Preparing for a GMP audit is a complex and structured process that requires full integration of quality management principles. In practice, many companies make similar mistakes that lead to delays, critical findings or failure to obtain certification. Below are the most common issues.

Treating GMP as a formal requirement 

One of the most common mistakes is implementing GMP only on paper. Procedures exist, but daily operations do not follow them. Auditors quickly identify gaps between documented processes and real practices.
GMP is not just documentation - it is a working quality system.
Poorly developed documentation
Typical documentation issues include:

• using generic templates without adaptation
• outdated SOPs and instructions
• inconsistencies between documents

Any discrepancy in documentation raises concerns and affects audit results.
Lack of personnel training
Even well-written procedures are ineffective if employees:

• are not familiar with GMP requirements
• do not understand their responsibilities
• cannot answer auditor questions

Training should focus on practical understanding, not only formal completion.
Ignoring internal audits
Some companies skip internal audits or conduct them superficially. As a result, critical non-conformities are identified only during the external audit.
Internal audits help detect weaknesses early and reduce certification risks.

Underestimating audit readiness 

Common problems include:

• no designated responsible staff during the audit
• unprepared facilities and equipment
• inconsistent answers from employees

A GMP audit evaluates how well processes are controlled in practice.
Ineffective CAPA management

After non-conformities are identified, companies may: 

• delay corrective actions
• implement formal fixes without real improvements
• fail to assess CAPA effectiveness

Auditors expect systematic corrective and preventive actions.

Lack of professional support 

Preparing for a GMP audit without expert guidance often results in unnecessary delays and mistakes. Issues that could be prevented early become major findings during the audit.

Conclusion 

A successful GMP audit depends on proper preparation, trained personnel and a fully implemented quality system. Avoiding common mistakes significantly increases the chances of passing the audit on the first attempt.
If you need professional GMP audit preparation, contact WorldWideBridge - we provide full-cycle GMP support, from system implementation to audit сопровождение, ensuring a smooth and successful certification process.