Vaccine manufacturers' corner
This part of our website was created to update our partners involved in the development of vaccines on strategies, policies, decisions and recommendations that would be of interest to them.
Validation of Production Processes for Vaccines for WHO prequalification- Compliance Expectations - for comments by 20 September 2013
A revised procedure for WHO prequalification of vaccines was endorsed by the WHO's Expert Committee on Biological Standardization (ECBS) in October 2010. Vaccines are currently prequalified as per this revised procedure. Manufacturers have requested guidance from WHO on systems and means to validate their production processes and analytical methods. The exercise of validation ensures that product is consistently produced to the specified standards for prequalification purposes. The validation and its scope is usually detailed in a master validation plan of the manufacturer. To assist manufacturers to implement appropriate validation procedure, this document on “Validation of Production Processes for Vaccines for WHO prequalification - Compliance Expectations” has been developed. This document has already undergone a few rounds of consultations with GMP experts, vaccine manufacturers, National Regulatory Authorities and WHO staff. The document is now posted for wider consultation and comments. It should be seen as a guidance to manufacturers of prequalified vaccines, and as a complement to the Procedure for assessing the acceptability, in principle, of vaccines for purchase by United Nations agencies. WHO/BS/10.2155. It provides the basis for the minimum scope for validation of production processes. It is a guidance limited to vaccines and it is recognized that it is not an all-inclusive document. As such, manufacturers should apply a flexible approach where new or certain approaches are not described in this document. It is also advised that this guidance should be interpreted on a case-by-case basis. The WHO Prequalification Secretariat requests comments, observations and / or recommendations to this draft addressed to email@example.com and firstname.lastname@example.org by 20 September 2013.
Eleventh WHO/UNICEF consultation with OPV/IPV manufacturers and NRAs
The eleventh WHO/UNICEF consultation meeting with OPV/IPV manufacturers and national regulatory authorities (NRAs) took place on 25 October 2012 at WHO/HQ, Geneva. The objectives of the meeting were:
- To update manufacturers and NRAs on the current status of the global polio emergency action plan for both WPV eradication and cVDPV elimination;
- To inform manufacturers on projected tOPV, bOPV1&3, mOPV1, mOPV3 and IPV demand for the period 2013-2016;
- To bring manufacturers and NRAs up-to-date on pre & post-eradication risk assessment and the ongoing research and programme of work to develop appropriate policies and products for managing these risks (including new developments in the elaboration of pre and post-eradication IPV policy); and
- To strengthen existing collaboration between manufacturers and NRAs involved in the Global Polio Eradication Initiative.
Oral Poliomyelitis Vaccine (OPV): Questions and Answers - production, control and prequalification process
Oral Poliomyelitis Vaccine (OPV) Questions and Answers (Q&A) - production, control and prequalifcation process (PQ)
UN Prequalification of Medicines, Diagnostics and Vaccines - Sixth consultative stakeholder meeting and second meeting with manufacturers, 4-5 April 2011, Geneva
The WHO Prequalification of Medicines Programme (PQP), in conjunction with the Prequalification of Vaccines Programme and the Prequalification of Diagnostics Programme, organized the Sixth Consultative Meeting with Stakeholders and the Second Meeting with Medicine Manufacturers. The meetings were held in Geneva on 4 and 5 April 2011.
Detailed information about the meetings may be found below.
agenda - day 1
agenda day 2 - medicines
agenda day 2 - vaccines
Programme update - Prequalification of vaccines
Update of the procedure for WHO vaccines prequalification
Procedure for the expedited review of imported prequalified vaccines with view to granting a marketing authorization
New approach to investigation of complaints and AEFIs report
Vaccine standardization in the context of prequalification
Integration of Influenza vaccine evaluations to the main stream prequalification procedure
Need for improved post-marketing surveillance in receiving countries and suggestions on how to monitor safety of newly introduced vaccines
List of participants
- Prequalification of Medicines Programme and Prequalification of Diagnostics Programme - more information
Points to consider for manufacturers of human vaccines
In response to a request from the Developing Country Vaccine Manufacturers Network (DCVMN) to provide more technical guidance to manufacturers wishing to submit vaccines for prequalification for supply to UN agencies, WHO has decided to produce a series of points to consider documents to help clarify WHO requirements to vaccine manufacturers and help harmonize interpretations among assessors.
These documents intend to provide specific technical clarification but without contradicting existing standards published in the WHO Technical Report Series and because no such guidance is currently available, will be published for general use and not just for prequalified vaccines.
- Clinical considerations for evaluation of vaccines for prequalification.
- Environmental monitoring of clean rooms in vaccine manufacturing facilities
Guide to Master Formulae
- New Guidance on variations to a prequalifed vaccine - for comments by 29 March 2013
Working Group meeting on oral poliomyelitis vaccines
The Working Group meeting on oral poliomyelitis vaccines: Revision to the current WHO Recommendations, was held at WHO, Geneva, Switzerland from 20 to 22 July 2010.
Trypsin in OPV and other vaccines
In the framework of the campaign to eradicate poliomyelitis, the quality and safety of Oral Polio Vaccines used for mass immunization is permanently being scrutinized and questioned by some customers or associations. Recently, concerns have been raised by Muslim communities in relation to the presence of a product derived from pig (the trypsin) which is used in the production of OPV and other vaccines manufactured in cell cultures.
In July 2003, the Session of the European Council of Fatwa and Research issued a statement addressed to Muslim leaders encouraging them to take into account the considerable benefits brought by OPV to Muslim children and encourage them to focus on the benefits for the future of their children.
Article 58 scientific opinion procedure - guideline on procedural aspects regarding a CHMP scientific opinion in context of cooperation with WHO for the evaluation of medicinal products intended exclusively for markets outside the european community.
Technical review of vaccine vial monitor implementation
- Further information on Poliomyelitis including guidelines for safe production and quality control of IPV
- Vaccine safety homepage
- Vaccine safety topics - thiomersal and vaccines
- SAGE conclusions and recommendations
- Guidelines on the international packaging and shipping of vaccines (WHO/V&B/05.23) [pdf 498kb]