Getting Prepared for an Audit

Based on the category of an audit, there may be differing levels of significance, preparation and personnel involvement, but, on the whole, an internal audit, customer audit or a regulatory authority audit, there are various aspects common to each audit procedure.

In fact, it matters how quality and manufacturing teams respond to observations and questions raised by an auditor. Even after full preparation for an audit, lack of confidence and inability to demonstrate compliance and control can make superior system look very bad.

A good preparation for an audit should include review of key procedures about

• Critical or Major Investigations,
• Corrective Action/Preventive Action (CAPA)
• Critical or Major Complaints and Proof of Approach to Dealing with Complaints
• Validation Protocols or Reports
• New Equipment Validations
• Risk Assessments
• Change Control Forms,
• Training Needs, Effectiveness of Training and Training Records

On the other hand, it’s important to spot key exposures within each area and communicate actions by designating task and timelines for each action, and promptness to evaluate the need for ‘arguable points’ where discontinuity or differences cannot be tackled.

For few companies, where irregularities are frequent, an audit may pose a hectic ordeal due to speeding up of activities for checking availability of proper documentation and reviewing operations for the sake of compliance.

For them, it becomes troublesome to retrieve, segregate and compile relevant documents and records pertinent to facility, processes or procedures.

Sometimes, during an investigation, there may be missing regulatory updates, deficient data, inconsistent logs or no records of changes done that may lead to warning letters.

Recently, the FDA issued a warning letter to Chinese drugmaker following an inspection of its facility. Investigators found that one of the APIs used in a topical OTC product was mislabelled by name, but the company’s own records showed the API was actually something else.

Although the company recalled all lots of the drug distributed in the U.S., but failed to document its investigation into the mistake or a plan to prevent it from recurring.

The company also failed to assess drug products for the strength and identity of the API ahead of distribution and release. In addition, it did not conduct process performance qualification studies to ensure product quality and it had no program in place to monitor process controls.

It’s totally unacceptable when some employees adhere to organization’s policies, and rest show an unconcerned involvement. What can be deduced is that there’s a drawback in organizational culture due to lack of discipline and tactical focus.

What’s worse is that when trainings are perceived as ‘traditional get-togethers’ for casual learning, genial interaction, appetizing refreshments and certified credentials.

If such a perception prevails among sluggish employees, then what’s the use when a trainer takes pains to chart out training programs? When employees are trained on objectives, it’s binding on employees to respond rightly and demonstrate evidence of progress.

In fact, when an organization is labeled as best entity, it means that there are sufficient contributions from all employees as per organization’s measurable objectives, and best practices are involved at appropriate roles and ranks to keep the operations as expected and essential.

In conclusion, an organization that remains compliant, perceptible and best everyday will experience an easygoing task at times of any audit schedule.

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