WHO publishes Qualification Guideline for Comment

The WHO is currently revising its validation guidelines and has recently published a superordinate umbrella guideline. Now, an independent chapter on qualification has been published for comment. So far, the topic "qualification" has only been present as Appendix 6 of the umbrella guideline from 2006 (WHO Technical Report Series, No. 937, 2006, Annex 4). In future, qualification will be dealt with in an independent document. Independent documents have also been announced for the appendices on analytical method validation, validation of water systems, validation of HVAC systems and validation of computerized systems. Up to now, they have been part of the umbrella guideline. Appendix 7 on the validation of non-sterile processes already exists as a new guideline.

The title of the new guideline draft "VALIDATION ON QUALIFICATION OF SYSTEMS, UTILITIES AND EQUIPMENT" is quite confusing - especially the 'Validation on' wording.

The draft includes the following chapters:

• Principle
• Scope
• Glossary (new)
• General
• User Requirement specifications (new)
• Factory acceptance and site acceptance test (new)
• Design Qualification
• Installation Qualification
• Operational Qualification
• Performance Qualification
• Requalification
• Qualification of "in-use" systems and equipment

The Chapters "Glossary", "URS" and "FAT & SAT" are new. Here, one can notice the influence of the new EU GMP Annex 15 which - in its new version - deals more intensively with the topics URS, FAT & SAT.

In the Chapter "General", the V-Model is introduced. This is not surprising as the V-Model has already been playing a major role in the new version of the superordinate validation guideline. What's new here is the risk-based approach: indeed, the extent of qualification or requalification has to be determined on a risk assessment. The qualification of premises and utilities is also new. Yet, the requirement according to which systems i.e. utilities have to be qualified before the equipment had already been contained in the previous version.

The new Chapter "User Requirement Specification" is very short and made up of only two items. Firstly, - where appropriate - URS should be created for systems, utilities and equipment. Secondly, URS should be used to check at a later time whether the systems/ equipment correspond to the (pharmaceutical) manufacturer's requirements.

According to the new Chapter "Factory and Site Acceptance Test", FAT and SAT are basically required. The tests performed should be recorded in writing; there should be a FAT report prior to any shipment. Nothing is mentioned about the use of FAT or SAT results in further qualification stages.

A requirement has been added to the Chapter DQ: supplier qualification should be done prior to any purchase. It is also explicitly pointed out that IQ may start first when DQ is completed. In many parts of the superordinate umbrella guideline, it is expressly highlighted that a qualification phase must be completed before the next one can start.

A few new items can also be found in the Chapter "Installation Qualification". Here, it is worth mentioning that all deviations from URS, DQ and installation should be noted and investigated. As in the previous version, the document contains the example of an IQ protocol. A new point has been added to the Chapter "Operational Qualification":  during this phase of qualification SOPs should be finalized and approved. Here again, you can find the explicit requirement for a sequential procedure: qualification can continue only after completion of the previous stage. Exemplary documents of OP are provided over 10 pages.

The new Chapter "Performance Qualification" is as short as the former one. What's new is the note that the simultaneous performance of OQ and PQ or PQ and process validation requires a written justification. This note is quite confusing as the paragraph just above refers to the requirement for a sequential procedure: PQ can only start after the successful completion of OQ. Here again, you can find examples of a PQ protocol.

The following Chapters "Requalification" and "Qualification on ‚in-use' equipment'" have only been slightly changed. There is now a new requirement for a document containing both the facility's qualification status and the requalification dates. The last point is remarkable: it describes the handling of not-qualified equipment which have been in use for a long time (unlike EU GMP Annex 15 which doesn't contain such a procedure any longer). Even if the term "retrospective qualification" is not used here, that's exactly the description for such a procedure.
The deadline for comments on the new guideline ends on 15th August.

Delegates and former delegates of ECA events as well as ECA members have access to the Members Area where the WHO Guideline VALIDATION ON QUALIFICATION OF SYSTEMS, UTILITIES AND EQUIPMENT can be downloaded.