1. Be Inspection-Ready Always

• Keep documentation, equipment, and facilities in a state of compliance at all times.

• Conduct regular self-inspections and mock audits.

• Ensure all records are updated, accurate, and readily retrievable.

2. Train Employees on GMP and Inspection Etiquette

• Employees should know their roles and responsibilities.

• Train staff to answer only what is asked, clearly and truthfully.

• Remind employees not to speculate or provide unnecessary information.

3. Organize and Control Documentation

• Have a document control system in place.

• Make sure SOPs, batch records, validation, and training files are up to date.

• Designate a documentation team to provide requested records promptly.

4. Establish an Inspection Response Team

• Assign roles: escort, scribe, subject matter experts (SMEs), and management liaison.

• The scribe should document every question and response during the inspection.

• Ensure SMEs can explain processes clearly and consistently.

5. Maintain Transparency and Professionalism

• Provide truthful, concise answers.

• Admit if you don’t know something but commit to finding the answer.

• Keep communication respectful, professional, and non-defensive.

✨ Bonus Tip: After the inspection, review all observations immediately, perform a root cause analysis, and implement corrective and preventive actions (CAPA) without delay.

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