Top GMP Deficiencies Commonly Identified During WHO Inspections

WHO GMP inspections are globally recognized for their rigor and structured evaluation of pharmaceutical manufacturing facilities. For companies seeking WHO prequalification, understanding the common deficiencies observed during WHO GMP inspections is crucial for proactive risk mitigation and audit preparedness. This article outlines key findings from actual WHO inspections, categorized by system areas, and provides best practices to avoid them.

Why It’s Important to Study WHO Inspection Deficiencies:

• Improves audit readiness and reduces risk of prequalification rejection
• Helps prioritize system improvements and training
• Supports sustainable compliance and reduces repeat observations
• Guides internal audit focus and CAPA planning

1. Documentation Deficiencies

WHO inspections frequently reveal issues related to poor documentation practices, including:

• Uncontrolled or obsolete SOPs in use on the shop floor
• Batch Manufacturing Records (BMRs) with missing entries or overwrites
• Backdated entries or unexplained corrections in logbooks
• Version mismatches between procedures and actual records

How to Address:

• Implement a robust document control system with audit trail features
• Train staff on GDP principles regularly
• Conduct periodic logbook reviews by QA
• Ensure alignment of SOPs with site practices and GMP modules

2. Quality Management System (QMS) Gaps

QMS-related deficiencies include:

• Incomplete or ineffective CAPA implementation
• No trending of deviations or complaint data
• Inadequate root cause analysis methods (e.g., missing 5-Why or Fishbone)
• Management reviews not covering critical GMP metrics

How to Address:

• Formalize QMS reviews at planned intervals
• Use CAPA tracking tools with effectiveness verification
• Trend deviation types, frequency, and impacted processes

3. Facility and Equipment-Related Observations

WHO inspectors often flag poor maintenance, qualification, or design issues such as:

• Inadequate HVAC system monitoring
• Damaged walls, ceilings, or flooring in classified areas
• Expired calibration of critical equipment
• Equipment cleaning without validated procedures

How to Address:

• Maintain updated preventive maintenance schedules
• Validate cleaning processes with recovery studies
• Keep calibration logs readily accessible during audits
• Inspect facility integrity weekly via QA walkthroughs

4. Personnel Training and Hygiene

• Gaps in training records or refresher course compliance
• Lack of job-specific training documentation
• Unclean or inappropriate gowning observed during walkthroughs

How to Address:

• Establish a training matrix and link it to job descriptions
• Conduct gowning simulations and hygiene checks routinely
• Include training KPIs in annual management review

5. Stability Testing Deficiencies

• Stability chambers with no alarm or backup systems
• Inconsistent stability summary reports and raw data
• Non-compliance with ICH Q1A protocol (e.g., missing intermediate time points)
• Failure to investigate out-of-trend (OOT) or out-of-specification (OOS) data

How to Address:

• Ensure all chambers are qualified and monitored continuously
• Train QC analysts on data trending and OOT detection
• Include stability data in annual product quality reviews (APQRs)

6. Cleaning Validation Gaps

• Missing worst-case product selection rationale
• No swab recovery studies performed
• Absence of cleaning hold time validation
• Inconsistent or unapproved cleaning procedures in use

How to Address:

• Establish cleaning validation protocols using toxicity and solubility data
• Include swab method validation in each new cleaning cycle
• Document hold time studies with visual and microbial controls

7. Data Integrity and Electronic System Failures

• No user access controls for laboratory systems
• Audit trail not enabled or reviewed periodically
• Inadequate backup and disaster recovery SOPs
• Data overwrites or deletion logs not available

How to Address:

• Implement role-based access controls and password policies
• Schedule routine audit trail reviews
• Train IT and QA on ALCOA+ principles

8. Environmental Monitoring and Cleanroom Controls

• No trending of viable and non-viable particulate counts
• Cleaning procedures not specific to room classification
• Missing action/alert limit justifications
• Inadequate gowning procedures for sterile zones

How to Address:

• Develop zone-wise monitoring plans with alert/action trends
• Use risk assessment to define monitoring frequencies
• Ensure HEPA filter integrity is tested bi-annually

9. Repeat Observations from Previous Inspections

One of the most damaging findings is the recurrence of previously cited issues, indicating failed CAPA or weak quality culture.

How to Address:

• Perform root cause effectiveness checks
• Document and train personnel on implemented CAPAs
• Establish a “lessons learned” SOP linked to internal audits

Conclusion:

WHO GMP inspections are among the most thorough in the pharmaceutical regulatory landscape. By understanding the patterns of deficiencies commonly cited—ranging from documentation and stability testing to facility hygiene and CAPA tracking—companies can better prepare and build sustainable compliance systems. Early identification, system-wide training, and robust QMS documentation are key pillars in minimizing inspection risks and achieving successful WHO prequalification.