POST 00939E : PIS/PQS
Follow-up on Post 00927E
12 June 2006
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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.
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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section of the PIS is no longer valid.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
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