A GMP inspection is a critical step in assessing compliance with Good Manufacturing Practice requirements. Manufacturers should clearly understand how the inspection is conducted and what inspectors focus on during the process.
Preparation stage

Before the inspection begins, the inspecting authority: 

• reviews the company application and dossier
• analyzes previous inspection reports and certificates
• prepares the inspection plan and assigns inspectors

Manufacturers should ensure that documentation, facilities and personnel are fully prepared in advance.

Opening meeting 

The GMP inspection starts with an opening meeting where:

• inspectors and company representatives are introduced
• the scope of inspection is confirmed
• the inspection schedule is discussed
• responsible persons are appointed

This stage helps establish clear communication and expectations.

Documentation review 

Documentation review is a core part of the inspection. Inspectors assess:

• quality management system
• SOPs and procedures
• manufacturing and quality control records
• deviations, changes and CAPA
• personnel training records

All documents must be current and aligned with actual practices.

Facility inspection 

Inspectors then examine production areas, including:

• warehouses
• manufacturing areas
• packaging and labeling zones
• quality control laboratories

They evaluate hygiene conditions, material and personnel flows, equipment status and overall compliance.
Personnel interviews
Inspectors may interview employees to assess:

• understanding of job responsibilities
• knowledge of SOPs
• actions taken in case of deviations

Personnel awareness is a key indicator of GMP system effectiveness.

Closing meeting 

At the end of the GMP inspection, a closing meeting is held to:

• present identified non-conformities
• provide preliminary conclusions
• discuss timelines for CAPA submission

Manufacturers receive clear guidance on next steps.
Post-inspection activities
After the inspection, the company:

• prepares corrective and preventive action plans
• submits responses to the authority
• implements corrective measures

Effective CAPA management plays a crucial role in certification outcomes.

Conclusion 

A GMP inspection is a structured and predictable process. Understanding each stage helps manufacturers minimize risks and successfully pass the inspection.
If you need GMP inspection support or full preparation services, contact WorldWideBridge - we provide end-to-end GMP inspection support and help manufacturers pass inspections smoothly and confidently.