Regulatory inspections are inevitable in pharmaceutical manufacturing. The question isn’t whether an auditor will arrive—it’s whether you’ll be ready. This checklist covers the key areas to address before any GMP audit.

Before the audit: Foundation work

Documentation readiness

Quality Management System

Quality manual is current and approved
Quality policy is communicated to all personnel
Organization chart reflects current structure
Job descriptions are current and signed
Training records are complete and current
Qualification records for key personnel are available

Standard Operating Procedures

SOP index is current and accurate
All SOPs are within review period
Superseded SOPs are properly archived
Training records exist for all applicable SOPs
Deviations from SOPs are documented

Batch Documentation

Batch records are complete and reviewed
Yield calculations are correct
In-process controls are documented
Equipment logs are complete
Environmental monitoring data is documented
All deviations are documented and investigated

Change Control

Change control log is current
All changes are formally documented
Impact assessments are complete
Validation requirements are addressed
Regulatory assessments are documented
Implementation is verified

Deviation/CAPA System

Deviation log is current
Open deviations have target dates
Investigations identify root cause
CAPAs address root causes
CAPA effectiveness is verified
Trending analysis is current

Facility and equipment

Facility Status

Facility is clean and organized
Areas are properly identified and posted
Status labels are current
Cleaning schedules are current
Pest control program is documented
Maintenance records are current

Equipment

Utilities

Water system qualification is current
Water testing is current and compliant
HVAC qualification is current
Compressed air/gases are qualified
Environmental monitoring is current

Computer Systems

System inventory is current
Validation documentation is available
User access is controlled and documented
Backup/recovery procedures are tested
Audit trails are enabled and reviewed
21 CFR Part 11 compliance is documented

Laboratory

Laboratory Systems

Analyst qualifications are documented
Method validation is current
Reference standards are qualified
Equipment is qualified and calibrated
Environmental controls are appropriate
Sample management is documented

Data Integrity

Audit trails are enabled
Raw data is accessible
No data manipulation evidence
Reprocessing/integration is controlled
Electronic records meet Part 11 requirements

Testing Records

Testing is complete per specifications
OOS investigations are complete
Stability programs are current
Retained samples are available
Reference standard logs are complete

Personnel

Training

Training program is documented
All personnel have completed required training
Training effectiveness is verified
GMP training is current
Job-specific training is documented
Retraining is completed as required

Interview preparation

Key personnel know their responsibilities
Staff can explain procedures they perform
Staff know location of relevant SOPs
Staff understand deviation reporting
Staff can demonstrate data integrity practices

Supplier management

Supplier Qualification

Approved vendor list is current
Supplier qualifications are current
Quality agreements are in place
Supplier audits are current
Certificates are current

Incoming Materials

Receiving procedures are followed
Identity testing is performed
CoA review is documented
Material status is clear
Storage conditions are appropriate

During the audit

Opening meeting

Be prepared to present:

Site overview and organization
Product portfolio
Quality management system overview
Recent changes or significant events
Response to previous inspection findings

Document retrieval

Have readily available:

Audit logistics

Dedicated audit room is prepared
Copying/printing capability is available
Subject matter experts are on standby
Escort personnel are assigned
Documentation runners are assigned
Management availability is confirmed

Communication protocols

Single point of contact designated
Back room team established
Response review process defined
Escalation procedures clear
Daily debriefing scheduled

After the audit

Closing meeting

Take detailed notes of observations
Ask clarifying questions
Do not argue or debate
Thank the auditor professionally
Understand timeline for formal response

Response preparation

For each observation:

Understand the specific concern
Investigate root cause
Develop corrective action plan
Assign responsibility and timeline
Document preventive actions
Consider systemic implications

Response review

Follow-up

Response submitted on time
CAPA tracking established
Progress monitoring in place
Evidence collection planned
Verification activities scheduled

Common audit focus areas

Data integrity

Inspectors increasingly focus on:

Audit trail review
User access controls
Raw data availability
Reprocessing/integration justification
Backup and recovery
Electronic records compliance

Quality systems

Key areas include:

CAPA effectiveness
Deviation trending
Change control rigor
Complaint handling
Annual product review

Laboratory

Focus areas:

OOS investigations
Method validation
Analyst qualification
Equipment qualification
Data integrity

Supplier management

Inspectors examine:

Qualification rigor
Ongoing monitoring
Certificate verification
Quality agreement compliance

Building audit readiness culture

The best audit preparation happens every day, not just before inspections:

Design for compliance - Build quality into processes, don’t inspect it in
Maintain continuously - Keep documentation current, not just for audits
Train thoroughly - Everyone should understand their GMP responsibilities
Address issues promptly - Don’t wait for audits to fix known problems
Learn from every audit - Use observations to improve systems

BioWise helps pharmaceutical companies maintain audit readiness with connected quality systems and real-time visibility. See how.