A Complete Guide to WHO Prequalification for Finished Pharmaceutical Products (FPPs)
The WHO Prequalification Programme (PQP) for Finished Pharmaceutical Products (FPPs) is a globally recognized pathway that assures the quality, efficacy, and safety of essential medicines for procurement by international agencies such as UNICEF, Global Fund, and GAVI. For manufacturers, prequalification is not just a regulatory milestone—it’s a gateway to international markets and public health impact. This guide walks you through the PQP process for FPPs, detailing each stage from dossier submission to GMP inspection and lifecycle management.
What Is an FPP in the Context of WHO PQP?
An FPP refers to the final dosage form of a pharmaceutical product, which includes the active pharmaceutical ingredient (API), excipients, container closure system, labeling, and insert. Under WHO PQP, FPPs must meet stringent quality criteria to be eligible for prequalification and global supply.
Eligibility for WHO PQP-FPP Submission:
- FPP must treat priority conditions (e.g., HIV, TB, malaria, NCDs, reproductive health)
- Manufacturer must be GMP-compliant or willing to undergo WHO inspection
- Product should be registered in country of manufacture or a reference country
- Commonly targeted dosage forms: tablets, capsules, suspensions, injectables
Step-by-Step Process of WHO PQP for FPPs:
1. Expression of Interest (EOI)
WHO publishes periodic EOIs inviting applications for specific disease areas. Manufacturers must submit an application form confirming their intent and eligibility.
2. Dossier Submission (CTD Format)
The FPP dossier must follow the Common Technical Document (CTD) structure and include:
- Module 1: Regional administrative and product information
- Module 2: Quality overall summary, nonclinical and clinical summaries
- Module 3: Quality data, including API specs, FPP specs, manufacturing process, and control strategy
- Module 4 & 5: Clinical and non-clinical studies (for new or innovator products)
3. Quality Assessment
WHO PQT evaluators assess the submitted dossier for adequacy in areas such as:
- FPP manufacturing process and control
- Batch formula and process validation
- Stability data in accordance with ICH Q1A(R2)
- Container-closure integrity
- Labeling and packaging inserts
4. GMP Inspection of FPP Manufacturing Site
Upon satisfactory dossier evaluation, WHO schedules a GMP inspection of the manufacturing facility using standards from WHO TRS 986 and TRS 961. Inspectors focus on:
- Quality Management System (QMS)
- Production operations, documentation, and cleaning validation
- In-process controls, batch records, and equipment qualification
- OOS, deviation, and complaint handling procedures
5. Prequalification Decision
If both the dossier and GMP site inspection are approved, WHO lists the product as “Prequalified” in its public database. This listing is valid for 3–5 years subject to continued compliance.
Post-Prequalification Lifecycle Management:
- Annual Product Quality Reports (APQR) submission
- Notification and approval of any product variations
- Requalification inspections after 3–5 years
- Timely reporting of safety concerns and recalls
Stability Testing Requirements for WHO FPPs:
- Real-time and accelerated stability under zone IVb conditions (30°C/75% RH)
- Minimum 6 months accelerated data and 12 months long-term data for final formulation
- In-use stability for multi-dose containers
- Stability indicating methods must be validated
Best Practices for a Successful PQP Application:
- Use WHO-prequalified APIs or those registered with SRAs
- Submit a gap analysis before dossier submission
- Ensure alignment of the dossier with actual GMP operations and SOPs
- Conduct a mock GMP audit using WHO TRS 986 standards
- Establish a variation management SOP for post-approval changes
Common Reasons for Delays or Rejection:
- Incomplete or poorly structured CTD modules
- Gaps in stability study design or data
- GMP deficiencies during site inspection
- Unjustified or incomplete CAPAs
- Poor training or awareness among facility staff
Role of WHO PQP in Global Access and Procurement:
WHO-prequalified FPPs are prioritized for international procurement, enabling rapid scale-up of essential medicines in LMICs. They are accepted by many national regulatory authorities under WHO’s Collaborative Registration Procedure (CRP), shortening time-to-market and reducing duplicate regulatory evaluations.
Conclusion:
For pharmaceutical manufacturers, WHO prequalification of FPPs is a hallmark of global GMP compliance and product quality. It demands meticulous dossier preparation, robust GMP systems, and a proactive quality culture. By understanding the end-to-end process, aligning stability testing, facility practices, and documentation with WHO expectations, companies can significantly improve their chances of success—delivering life-saving medicines to the patients who need them most.