WHO GMP TRS 1044 (2022)

TRS 1044 Annex 2 is the WHO Expert Committee on Specifications for Pharmaceutical Preparations' main-principles GMP for finished pharmaceutical products. It is not a regulation in its own right; it becomes binding through (a) the WHO Prequalification Programme's reliance on it for prequalification inspections, (b) national regulatory adoption (many LMIC regulators adopt WHO TRS GMP by reference), and (c) UN procurement specifications that cite it. For products supplied through the Global Fund, UNICEF, UNFPA, GAVI or the Stop TB Partnership Global Drug Facility, WHO GMP compliance is contractually required.

• Glossary
• Pharmaceutical quality system (PQS) — aligned with ICH Q10
• Good manufacturing practices for pharmaceutical products
• Sanitation and hygiene
• Qualification and validation
• Complaints, quality defects and product recalls
• Contract production, analysis and other activities
• Self-inspection, quality audits and suppliers' audits
• Personnel
• Training
• Personal hygiene
• Premises
• Equipment
• Materials
• Documentation
• Good practices in production
• Good practices in quality control

• Pharmaceutical Quality System framing now explicitly aligned to ICH Q10 — including senior-management responsibility, knowledge management, quality risk management integration, change management and continual improvement.
• Quality Risk Management section updated to reflect ICH Q9(R1) thinking — formality of QRM, subjectivity in risk assessment, and product-availability risk as a legitimate QRM input.
• Data integrity expectations strengthened — ALCOA+ language and audit-trail requirements in line with WHO TRS 1033 Annex 4 (Data Integrity) and PIC/S PI 041.
• Contract manufacturing section expanded to reflect outsourced-activity governance expectations.
• Self-inspection and supplier-audit expectations clearer on documentation and follow-up.
• Personal hygiene, premises and equipment text modernised; cross-contamination control language harmonised with EU GMP Chapter 3 / Chapter 5.
• Documentation chapter accommodates electronic records and electronic signatures with reference to Annex 11-equivalent controls.

WHO Prequalification inspections are conducted against WHO GMP. After publication of TRS 1044 Annex 2, the inspection framework progressively shifted to reference the 2022 text. Manufacturers in the PQ programme should expect:

• Inspector focus on PQS maturity — formal product-quality reviews, management review, change-control governance, CAPA effectiveness.
• QRM challenged on formality and on whether the assessment matches the risk question (per ICH Q9(R1)).
• Data integrity sampling of electronic records, audit trails, user-access controls and dynamic data (chromatographic raw data, balance prints, EMS).
• Outsourced-activity oversight — contract analytical, contract sterilisation, contract release.
• Cross-contamination control with toxicology-based health-based exposure limits (PDE/ADE) where applicable.

1. Confirm internal SOPs and PQS documentation reference TRS 1044 Annex 2 (2022) rather than TRS 986 (2014).
2. Update QRM SOPs to reflect ICH Q9(R1) — formality, subjectivity, product-availability risk.
3. Verify data-integrity controls against the WHO TRS 1033 Annex 4 (Data Integrity) and PIC/S PI 041 expectations now embedded in TRS 1044.
4. Refresh contract-manufacturing technical agreements and oversight programmes against the expanded chapter.
5. Update training matrices so quality, production and QC staff are trained on TRS 1044 expectations.
6. If WHO Prequalification or a WHO-aligned regulator inspection is scheduled, verify self-inspection coverage against the 2022 structure.

• 'WHO GMP is lower than EU GMP.' Not materially — the main principles are aligned. WHO does have separate annexes for some product types (e.g. heating, ventilation and air-conditioning for non-sterile dosage forms) that may differ in operational detail.
• 'WHO GMP is voluntary.' It is voluntary as international guidance but contractually binding through PQ and UN procurement, and adopted by reference in many national frameworks.
• 'TRS 1044 supersedes ICH guidelines.' No — TRS 1044 explicitly aligns with ICH Q7/Q9/Q10 and assumes them as the underlying expectations.
• 'Once we are EU GMP-compliant we are WHO GMP-compliant.' Largely true on principles, but PQ has dossier-format and labelling-specific expectations that EU compliance does not automatically satisfy.