WHO GMP, Vaccine & Biopharmaceutical Consultancy
Manufacturing vaccines and biologicals to WHO GMP standards demands expertise that goes beyond conventional pharmaceutical compliance. PCS provides consultants who understand the specific requirements for biological products, WHO prequalification and the regulatory landscape of global health supply chains.
When this is the right fit
Organisations seek our WHO GMP and biopharma consultancy when:
Preparing a vaccine or biological product dossier for WHO prequalification and needing GMP compliance support
A WHO inspection or national regulatory authority audit for biological products is approaching
Transitioning from R&D or clinical manufacturing to commercial-scale production of biologicals
Existing GMP systems need to be assessed against WHO-specific requirements for vaccines, blood products or biotherapeutics
Establishing or upgrading a quality system for a manufacturing site that supplies to WHO-procured programmes (UNICEF, GAVI, PAHO)
What you get
Our WHO GMP and biopharma consultants deliver:
WHO Prequalification Support
End-to-end support for the WHO prequalification process: site master file preparation, GMP gap assessment against WHO TRS requirements, mock inspections and remediation of findings. We help you understand exactly what WHO inspectors expect.
Biological Products GMP Compliance
Specialist guidance on GMP requirements unique to biological products: cold chain validation, contamination control strategy for biologicals, biosafety considerations, viral safety and clearance, and aseptic process validation for biopharmaceuticals.
Gap Assessment & Remediation
Detailed assessment of your current GMP status against WHO Technical Report Series guidelines, EU GMP Annex 2 (biological products) and relevant national requirements. Prioritised remediation plans with realistic timelines.
Quality System Development
Design and implementation of quality management systems tailored to vaccine and biopharma manufacturing — including batch release protocols for biologicals, stability programmes for temperature-sensitive products and deviation management for complex processes.
Regulatory Dossier Support
Preparation and review of the quality sections (Module 3 / Product Information) of WHO prequalification dossiers and national registration submissions for biological products.
How we work
We structure engagements around the stage of your product or facility lifecycle:
2–6 weeks
For organisations needing a clear picture of their WHO GMP compliance status before committing to a full programme
Typical deliverables
- On-site assessment against WHO TRS requirements and applicable annexes
- Detailed gap report with risk-prioritised findings
- Recommended remediation roadmap with effort estimates
6–24 months
For manufacturers pursuing WHO prequalification for a vaccine or biopharmaceutical product
Typical deliverables
- Complete GMP remediation and quality system upgrade to WHO standards
- Site master file preparation and dossier quality sections
- Mock WHO inspection and pre-inspection readiness verification
Ongoing
For organisations maintaining WHO GMP compliance and needing periodic specialist input
Typical deliverables
- Named WHO GMP / biopharma specialist available on agreed schedule
- Support for annual product reviews, change assessments and supplier qualification
- Rapid response for inspection preparation or critical deviation support
Typical timeline
Scoping & Baseline Assessment
We begin by understanding your product portfolio, target markets and current GMP status. An on-site baseline assessment identifies the distance to WHO compliance and shapes the project plan. For prequalification projects, we map the full submission timeline backwards from your target date.
Remediation & System Building
Our consultants work on-site with your quality and production teams to close identified gaps. This includes upgrading SOPs, implementing WHO-specific requirements for biologicals, training staff, and validating critical processes. We maintain a live tracker of all open items against the remediation plan.
Mock Inspection & Submission
Before the WHO inspection or dossier submission, we conduct a comprehensive mock inspection mirroring the WHO approach. All findings are remediated. For prequalification, we support the complete submission process and prepare your team for the on-site WHO audit.
What clients see
Example (anonymised)
A vaccine manufacturer in an emerging market engaged PCS to support their first WHO prequalification application. Over eighteen months, we performed a baseline gap assessment, guided the remediation of over sixty findings, rebuilt the quality system documentation and conducted two mock inspections. The facility achieved WHO prequalification on the first submission cycle.
See more clients and outcomes →"PCS brought the practical experience we needed. They had seen what WHO inspectors look for and prepared us accordingly."
Frequently asked questions
WHO GMP standards are published in the WHO Technical Report Series and are broadly aligned with EU GMP but contain additional requirements specific to WHO-procured products, particularly for vaccines and biologicals. Key differences include specific guidance on cold chain, biosafety, and requirements for the WHO prequalification process. We help manufacturers understand and bridge these differences.
Yes. Our consultants have experience across vaccines (viral and bacterial), blood and plasma-derived products, monoclonal antibodies, recombinant proteins, cell and gene therapy products, and other biotherapeutics. The specific GMP requirements vary by product type, and we tailor our approach accordingly.
Yes. A significant portion of our WHO GMP work is with manufacturers in Asia, Africa and Latin America who supply to international organisations. PCS is Netherlands-based but our consultants travel worldwide and have experience navigating the regulatory landscapes across multiple regions.
The timeline depends on your starting point. For a facility with a mature GMP system that needs targeted improvements, 12–18 months is realistic. For a facility building GMP capability from an earlier stage, 18–36 months is more typical. We provide an honest assessment of your timeline during the scoping phase.
Our primary focus is manufacturer GMP compliance. However, we understand the NRA maturity requirements that underpin WHO prequalification and can advise on how your facility documentation and systems should align with what your national authority needs to demonstrate to WHO.