Post 00939e : Pis/pqs

POST 00939E : PIS/PQS Follow-up on Post 00927E 12 June 2006 _______________________________________________________________ Umit Kartoglu (mailto:[email protected]) responds to Anthony Battersby and addresses this message also to the whole TechNet community. Your comments are requested and please meet the different deadlines indicated for submitting them. __________________________________ Dear Anthony, TechNet21 members and PIS/PQS users, When WHO introduced the new initiative "Performance, Quality and Safety" (PQS) during TechNet21 Antalya consultation in 2004, it was apparent that the process would take some time. It was targeted that the system would be fully functional by the end of 2006. I would like to summarize what has happened since TechNet21 Antalya consultation. The PIS catalogue, together with its associated specifications, test procedures and administrative infrastructure is in the process of being replaced by the PQS initiative. The PQS team has carried out the following tasks: * A formal organizational structure has been established to administer the PQS process. * A set of Standard Operating Procedures dealing with all aspects of the PQS process has been prepared. These SOPs can be viewed at the following link: http://www.who.int/vaccines-access/vacman/pis/pqs.htm * Existing WHO performance specifications and test procedures have been updated and re-written as PQS performance specifications and PQS verification protocols. Drafts of these documents are now being reviewed by industry. Following this process they will be published. Currently, E8 section on injection devices was published on 30 June 2005 and the E8 section of the PIS is no longer valid. To this effect, we have included a warning note on the 2000 version of the PIS. New PQS prequalified injection devices can be viewed at the following link: http://www.who.int/vaccines-access/vacman/pis/pqs_prequalified_devices.htm * E6 temperature monitoring devices final PQS specifications and verification protocols are being sent to industry for their second round comments with a deadline of 23 June 2006. Once the new specifications and verification protocols are approved by the PQS steering committee, companies will then be able to offer products that comply with new specifications. As for old PIS items, all will be subjected to submit product dossiers that they comply with new specifications. Products that fail to comply during an announced transition period will no longer be valid. Once all categories are final and PQS process is completed, the 2000 version of PIS will be fullyabandoned. * Products that are found to be compliant will formally be pre-qualified by the PQS Secretariat. PQS pre-qualified status indicates that a product is technically suitable for procurement by the United Nations procurement agencies, Governments and by other organizations involved with immunization delivery. * The PQS interface will be web-based and there will no longer be a printed catalogue. Instead, data on all pre-qualified products will be held on the on-line database described in a new document prepared by the PQS secretariat. Currently secretariat is working to identify a best source for the application of the software. An on-line catalogue will be available to users of the public realm website and this will automatically be updated on a periodic basis. * It was decided that until new specifications and verification protocols are in force, the old PIS system would function. It was also decided that the 2000 version would not be updated as a document, rather new items would be published separately on the WHO website. All items that are entered to the PIS system can be found in the following link: http://www.who.int/vaccines-access/vacman/pis/new%20sheets%20intro.htm * All other sections of the PIS are still valid along with new products that are listed in the above link. With this posting, we would also like to draw attention of TechNet21 members to comment on the following documents: 1. E6 temperature monitoring devices final PQS specifications and verification protocols: http://www.who.int/vaccines-access/vacman/specs_intro.htm#E6%20Temperature%20monitoring%20devices Comments should be sent to Dr. Umit Kartoglu (mailto:[email protected]) not later than 23 June 2006. 2. Transport guidelines (attached). This is quite different than the current E2 transport section of the PIS. PQS decided to give guidance on purchase of transport vehicles rather than listing specific vehicles. Comments should be sent to Dr. Umit Kartoglu (mailto:[email protected]) not later than 30 June 2006. 3. Software guidelines (attached). This is a new category in the PQS initiative. The guidelines brings together tools available on decision analysis, disease control, vaccine procurement, logistics, programme management, and infection control subheadings. Comments should be sent to Dr. Umit Kartoglu (mailto:[email protected]) not later than 30 June 2006. We are aware at WHO that the establishment of PQS initiative is taking longer than it is anticipated. We thank all users for their understanding and cooperation during this important transition period. Looking forward to receive TechNet21 members' comments on the newly posted specifications and guidelines. Warm regards, Umit ______________________________________________________________________________ Visit the TECHNET21 Website at http://www.technet21.org You will find instructions to subscribe, a direct access to archives, links to reference documents and other features. ______________________________________________________________________________ To UNSUBSCRIBE, send a message to : mailto:[email protected] Leave the subject area BLANK In the message body, write unsubscribe TECHNET21E ______________________________________________________________________________ The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de internationale en sant, Canada (http://www.ccisd.org) ______________________________________________________________________________ ##text## ##text##