WHO Prequalification for Medicines & Vaccines – Global Access, Global Scrutiny

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • GMP, QMS, QRM, Stability, Process Validation, Data Integrity • Regulatory Affairs, QA, CMC, Clinical, Global Supply

WHO Prequalification (WHO PQ) is a programme run by the World Health Organization to assess whether medicines and vaccines meet global standards of quality, safety and efficacy for procurement by UN agencies and other international funders. In operational terms, a WHO PQ decision is a gatekeeper for access to many low- and middle-income markets and donor-funded tenders. It is not a rubber stamp: WHO PQ reviews dossiers, inspects manufacturing and clinical sites, and expects ongoing performance data. For manufacturers, WHO PQ is a parallel—but not duplicate—layer of scrutiny on top of national regulatory approvals. It tests whether your dossiers, plants and QMS are robust enough for global, multi-country supply.

“WHO Prequalification doesn’t replace local approval. It answers a tougher question: ‘Can we trust this product across dozens of countries and thousands of clinics?’”

1) What WHO Prequalification Actually Is

WHO Prequalification is a centralised assessment for selected categories (e.g. HIV, TB, malaria, reproductive health, some NCDs, vaccines) that many UN agencies and donors use to decide which products they will buy. For each product, WHO reviews the quality dossier (similar to a CTD Module 3), evaluates clinical or bioequivalence data where relevant, inspects the FDF and API sites under GMP, and may inspect clinical and bioequivalence facilities under GCP/GLP. A positive decision places the product on the WHO PQ list, but that listing is conditional on ongoing compliance and can be suspended or withdrawn.

2) Why WHO PQ Matters for Global Access and Business Strategy

For many countries and procurement agencies, WHO PQ is either a formal requirement or a strong de-facto expectation. Prequalified products are often prioritised in tenders and funded programmes. From a public health perspective, PQ reduces the risk of substandard or falsified products entering critical treatment programmes. From a business perspective, PQ opens and sustains markets that depend on pooled procurement and donor funding. That makes WHO PQ both a technical and commercial milestone for manufacturers targeting global health portfolios.

3) Scope – Which Products Fall Under WHO PQ

WHO PQ focuses on priority public health interventions: essential medicines for HIV, TB, malaria, hepatitis, reproductive health, some oncology and NCDs; quality-assured generic and innovator products; and a wide range of vaccines supplied through global alliances. PQ also covers in vitro diagnostics and vector control products, but this article concentrates on medicines and vaccines. Not every product is eligible; WHO prioritises therapeutic areas and formulations that align with global disease-burden and programme needs. Manufacturers must confirm eligibility before investing in PQ submissions.

4) Dossier Expectations – Quality, Clinical and Bioequivalence Data

The PQ dossier largely mirrors stringent regulatory authority expectations: detailed CMC information (drug substance, drug product, control strategy), process validation data, stability studies under relevant climatic zones, and validated analytical methods. For generics, robust bioequivalence data are required; for vaccines and some medicines, clinical data, immunogenicity and safety information are central. WHO also emphasizes suitability for target use environments: pack configuration, labelling and instructions must support use in resource-limited settings, cold-chain realities, and large-scale public programmes.

5) GMP Inspections – Manufacturing Sites Under the WHO Lens

WHO PQ includes GMP inspections of FDF and often API manufacturers. These inspections assess facility design, utilities, qualification and CIP/SIP strategies, aseptic controls (for sterile products and vaccines), cleaning validation, environmental monitoring, and compliance with WHO GMP guides (harmonised with PIC/S and other global standards). Inspectors look hard at the maturity of the QMS, including deviations, CAPA, PQR/APR, and CPV. PQ inspections often expose weaknesses that local NRAs have not yet challenged, especially in data integrity and lifecycle validation.

6) GCP/GMP Interface – PQ for Products with Clinical Data

For products requiring clinical or bioequivalence studies, WHO PQ also considers GCP and GLP aspects. That may involve reviewing inspection reports or conducting its own inspections of CROs, clinical sites and bioanalytical labs. The idea is simple: clinical data can’t support PQ if its integrity is doubtful. For sponsors, this means aligning clinical development QA with manufacturing QA and ensuring that the same data integrity expectations apply across GxP domains—rather than treating GCP and GMP as separate universes.

7) Data Integrity and QMS Expectations in WHO PQ

WHO PQ has progressively raised the bar on data integrity: complete records, controlled access, validated computerised systems, meaningful audit trails, and clear governance over hybrid systems and spreadsheets. WHO guidance explicitly references ALCOA+ principles and expects them to be embedded in the QMS—not treated as an add-on. Firms seeking PQ must be prepared to show that their MES, LIMS, ERP and local tools work together without creating blind spots or opportunities for undocumented changes.

8) Lifecycle Management – PQ Is Maintained, Not “One and Done”

Once a product is prequalified, WHO monitors its lifecycle: variations, safety signals, complaints, recalls, inspection outcomes and quality trends. Manufacturers must notify WHO of significant changes—new sites, process changes, composition shifts, container/closure updates—and obtain approval where required. Internally, these changes should run through robust change control and QRM assessments. A PQ listing can be suspended or delisted if the product no longer meets requirements or if change management fails. Practically, PQ should be treated as an ongoing relationship, not as a static certificate.

9) PQ, Supply Chains and Contract Manufacturers

Modern supply chains often involve contract manufacturers (CMOs), multiple API sites and regional packaging hubs. WHO PQ looks at the full, declared supply chain, not just a single flagship site. That means contracts, quality agreements, serialization and traceability all matter. Blurry ownership between sponsor and CMO (“they handle that, we don’t see it”) is a red flag. PQ applicants must demonstrate they control and can monitor CMOs, not merely outsource responsibility. When multiple sites manufacture the same PQ product, comparability and robust technology transfer become central topics.

10) Stability, Cold Chain and Field Realities

WHO PQ pays close attention to stability in real-world conditions: hot and humid climates, fragmented cold chains, variable storage practices. Stability programmes must cover appropriate climatic zones and packaging configurations, and justify shelf life and in-use periods realistically. For vaccines and some biotherapeutics, cold-chain robustness and temperature excursion handling are critical. Manufacturers should expect WHO to challenge optimistic claims that are not backed by data and to examine how stability data are trended, reported in PQR/APR, and reflected in labelling and transport SOPs.

11) Pharmacovigilance, Complaints and PQ Oversight

For many products, WHO PQ expects a functioning pharmacovigilance (PV) and complaint-handling system in line with national and donor requirements. Serious quality complaints, product defects or safety signals can trigger re-evaluation of PQ status. From an operational standpoint, this means complaints and PV data must be integrated into the QMS, with deviation/NC handling, RCA, and CAPA feeding back into manufacturing, QC, labelling and training. WHO is not just interested in whether you record complaints, but in whether you learn from them quickly enough to protect programmes.

12) Common Findings and Reasons for PQ Delays or Denials

When PQ is delayed or denied, the reasons often look familiar: incomplete or inconsistent dossiers, weak validation (process, cleaning, analytical), gaps in data integrity, under-developed QMS, inadequate risk management, or quality agreements and oversight that don’t match the reality of multi-site manufacturing. For vaccines, cold-chain gaps and incomplete control of critical process parameters are frequent themes. Many of these issues reflect fundamental operational maturity rather than purely regulatory sophistication. WHO PQ tends to expose, not create, those weaknesses.

13) Role of Risk Management, PQR and CPV in Maintaining PQ

To keep PQ status, manufacturers must show that they understand and actively manage risk. That means using structured QRM (e.g. for changes, deviations, process design), performing meaningful PQR/APR that synthesise data from multiple sites and markets, and implementing CPV to demonstrate ongoing process capability. When WHO sees that metrics, trending and risk registers are actually used to drive decisions—rather than simply filed—it tends to gain confidence that the manufacturer can self-identify and correct problems between WHO interactions.

14) Using PQ Strategically – Tenders, Access and Portfolio Planning

PQ status is more than a technical badge; it’s a strategic asset. It can unlock participation in global tenders, provide a reputational signal to national NRAs, and create a platform to introduce future line extensions or reformulations. At the same time, maintaining PQ requires resources—inspection readiness, lifecycle management, and ongoing oversight of partners. Portfolio planning should therefore weigh both commercial opportunity and organisational capacity: adding PQ products without strengthening QMS, digital infrastructure and supplier management is a good way to accumulate risk faster than revenue.

15) Implementation Roadmap – Preparing for WHO PQ

Most organisations move through stages: initially focusing on national approvals, then engaging PQ as they enter global health markets, and eventually integrating PQ fully into their global QMS. A practical roadmap starts with a candid gap assessment against WHO guidance: dossier quality, GMP maturity, data integrity, validation, stability and supply chain oversight. Next come targeted upgrades—often including strengthening documentation, digitising records, and clarifying governance with CMOs—followed by pilot PQ applications on a small number of products. Over time, lessons from those first PQ journeys should flow back into templates, training and system design so each new PQ is less painful than the last.

16) FAQ

Q1. Does WHO Prequalification replace national regulatory approval?
No. WHO PQ is a separate assessment used mainly by international procurers; national marketing authorisations from local NRAs are still required. In some countries, PQ can streamline or support local approval, but it does not automatically substitute for it.

Q2. Is PQ only for generic medicines?
No. PQ covers both innovator and generic products in priority disease areas, as well as a broad range of vaccines. However, many PQ applications are for multisource products intended for donor-funded programmes.

Q3. If a product is approved by a stringent regulatory authority, is PQ automatic?
No. Approval by an SRA is a strong positive signal, but WHO still reviews the dossier, assesses suitability for programme use, and may inspect sites. Some PQ requirements—such as stability under certain climatic zones—go beyond the original SRA’s focus.

Q4. Can PQ status be suspended or withdrawn?
Yes. Serious GMP issues, quality defects, unresolved safety concerns, or failure to manage lifecycle changes appropriately can lead to suspension or delisting. Manufacturers must treat PQ as an ongoing commitment, not a one-time milestone.

Q5. What is a practical first step for a company considering WHO PQ?
Select one high-priority product and perform a structured gap analysis against WHO PQ guidance, focusing on dossier completeness, GMP maturity, data integrity and stability. Use the findings to build a remediation plan and only then commit to a formal PQ submission timetable.

Related Reading
• Quality & Risk: QMS | QRM | PQR/APR | CPV
• Technical Controls: Process Validation | Cleaning Validation | Stability Studies | TMV
• Data & Deviations: Data Integrity | Audit Trail | Deviation / NC | RCA | CAPA
• Systems & Supply Chain: Supplier Qualification | Traceability | WMS | ERP