QFacts blog

Quality, in practice.

Notes on document control, training and the work behind a well-run quality system.

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Practical guidance on SOPs, deviations, CAPAs, change control and training in regulated organisations.

Two operators in blue cleanroom suits at a stainless-steel pharmaceutical filling line enclosed behind glass panels with glove ports

Change control traceability: what an inspector expects to find in a GMP change record

What makes a GMP change record traceable? The regulatory basis in EU GMP, ICH Q10 and Q9(R1), 21 CFR 211 and ISO 13485, the elements every record needs, and the gaps inspectors look for.

October 15, 202612 min

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