The Importance of Mock Internal Audits in the Pharma Sector

In 2017, there were more than 200 audits or FDA inspections carried out in India. This resulted in an increase in the issuance of Warning Letters or 483s being issued and the reputations of a number of pharma companies being questioned. The big takeaway from these recurrences, is the question about what can be done to reduce the chances of negative outcomes of FDA audits. One of the recommended ways to prevent such situations from occurring is to conduct regular mock audits. While mock audits are not new to the pharmaceutical industry in India, the extent and regularity of these audits can vary considerably from company to company. Reports indicate that companies that remain competitive as well as meet quality and government standards are those that develop a risk-based approach to audits. While those businesses that lag behind in developing and following strong risk management programs put themselves at significant risk for non-compliance.

What is a mock audit?

A mock audit is nothing but a simulation of an actual FDA audit conducted on a regular basis to assess management about the compliance of all departments to Good Clinical Practice, Good Laboratory Practices, and Good Manufacturing Practices. Mock audits can be conducted by either an internal team or outsourced to an external company as long as both follow FDA procedures and are experienced in regulatory compliance. In fact there are many ex-FDA employees who now consult for companies and provide mock audits as part of their services. Usually an external audit team is preferred as this prevents any biases from cropping up as it is often easier to offer objective insights when one is not part of the team itself. That said, what’s most important is the carrying out of regular audits and the complete support of the upper management for the mock audit to succeed.

How can a mock audit help?

There are three main ways a mock audit can help your company. These are -

• It lists out clearly what the FDA inspectors will be investigating during an actual audit.
• It prepares all employees for an FDA audit in terms of what to expect and how to behave.
• It identifies any compliance issues and deviations from recommended practices and allows management to rectify the issue before an actual FDA audit takes place. This in turn can save the company in terms of finances and reputation.

What happens during a mock audit?

A mock audit usually lasts four days much the same as a regular FDA audit. Here’s the break up of what should happen on a day to day basis -

• Day one involves meeting the consultant to discuss the logistics of his or her inspection. Details about the actual tour of the facility will be decided upon and the letter regarding the inspection will be presented. All interviews to be conducted will be scheduled and there should be a detailed review of standard operating procedures.
• Day two begins with reviewing all retention records and policies as well as procedures regarding data integrity. Interviews of various personnel from different departments will begin as per schedule. Later in the day and on site review will take place that should include checking procedures for storage, manufacturing, and preparation.
• During day three the consultant will continue with the interviews as well as review supplier controls at the site.
• Finally on day four, any outstanding compliance issues will be dealt with and personnel can be called in to clarify any questions or issues that may have arisen over the past three days. An exit meeting will be conducted where major and minor findings will be discussed along with strategies on how to fix issues and plan next steps.

What can you do to ensure the success of a mock audit?

A mock audit prepares all employees to work in co-operation and identify and solve problems as a team. Therefore the ideal tone for any mock audit should be of a team-oriented activity. Management should encourage honesty, inclusivity and openness with no fear of negative repercussions. One way of doing this is to publish the audit schedule ahead of time and inform all concerned about what is expected from them. Talking to as many employees as possible will also help set the correct background for a successful audit.

The behaviour of the auditor is also important. Questions should be direct yet non-confrontational. The overall emphasis should be on teaching rather than scolding, listening rather than judging. A friendly auditor can accomplish a lot more than an antagonistic one and all parties should remember that they are on the same side and work together as partners rather than enemies.

Training your employees on how to handle questions about their work and inform them about what areas will be highlighted in an audit is also essential for success. Such an environment of continuous readiness can only work in your favour whether the audit planned is a mock one or the real FDA deal.

Do not forget to include third party vendors and external staff in your audit plans as well. Inspections on all fronts should occur on a regular basis and interviews with outside vendors can also provide management with an objective analysis of any gaps in compliance.

How to use the results of a mock audit

With all the information provided from a mock audit, pharmaceutical companies can collect evidence that operations are being carried out smoothly in all departments. Management can also review compliance of third party contractors as well as its own employees and evaluate the documentation and records of data. All this information can be used again when a real audit takes place to assure FDA professionals of proactive plans and strategies.

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