author
Sharon Shutler, MPhil, FCQI CQP is a member of IRCA, the CQI and the PQG. She is also a freelance quality professional specializing in auditing, risk-based quality management, supply chain assurance and corporate social responsibility.
