Process validation

Process stability – process capability – controlled state –
Important terms that should not be missing in any current process validation!

Guidelines for process validation

In the current guidelines on process validation (FDA Guidance, Annex 15, Aide memoire 07122901) as well as in more and more inspection reports, there is a requirement for proof of process stability, process capability and the continuation of the controlled state. What is meant by this?

A stable process is a process that predictably delivers products of comparable quality batch after batch. This state can also be referred to as a “controlled process” or a “process under (statistical) control”.

However, process stability does not automatically mean that the process also delivers a product that conforms to specifications. A stable process can also predictably deliver products that are not of the desired quality.

Process stability

Fig. 2: Stable process that violates the specification limits

Therefore, in addition to the term process stability, the guidelines also include the requirement for appropriate process capability. The calculation of the process capability in the form of the process capability index (Ppk or Cpk) sets the scatter of the results and the position of the mean value in relation to the specification limits. High process capability means that the results are so far away from the specification limits that it is very unlikely that OOS results will occur in the batch.

If a process is stable and has good process capability, a product is manufactured that is firstly comparable with the previously produced batches (process stability) and secondly lies safely within the specification limits (process capability).

Process capability

However, the terms process stability and process capability always refer only to a single product characteristic, e.g. the content of the medicinal product, and not, as the terms imply, to the entire process. It is therefore quite possible that a process delivers tablets with reproducible, specification-compliant content, but that these show completely different active ingredient releases from batch to batch.

Product features

Accordingly, it is essential to first identify all critical product features that need to be assessed as part of process validation in a risk-based manner and then, in a second step, to check whether the process is stable and capable with regard to all critical product features.

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Dipl. oec. troph. Christian Reinfelder

Vita

• 25 Jahre Erfahrung in der Unternehmensberatung
• 20 Jahre Lehrbeauftragter für Qualitätsmanagement an der Hochschule Fulda

Expertise:

• Zertifizierungsstellenleiter
• Leiter Qualitätsmanagement und QMB
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• Lead Auditor
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