PRACTICAL GUIDANCE

Bring the evidence
into everyday work.

Focused starting points for the questions behind protocols, sampling plans and programme reviews.

Evergreen guidance, kept current with the regulations it refers to.

Three outcomes to assess training poster

Published: 3 Nov 2026 · Companion article 1 of 5

What manual wipe cleaning results actually demonstrate

Removal, inactivation and secondary transfer are separate outcomes. This article shows what culture, PCR and residue methods can each support, and which four questions expose an over-broad claim.

Manual wipe cleaning: whitepaper, working forms and printable posters

Published: 31 Oct 2026 · Whitepaper & toolkit

Manual wipe cleaning in pharmaceutical manufacturing

A technical whitepaper, editable working forms, chemical-result worksheet and A2/A3 posters. Five companion articles follow weekly from 3 November.

Five rounded cards on an ivory background joined left to right by four teal arrows: 01 Sample + location, asking which sample and which spot; 02 Original record, asking what the record said; 03 Method + calculation, asking how the value was derived; 04 Criteria + deviations, asking which rules were preset; 05 Report conclusion, asking what is claimed and why. A note below the chain states that the next checkpoint cannot be reconstructed without the previous one; a lower note says to follow identifiers and versions and not to replace original records. A footer states that this is an editorial traceability aid, not a regulator-prescribed form, with illustrative logic only and no pass/fail verdict implied.

Published: 28 Oct 2026

Reconstructing a Cleaning-Validation Decision: Trace One Sample End to End

A seven-link drill for tracing one cleaning-validation sample back through location, execution record, raw data, method and recovery versions, pre-set criteria, deviations and the report conclusion — with an editable twelve-field sample record and a worked broken-chain repair.

Technical diagram concept showing separate API, detergent, and microbiological cleaning-validation evidence paths

Published: 14 Oct 2026

Cleaning-agent residues: why an API pass is not a detergent clearance

Why an API pass does not prove detergent clearance: residue limits, method capability, sampling recovery and separate microbiological controls.

Overview poster of PIC/S PI 058-1: cleaning, bio-decontamination and residue control.

Regulatory Watch

PIC/S PI 058-1: Reading the New Annex 1 Interpretation for Cleaning and Bio-Decontamination

PIC/S PI 058-1 interprets the revised EU GMP Annex 1 (2022). For cleaning validation the key points are chemical residue control in isolators and RABS, the separation of cleaning from bio-decontamination, and why VHP surface bio-decontamination is not automatically sterilisation.

Source: 28 Oct 2026regulatory watch

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