GxP Lifeline Feature Article
Establishing and Operating an Effective GMP Auditing Program
By Robert L. Dana
An audit is an independent assessment of operations, not a tattling expedition. It may not be a joyous experience but it is a necessary exercise in regulatory compliance. GMP auditors are professionals with a special set of skills that ensure an auditee is in good shape from a regulatory compliance perspective.
“Hi, I’m from the Corporate Auditing Group and I’m here to help.” This popular phrase, appropriately modified to reflect the place from where the “helper” comes, is often heard and sometimes associated with Corporate Auditors and Corporate Auditing Groups. No one likes to have their work reviewed and evaluated by an outside pair of eyes, especially when those eyes belong to someone who has been trained to be critical and look for operational inconsistencies and examples of regulatory non-compliance - and worse yet, report on those examples to one’s superiors and senior management. Yet performing an independent assessment of operations, identifying an area of potential concern and ensuring that appropriate and effective corrective actions are taken is critical to ensuring that firms maintain a solid compliance posture and that management is aware of any potential compliance concerns. So who are these Corporate Auditors, how did they come to be what they are, and how do world class auditors and audit groups operate?
To begin with, audit programs should be structured so that the auditors have complete independence of the functions they are auditing. They must also have the complete support of management to ensure they are free to evaluate what they see and hear, and report on their findings without fear of retribution. Corporate audit programs should report to components that are reasonably high within the company organization, again to ensure they have the ability to engage in dialogue with other senior management of their company on an equal footing.
Auditors require special skills and attributes. They must, of course, be intimately familiar
with the regulatory requirements of the operations they are auditing, as well as
appropriate company policies and practices. They must also have a sound understanding
of the technology involved in the operations they are auditing. Strong interpersonal skills
are critical to the success of an auditor and the audit he or she is performing. There is a
natural defensiveness which occurs on the part of the auditee and an audit can be an
emotional experience. Anyone who has ever sat through a tax audit by the Internal
Revenue Service can attest to this fact. Empathy, good listening skills and good
organizational skills are critical elements associated with good auditors. Good auditors
are persistent without being relentless; ensure they have their questions answered and
thoroughly understand a situation before they evaluate whether what they have seen and
So, while the job of a GMP auditor can be difficult (many auditors feel that no one is loved or appreciated less), the role that they play in helping to ensure that a company is on sound ground from a compliance role is critical. That is not to suggest that the people involved in daily operations aren’t critical to the compliance of an organization – they are clearly the first line of defense in this situation. Their day in and day out involvement and familiarity with the operations they work in and manage is of paramount importance. When their diligence and hard work is complemented by an effective audit program which provides an independent and second pair of eyes looking at an operation, a company should be in good shape from a regulatory compliance perspective.
Robert Dana is Vice President, Quality and Regulatory Affairs at the Parenteral Drug Association (PDA) in Bethesda, MD. He has over 40 years of experience in the pharmaceutical industry, and over the course of his career, has been a GMP auditor, directed a corporate compliance organization responsible for GCP, GLP and GMP compliance support for a large multinational pharmaceutical company and consulted in the areas of quality and regulatory compliance. He also has experience in product development and CMC filings in support of NDA’s and NADA’s.