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).
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.
Join the pharmaceutical and biotech companies who used our WHO PQ services.
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.
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.
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.
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).
Depending on your requirements, PCS can supply you with an A-to-Z service for WHO prequalification or WHO GMP compliance.
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!