WHO GMP Inspection Guidelines: Scope and Structure Explained

Decoding the WHO GMP Inspection Guidelines: Scope and Structural Overview

The World Health Organization (WHO) plays a pivotal role in setting global standards for pharmaceutical manufacturing. Its GMP inspection guidelines, particularly as outlined in WHO Technical Report Series (TRS) 986 and 961, are used worldwide to assess the quality of pharmaceutical production. These guidelines serve as the foundation for WHO Prequalification inspections and have been adopted or adapted by numerous national regulatory authorities (NRAs). This article provides an expert breakdown of the structure, scope, and application of the WHO GMP inspection guidelines.

What Are WHO GMP Inspection Guidelines?

The WHO GMP inspection guidelines provide a standardized framework for evaluating pharmaceutical manufacturing facilities for compliance with international GMP requirements. They are published as part of the WHO Technical Report Series, which includes modules, model checklists, and procedural documentation for inspectors.

Core Reference Documents:

TRS 986 Annex 2: Main document outlining GMP principles for pharmaceutical products
TRS 961 Annex 1: Model guidance for inspection of manufacturing facilities
WHO PQP Inspection Procedures: Procedural documents for prequalification inspections of FPPs, APIs, and IVDs

Also Read: GMP Surveillance Audits: Global Best Practices

Scope of WHO GMP Inspections:

WHO inspections focus on assessing compliance in the following areas:

Quality Management Systems (QMS)
Production and in-process controls
Validation and qualification
Personnel and training
Documentation practices and record-keeping
Premises and equipment maintenance
Stability testing and shelf-life justification
Material management and supplier qualification
Self-inspection and continuous improvement systems

Inspection Structure: Modules and Components

WHO inspections are structured into modules that mirror GMP systems:

Module 1: Pharmaceutical Quality System (PQS)
Module 2: Good Documentation Practices (GDP)
Module 3: Premises, Equipment, and Maintenance
Module 4: Production and Process Controls
Module 5: Quality Control Laboratories
Module 6: Validation and Qualification
Module 7: Materials Management and Supplier Control
Module 8: Product Distribution and Recall Procedures
Module 9: Complaint Handling and Pharmacovigilance

WHO GMP Inspection Process: Step-by-Step

1. Preparation and Planning

Risk-based selection of sites based on product dossier
Review of previously submitted documents (Site Master File, Quality Manual)
Development of a customized inspection plan

2. On-Site Inspection

Typically conducted over 3–5 days by a WHO inspection team. Includes facility tours, interviews with personnel, document review, and traceability audits of specific batches.

Also Read: Role of ICH, WHO, and PIC/S in Setting Global GMP Inspection Benchmarks

3. Grading of Observations

Critical: Likely to result in products that pose significant risk to patients
Major: Could result in products not meeting their intended quality
Other: Deficiencies that do not directly impact product quality

4. Inspection Report and CAPA

A detailed report is issued outlining all observations. The manufacturer must submit a Corrective and Preventive Action (CAPA) plan, typically within 30 days.

5. CAPA Review and PQ Decision

The WHO reviews the CAPA plan and decides whether to approve, defer, or reject the product’s prequalification status.

Inspection Tools and Checklists:

WHO inspectors use standardized checklists and templates covering:

Manufacturing activities (solid oral, injectables, APIs)
Environmental controls (cleanroom classification, HVAC)
Water systems and contamination control
GMP documentation audit trails

Differences from Other Inspection Models:

While WHO aligns with PIC/S and ICH, its inspection scope often places heavier emphasis on:

Stability protocol justification for tropical conditions
Document transparency for donor procurement
Cross-site harmonization and lifecycle monitoring

Regulatory Reliance and Global Recognition:

Over 100 countries and procurement agencies use WHO GMP findings as the basis for:

Product registration via Collaborative Registration Procedure (CRP)
Import clearance and post-shipment quality checks
Procurement qualification by UNICEF, Global Fund, and others

Also Read: Frameworks for Joint GMP Inspections by Multiple Regulatory Authorities

Best Practices for Manufacturers Preparing for WHO GMP Inspections:

Conduct internal audits using WHO TRS 986 and 961 guidelines
Ensure all SOPs align with WHO’s document hierarchy and version control expectations
Develop a CAPA readiness plan prior to inspection
Use risk assessments to justify process deviations and change controls
Train all QA, QC, and production staff on WHO-specific expectations

Role of QA in WHO GMP Compliance:

QA units are central to successful inspections. Their responsibilities include:

Maintaining GMP documentation in line with WHO templates
Coordinating facility readiness for on-site visits
Managing inspector queries and traceability exercises
Consolidating CAPA responses with clear timelines and impact analysis

Conclusion:

The WHO GMP inspection guidelines are a cornerstone of global pharmaceutical compliance. Their structured, risk-based, and transparent methodology ensures that only high-quality products enter international supply chains. For manufacturers aiming to participate in WHO Prequalification or expand into international public health markets, mastering these guidelines is not just important—it’s essential. Aligning internal systems, training personnel, and continuously reviewing WHO updates are key steps toward sustainable global compliance.