New EU Requirements in the Validation Process in the Form of a Revision of Section 1 of the EC GMP Guidelines?

In our GMP News from 13 January 2010, we informed about the draft of a planned revision of Section 1 of the EC GMP Guidelines. The aim of the revision is to be integrated into the contents of ICH Q 10.

Surprising, however, are the hints in the draft which concern the subject of process validation. Relatively early in the draft, in chapter 1.1, the establishment and retention of a "state of control" is demanded as a part of the quality management system. This also requires an effective "monitoring and control" system to "process performance", whereby the process suitability and process ability be continuously ensured. Quality risk management is recommended as a helpful tool for this. Within the scope of a continual improvement of processes, process improvements and the reduction of variability should become possible, here again with the aid of quality risk management.

With regard to the requirements concerning "Product Quality Review" (PQR), "process of performance" is also monitored.

The "process performance, product quality monitoring and review systems" should

  • be risk-based in order to set up a suitable controlling strategy
  • have "tools" for measuring and analysing the parameters and attributes of the controlling strategy. In brackets are examples of the names of data management systems and statistical tools
  • enable meaningful parameters and attributes from the controlling strategy which verify the continuous manufacturing within the "state of control"
  • identify sources of variability which influence "process performance" and product quality, in order to reduce this.
  • integrate internal and external feedback relating to the product quality, (recalls, divergences, audits...)
  • contribute to the increase of process understanding and information about Design Space (if available), as well as enabling innovative process validation attempts

In addition to the above, section 1.13 in the Product Quality Review (PQR) should continue to be assessed. In this way, trends can become apparent, thereby assisting in the aim of identifying product and process improvement opportunities.

Conclusion: The new aspects, which are also those required by PQR regarding "process performance" do resemble rather conspicuously the requirements of Step 3 "continued process verification" of the validation life cycle in the new FDA Draft Guidance on process validation. It is the continuous efficiency of the process which has to be shown - apart from it also being statistically verifiable. Trends should be discoverable and should be able to flow in as process variability to serve process improvement. The wording "innovative attempts", with regard to process validation in the draft of Section 1 of the EC GMP Guide could mean the substitution of a revalidation by a continuous validation. This is the direction that the world of validation is moving in: Following the widening of the gap with the publication of the FDA Draft Guidance, this new draft might serve to close that gap a little.

The ECA is presenting a process validation themed event: "The new FDA/EU Approach to Process Validation" on 8-9 June 2010 in Prague, Czech Republic. An EU GMP Inspector will be there to present his perception of the planned changes in the EC GMP Guidelines.

Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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