C E A N Q F O R M UALIT PQS project E R Y P SAFETY · EHT Essential Health Technologies ... 5 and 7...

D4 – Final draft

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PQS projectPE

RFOR

MAN

CE QUALITY

SAFETY

PERF

ORM

ANCE QUALITY

SAFETY

PQS projectPE

RFOR

MAN

CE QUALITY

SAFETY

PERF

ORM

ANCE QUALITY

SAFETY

Review of product specifications and verification procedures and criteria for

re-verifying existing products and accrediting testing laboratories

(T.o.R 2 , 3, 5 and 7)

Andrew Garnett

January 2004

Revision history:

D1: 31.01.03 – Issued to WHO D2: 04.02.04 – Minor revisions. Issued to WHO D3: 18.02.04 – Title change and general update following Geneva meeting. Section 5 added. Issued to WHO. D4: 17.06.04 – Final draft incorporating comments from industry.

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Contents Glossary .........................................................................................................................3

1. Introduction............................................................................................................4

1. Introduction............................................................................................................4

1.1 Terms of reference .........................................................................................4

1.2 PQS specification writing procedures............................................................4

1.3 PQS product verification procedures .............................................................4

2. Existing specifications and test procedures ...........................................................5

3. Proposed changes and additions ............................................................................6

4. Managing the transition from PIS to PQS .............................................................7

4.1 The PQS coding system for specifications and verification procedures .......7

4.2 The PQS coding system for individual products ...........................................8

4.3 Upgrading PIS documents to PQS standards.................................................8

4.4 Re-qualifying PIS pre-qualified products to PQS standards .......................13

5. Pre-qualifying testing laboratories.......................................................................16

Annex 1 - Existing PIS performance specifications and test procedures ....................17

Annex 2 – Proposed alterations to specifications and test procedures ........................24

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Glossary AD Auto-disable (syringes)

ATT Access to Technologies team in the WHO department of Immunization Vaccines and Biologicals

BEAB British Electrotechnical Approval Board

BS British Standard

DIN Deutches Institut für Normnung e.V. (German standards institute)

EHT Essential Health Technologies (WHO)

FMWG Field Monitoring Working Group

IEC International Electro-technical Commission

ISO International Standards Organization

IVB Immunization Vaccines and Biologicals

PIS Product Information Sheets

PQS Performance Quality and Safety

PQS Performance, Quality, Safety

PQS-SG PQS Steering Group

QA Quality Assurance

QAC Quality Assurance Centre (UNICEF)

QC Quality Control

SIGN Safe Injection Global Network

SOP Standard Operating Procedure

SWG Specification Working Group

UNICEF-SD UNICEF Supply Division, Copenhagen

VDE Verband der Elektrotechnik Elektronik Informationstechnik e.V (German Association for Electrical, Electronic & Information Technologies)

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1. Introduction

1.1 Terms of reference

Item 2, 3, 5 and 7 of the PQS project terms of reference require the consultant:

• To review current product specifications and test procedures to recommend the ones that need to go through a revision process

• To advise on new product specifications and test procedures to be developed.

• Review the established criteria for accreditation of laboratories for conducting tests.

• Recommend criteria for re-testing of products to maintain in the PQS system

This document covers these topics.

1.2 PQS specification writing procedures

Refer to document Overview of the PQS Standard Operating Procedures (T.o.R. 6) and to SOP No FCH/ IVB/ATT/…/00X: How to develop and publish a PQS product performance specification for more details of the recommended procedures for writing PQS performance specifications.

1.3 PQS product verification procedures

Products are generally pre-qualified for inclusion in the PIS only after they have been evaluated in a WHO-accredited testing laboratory against a standard PIS test procedure. However a number of pre-qualified PIS products have been accepted for inclusion without being subjected to any form of formal evaluation. Moreover, there are few systematic procedures in place for evaluating complex site-installed items such as cold-rooms and standby generator installations.

In order to overcome these shortcomings PQS documents adopt the broader term – product verification procedure. A product verification procedure can be one of three types, namely:

1. Type-examination procedure. 2. Independent type-testing procedure. 3. Full Quality Assurance procedure.

One of the key lessons learned from the recent WHO-EHT project on pre-qualification of injection devices1 is that effective quality control (QC) throughout the manufacturing process is an absolutely essential pre-requisite for consistent product quality. In the absence of effective QC procedures, laboratory testing, which relies on a limited number of samples, can never provide the assurance that a product will perform satisfactorily in the field. Consequently, a central element of all three of the verification routes described below is an examination of the manufacturer’s QC procedures. The distinction between the first two routes and the Full Quality

1 See WHO/BCT/03.09: Procedure for assessing the acceptability, in principle, of single-use injection devices for procurement by United Nations agencies.

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Assurance route is that examination of QC in the latter case extends to on-site operations. A type-examination procedure involves the systematic inspection of product samples supplied by the product manufacturer who wishes to be pre-qualified. The technique is checklist-based and it is a suitable verification method for technologically simple items that are supplied in relatively small quantities. Where the risks arising from product failure are low it may also be a suitable method of verification for simple high volume items, and also for more complex items that are supplied in small quantities. An independent type-testing procedure is equivalent to a PIS test procedure and will still be applicable to many PQS products. Full Quality Assurance is justified for complex high value, low volume products which require an element of site-specific design as well as on-site assembly and commissioning work; cold rooms and standby generator installations are examples which fall into this category.

Refer to document Overview of the PQS Standard Operating Procedures (T.o.R 6) and to SOP No FCH/ IVB/ATT/…/00X: How to develop and publish a PQS product verification protocol for more details.

2. Existing specifications and test procedures Annex 1 lists all the existing WHO performance specifications and test procedures. The proposal is that all those specifications that are shaded grey should be phased out during the lead-in to full implementation of PQS. The majority of these exclusions were discussed and agreed at the PQS review meeting in Copenhagen on 18th November 2004. Figure 1 summaizes the omissions.

Figure 1 – Proposed omissions Code Description Notes E2 Motorcycles E2/MC.1 Mopeds Will be replaced with PQS Buyer’s Guide. PIS 2000 refers to IAPSO

categories. No mention of existing E2 specs. E2/MC.2 Off-road motorcycles Will be replaced with PQS Buyer’s Guide. PIS 2000 refers to IAPSO

categories. No mention of existing E2 specs. E2/MC.3 Medium size off-road

motorcycles Will be replaced with PQS Buyer’s Guide. PIS 2000 refers to IAPSO categories. No mention of existing E2 specs.

E3 Refrigerators and freezers E3/FR.2 Icepack freezer, compression If there is a policy change to chilled water packs for all but OPV, it

may no longer be necessary is to retain this specification. In PIS 2000 it only applies to product E3/80-M.

E6 Temperature monitoring devices E6/TR.1 7 day temperature recorder,

fixed Omit because this is old technology. Sensitivity only ± 1° C. ± 0.5° C now required.

E6/TR.2 7 day temperature recorder, portable

Omit because this is old technology. Sensitivity only ± 1° C. ± 0.5° C now required.

E6/IN.3 Freezewatch indicator, irreversible

StopWatch indicator only to be omitted

E8 Equipment for administration of vaccine and micronutrients E8/SS.1 0.5ml sterilizable plastic syringe Omit in line with WHO policy on reusable syringes E8/SS.2 0.05 sterilizable plastic syringe Omit in line with WHO policy on reusable syringes E8/SS.3 5ml sterilizable plastic syringe Omit in line with WHO policy on reusable syringes E8/NH.1 Universal sterilizable syringe

hub Omit in line with WHO policy on reusable syringes

E8/SN.1 Sterilizable needles Omit to comply with WHO policy to phase out sterilizables. Sterilizable needles are not listed in PIS 2000.

E9 Steam sterilizers E9/PS.1 Single rack portable sterilizer Omit in line with WHO policy on reusable syringes E9/PS.2 Double rack portable sterilizer Omit in line with WHO policy on reusable syringes E9/PS.3 Double rack electric sterilizer Omit in line with WHO policy on reusable syringes E9/PS.4 Triple rack sterilizer Omit in line with WHO policy on reusable syringes E9/SR.1 Syringe and needle rack Omit in line with WHO policy on reusable syringes

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E9/SD.1 Removable sterilizer drum Omit in line with WHO policy on reusable syringes E10 Injection accessories E10/TS.1 Time, steam and temperature

indicator Omit in line with WHO policy on reusable syringes

E12 Waste management E12/XX Needle/syringe destroyers Use of these devices is contrary to current WHO policy. No WHO

performance specification exists. Note: PATH are developing performance specifications and field-testing protocols for this type of equipment.

GEN Equipment performance & test procedure: Annexes

Likely to be omitted under PQS. Although the content of the annexes will in many cases still be valid, they should really be incorporated into the individual specifications and verification procedures.

3. Proposed changes and additions Annex 2 lists the principal changes to retained specifications and test procedures that are needed to bring them into line with the new PQS standards. The table also includes (in yellow) a number of proposed new guidelines, specifications and product verification procedures. Figure 2 summarizes theses additions.

Figure 2 – Proposed additions Code Description Notes E01 Cold rooms and freezer rooms E01/XX Cool rooms If WHO endorses the ‘flexible cold chain’ approach then there may

be a need for specifications and/or guidelines for preparing, commissioning and maintaining air-conditioned cool stores.

E01/XX Heavy duty standby generators For large vaccine stores with cold room(s) and freezer room(s) and/or multiple refrigerators and freezers. This would replace the outline specification in PIS 2000. Thorough testing and commissioning of this equipment is essential and a QA procedure is required to ensure that this is done properly.

E01/XX Heavy duty voltage regulators For large vaccine stores with cold room(s) and freezer room(s) and/or multiple refrigerators and freezers. There are guidance notes in PIS 2000, but no specification. Thorough testing and commissioning of this equipment is essential and a QA procedure is required to ensure that this is done properly.

E02 Transport E02/XX Motorcycles Provide a Buyer’s Guide to motorcycles on the PQS website with

links to the UNICEF and IAPSO catalogues. E02/XX Cars and FWD Provide a Buyer’s Guide to cars and FWDs on the PQS website

with links to the UNICEF and IAPSO catalogues. E02/XX Refrigerated vehicles Provide a Buyer’s Guide to refrigerated vehicles and FWDs on the

PQS website with links to the UNICEF and IAPSO catalogues. E03 Refrigerators and freezers E03/RF.X Icepack cooler, compression If WHO endorses the use of chilled water packs for passive cooling

then there will be a need for refrigerators suitable for cooling icepacks in bulk. There will be need for a guideline to ensure that chilled water packs are at the correct temperature when placed in cool boxes.

E03/RF.X Icepack cooler, absorption If WHO endorses the use of chilled water packs for passive cooling then there will be a need for refrigerators suitable for cooling icepacks in bulk. There will be need for a guideline to ensure that chilled water packs are at the correct temperature when placed in cool boxes.

E03/RF.X Freeze-proof refrigerators Proposed by PATH. E05 Icepacks E05/IP.X Icepack, 0.3 litre Several 0.3 litre icepacks are in PIS 2000, but there is no

specification to cover this size. E06 Temperature monitoring devices E06/XX PC-based temperature and

event logger Preferred option specified in E1/CR and E1/FR.

E06/XX Digital recording thermometer with print-out facility

Alternative option specified in E1/CR and E1/FR.

E06/XX 7-day wall-mounted pen Alternative option specified in E1/CR and E1/FR.

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recording thermometer E06/XX Temperature alarm system E7/AS.1 is referred to in the Equipment descriptions of the E7

document, but there is currently no performance specification or test procedure for alarm systems.

E06/XX Temperature data logger Several temperature data loggers are in PIS 2000, but no WHO/UNICEF standard currently exists. These items are now assuming greater importance.

E07 Cold chain accessories E07/XX Light duty standby generators For small vaccine stores with a few refrigerators and/or freezers.

Product verification could be on a type-examination or type-testing basis as these are likely to be ‘off the shelf’ items.

E07/XX Refrigerator tool kits There are a number of tool kits in E7. There needs to be some means to assess these formally.

E07/XX Refrigerator spare parts kits

There are a number of spare parts kits in E7. There needs to be some means to assess these formally.

E08 Equipment for administration of vaccine All The introduction of ISO/DIS 7886-3 and WHO/BCT/03.09: Procedure for assessing the acceptability, in

principle, of single-use injection devices for procurement by United Nations agencies should lead to a general revision of these specifications and the companion verification procedure(s).

E08/XX Jet injectors Agreed at Geneva meeting to be provisionally included

E10 Waste management E10/XX Incinerators Requires further discussion. E10/XX Syringe melters & other devices Requires further discussion. E?? Software E??/XX Stock control software Provide a Buyer’s Guide. Requires further discussion E??/XX Programme evaluation software Requires further discussion.

Minor items: This list leaves out a number of minor items in PIS for which no form of specification or test procedure exists – for example E7/08 – surface level, E7/13 – wicks, etc. Such items do not seem to justify the writing of a full-blown performance specification. However they may justify a short type-examination product verification document. The way to deal with sundries needs further discussion by the SWGs.

4. Managing the transition from PIS to PQS This section covers some of the issues that will arise during the transition from PIS to PQS.

4.1 The PQS coding system for specifications and verification procedures

The PIS coding system has satisfactorily stood the test of time; there seems little reason for changing the basic subdivision into product categories; the coding system for the individual specifications and test procedures is also perfectly satisfactory and is widely understood. However, in the transition phase from PIS to PQS, a clear distinction does need to be made between performance specifications and test procedures developed under the old regime and performance specifications and product verification procedures developed for PQS.

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The simplest way to achieve this is to prefix all new codes with PQS. Thus category E3 will become PQS-E032 and performance specification E3/RF-1 will become PQS-E03/RF-01, after it has been updated to meet PQS standards. Because they will not necessarily match the PIS test procedures on a one-for-one basis there should be a new coding system for PQS product verification protocols. The proposed format is: PQS-E<n, n>/PVP/< n, n> - thus for example, PQS-E03/PVP/01.

One small inconsistency remains to be resolved. Because all items in category E9 will be omitted from PQS, the new category numbering system will run PQS-E01 to PQS-E08, and then from PQS-E10 to PQS-E12.

4.2 The PQS coding system for individual products

The PQS coding system for individual products should follow the same principles outlined in 4.1. Thus, during the transition phase, the ice-lined refrigerator PIS E3/81-M will be listed on the PQS website with this old code. However, as soon as has been formally pre-qualified under the PQS regime it will be re-coded using the following format: PQS-E<n, n>/<n, n, n><- optional letter> - thus for example, PQS-E03/002-M.

4.3 Upgrading PIS documents to PQS standards

One of the first jobs of the PQS-SG and the SWGs will be to prioritize the task of drafting performance specifications and verification procedures to PQS standards. The drafting task will include writing entirely new documents as well as re-writing existing documents. This is a significant body of work which will take some 18 months to complete.

Figures 5, 6, 7, 8, 9, 10 and 11 are a preliminary attempt to prioritize the standards drafting exercise for each of the seven SWGs3, namely:

1. Refrigeration (E01, E03 and E07) 2. Passive cooling (E04, E05 and E11) 3. Temperature monitoring (E06) 4. Injection equipment (E08) 5. Waste management (E10) 6. Transport guideline group (E02) 7. Software guideline group (code to be agreed4)

The priority ranking is based upon two factors: first, an assessment of the need for a new or improved specification, and second, the number of products in PIS 2000 that comply with each of the current specifications5. Figures 3 and 4 illustrate this breakdown for groups 1 and 2. In the remaining categories this analysis is not very

2 Note the leading zero in this example and below. Leading zeros are essential for database management purposes. 3 See PQS organizational structure (T.o.R 1). 4 REVIEW D1: Both E09 and E12 will be unused in PQS 5 REVIEW D1: Another approach would be to analyse these frequencies on the basis of the numbers of products of each specification type purchased through UNICEF-SD.

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helpful; either there are numerous products for which no standard specification exists or specifications relate to small numbers of essential items.

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Figure 3 – Refrigeration: products per performance specification

Specification Working Group 1

0

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/CR

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/FR

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VR

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PIS performance specification

No.

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Figure 4 – Passive cooling: products per performance specification

Specification Working Group 2

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IP.1

E05/

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PIS performance specification

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Figure 5 – Priorities for Refrigeration Working Group E01, E03 and E07

PQS code Description Latest

revision Priority (high, medium, low)

E01/CR Cold rooms 2002 High (safety critical item and urgent need for pre-qualified mfrs)

E01/FR Freezer rooms 2002 High (safety critical item and urgent need for pre-qualified mfrs)

E01/XX Cool rooms new Low

E01/XX Heavy duty standby generators new High (safety critical item and urgent need for pre-qualified mfrs)

E01/XX Heavy duty voltage regulators new High (safety critical item and urgent need for pre-qualified mfrs)

E03/RF.1 Refrigerator and freezer combination, compression 1998 High (safety critical items)

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E03/RF.2 Large refrigerator and icepack freezer, absorption 1998 High (safety critical items) E03/RF.3 Ice-lined refrigerator and/or freezer, compression 1998 High (safety critical items) E03/RF.4 Photovoltaic solar refrigerator and/or icepack freezer,

compression DC 1998 High (safety critical items) E03/RF.5 Refrigerator and icepack freezer, thermal solar 1998 Low (currently only one example)

E03/RF.6 Small refrigerator and freezer combination, absorption 1998 Medium

E03/RF.X Icepack cooler, compression new High (chilled water pack policy) E03/RF.X Icepack cooler, absorption new High (chilled water pack policy) E03/RF.X Freeze-proof refrigerators new. High (frozen vaccine problem)

E03/FR.1 Vaccine/icepack chest freezer, compression 1998 Low

E03/FR.2 Icepack freezer, compression 1998 Low

E03/FR.3 Icepack freezer, thermal solar 1998 Low E03/FR.4 Icepack freezer, absorption 1998 Low E7/VR.1 Voltage regulator, for compression refrigerators and

freezers 1998 Medium

E07/VR.2 Voltage regulator, for absorption refrigerators and freezers 1998 Medium

E07/XX Light duty standby generators new Medium

E07/XX Refrigerator tool kits new Medium E07/XX Refrigerator spare

parts kits new Medium

Figure 6 – Priorities for Passive Cooling Working Group E04, E05 and E11



E04/VC.0 Small vaccine carrier, short range 1998 High (chilled water pack policy) E04/VC.1 Small vaccine carrier 1998 High (chilled water pack policy) E04/VC.2 Large vaccine carrier 1998 High (chilled water pack policy) E04/CB.1 Small cold box, long range 1998 High (chilled water pack policy) E04/CB.2 Large cold box, long range 1998 High (chilled water pack policy) E04/CB.3 Small cold box, short range 1998 High (chilled water pack policy) E04/CB.4 Small cold box, short range 1998 High (chilled water pack policy) E05/IP.1 Icepack, 0.6 litre 1998 High (chilled water pack policy) E05/IP.2 Icepack, 0.4 litre 1998 High (chilled water pack policy) E05/IP.X Icepack, 0.3 litre new High (chilled water pack policy) E11.VC2 Specimen carrier 1998 Low

E11.XX Polio specimen collection kit new Low

Figure 7 – Priorities for Temperature Monitoring Working Group E06



E06/XX PC-based temperature and event logger new High (safety critical items) E06/XX Digital recording thermometer with print-out facility new High (safety critical items) E06/XX 7-day wall-mounted pen recording thermometer new High (safety critical items)

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E06/XX Temperature alarm system new High (safety critical items) E06/XX Temperature data logger new High E06/TH.1 Electronic thermometer, portable 1998 Low

E06/TH.2 Gas or vapour pressure dial thermometer, fixed 1998 Medium

E06/TH.3 Alcohol or bi-metal thermometer, portable 1998 Medium

E06/TH.4 Bi-metal stem thermometer, fixed 1998 Low

E06/TH.5 Liquid crystal thermometer, portable 1998 Low

E06/IN.1 Temperature threshold indicator 1998 Low

E06/IN.2 Cold chain monitor 1998 Low

E06/IN.3 Freezewatch indicator, irreversible 1998 Low

E06/IN.4 Freezewatch indicator, reversible 1998 Medium

E06/IN.5 Vaccine vial monitors 2002 Low

Figure 8 – Priorities for Injection Equipment Working Group E08



E08/DS.1 0.5ml auto-destruct syringe 1998 High (need for harmonization between EHT and PQS)

E08/DS.2 0.05ml auto-destruct syringe 1998 High (need for harmonization between EHT and PQS)

E08/HN.1 Hypodermic needles for single use 1998 High (need for harmonization between EHT and PQS)

E08/XX WHO template procurement specifications for sterile hypodermic syringes for single use including a reuse prevention feature

2002 High (need for harmonization between EHT and PQS)

E08/XX 0.1ml auto-disable syringe 2003 High (need for harmonization between EHT and PQS)

E08/XX 0.2ml auto-disable syringe 2003 High (need for harmonization between EHT and PQS)

E08/XX Auto-disable mixing syringe new High (need for harmonization between EHT and PQS. Specification should be merged with ISO CD 7886-4)

E08/XX Jet injectors new Low? (depends on technical developments)

Figure 9 – Priorities for Waste Management Working Group E10



E10/IC.1 Safety box and incinerator container 1998 Low

E10/IC.2 Safety box for used syringes and needles 1998 Low

E10/XX Incinerators new High (safety critical items)

E10/XX Syringe melters and other devices new High?

Figure 10 – Priorities for the Transport Working Group E02

PQS Description Latest Priority

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code revision (high, medium, low)

E02/XX Motorcycles guideline Low - medium

E02/XX Cars and FWD guideline Low - medium

E02/XX Refrigerated vehicles guideline High (safety critical items)

Figure 11 – Priorities for the Software Working Group E??



E??/XX Stock control software new High (safety critical items)

E??/XX Programme evaluation software new High?

4.4 Re-qualifying PIS pre-qualified products to PQS standards

In addition to the tasks outlined above, it will be necessary to re-verify all the products that are currently listed in PIS. Figure 10 shows the distribution of most recent laboratory test reports for 134 tested products listed in PIS 2000. In the chosen categories (E3, E4, E5, E6, E7, E8, E11 and E12) one third of products were still being pre-qualified on the basis of test reports that were then more than 10 years old.

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Figure 10 – PIS 2000: distribution of products by most recent year of testing.

n= 134 (total no. of tests)

0%

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16%

1978

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%ag

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The re-qualification of products under the PQS regime will logically follow on from the re-drafting exercise discussed in section 4.3. As soon as a PQS performance specification, and its companion verification procedure, has been approved and published, the PQS Secretariat should begin the process of re-qualifying existing products covered by that documentation package6.

Some products will require immediate re-testing and some will not. The flowchart in Figure 11 summarizes the decision-making process. The questions to ask are as follows:

1. Are there significant technical differences between the new PQS performance specification and the old PIS specification? If there are, re-testing is likely to be required.

2. Are there significant technical differences between the new PQS product verification procedure and the old PIS test procedure? Again, if there are, re-testing is likely to be required.

3. Has the product been tested within the last five years? If it has not then re-testing will generally be justified.

4. If the product has been tested within the last five years, is the current model substantially identical to the model that was tested? Again, if significant changes have been made, re-testing will be justified.

5. Is the product safety-critical? If it has passed through the previous filters safety-critical products (for example vaccine refrigerators) may be re-

6 See SOP No FCH/ IVB/ATT/…/00X: How to evaluate applications for the pre-qualification of PQS products.

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qualified, but this should be subject to re-testing within a reasonable period to be agreed with the manufacturer.

One of three decisions will emerge from the evaluation; to test the product immediately in accordance with the PQS verification procedure; to issue a provisional pre-qualification, subject to re-testing within an appropriate period, or to pre-qualify the product subject to on-going surveillance.

Figure 11 – Decision tree for re-qualifying PIS products under PQS

Start

PQS specsimilar to PIS spec?

PQS verificationprocedure similarto PIS procedure?

yesyes

yes

no

no

Tested withinlast 5 years?

yes

no

Safety-criticalproduct?

yes

no

Pre-qualify productsubject to close

surveillance

Issue provisionalpre-qualification,

subject to re-testing

Substantiallyidentical to

test product?

Test productbefore

pre-qualification

yes

no

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5. Pre-qualifying testing laboratories This section covers some of the issues that will arise when new testing laboratories are newly pre-qualified or existing laboratories are re-accredited during the transition from PIS to PQS.

There are currently eleven testing institutions listed in WHO/EPI/LHIS 97.14 Equipment performance specifications and test procedure: Annex 1 (May 1998 revision). These are as follows:

Americas 1. UNIVALLE, Cali, Columbia Asia and Western Pacific 2. MUERI, Murdoch, Australia 3. China Household Electric Appliances Research, Beijing, P.R. China 4. PSB, Singapore 5. Asian Institute of Technology, Bangkok, Thailand Europe 6. FORCE Institute, Broendby, Denmark 7. GET, Juelich, Germany 8. SEMKO, Kista, Sweden 9. BSI Testing, Hemel Hempstead, UK 10. Consumer’s Research & Testing Centre, Milton Keynes, UK 11. Central Public Health Laboratory, London, UK.

At the time of writing there is no up to date record of the product categories that each of these laboratories is qualified to test. In order to gain pre-qualification status under PQS, existing testing laboratories should be invited to apply for re-qualification in accordance with the procedures described in SOP No FCH/ IVB/ATT/…/00X: How to pre-qualify a PQS testing laboratory. A number of these laboratories have had a continuing association with WHO over many years; it may be possible to shorten the pre-qualification process in some of these instances. However, when doing so, it is essential to review each laboratory’s core competencies against the new PQS criteria, and also to establish clearly which product categories each laboratory is competent to test7.

The goal of the pre-qualification process should be to establish a list of laboratories that can cover the entire range of PQS testing requirements, including type-examination and full quality assurance which did not feature in the PIS system. Ideally the full range of competencies should be available in each of the key regions; this will encourage skills transfer to less developed countries and will reduce the need to ship test samples over long distances. However it is extremely important to ensure that no possibility exists that products that are produced in the country where the tests take place are unreasonably favoured by local testing laboratories.

7 See SOP No FCH/ IVB/ATT/…/00X: How to pre-qualify a PQS testing laboratory. The evaluation checklist in Annex 8 gives the format for recording this information.

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Annex 1 - Existing PIS performance specifications and test procedures General notes: 1) Grey shaded rows indicate items proposed to be omitted from PQS. Related specifications and test procedures are to be withdrawn. PIS Code

Description WHO document ref.

Refs to external

standards

Latest rev.

Test procedure

Refs to external

standards

Latest rev.

Spec used in

PIS 2000

Notes

E1 Cold rooms and freezer rooms E1/CR Cold rooms WHO/V&B/02.33 ISO 9001-

2000. Incoterms 2000

2002 In spec n/a 2002 no 2002 rev. issued after publication of PIS 2000. No specific pre-qualified products in PIS 2000.

E1/FR Freezer rooms WHO/V&B/02.33 ISO 9001-2000. Incoterms 2000

2002 In spec n/a 2002 no 2002 rev. issued after publication of PIS 2000. No specific pre-qualified products in PIS 2000.

E2 Motorcycles

E2/MC.1 Mopeds WHO/EPI/LHIS/97.05

1997 None n/a n/a no Will be replaced with PQS Buyer’s Guide. PIS 2000 refers to IAPSO categories. No mention of E2 specs.

E2/MC.2 Off-road motorcycles

WHO/EPI/LHIS/97.05


E2/MC.3 Medium size off-road motorcycles

WHO/EPI/LHIS/97.05


E3 Refrigerators and freezers E3/RF.1 Refrigerator and

freezer combination, compression

WHO/LHIS/97.06 DIN8985 1998 E3/PROC/3 VDE, BEAB, IEC 3351(1991 & Amendment 1 (1994-11), DIN 8985

1998 yes

E3/RF.2 Large refrigerator and icepack freezer, absorption


1998 yes

Code Description WHO

document ref. Refs to external

standards

Latest rev.

Test procedure

Refs to external

standards

Latest rev.

Spec used in

PIS 2000

Notes

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E3/RF.3 Ice-lined refrigerator and/or freezer, compression


1998 yes

E3/RF.4 Photovoltaic solar refrigerator and/or icepack freezer, compression DC

WHO/LHIS/97.06 DIN8985,Jet Propulsion Lab, JRC-Ispra

1998 E3/PROC/7 VDE, BEAB, DIN 8985

1998 yes

E3/RF.5 Refrigerator and icepack freezer, thermal solar

WHO/LHIS/97.06 DIN8985 1998 None n/a 1998 yes Only one example in PIS 2000.

E3/RF.6 Small refrigerator and freezer combination, absorption


1998 yes

E3/FR.1 Vaccine/icepack chest freezer, compression


1998 yes

E3/FR.2 Icepack freezer, compression


1998 yes If there is a policy change to chilled water packs for all but OPV, it may no longer be necessary is to retain this specification. In PIS 2000 it only applies to E3/80-M.

E3/FR.3 Icepack freezer, thermal solar

WHO/LHIS/97.06 DIN8985 1998 None n/a n/a ? Only ref. in PIS 2000 to E3/FR.3 is to item E3/73M which is NOT a thermal solar unit, so must be an error.

E3/FR.4 Icepack freezer, absorption


1998 yes



standards

Latest rev.

Test procedure

Refs to external

standards

Latest rev.

Spec used in

PIS 2000

Notes

E4 Insulated containers (vaccines)

E4/VC.0 Small vaccine carrier, short range

WHO/LHIS/97.07 1998 E4/PROC/1 1998 yes

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E4/VC.1 Small vaccine carrier


E4/VC.2 Large vaccine carrier


E4/CB.1 Small cold box, long range


E4/CB.2 Large cold box, long range


E4/CB.3 Small cold box, short range




E5 Icepacks

E5/IP.1 Icepack, 0.6 litre WHO/LHIS/97.08 1998 E5/PROC/1 1998 yes

E5/IP.2 Icepack, 0.4 litre WHO/LHIS/97.08 1998 E5/PROC/1 1998 yes See note above

E6 Temperature monitoring devices E6/TR.1 7 day

temperature recorder, fixed

WHO/EPI/LHIS/97.09 Rev.1

1998 E6/PROC/1 1998 yes Omit because this is old technology. Sensitivity only ± 1° C. ± 0.5° C now required.

E6/TR.2 7 day temperature recorder, portable


1998 E6/PROC/2 1998 yes Omit because this is old technology. Sensitivity only ± 1° C. ± 0.5° C now required.

E6/TH.1 Electronic thermometer, portable


1998 E6/PROC/1 1998 no



standards

Latest rev.

Test procedure

Refs to external

standards

Latest rev.

Spec used in

PIS 2000

Notes

E6/TH.2 Gas or vapour pressure dial thermometer, fixed


1998 E6/PROC/1 1998 yes

E6/TH.3 Alcohol or bi-metal thermometer, portable


1998 E6/PROC/2 1998 yes

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E6/TH.4 Bi-metal stem thermometer, fixed


1998 E6/PROC/1 1998 yes

E6/TH.5 Liquid crystal thermometer, portable


1998 E6/PROC/2 1998 yes

E6/IN.1 Temperature threshold indicator


1998 E6/PROC/3 1998 yes

E6/IN.2 Cold chain monitor


1998 E6/PROC/4 1998 yes



1998 E6/PROC/3 1998 yes StopWatch indicator to be omitted

E6/IN.4 Freezewatch indicator, reversible


1998 E6/PROC/3 1998 no

E6/IN.5 Vaccine vial monitors


2002 E6/PROC/5 2002 no VVMs are not purchased separately from vaccines and are not currently included in the PIS.

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standards

Latest rev.

Test procedure

Refs to external

standards

Latest rev.

Spec used in

PIS 2000

Notes

E7 Cold chain accessories E7/VR.1 Voltage

regulator, for compression refrigerators and freezers

WHO/EPI/LHIS/97.10

IEC 335-1 (1991) & Amendment 1 (1994-11) IEC 68-2-6 Part FC

1998 E7/PROC/1 IEC 335-1 (1991) & Amendment 1 (1994-11) IEC 68-2-6 Part FC

1998 yes

E7/VR.2 Voltage regulator, for absorption refrigerators and freezers

WHO/EPI/LHIS/97.10



1998 yes

E8 Equipment for administration of vaccine and micronutrients

E8/SS.1 0.5ml sterilizable plastic syringe

WHO/EPI/LHIS/97.11

ISO 594-1:1986 & 594-2: 1991

1998 E8/PROC/1 ISO 594-1:1986 & 594-2: 1991

1998 yes Omit in line with WHO policy on reusable syringes

E8/SS.2 0.05 sterilizable plastic syringe

WHO/EPI/LHIS/97.11

ISO 594-1:1986 & 594-2: 1991

1998 E8/PROC/1 ISO 594-1:1986 & 594-2: 1991


E8/SS.3 5ml sterilizable plastic syringe

WHO/EPI/LHIS/97.11

ISO 594-1:1986 & 594-2: 1991

1998 E8/PROC/1 ISO 594-1:1986 & 594-2: 1991


E8/DS.1 0.5ml auto-disable syringe

WHO/EPI/LHIS/97.11

1999 E8/PROC/2 ISO 7864:1993, ISO 9628:1991

1998 yes


WHO/EPI/LHIS/97.11

1998 E8/PROC/2 ISO 7864:1993, ISO 9628:1991

1998 yes

E8/NH.1 Universal sterilizable syringe hub

WHO/EPI/LHIS/97.11

1998 None 1998 no Omit to comply with WHO policy to phase out sterilizables. Sterilizable needles are not listed in PIS 2000.

E8/HN.1 Hypodermic needles for single use

WHO/EPI/LHIS/97.11

ISO 7864 1993(E) ISO 594-1 1986(E) ISO 6009 1992(E) ISO9626 1991(E)

1998 E8/PROC/3 ISO 7864 1993(E) ISO 594-1 1986(E) ISO 6009 1992(E) ISO9626 1991(E)

1998 no Single use needles are not listed in PIS 2000

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Code Description WHO document ref.

Refs to external

standards

Latest rev.

Test procedure

Refs to external

standards

Latest rev.

Spec used in

PIS 2000

Notes

E8/SN.1 Sterilizable needles

WHO/EPI/LHIS/97.11

1998 None 1998 no Omit to comply with WHO policy to phase out sterilizables. Sterilizable needles are not listed in PIS 2000.


WHO/BCT/02.12 ISO 7886-1 2002 None 2002 no Developed by EHT specifically for China

E8/XX 0.1ml auto-disable syringe

WHO/BCT/03.07 ISO 7886-1 2003 None 2003 no Developed by EHT specifically for China


WHO/BCT03.08 ISO 7886-1 2003 None 2003 no Developed by EHT specifically for China

E9 Steam sterilizers (Omit entire category to comply with WHO policy to phase out sterilizable syringes) E9/PS.1 Single rack

portable sterilizer WHO/EPI/LHIS/91.2

BS1746:1987 BS6743:1987

1997 E9/PROC/1 BS1746:1987, J. of Clinical Pathology, 1961,14,313.

1997 yes

E9/PS.2 Double rack portable sterilizer

WHO/EPI/LHIS/91.2

BS1746:1987 BS6743:1987


1997 yes

E9/PS.3 Double rack electric sterilizer

WHO/EPI/LHIS/91.2

BS1746:1987 BS6743:1987 IEC335-1 1991 & Amendment 1 (1994-11) IEC68-2-6 Part FC

1997 E9/PROC/2 BS1746:1987 BS6743:1987 IEC335-1 1991 & Amendment 1 (1994-11) IEC68-2-6 Part FC, J. of Clinical Pathology, 1961,14,313.

1997 yes E9/07 is an electric sterilizer listed as meeting E9/PS.2 in PIS 2000. This must be an error.

E9/PS.4 Triple rack sterilizer

WHO/EPI/LHIS/91.2

BS1746:1987 BS6743:1987


1997 ? E9/04 is triple rack sterilizer listed as meeting E9/PS.2 in PIS 2000. This must be an error.

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Code Description WHO document ref.

Refs to external

standards

Latest rev.

Test procedure

Refs to external

standards

Latest rev.

Spec used in

PIS 2000

Notes

E9/SR.1 Syringe and needle rack

WHO/EPI/LHIS/91.2

1997 E9/PROC/3 1997 no Racks are included with sterilizers.

E9/SD.1 Removable sterilizer drum

WHO/EPI/LHIS/91.2

1997 E9/PROC/4 1997 no

E10 Injection accessories E10/IC.1 Safety box and

incinerator container

WHO/EPI/LHIS/97.13

BS7320:1990 IATA approved ignition

1998 E10/PROC/1

BS7320:1990 1998 yes

E10/IC.2 Safety box for used syringes and needles

WHO/EPI/LHIS/97.13

BS7320:1990 1998 E10/PROC/2

BS7320:1990 1998 yes

E10/TS.1 Time, steam and temperature indicator

WHO/EPI/LHIS/97.13

1998 E10/PROC/3

1998 ? Omit to comply with WHO policy to phase out sterilizables. E10/06 & E10/07 make no reference to E10/TS.1 in PIS 2000

E11 Specimen collection equipment E11.VC2 Specimen carrier WHO/LHIS/97.07 1998 E4/PROC/2 1998 yes

None Polio specimen collection kit

None None

E12 Waste management (see Annex 2 – E10 to be re-titled ‘Waste management’) E12/XX Needle/syringe

destroyers None None Use of these devices is contrary to current WHO

policy. No WHO performance specification exists. EC Equipment for emergency campaigns (Omit entire category)

None Not thought to be necessary for PQS. Only one item in PIS 2000, based on MSF emergency kit.

GEN Equipment performance & test procedure: Annexes WHO/EPI/L

HIS/97.14 IEC335-1 1991 & Amendment 1 (1994-11) IEC68-2-6 Part FC,

1998 Likely to be omitted under PQS. Although the content of the annexes will in many cases still be valid, they should really be incorporated into the individual specifications and verification procedures.

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Annex 2 – Proposed alterations to specifications and test procedures General notes: 1) All specifications and verification procedures should be updated in a phased programme in order to meet PQS standards as set out in PQS Standard Operating Procedures. The notes below relate to specific shortcomings that have been identified in the existing documents. 2) Proposed new guidelines, specifications and test procedures are highlighted in yellow.

PQS code

Description Current WHO document ref.

Refs to external

standards

Latest rev.

Current verification procedure

Refs to external

standards

Latest rev.

Notes

E01 Cold rooms and freezer rooms E01/CR Cold rooms WHO/V&B/02.33 ISO 9001-

2000. Incoterms 2000

2002 In spec n/a 2002 Correct printing errors and omissions. Add cross references to E6 & to new voltage regulation/standby generator specifications. Develop a Full QA verification procedure to replace the existing guidance notes on this topic.

E01/FR Freezer rooms WHO/V&B/02.33 ISO 9001-2000. Incoterms 2000

2002 In spec n/a 2002 Correct printing errors and omissions. Add cross references to E6 & to new voltage regulation/standby generator. Develop a Full QA verification procedure to replace the existing guidance notes on this topic.

E01/XX Cool rooms New specification?

New Full QA procedure?

If WHO endorses the 'flexible cold chain' approach then there may be a need for specifications and/or guidelines for preparing, commissioning and maintaining air-conditioned cool stores.

E01/XX Heavy duty standby generators

New specification

New Full QA procedure

For large vaccine stores with cold room(s) and freezer room(s) and/or multiple refrigerators and freezers. This would replace the outline specification in PIS 2000. Thorough testing and commissioning of this equipment is essential and a QA procedure is required to ensure that this is done properly.

E01/XX Heavy duty voltage regulators

New specification

New Full QA procedure

For large vaccine stores with cold room(s) and freezer room(s) and/or multiple refrigerators and freezers. There are guidance notes in PIS 2000, but no specification. Thorough testing and commissioning of this equipment is essential and a QA procedure is required to ensure that this is done properly.

E02 Transport (category re-named)

E02/XX Motorcycles Provide a Buyer’s Guide to motorcycles on the PQS website with links to the UNICEF and IAPSO catalogues.

E02/XX Cars and FWD Provide a Buyer’s Guide to cars and FWDs on the PQS website with links to the UNICEF and IAPSO catalogues.

E02/XX Refrigerated vehicles

Provide a Buyer’s Guide to refrigerated vehicles and FWDs on the PQS website with links to the UNICEF and IAPSO catalogues.

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PQS code


Refs to external

standards

Latest rev.


Refs to external

standards

Latest rev.

Notes

E03 Refrigerators and freezers E03/RF.1 Refrigerator and

freezer combination, compression


1998 Revise specification and verification procedure in light of recurrent vaccine freezing problems.

E03/RF.2 Large refrigerator and icepack freezer, absorption


1998 As note above.

E03/RF.3 Ice-lined refrigerator and/or freezer, compression


1998 As note above.

E03/RF.4 Photovoltaic solar refrigerator and/or icepack freezer, compression DC

WHO/LHIS/97.06 DIN8985,Jet Propulsion Lab, JRC-Ispra

1998 E3/PROC/7 VDE, BEAB, DIN 8985

1998 As note above.

E03/RF.5 Refrigerator and icepack freezer, thermal solar

WHO/LHIS/97.06 DIN8985 1998 None n/a 1998 As note above.

E03/RF.6 Small refrigerator and freezer combination, absorption


1998 As note above.

E03/RF.X Icepack cooler, compression

New specification

New type-testing procedure

If WHO endorses the use of chilled water packs for passive cooling then there will be a need for refrigerators suitable for cooling icepacks in bulk. There will be need for a guideline to ensure that chilled water packs are at the correct temperature when placed in cool boxes.

E03/RF.X Icepack cooler, absorption

New specification


If WHO endorses the use of chilled water packs for passive cooling then there will be a need for refrigerators suitable for cooling icepacks in bulk. There will be need for a guideline to ensure that chilled water packs are at the correct temperature when placed in cool boxes.

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E03/RF.X Freeze-proof refrigerators

New specification


There is an urgent need for new technological solutions to overcome the vaccine freezing problem. PATH in particular is strongly promoting the effort to solve this problem.

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PQS code


Refs to external

standards

Latest rev.


Refs to external

standards

Latest rev.

Notes

E03/FR.1 Vaccine/icepack chest freezer, compression


1998

E03/FR.2 Icepack freezer, compression


1998

E03/FR.3 Icepack freezer, thermal solar

WHO/LHIS/97.06 DIN8985 1998 None n/a n/a

E03/FR.4 Icepack freezer, absorption


1998

E04 Insulated containers (vaccines)

E04/VC.0 Small vaccine carrier, short range

WHO/LHIS/97.07 1998 E4/PROC/1 1998 Specification and verification procedure should be revisited in light of problems with vaccine freezing and forthcoming wider use of chilled water packs. Note also that warm life data are not included in PIS 2000 contrary to statement in test procedures. This omission should be corrected.

E04/VC.1 Small vaccine carrier

WHO/LHIS/97.07 1998 E4/PROC/1 1998 As note above

E04/VC.2 Large vaccine carrier

WHO/LHIS/97.07 1998 E4/PROC/1 1998 As note above E04/CB.1 Small cold box,

long range WHO/LHIS/97.07 1998 E4/PROC/1 1998 As note above

E04/CB.2 Large cold box, long range

WHO/LHIS/97.07 1998 E4/PROC/1 1998 As note above E04/CB.3 Small cold box,

short range WHO/LHIS/97.07 1998 E4/PROC/1 1998 As note above


WHO/LHIS/97.07 1998 E4/PROC/1 1998 As note above

PQS code


Refs to external

Latest rev.

Current verification

Refs to external

Latest rev.

Notes

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standards procedure standards E05 Icepacks E05/IP.1 Icepack, 0.6 litre WHO/LHIS/97.08 1998 E5/PROC/1 1998 Robustness testing in E5/PROC/1 is carried out with fully frozen

icepacks. Chilled water packs will only contain liquid water and the test procedure should be changed to reflect this.

E05/IP.2 Icepack, 0.4 litre WHO/LHIS/97.08 1998 E5/PROC/1 1998 As note above

E05/IP.X Icepack, 0.3 litre New specification

New verification procedure

Several 0.3 litre icepacks are in PIS 2000, but there is no specification to cover this size.

E06 Temperature monitoring devices E06/XX PC-based

temperature and event logger

New specification


Preferred option specified in E1/CR and E1/FR.

E06/XX Digital recording thermometer with print-out facility

New specification



E06/XX 7-day wall-mounted pen recording thermometer

New specification



E06/XX Temperature alarm system

New specification


E7/AS.1 is referred to in the Equipment descriptions of the E7 document, but there is currently no performance specification or test procedure for alarm systems.

E06/XX Temperature data logger

New specification


Several temperature data loggers are in PIS 2000, but no WHO/UNICEF standard currently exists. These items are now assuming greater importance.

E06/TH.1 Electronic thermometer, portable


1998 E6/PROC/1 1998

E06/TH.2 Gas or vapour pressure dial thermometer, fixed


1998 E6/PROC/1 1998

E06/TH.3 Alcohol or bi-metal thermometer, portable


1998 E6/PROC/2 1998

PQS code


Refs to external

standards

Latest rev.


Refs to external

standards

Latest rev.

Notes

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E06/TH.4 Bi-metal stem thermometer, fixed


1998 E6/PROC/1 1998

E06/TH.5 Liquid crystal thermometer, portable


1998 E6/PROC/2 1998

E06/IN.1 Temperature threshold indicator


1998 E6/PROC/3 1998

E06/IN.2 Cold chain monitor


1998 E6/PROC/4 1998



1998 E6/PROC/3 1998

E06/IN.4 Freezewatch indicator, reversible


1998 E6/PROC/3 1998

E06/IN.5 Vaccine vial monitors


2002 E6/PROC/5 2002 This specification is already very comprehensive and probably only needs to be reissued in PQS format.

E07 Cold chain accessories E07/XX Light duty

standby generators

New specification

E7/PROC/4 currently exists

For small vaccine stores with a few refrigerators and/or freezers. Product verification could be on a type-examination or type-testing basis as these are likely to be ‘off the shelf’ items.

E07/XX Refrigerator tool kits

New specification


There are a number of tool kits in E7. There needs to be some means to assess these formally.

E07/XX Refrigerator spare parts kits

New specification


There are a number of spare parts kits in E7. There needs to be some means to assess these formally.

E07/VR.1 Voltage regulator, for compression refrigerators and freezers

WHO/EPI/LHIS/97.10



1998

E07/VR.2 Voltage regulator, for absorption refrigerators and freezers

WHO/EPI/LHIS/97.10

IEC 335-1 (1991) & Amendment 1 (1994-11) IEC 68-2-6 Pt FC

1998 E7/PROC/2 IEC 335-1 (1991) & Amendment 1 (1994-11) IEC 68-2-6 Pt FC

1998

PQS code


Refs to external

Latest rev.

Current verification

Refs to external

Latest rev.

Notes

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standards procedure standards E08 Equipment for administration of vaccine and micronutrients. E08/DS.1 0.5ml auto-

disable syringe WHO/EPI/LHIS/97.11

1999 E8/PROC/2 ISO 7864:1993, ISO 9628:1991

1998 The introduction of ISO/DIS 7886-3 and WHO/BCT/03.09: Procedure for assessing the acceptability, in principle, of single-use injection devices for procurement by United Nations agencies should lead to a general revision of this specification and verification procedure.


WHO/EPI/LHIS/97.11

1998 E8/PROC/2 ISO 7864:1993, ISO 9628:1991

1998 As previous item.

E08/HN.1 Hypodermic needles for single use

WHO/EPI/LHIS/97.11

ISO 7864 1993(E) ISO 594-1 1986(E) ISO 6009 1992(E) ISO9626 1991(E)

1998 E8/PROC/3 ISO 7864 1993(E) ISO 594-1 1986(E) ISO 6009 1992(E) ISO9626 1991(E)

1998 As previous item.


WHO/BCT/02.12 ISO 7886-1 2002 None 2002 As previous item. At present this is a country-specific specification (China).


WHO/BCT/03.07 ISO 7886-1 2003 None 2003 As previous item. At present this is a country-specific specification (China)


WHO/BCT03.08 ISO 7886-1 2003 None 2003 As previous item. At present this is a country-specific specification (China)

E08/XX Auto-disable mixing syringe

New specification(s)

New verification procedure(s)

E08/XX Jet injectors New specification(s)


E09 Steam sterilizers (Entire category omitted to comply with WHO policy to phase out sterilizable syringes)

PQS code


Refs to external

standards

Latest rev.


Refs to external

standards

Latest rev.

Notes

E10 Waste management (Note new category title. All retained items under this heading relate to waste management)

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E10/IC.1 Safety box and incinerator container

WHO/EPI/LHIS/97.13

BS7320:1990 IATA approved ignition

1998 E10/PROC/1 BS7320:1990 1998

E10/IC.2 Safety box for used syringes and needles

WHO/EPI/LHIS/97.13

BS7320:1990 1998 E10/PROC/2 BS7320:1990 1998

E10/XX Incinerators New specification(s)


Requires further discussion.

E10/XX Syringe melters and other devices

New specification(s)


Requires further discussion.

E11 Specimen collection equipment E11.VC2 Specimen carrier WHO/LHIS/97.07 1998 E4/PROC/2 1998

E11.XX Polio specimen collection kit

None None Is a specification/verification procedure required?

GEN Equipment performance & test procedure: Annexes WHO/EPI/LHI

S/97.14 IEC335-1 1991 & Amendment 1 (1994-11) IEC68-2-6 Part FC,

1998 Likely to be omitted under PQS. Although the content of the annexes will in many cases still be valid, they should really be incorporated into the individual specifications and verification procedures.

C E A N Q F O R M UALIT PQS project E R Y P SAFETY · EHT Essential Health Technologies ... 5 and 7...

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