WHO Prequalification services

WHO PQ audit, WHO GMP implementation or upgrade

For biotech and pharmaceutical organizations

Looking for WHO prequalification consultancy?

The Prequalification project, set up in 2001, is a service provided by the World Health Organization (WHO) to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis.

Any manufacturer that wishes to have it's medicine included in the prequalification list can submit to the WHO. Subsequently the GMP manufacturer must submit its product data to the WHO so quality and efficacy may be assessed.

The manufacturer must also open its manufacturing sites to an inspection team which assesses working procedures for compliance with WHO Good Manufacturing Practices (GMP).

Our commitment

Medicine supplied to the WHO are often provided to patients in challenging environments. Although patient safety is at the core of our business, we emphasize this even more when we're working on World Health Organization PQ/GMP projects.

By emphasizing patient safety we can ensure that organizations such as UNICEF, the ICRC, MSF and UNFPA receive safe medicine of constant pharmaceutical quality. These metrics are essential to the WHO/UNFPA procurement procedure.

Our clients

Join the pharmaceutical and biotech companies who used our WHO PQ services.

Sinovac, China

PCS provided a WHO GMP mock-audit at Sinovac, China in the run-up to it's WHO prequalification for a number of Sinovac products. The mock-audit was concluded with good result. Sinovac is one of the world's leading supplier of COVID-19 vaccines.

Yuxi Walvax, China

In the run-up to WHO prequalification of two manufacturing sites in China, Walvax Biotechnology has asked PCS to perform a WHO PQ mock-audit and consultancy services to Shanghai Zerun Biotechnology. The mock-audit was concluded with good result. Yunnan Walvax Biotechnology is the first company in China to produce a mRNA vaccine against COVID-19.

Panacea Biotec, India

To prepare Panacea Biotec for an upcoming WHO GMP audit PCS deployed a team of expert consultants. The project was completed succesfully with WHO qualification being obtained. The services were performed at a number of sites in Baddi, Lalru, New Delhi and Chandigarh.

United Nations Industrial Development Organization, Austria

A number of leading pharmaceutical organizations in Zimbabwe had to be inspected against the WHO GMP. PCS performed eight WHO GMP audits of these Zimbabwean companies over the course of six months. The audits were executed under the mandate of the United Nations Industrial Development Organisation (UNIDO).

How can we help you with WHO prequalification?

Depending on your requirements, PCS can supply you with an A-to-Z service for WHO prequalification or WHO GMP compliance.

Market research

  • Supply you with details of UNICEF/World Bank tender details

  • Evaluation of worldwide/regional potential for your product(s)

  • Assistance with EOI submission to the WHO

WHO GMP mock audit

  • Mock audit using WHO GMP experts

  • Comprehensive report on the 17-key elements of the WHO GMP

  • Recommendations on CAPA's and required investments for WHO GMP compliance/WHO prequalification

WHO GMP implementation

  • Implementing the CAPA's following the gap assessment

  • WHO inspection readiness training

Logo BBNCIPD
Logo Sinovac China
Logo Bharat biotech
Logo UNIDO WHO GMP
Logo Walvax Biotech
Logo Indian Immunologicals Limited

How can you request WHO prequalification support?

We are happy to (e-)meet you and discuss your WHO prequalification / WHO GMP implementation needs. By filling in the form below you can reserve a timeslot in our agenda. We hope to talk to you soon!

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