Glossary
Line Clearance
The procedure confirming, before new work starts, that no previous product, material, or document remains in the working area or on the equipment.
Source · PIC/S PE 009-17, Part I, Chapter 5, Production, §§5.40 and 5.50
Details
Line clearance is the on-the-floor control that removes previous product, materials, labelling, documents, and residues before and after an operation so that mix-ups and cross-contamination are prevented. Inspections cite check items applied as a formality, labelling and records from the previous batch left in place, and no evidence of the person performing and an independent checker. Check the line clearance checklist, material issue and reconciliation, the state of the equipment and area, batch and packaging records, and deviations.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Major issues also involved poor risk assessments, weak documentation and data integrity controls, and deficiencies in line clearance, deviation management, and sampling practices.
EMA · EU GMP NCR (EudraGMDP) · 2025-05-12 -
For example, you relabeled Dasatinib monohydrate API and repackaged sirolimus API without label issuance, line clearance procedures, and documentation such as a batch record…
FDA · FDA Warning Letter · 2022-12-27 -
The "Clearance Procedure for Filling Interventions in Buildi cument #030-SOP-D-80, effective date 22 Mar 2011, "outlines the steps to be followed for line clearances performed after interventions in sterile filling", which are also performed during aseptic media fill processing.
FDA · FDA 483 · 2024-01-17
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
PIC/S PE 009-17, Part I, Chapter 5, Production, §§5.40 and 5.50GRM Regulatory Glossary
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