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Change control vs Control on change - part 2: QC laboratories

Updated: Aug 10, 2023

In part 1, I cautiously questioned that the big-guy change control system should be used for every change.

Let me give an example area: the QC-laboratories.

Let me lean on the related EDQM QM document: Management of changes.

In section 3, some specific examples are described where they don't think the change control should be the driving process:

'Typical examples which would not trigger a change management process include:

• New batch of a chemical substance used in an analytical method and quality defined in the relevant SOP (change identified to be “within the design space”)

• Change of typical method parameters , e.g. incubation time, temperature (already covered via validation and verification)*

• Change of test equipment (already covered via PQ and verification of test method)

• Any single occurrence or non-conformity covered by the corrective action plan or elsewhere (e.g. complaint management).

• Changes/amendments to technical records'

I think this gives a lot to think if we can make our lab's continuous improvement more efficient.


* Naturally, the sanctity of the DMF must be kept, but QC needs to have access to all necessary regulatory documents to be able to decide which parameter change would need a full change control process, involving RA.

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