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← Document librarySupplier Qualification
Fictional document for the demonstration.
§4.1 Qualification before purchase
A purchase order for a GMP material is not raised with a supplier that has no qualification record. Qualification is by questionnaire and, for critical materials, an audit or documented desk review.
§4.3 Change of supplier
Introducing a new supplier for an existing material is a change under change control and requires qualification, and where applicable regulatory notification, before first use.