{"authorities":[{"slug":"fda","name":"U.S. Food and Drug Administration","short":"FDA","region":"United States","url":"https://www.fda.gov"},{"slug":"eu-gmp","name":"European Commission","short":"EU GMP","region":"European Union","url":"https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en"},{"slug":"ema","name":"European Medicines Agency","short":"EMA","region":"European Union","url":"https://www.ema.europa.eu"},{"slug":"health-canada","name":"Health Canada","short":"Health Canada","region":"Canada","url":"https://www.canada.ca/en/health-canada.html"},{"slug":"mhra","name":"Medicines and Healthcare products Regulatory Agency","short":"MHRA","region":"United Kingdom","url":"https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency"}],"documents":[{"slug":"eu-gmp-annex-15","authority":"eu-gmp","title":"EU GMP Annex 15: Qualification and Validation","version":"2015 revision","date":"2015-03-30","effective":"2015-10-01","type":"GMP guideline","status":"Current","url":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","lastVerified":null,"accessedAt":"2026-09-16","statusNote":"Provisional source status; human verification pending."},{"slug":"fda-cleaning-processes","authority":"fda","title":"Validation of Cleaning Processes","version":"July 1993","date":"1993-07-01","datePrecision":"month","effective":null,"type":"Inspection guide","status":"Current","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793","lastVerified":null,"accessedAt":"2026-09-16","statusNote":"Provisional source status; human verification pending."},{"slug":"ich-q7","authority":"fda","title":"Q7A: Good Manufacturing Practice for APIs","version":"August 2001","date":"2001-08-01","datePrecision":"month","effective":null,"type":"Guidance","status":"Current","url":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","lastVerified":null,"accessedAt":"2026-09-16","statusNote":"Provisional source status; human verification pending."},{"slug":"ema-hbel-qa","authority":"ema","title":"HBEL and cross-contamination: questions and answers","version":"EMA/CHMP/CVMP/SWP/246844/2018","date":"2018-04-19","effective":null,"type":"Questions and answers","status":"Current","url":"https://www.ema.europa.eu/system/files/documents/other/wc500219500_en.pdf","lastVerified":null,"accessedAt":"2026-09-16","statusNote":"Provisional source status; human verification pending."},{"slug":"health-canada-gui-0028","authority":"health-canada","title":"Cleaning validation guide (GUI-0028)","version":"2021 edition","date":"2021-06-29","effective":null,"type":"Guidance","status":"Current","url":"https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028/document.html","lastVerified":null,"accessedAt":"2026-09-16","statusNote":"Provisional source status; human verification pending."},{"slug":"mhra-hbel-commentary","authority":"mhra","title":"Cross-contamination control and HBEL Q&As","version":"22 October 2018","date":"2018-10-22","effective":null,"type":"Inspectorate commentary","status":"Current","url":"https://mhrainspectorate.blog.gov.uk/2018/10/22/cross-contamination-control-and-health-based-exposure-limits-hbel-qas/","lastVerified":null,"accessedAt":"2026-09-16","statusNote":"Provisional source status; human verification pending."}],"topics":[{"slug":"cleaning-validation","name":"Cleaning Validation","description":"A connected view of process design, qualification and continued control."},{"slug":"hbel-pde","name":"HBEL & PDE","description":"Health-based exposure limits and their role in cross-contamination risk assessment."},{"slug":"maco","name":"MACO","description":"Translating an exposure assessment into a justified carryover limit."},{"slug":"recovery","name":"Recovery","description":"Understanding what the sampling and analytical procedure can retrieve."},{"slug":"swab-sampling","name":"Swab Sampling","description":"Direct surface sampling, location selection and material compatibility."},{"slug":"rinse-sampling","name":"Rinse Sampling","description":"Sampling accessible and enclosed equipment through a justified rinse procedure."},{"slug":"worst-case","name":"Worst Case","description":"Selecting representative challenges and recording the limits of that representation."},{"slug":"visual-inspection","name":"Visual Inspection","description":"Making visual cleanliness an explicit, reproducible part of the control strategy."},{"slug":"hold-times","name":"Hold Times","description":"The intervals before cleaning and between cleaning and equipment reuse."},{"slug":"analytical-methods","name":"Analytical Methods","description":"Analytical suitability in the context of the residue and the acceptance criterion."},{"slug":"acceptance-criteria","name":"Acceptance Criteria","description":"Documented decisions about limits, measurement and acceptance."},{"slug":"shared-equipment","name":"Shared Equipment","description":"Connecting product characteristics, equipment and cross-contamination controls."},{"slug":"revalidation","name":"Revalidation","description":"Evaluating the effect of change on an established cleaning process."},{"slug":"microbial-control","name":"Microbial Control","description":"Considering microbial contamination alongside chemical residue risks."},{"slug":"detergents","name":"Detergents","description":"Cleaning-agent selection and the evidence supporting residue removal."}],"requirements":[{"id":"CV-REQ-000001","slug":"demonstrate-sampling-recovery","document":"eu-gmp-annex-15","authority":"eu-gmp","region":"European Union","section":"10.12","title":"Demonstrate sampling recovery","summary":"Recovery should be demonstrated for sampled contact materials and methods.","topics":["recovery","swab-sampling","rinse-sampling"],"interpretation":"Connect each material to the recovery study that supports its sampling procedure.","audit":"Which material–method combinations have supporting data?","evidence":["Material inventory","recovery results","sampling procedure"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","revision":1},{"id":"CV-REQ-000002","slug":"justify-residue-acceptance-limits","document":"eu-gmp-annex-15","authority":"eu-gmp","region":"European Union","section":"10.6","title":"Justify residue acceptance limits","summary":"Carryover limits should be set from a toxicological evaluation, with the selected limits and supporting references documented in a risk assessment. Limits should also cover cleaning-agent removal, and acceptance criteria should account for cumulative exposure across the equipment train. For therapeutic macromolecules and peptides that degrade or denature under extreme pH or heat and may lose pharmacological activity, a toxicological evaluation may not be applicable.","topics":["hbel-pde","maco","acceptance-criteria"],"interpretation":"Keep the limit calculation traceable to its assumptions and source assessment.","audit":"Can the calculation be reconstructed independently?","evidence":["Assessment reference","calculation","equipment allocation"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","revision":1},{"id":"CV-REQ-000003","slug":"define-dirty-and-clean-hold-times","document":"eu-gmp-annex-15","authority":"eu-gmp","region":"European Union","section":"10.8","title":"Define dirty and clean hold times","summary":"Account for both pre-cleaning and post-cleaning storage intervals.","topics":["hold-times","cleaning-validation"],"interpretation":"Specify start and end events for each operational clock.","audit":"Do recorded timestamps match the defined events?","evidence":["Hold-time definitions","study records"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","revision":1},{"id":"CV-REQ-000004","slug":"support-worst-case-product-selection","document":"eu-gmp-annex-15","authority":"eu-gmp","region":"European Union","section":"10.10","title":"Support worst-case product selection","summary":"Worst-case selection needs a scientific rationale and assessment of new products.","topics":["worst-case","shared-equipment"],"interpretation":"Record what the selected product represents and what it does not.","audit":"Which changes would invalidate the selection?","evidence":["Selection matrix","change assessment"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","revision":1},{"id":"CV-REQ-000005","slug":"use-visual-inspection-within-validation","document":"eu-gmp-annex-15","authority":"eu-gmp","region":"European Union","section":"10.2","title":"Use visual inspection within validation","summary":"A visual cleanliness check should form part of cleaning-validation acceptance criteria, but it is not generally acceptable as the sole criterion. Recleaning and retesting until residue results pass is not an acceptable validation approach.","topics":["visual-inspection","acceptance-criteria"],"interpretation":"Give visual findings a defined place in the acceptance decision.","audit":"How are visible residues recorded and investigated?","evidence":["Inspection instruction","deviation record"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","revision":1},{"id":"CV-REQ-000006","slug":"justify-sampling-locations","document":"eu-gmp-annex-15","authority":"eu-gmp","region":"European Union","section":"10.11","title":"Justify sampling locations","summary":"Protocols should identify sampling locations, their rationale and acceptance criteria.","topics":["swab-sampling","worst-case"],"interpretation":"Use equipment identifiers that remain recognizable at the sampling point.","audit":"Can a second sampler locate the same area?","evidence":["Annotated drawing","sampling map"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","revision":1},{"id":"CV-REQ-000007","slug":"include-microbial-and-endotoxin-risk","document":"eu-gmp-annex-15","authority":"eu-gmp","region":"European Union","section":"10.7","title":"Include microbial and endotoxin risk","summary":"Consider microbial and endotoxin contamination when developing protocols.","topics":["microbial-control","cleaning-validation"],"interpretation":"Document applicability before choosing the study endpoints.","audit":"What supports the inclusion or exclusion of microbial testing?","evidence":["Risk assessment","protocol rationale"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf","revision":1},{"id":"CV-REQ-000008","slug":"define-cleaning-responsibilities","document":"fda-cleaning-processes","authority":"fda","region":"United States","section":"General requirements","title":"Define cleaning responsibilities","summary":"Written validation procedures should address responsibilities and acceptance decisions.","topics":["cleaning-validation"],"interpretation":"Assign an owner to each decision rather than relying on an unsigned checklist.","audit":"Who approves the final conclusion?","evidence":["Responsibility matrix","approval record"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793","revision":1},{"id":"CV-REQ-000009","slug":"prepare-a-study-protocol","document":"fda-cleaning-processes","authority":"fda","region":"United States","section":"General requirements","title":"Prepare a study protocol","summary":"Prepare protocols addressing sampling and analytical method sensitivity.","topics":["analytical-methods","cleaning-validation"],"interpretation":"Make the study executable by linking instructions, sample IDs and reporting fields.","audit":"Is the planned method available before execution?","evidence":["Approved protocol","method reference"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793","revision":1},{"id":"CV-REQ-000010","slug":"understand-swab-compatibility","document":"fda-cleaning-processes","authority":"fda","region":"United States","section":"Direct surface sampling","title":"Understand swab compatibility","summary":"Sampling materials and extraction solvents can influence analytical results.","topics":["swab-sampling","recovery"],"interpretation":"Include the consumables used on site in the study design.","audit":"Are the study swabs the same as routine swabs?","evidence":["Consumable specification","blank results"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793","revision":1},{"id":"CV-REQ-000011","slug":"understand-the-rinse-result","document":"fda-cleaning-processes","authority":"fda","region":"United States","section":"Rinse samples","title":"Understand the rinse result","summary":"Rinse testing must meaningfully represent residues on equipment surfaces.","topics":["rinse-sampling","recovery"],"interpretation":"Record which surfaces a rinse reaches and which remain uncertain.","audit":"What does a passing rinse result actually cover?","evidence":["Rinse coverage map","method rationale"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793","revision":1},{"id":"CV-REQ-000012","slug":"control-time-before-cleaning","document":"fda-cleaning-processes","authority":"fda","region":"United States","section":"Evaluation of cleaning validation","title":"Control time before cleaning","summary":"Residue drying can affect the effectiveness of a cleaning procedure.","topics":["hold-times","worst-case"],"interpretation":"Connect the scheduling rule to the interval examined in the study.","audit":"Can production exceed the studied interval?","evidence":["Equipment log","hold-time record"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793","revision":1},{"id":"CV-REQ-000013","slug":"document-the-validation-conclusion","document":"fda-cleaning-processes","authority":"fda","region":"United States","section":"General requirements","title":"Document the validation conclusion","summary":"A management-approved report should establish whether cleaning is validated.","topics":["cleaning-validation"],"interpretation":"Make unresolved deviations visible alongside the overall conclusion.","audit":"Does the conclusion account for every deviation?","evidence":["Final report","deviation disposition"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793","revision":1},{"id":"CV-REQ-000014","slug":"reflect-actual-equipment-use","document":"ich-q7","authority":"fda","region":"United States","section":"12.7 — equipment usage","title":"Reflect actual equipment use","summary":"Cleaning validation should reflect how equipment is actually used.","topics":["shared-equipment","worst-case"],"interpretation":"Compare the study sequence with the production schedule it is intended to support.","audit":"Which production sequences are represented?","evidence":["Equipment-use matrix","study sequence"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","revision":1},{"id":"CV-REQ-000015","slug":"describe-the-cleaning-study","document":"ich-q7","authority":"fda","region":"United States","section":"12.7 — protocol","title":"Describe the cleaning study","summary":"Protocols should describe equipment, procedures, criteria and sample collection.","topics":["cleaning-validation","acceptance-criteria"],"interpretation":"Keep the sampling record usable without reconstructing undocumented assumptions.","audit":"Can samples be traced back to the equipment?","evidence":["Protocol","sample labels","chain of custody"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","revision":1},{"id":"CV-REQ-000016","slug":"select-suitable-sampling-methods","document":"ich-q7","authority":"fda","region":"United States","section":"12.7 — sampling","title":"Select suitable sampling methods","summary":"Sampling should address soluble and insoluble residues appropriately.","topics":["swab-sampling","rinse-sampling"],"interpretation":"Match the sampling question to the residue and accessible surface.","audit":"Which residue types could be missed?","evidence":["Residue assessment","sampling rationale"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","revision":1},{"id":"CV-REQ-000017","slug":"establish-method-capability","document":"ich-q7","authority":"fda","region":"United States","section":"12.7 — analytical methods","title":"Establish method capability","summary":"Analytical sensitivity and attainable recovery should support residue evaluation.","topics":["analytical-methods","recovery"],"interpretation":"Read the laboratory result together with the method capability statement.","audit":"Is a low result distinguishable from a method limitation?","evidence":["Validation report","recovery data"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","revision":1},{"id":"CV-REQ-000018","slug":"monitor-cleaning-after-validation","document":"ich-q7","authority":"fda","region":"United States","section":"12.7 — ongoing monitoring","title":"Monitor cleaning after validation","summary":"Monitor validated cleaning procedures at appropriate intervals during production.","topics":["cleaning-validation","revalidation"],"interpretation":"Give each monitoring trend an owner and a response rule.","audit":"Who reviews emerging trends?","evidence":["Monitoring plan","trend review"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","revision":1},{"id":"CV-REQ-000019","slug":"review-the-validated-state","document":"ich-q7","authority":"fda","region":"United States","section":"12.6","title":"Review the validated state","summary":"Periodically evaluate whether systems remain in a valid state.","topics":["revalidation","cleaning-validation"],"interpretation":"Record the reasoning behind both revalidation and continued-use decisions.","audit":"What evidence supports the review conclusion?","evidence":["Periodic review","change history"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients","revision":1},{"id":"CV-REQ-000020","slug":"establish-and-reassess-hbels","document":"ema-hbel-qa","authority":"ema","region":"European Union","section":"Q1","title":"Establish and reassess HBELs","summary":"Establish HBELs for medicinal products and reassess supporting data periodically.","topics":["hbel-pde","shared-equipment"],"interpretation":"Keep a review owner and assessment version against each product.","audit":"Which assessment is currently used?","evidence":["HBEL register","review assignment"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.ema.europa.eu/system/files/documents/other/wc500219500_en.pdf","revision":1},{"id":"CV-REQ-000021","slug":"qualify-the-hbel-assessor","document":"ema-hbel-qa","authority":"ema","region":"European Union","section":"Q4","title":"Qualify the HBEL assessor","summary":"HBEL development requires suitable toxicological and pharmacological expertise.","topics":["hbel-pde"],"interpretation":"Make assessor qualification part of the commissioning record.","audit":"How was the assessor evaluated?","evidence":["Qualification assessment","contract scope"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.ema.europa.eu/system/files/documents/other/wc500219500_en.pdf","revision":1},{"id":"CV-REQ-000022","slug":"distinguish-hbels-from-cleaning-alert-limits","document":"ema-hbel-qa","authority":"ema","region":"European Union","section":"Q6","title":"Distinguish HBELs from cleaning alert limits","summary":"An HBEL is not automatically the operational cleaning limit.","topics":["hbel-pde","maco","acceptance-criteria"],"interpretation":"Display the safety basis and operating decision as separate values.","audit":"Can staff explain the purpose of each limit?","evidence":["Limit rationale","performance review"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.ema.europa.eu/system/files/documents/other/wc500219500_en.pdf","revision":1},{"id":"CV-REQ-000023","slug":"justify-the-changeover-control-strategy","document":"ema-hbel-qa","authority":"ema","region":"European Union","section":"Q7–Q8","title":"Justify the changeover control strategy","summary":"Reduced analytical testing requires robust justification, including visual-inspection capability.","topics":["visual-inspection","shared-equipment"],"interpretation":"Treat an exception as a documented decision with boundaries.","audit":"When must the exception be reassessed?","evidence":["QRM record","inspection capability study"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.ema.europa.eu/system/files/documents/other/wc500219500_en.pdf","revision":1},{"id":"CV-REQ-000024","slug":"manage-the-cleaning-lifecycle","document":"health-canada-gui-0028","authority":"health-canada","region":"Canada","section":"7","title":"Manage the cleaning lifecycle","summary":"Connect cleaning development, qualification and ongoing monitoring.","topics":["cleaning-validation","revalidation"],"interpretation":"Keep development assumptions available to the team reviewing routine performance.","audit":"Where are the original assumptions recorded?","evidence":["Development summary","monitoring review"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028/document.html","revision":1},{"id":"CV-REQ-000025","slug":"address-manual-cleaning-variability","document":"health-canada-gui-0028","authority":"health-canada","region":"Canada","section":"7.1.1","title":"Address manual cleaning variability","summary":"Control operator-related variability in manual cleaning.","topics":["worst-case","cleaning-validation"],"interpretation":"Write instructions around observable actions that can be assessed consistently.","audit":"Could two trained operators follow the instruction differently?","evidence":["Training observation","procedure assessment"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028/document.html","revision":1},{"id":"CV-REQ-000026","slug":"assess-new-products-before-introduction","document":"health-canada-gui-0028","authority":"health-canada","region":"Canada","section":"7.3.2","title":"Assess new products before introduction","summary":"Evaluate new products within the existing cleaning control strategy.","topics":["shared-equipment","worst-case"],"interpretation":"Make the cleaning assessment a named step in product introduction.","audit":"Who checks the existing study coverage?","evidence":["Introduction checklist","coverage review"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028/document.html","revision":1},{"id":"CV-REQ-000027","slug":"design-direct-surface-sampling","document":"health-canada-gui-0028","authority":"health-canada","region":"Canada","section":"9.2.1","title":"Design direct surface sampling","summary":"Surface sampling needs a justified, reproducible collection approach.","topics":["swab-sampling","recovery"],"interpretation":"Document the sampled area in a form a colleague can reproduce.","audit":"Is the area identifiable and repeatable?","evidence":["Sampling diagram","operator instruction"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028/document.html","revision":1},{"id":"CV-REQ-000028","slug":"assess-cleaning-agent-residues","document":"health-canada-gui-0028","authority":"health-canada","region":"Canada","section":"12.1","title":"Assess cleaning-agent residues","summary":"Consider the selection and removal of cleaning agents.","topics":["detergents","acceptance-criteria"],"interpretation":"Track cleaning-agent changes alongside product and equipment changes.","audit":"Does a detergent change trigger an assessment?","evidence":["Agent specification","residue rationale"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028/document.html","revision":1},{"id":"CV-REQ-000029","slug":"use-hbels-within-risk-assessment","document":"mhra-hbel-commentary","authority":"mhra","region":"United Kingdom","section":"Inspectorate commentary — HBEL implementation","title":"Use HBELs within risk assessment","summary":"HBEL implementation supports assessment of cross-contamination controls.","topics":["hbel-pde","shared-equipment"],"interpretation":"Connect the assessment to named controls that can be checked on the floor.","audit":"Which control responds to each identified risk?","evidence":["Risk-to-control map"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://mhrainspectorate.blog.gov.uk/2018/10/22/cross-contamination-control-and-health-based-exposure-limits-hbel-qas/","revision":1},{"id":"CV-REQ-000030","slug":"evaluate-visual-inspection-capability","document":"mhra-hbel-commentary","authority":"mhra","region":"United Kingdom","section":"Inspectorate commentary — visual inspection","title":"Evaluate visual inspection capability","summary":"Reliance on visual inspection needs evidence supporting the intended limit.","topics":["visual-inspection","acceptance-criteria"],"interpretation":"Specify the viewing conditions when evaluating detection capability.","audit":"Are actual viewing conditions represented?","evidence":["Visual assessment","viewing conditions"],"status":"Current","editorialState":"draft","reviewedAt":null,"reviewer":null,"sourceUrl":"https://mhrainspectorate.blog.gov.uk/2018/10/22/cross-contamination-control-and-health-based-exposure-limits-hbel-qas/","revision":1}],"release":"preview-2026-09-16"}