Specialists at the Eurasian Academy of Good Practices’ GxP audit training center consistently identify recurring, systemic errors made by manufacturers during inspections.
A common issue is that many companies still approach external audits or pharmaceutical inspections as isolated events, rather than as a managed process. This process requires careful advance preparation, clearly assigned roles, and a well-developed strategy for interacting with inspectors.
“An audit is not a test of luck or a pop quiz. It is a managed, professional process where success is determined by the quality of preparation and the maturity of the pharmaceutical quality system,” notes Professor Irina Spichak, Executive Director of the Eurasian Academy of Good Practices.
Based on an analysis of GxP training audits conducted over the past two years, Academy experts have pinpointed three of the most frequent errors at both domestic and international sites—errors that directly compromise audit outcomes.
1 Late submission of documents
Prior to any GxP audit, the inspection team develops a program outlining objectives, focus areas, the sequence of inspection, and a list of required documentation. This program is always shared with the production site in advance and should form the cornerstone of their preparation.
In practice, however, auditors often find that requested documents are not ready, or are archived as hard copies in another building, requiring significant time to retrieve. Given the strict time constraints of an audit, this creates a high risk of failing to provide documentation, which can then be recorded as a non-compliance.
“The proper functioning of a document management system is a critical element of a pharmaceutical company’s quality system and is a primary focus during audits,” emphasizes Stanislav Volkov, a leading specialist at the GxP Audit Training Center. “Late document submission signals poor audit preparedness. This is why we consistently train companies to prepare documentation proactively, not just when it’s requested.”
Academy experts recommend a thorough review of the audit program and the assembly of a complete, easily accessible document set before the auditors arrive.
2 A poorly planned audit route
A standard GxP audit program follows a logical sequence through the production site: warehouses, manufacturing areas, laboratories, utility systems, and auxiliary spaces. This route is designed to trace the entire drug lifecycle, from raw material receipt to final product shipment and quality control. A well-planned route minimizes on-site inspection time and allows auditors to understand processes from start to finish.
In reality, the planned route is often disrupted due to site-specific issues: unique infrastructure layouts, the unavailability of responsible personnel, ongoing renovations, a shortage of protective gear, or inadequately trained escorts. Attempts to bypass certain areas typically backfire, leading to longer inspection times and less time for document review—ultimately increasing risk rather than reducing it. The audit becomes harder to manage, and critical issues may be missed.
Academy experts stress that at the opening meeting on the first audit day, the manufacturing site should present inspectors with an optimal, pre-confirmed route that fully aligns with the audit program’s objectives.
3 Absence of process owners during the audit
Effective GxP audits are impossible without the direct involvement of the personnel responsible for the processes being examined. Despite this, interaction at many companies is often limited to department heads who may not possess granular, operational knowledge. When deeper questions arise, process owners or document authors are then summoned, causing delays.
This approach results in slow responses, incomplete or inaccurate information, and consequently, a flawed representation of the site’s processes in the final audit report.
“Modern GxP audits have moved far beyond formal checklists,” notes Stanislav Volkov. “Auditors seek a deep, evidence-based understanding of processes, supported by documentation and practical experience. This depth is unattainable without engaging the actual process owners.”
Academy experts recommend including the relevant specialists in the dialogue from the outset. This enables the swift resolution of complex issues, demonstrates the real-world workings of the quality system, and significantly reduces the risk of erroneous audit conclusions.