Auditing in a fast changing world

Auditing specialist Sharon Shutler looks at the changing shape of the pharmaceutical industry and how it affects auditing practices and auditor training.

While the basic functions of discovery, design, development, manufacture and commercial supply of life-saving and life-enhancing medicines remain in place, the international pharmaceutical industry is a complex and changing business. Consequently, the role of pharmaceutical auditors has become more global and complex; it is also changing to ensure the industry’s future compliance and success.

There have been vast changes in the industry over the past few decades that have directly affected the auditor:

Globalisation – Many medicines are now manufactured in developing countries with emerging markets and varying regulatory frameworks. Auditors have to deal with cultural acceptance of differing 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 (e.g. 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 e.g. Glaxo-SmithKline, AstraZeneca, Sanofi-Aventis. The larger companies that dominate the market often like to train auditors internally in their own ‘company way’ and auditors may miss the benefit of differing opinions and experiences during their training.

Proliferation 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 can be on a very steep learning curve regarding knowledge and appreciation of quality management, compliance and the need to close audit findings.

The same medicine can be handled by numerous companies, in many locations, throughout its lifecycle of development, manufacture, labelling, packaging, storage, distribution, marketing and sale. There is one medicine known to the author that actually circumnavigates the globe before it reaches the pharmacist’s shelf in the US. Auditors must ensure that there is adequate traceability, interface and compliance of each stakeholder’s information about the medicine.

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, e.g. independently verifying the address of a manufacturing site.

Furthermore, the 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 therefore be familiar with and current in their knowledge of a plethora of technical documentation to perform effective audits.

unchanging aim

Even though the industry has and still is 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 (i.e. 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 in 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 would check to ensure there is evidence that a medicine has been:

• Developed and tested comprehensively
• Protected from contamination during manufacture
• Tested throughout manufacture 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 always traceable during transport, particularly if temperature control has to be maintained
• Only delivered to bona fide customers e.g. doctors and pharmacists
• Taken out of distribution for routine use once its shelf-life has expired.

The majority of auditors would rank any findings or nonconformities against legislation, regulatory publications, standards, guidelines and internal procedures in accordance with the potential impact on product quality, identity, safety and efficacy and threat to the patient. With this in mind, audit findings are often categorised either as ‘Critical’, ‘Major’, ‘Minor’ or ‘Recommendations for Improvement’ to enable auditees to prioritise appropriate corrective and preventive actions and establish or re-establish compliance.

The approach to auditing within the industry is diverse. Generally, pharmaceutical auditors are not familiar with the audit management standard ISO 19011 but the majority of audits are performed by trained auditors who are respectful that auditing is a process that has to be professionally managed.

Most audits have a quality management element (to assess systems like documentation control, customer complaints and training) led by a trained auditor and a technical element led by a competent individual who may or may not be a trained auditor. On occasion, technical experts can become distracted by a novel technique or new shiny piece of equipment, have a lengthy stimulating discussion and forget that they are actually undertaking an audit. The scenario also exists where a trained auditor can be found to be out of their depth with some aspects of the science and technology behind the manufacture and testing of a medicine unless supported by a technical expert.

Pharmaceutical auditors can be regulators, consultants, representatives of certification bodies, external (i.e. supplier) or internal auditors. In many companies, auditing will be part of the role of a quality manager and other members of a quality department. Regulatory auditors and inspectors will focus on compliance with legislation, product licences and regulatory publications.

Auditors representing certification bodies will be contracted to assess specific processes (e.g. supply of active ingredients) in accordance with discrete guidelines. External auditors have a focus on due diligence (i.e. before a merger), supplier approval, compliance, and disqualification as well as supply chain assurance. Internal auditors have the remit of compliance with internal procedures.

Consultants performing audits can adopt a regulatory, external or internal auditor’s approach depending on the company’s needs. Regulatory, external and internal audits are usually structured as a process that includes an opening meeting with the auditees, site inspection, evidence gathering (by reviewing documentation, listening to auditees and observing practices), following a checklist to ensure all areas are covered, relaying findings at a closing meeting, report writing and closure of any findings within agreed timeframes.

certificated schemes

In August 2011, the International Register for Certificated Auditors (IRCA), a division of the Chartered Quality Institute (CQI), launched a certification scheme specifically for pharmaceutical auditors. The scheme has been received with much interest from influential industry stakeholders as 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 maximise 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
• Professionalise 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.

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 protecting patients and improving the compliance of this changing industry in challenging times.

• X
• LinkedIn

• Companies:
• International Register of Certificated Auditors IRCA

See more