While audits are the commonplace in the pharmaceutical industry, the preparedness for those events varies. The companies that develop a risk-based approach to audits are able to remain competitive while meeting quality and government compliance standards on a regular basis. Conversely, the companies that have not implemented strong processes are putting themselves at risk for non-compliance.
Partnering with knowledgeable partners who can offer audit-ready learning solutions supporting regulatory authority requirements such as, but not limited to, the Food and Drug Administration’s (FDA) coupled with training of key staff helps companies streamline the process and be always ready for an audit.
The Gold Standard Approach
According to the Federal Food, Drug and Cosmetic Act, “Registered domestic drug establishments shall be inspected by the FDA at least once every two years.” Under some conditions the inspections may be even more frequent, such as when a drug is being manufactured for the first time, if there have been previous problems validating a similar process, if production of a product or a new process is substantially different from past operations, or when a process is particularly complex. As regulations become more stringent, regulatory authorities are likely to step up audits which is even more reason for companies to be prepared.
Among the factors that will be looked into during an audit, will be whether the employees are knowledgeable and familiar with federal/ state/country regulations and what documentation the company can provide to demonstrate training, monitoring and compliance programs.
Training the associates in all areas necessary to their position and for how to handle questions about their work are key to a company be inspection and audit ready are key.
A case study put forth by a European life sciences company identified how their preparedness and reduced preparatory work required for each audit helped them streamline the process and ensure success. Each department head is informed when the inspection is due, what products or processes will be inspected and if any specific areas will be highlighted in the audit. At this stage, the staff doesn’t rely on the audit agenda, instead, the continuous readiness ensures that different members of staff have specific strategic areas of responsibilities that are well communicated, allowing seamless integration of information.
When the inspector asks questions during any portion of the audit, the company is always ready with a full and relevant response and the answers the inspector receives will always be the same correct ones – regardless of the employee or department.
However, the company ensures that the a member of the Quality Assurance equivalent is present at all times during every audit to get the correct subject matter expert, clarify and respond to questions.
Getting to the State of Constant Preparedness
As mentioned above, training the employees to address any and all questions posed by inspectors is on par with the need to organize the company’s Standard Operating Procedures (guiding documents) and data in clear, logical order.
Training of associate, and even contractors and other third parties should cover any and all expectations, such as process validation, process controls, corrective and preventative actions, documentation, care and handling of drug product components, maintenance of drug manufacturing equipment among others. Companies should establish and maintain complete training records for each associate. In order to stay current with changing regulations, companies should hold retraining sessions at regular intervals to ensure all associates are on track.
Additionally, internal and third-party auditors should perform extensive mock audits as audits/inspections can occur at any time. Third-party auditors who can not only provide audit-ready learning solutions, can also provide an objective analysis of the company’s procedures and uncover any gaps that may result in non-compliance.
Being in a constant state of readiness allows companies to be organized and effective in advance of, during and after an audit. By allotting sufficient time and money to train employees to completely understand and comply with the regulatory standards helps companies meet increasing regulations and audit challenges. All compliance officers must keep in mind that the level of the company’s audit preparedness makes a difference between compliance and non-compliance and resulting penalties and fines.