Common Compliance Issues in GxP Audits and How to Address Them

One of the most frequently encountered compliance issues in pharma is poor documentation management, such as outdated Standard Operating Procedures (SOPs) or incomplete training files. Nan Huddy emphasizes that outdated or incomplete training records are a frequent source of non-compliance, saying, “Inspectors often look at training files first, and it’s easy to miss keeping those up to date.”

To avoid this pitfall, companies should implement a system for regularly reviewing and updating SOPs and ensure that employee training files accurately reflect current job responsibilities and qualifications.

Failing to maintain equipment calibration is a common reason for audit findings. Inadequate calibration leads to pharma compliance issues, impacting product quality and data integrity. Implement a regular calibration and maintenance schedule, ensuring every piece of equipment is tested according to GxP compliance requirements.

The lack of internal audits is also a major contributor to GxP compliance issues: without continuous monitoring, small problems can escalate during official inspections.

Regular internal reviews that focus on documentation, training, equipment, and procedures will help ensure that compliance issues in pharma are addressed proactively, keeping operations in line with regulatory standards.

Compliance issues in pharma often stem from poorly trained staff or unclear role definitions. Without clarity, employees may be unaware of their responsibilities, leading to non-compliance. Huddy suggests that continuous training and preparation are essential.

Conduct regular training sessions, perform mock audits, and practice interview scenarios to ensure employees are well-prepared. Keep detailed training records and update them frequently to ensure they meet GxP compliance requirements.

Improper management of data and access control is another key compliance issue in pharma. Companies that fail to remove former employees from systems or inadequately secure data archives are at risk of data breaches.

“Not removing former employees from systems is a common issue inspectors look for”, says Huddy. Companies should ensure that their access control policies are regularly reviewed and updated to reflect current personnel. Additionally, ensuring the security of data centers and archives is critical to avoiding unauthorized access and staying compliant.

Maintaining audit readiness requires ongoing effort, with a focus on updated documentation, regular equipment calibration, thorough employee training, and internal audits to reduce pharma/biopharma compliance issues. Having clear processes for reporting compliance issues also fosters transparency and accountability.