In the world of pharmaceutical audits, maintaining a calm and open atmosphere is key. People are more forthcoming when they feel at ease. However, sometimes, despite our best efforts, tensions can escalate. One such incident occurred during an audit of an excipient supplier in Germany.

The Unexpected Turn

This particular supplier had a long-standing relationship with the pharmaceutical industry and was well-versed in Good Manufacturing Practice (GMP) expectations, especially concerning change control. They had recently added an extra reactor to homogenize a product suspension, aiming to reduce batch variability. While this was an improvement, they chose not to document it under change control, contrary to their own procedures.

When I pointed out this oversight, the atmosphere shifted dramatically. A group of five individuals stood up, shouting in German, questioning my intelligence, background, and even making personal insults. They went as far as to threaten that if I reported this observation, they would cease supplying our mutual client.

Staying the Course

Despite the hostility, I remained composed. My physical presence and experience helped defuse the situation. We steered the conversation to other topics, and the audit proceeded without further incident. However, the non-compliance regarding change control was duly noted in the audit report.

Upon reviewing the findings, our client decided to terminate their business relationship with the supplier. Ironically, the supplier’s aggressive stance led to the very outcome they were trying to avoid.

The Importance of Change Control

Change control is a critical component of GMP. Any modification to processes, equipment, or systems must be documented, evaluated, and approved before implementation. This ensures product quality, safety, and regulatory compliance. Neglecting this can lead to serious consequences, including loss of business and legal repercussions.

Takeaways

• Always adhere to established procedures, especially concerning change control, to maintain compliance and trust.
• Professionalism in audits is crucial, even when faced with hostility. Staying calm can prevent situations from escalating further.

If you’re seeking an experienced pharmaceutical auditor who can navigate challenging situations with professionalism and ensure GMP compliance, contact me. For more stories and insights, visit my blog page under the ‘supplier audits’ category.