New Publication - ECA's Good Practice Guideline Integrated Qualification and Validation

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After two draft documents and version 1.0, the ECA Good Practice Guide "Qualification and Validation - A guide to effective qualification based on Customer - Supplier Partnership" was published as version 2.0 at the ECA Launch Conference in November 2021.

Authors and users of the Guide explained its content and possibilities of application to the more than 40 participants from 13 different countries at the conference. At the beginning of the event, the still acting Chairman of the Validation Group, Gert Moelgaard, gave an overview of the Guide and outlined the changes from version 1.0:

  • New chapter on Contracts as Part of Qualification Services
  • New chapter on (Remote) FAT/SAT
  • Revision of the chapter on Electronic Documentation
  • Revision of the chapter on Manufacturing Systems Categorisation
  • New Appendix Remote FAT/SAT
  • New Appendix Contracts
  • Revision Appendix "Integrated Qualification Core Concept"
  • Revision Annex Categorisation

Gert Moelgaard identified the following as the core topics of the guide:

  • How to use documents developed by equipment suppliers?
  • How to integrate qualification activities into validation activities?
  • How to perform a risk-based qualification starting with user requirements up to PQ?

He further emphasized the compatibility of the ECA Good Practice Guide with the ISPE Guides "Commissioning and Qualification" 2nd edition (2019) and "Good Engineering Practice" (2021).

Following, Dr Rainer Gnibl, a European GMP Inspector, and Grace McNally, a former FDA Inspector and Group Leader in the revision of the US Process Validation Guide from 1993, lectured. Dr Gnibl specifically noted the flexibility that Annex 15 allows. Especially in the context of FAT tests, many of these tests can be included in the qualification without having to be explicitly repeated again - if the framework conditions are right (appropriate documentation and a science-based approach as rationale), see Fig.1.

Fig. 1: Singe performance of tests, checks, reviews...

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Rainer Gnibl is also positive about categorizing equipment to facilitate qualification activities. Citing the preamble of 21 Code of Federal Regulation 210/211 (the U.S. GMP rules for pharmaceuticals), Grace McNally also pointed out in her presentation that tests that have already been performed by an engineering department do not have to be repeated again by a "Quality Control Unit". However, the Quality Control Unit must ensure that the tests were performed by appropriate persons.

Grace McNally also gave an overview of the draft ICH Guideline 13 on continuous manufacturing, including qualification/validation issues, and an outlook on where the draft might be heading.

Referring to Gert Moelgaard's statement about the compatibility of the two ISPE Guides mentioned above with the ECA Guide, Taha Jalal from Antaes Consulting spoke about version two of the ISPE "Commissioning and Qualification" Guide. He pointed out what drove the revision and what benefits are now included in version 2. Very practical and with examples, he then talked about "Do's and Don'ts" regarding user requirements, system classifications, risk analysis, DQ and the planning and execution of commissioning and qualification activities.

Ralf Gengenbach from gempex, at this point still the designated successor to Gert Moelgaard, then took up the topic of Good Engineering Practice (GEP) again and went into detail. He sees the great advantages of GEP in the clearly determined "milestones" and the clearly defined workflow. Both lead to explicit project plans. Using practical examples, he then showed possible implementations of the most important GEP documents:

  • Process Documents
  • Engineering Documents
  • Management Specifications
  • Commissioning Documents

At the end of the first day, the previous leader of the ECA Validation Group, Gert Moelgaard, handed over the group leadership to Ralf Gengenbach, CEO of gempex. Ralf Gengenbach gave an adhoc statement about his thoughts on the further development of the guide itself and the group. To watch a short video on the handover from Gert Moelgaard to Ralf Gengenbach as new chair and his thoughts about the further development of the Guide and the Group, please scan the QR Code.

Day two started with two presentations by Rafael Leandro de Souza from Pharmaplan. He covered the topics of how to perform a risk-based qualification starting with user requirements up to PQ and "Remote FAT/SAT". Using fixed forms as an example, Rafael de Souza explained how qualification activities - really limited to the bare essentials - can be carried out via various risk analyses (see Fig. 2).

Fig. 2: CARA and the read thread

Especially the topic "Remote FAT/SAT" was discussed intensively. Mr de Souza gave a comprehensive overview of this topic regarding preparations, the tests themselves up to the end of a remote test and of course tips and tricks. He also mentioned advantages and disadvantages of remote testing, among others based on an ECA survey on this topic. Two case studies rounded off the topic.

Following, the new Chairman of the ECA Validation Group, Ralf Gengenbach, presented the new Chapter and Annex on Contracts in the context of qualification services. He particularly emphasized the practical parts on this topic (see Figure 3)

Fig. 3: Content of Contracts

Independently of the ECA Good Practice Guide, Dr Michael Jahnke from Octapharma explained his approach regarding "lean qualification". His presentation showed parallels to the ECA Guide, e.g. with regard to manufacturing systems categorisation, but also differences, e.g. with regard to the integration of QA in the context of FAT tests.

Igor Krasula from Valicare presented the revised chapter on electronic documentation. This topic also met with great interest. Regardless of whether a commercially available soft ware tool or a self-developed system is used, three basic conditions apply:

  • A description of the system
  • Descriptions of the operation and the training of personnel
  • The validation of the system

In four practical examples he presented electronic systems of varying complexity and functionality. He explicitly emphasized the advantages the electronic documentation has for a review (see Fig. 4)

Fig. 4: Electronic Documentation – Practical Review

Maik Guttzeit from Bayer presented the revised Chapter and Appendix on Manufacturing Systems Categorisation. Divided into the three categories

  • Standard Equipment (Commercialof- the shelf systems, COTS)
  • Configured Equipment
  • Individually manufactured Equipment

He demonstrated possible qualification simplifications (see Fig. 5)

Fig. 5: Typical Project Quality Aspects for the three main categories

Maik Guttzeit ended his presentation with the statement: Categorization could reduce the eff ort, but should never compromise the quality.

Finally, Lene Bjerregaard and Lars Hovmand-Lister from Novo- Nordisk jointly presented how to work with suppliers to allow that their documentation can be included in the qualification. Novo Nordisk has a stand-alone validation model (see Fig. 6) in which suppliers are involved.

Fig. 6: Novo Nordisk's "Donut" Validtion Model

At Novo, qualification is also based on a risk analysis starting from a device categorization, comparable to the categorization in the ECA Guide. The focus is on determining supplier capability according to a defined procedure (see Fig. 7).

Fig. 7: How to assess supplier capability

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A special feature at Novo Nordisk is the further development of suppliers when gaps become apparent. Starting with the design phase through to commissioning and qualification, all qualification activities are carried out jointly between suppliers and Novo - but with permanent risk-based monitoring of the supplier. The involvement of quality assurance is interesting. The quality assurance department approves the user requirements, the design qualification, the performance verification - and then the respective device is qualified (see Fig. 8).

Fig. 8: Validation Overview

The Good Practice Guide "Integrated Qualification and Validation - A guide to effective qualification based on Customer-Supplier Partnership" is available as Version 2.0 free of charge for members of the ECA Validation Interest Group at www.validationgroup.org. If you are not a member yet, please use the membership application form on the website.

 

About the Author
Sven Pommeranz
... is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy in the area validation.

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