Considerations on the new edition of the ISPE guideline on C.&Q.

With this article we want to give a non-exhaustive view e very personal on the minimum needs related to the execution of Commissioning and Qualification activities in accordance with the provisions of the new one (2019) “ISPE Guideline on C&Q ”and what the impacts may be for what the team will be of C&Q.

This article sit will therefore consist of three parts, an introduction to the guideline concepts, one that evaluates the impacts on the group of C&Q and a third at the end to evaluate how all the actors involved in a project can be directed to use the possibilities of the new guideline.

In short, the ISPE guideline for C&Q confirms the possibility of using the results of the FAT and SAT activities (of suppliers) and those relating to Commissioning (field team of C&Q) for qualification activities, in a very simplified way the good concept of leveraging.

The guideline defines a number of key elements to be able to do C's work&Q. The following points are therefore requested and mandated:

compliance with good documentation practices (GDP), not new concept, but fundamental, based on compliance with ALCOA attributes (Attributable, Readable, Contemporary, Original and Accurate or as per the original English language "Attributable", “Legible”, Contemporaneous”, “Original” e “Accurate”);

“engineering quality process” the integration of the quality system that respects GMP criteria, in the activities of C&Q,(chapter 11 of the guideline and ICH Q10). The quality department is fundamental in this role.

ability of suppliers to perform and record their activities in compliance with GMP regulatory constraints applying the methods of the integrated approach C&Q correctly. The identification of a suitable supplier is therefore very critical (the chapter 10 of the guideline);

exchange management. Fundamental activity in any C project&Q that, for better or for worse, are inevitable and that in the phase of C&Q di are sometimes necessary to configure systems in accordance with functional specifications. For the stage of C&Q the guideline suggests a system called “ECM, engineering change management ”more streamlined and suitable to intervene quickly, but complete with all the necessary assessments for change management;

use of the traceability matrix in order to test and verify all the points defined in the URS and during the identification of CAs and CDEs.

The interesting aspect of this new guideline, from my point of view, it is the transfer of the attention and documentary responsibility of the qualification phase to the commissioning phase proper.

The new ISPE guideline reiterates the need to have a group of C&Q composed of technicians who include both plants and systems (typical of Commissioning) both needs, allow me the trivial simplification, bureaucratic and formal (typical of the Qualification).

Starting from this consideration, I believe that the old single actors who are members of the group of C&Q will have to:

  • Commissioning team: be increasingly open and available to qualification and documentary needs, at the same time increasing the regulatory knowledge related to the systems that will be put into operation.
  • Providers: improve and push towards a service more suited to the requests for integrated methods, perhaps using specialized services companies for this purpose;
  • Qualification Team, always the glue between technicians and their technicalities and quality understood in the figure of QA, he will have to interact in projects not as a guest, but as a constant and collaborative entity right from the "Basic Engineering" phases.

All of this is possible?

If we ask individual actors (Commissioning and Qualification) the answer is certainly positive, for better or for worse, it is a question of professional growth and of having a greater specific weight on projects.

If we ask the suppliers, for them it means being able to develop an additional market branch, for which, if interested in the pharma business, in one way or another they will be (and some already are) willing to integrate and respond to customer requests.

But let's ask the various Project Managers and Sponsors who manage the budget of a project. Seeing initial costs increase, combined with the need to contain and reduce costs, could break the concept of activities as described by the new ISPE guideline, this is regardless of the fact that overall costs may ultimately be lower.

Therefore, it is essential to sensitize the project management (and therefore not only group C&Q) to this new guideline making him increasingly aware of the needs and possibilities that this guideline requires and offers.

They will then guide the other actors in the projects, perhaps not directly involved in the activities of C&Q. We will have so:

  • the engineering teams aware of the presence and needs of C.&Q, thus being able to better understand and manage the information they will receive;
  • i team di constructon sensitized and attentive to the details necessary to save time in subsequent activities,
  • quality control oriented to managing documentation appropriately.

All of this will eventually make the "Cost" of C&Q amortized and therefore manageable.

My experience leads me to say that the projects where the group of C&Q was an integral part of the project from the initial engineering stages and during construction activities were the projects with the least impact on schedule and costs.

In summary and closing I believe that the new ISPE guideline on C&Q is an excellent tool for improvement in the pharmaceutical field.

It allows a vision and an approach to the world of projects such as to impact all the actors involved (not only C&Q), without distinction of position and role, and at the same time the possibility of raising awareness of a discipline seen as marginal by non-experts.

The road is long, but ideas, at least on paper, they are clear and allow for a starting point for the future.

Savino Carlone
C&Q Manager & Technical Director
Engineering Projects Consulting srl.
www.epcmilano.com