{"id":"https://openalex.org/W7220912468","doi":"https://doi.org/10.18311/jeoh/2026/24904","title":"Occupational Exposure Limits for Active Pharmaceutical Ingredients: A Comparative Review of ICH Q3C, OSHA, NIOSH, and European Medicines Agency Regulatory Frameworks and their Implications for Worker Health Surveillance","display_name":"Occupational Exposure Limits for Active Pharmaceutical Ingredients: A Comparative Review of ICH Q3C, OSHA, NIOSH, and European Medicines Agency Regulatory Frameworks and their Implications for Worker Health Surveillance","publication_year":2026,"publication_date":"2026-10-08","ids":{"openalex":"https://openalex.org/W7220912468","doi":"https://doi.org/10.18311/jeoh/2026/24904"},"language":"en","primary_location":{"id":"doi:10.18311/jeoh/2026/24904","doi":"https://doi.org/10.18311/jeoh/2026/24904","is_oa":true,"landing_page_url":"https://doi.org/10.18311/jeoh/2026/24904","pdf_url":null,"source":{"id":"https://openalex.org/S2764950255","display_name":"Journal of Ecophysiology and Occupational Health","issn_l":"0972-4397","issn":["0972-4397","0974-0805"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4323972300","host_organization_name":"Informatics Publishing Limited","host_organization_lineage":["https://openalex.org/P4323972300"],"host_organization_lineage_names":["Informatics Publishing Limited"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Ecophysiology and Occupational Health","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"diamond","oa_url":"https://doi.org/10.18311/jeoh/2026/24904","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5016276661","display_name":"Agilandeswari Devarajan","orcid":"https://orcid.org/0000-0002-5953-0511","observed_orcids":["https://orcid.org/0000-0002-5953-0511"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Agilandeswari Devarajan","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-5953-0511","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5157962688","display_name":"K. Murali","orcid":"https://orcid.org/0009-0001-5632-0201","observed_orcids":["https://orcid.org/0009-0001-5632-0201"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"K. Murali","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0009-0001-5632-0201","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5157906045","display_name":"Sudarshan Bhimappa Daddi","orcid":"https://orcid.org/0009-0001-8181-9880","observed_orcids":["https://orcid.org/0009-0001-8181-9880"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Sudarshan Bhimappa Daddi","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0009-0001-8181-9880","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5157904332","display_name":"Shivraj Patil","orcid":"https://orcid.org/0009-0002-1775-7790","observed_orcids":["https://orcid.org/0009-0002-1775-7790"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Shivraj Patil","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0009-0002-1775-7790","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5157948511","display_name":"N. Nithya Shree","orcid":"https://orcid.org/0009-0007-2909-461X","observed_orcids":["https://orcid.org/0009-0007-2909-461X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"N. Nithya Shree","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0009-0007-2909-461X","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5157982382","display_name":"Bhavana Kavalipurapu","orcid":"https://orcid.org/0009-0002-2069-5180","observed_orcids":["https://orcid.org/0009-0002-2069-5180"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bhavana Kavalipurapu","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0009-0002-2069-5180","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5157960029","display_name":"H. M. Megha","orcid":"https://orcid.org/0009-0002-4362-5935","observed_orcids":["https://orcid.org/0009-0002-4362-5935"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"H. M. Megha","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0009-0002-4362-5935","affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5157914464","display_name":"Harshita Nehru","orcid":"https://orcid.org/0009-0007-1336-9367","observed_orcids":["https://orcid.org/0009-0007-1336-9367"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Harshita Nehru","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0009-0007-1336-9367","affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"2026","issue":"3","first_page":"419","last_page":"438"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13315","display_name":"Occupational Health and Safety in Workplaces","score":0.8988999724388123,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T13315","display_name":"Occupational Health and Safety in Workplaces","score":0.8988999724388123,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T13840","display_name":"Chemical Safety and Risk Management","score":0.06260000169277191,"subfield":{"id":"https://openalex.org/subfields/1504","display_name":"Chemical Health and Safety"},"field":{"id":"https://openalex.org/fields/15","display_name":"Chemical Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T12208","display_name":"Occupational exposure and asthma","score":0.009999999776482582,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/active-pharmaceutical-ingredients","display_name":"active pharmaceutical ingredients","score":0.9710000157356262},{"id":"https://openalex.org/keywords/occupational-exposure-limits","display_name":"occupational exposure limits","score":0.9980000257492065},{"id":"https://openalex.org/keywords/pharmaceutical-manufacturing","display_name":"pharmaceutical manufacturing","score":0.6869999766349792},{"id":"https://openalex.org/keywords/occupational-health-surveillance","display_name":"occupational health surveillance","score":0.6589999794960022},{"id":"https://openalex.org/keywords/residual-solvents","display_name":"residual solvents","score":0.9459999799728394},{"id":"https://openalex.org/keywords/osha-permissible-exposure-limit","display_name":"OSHA permissible exposure limit","score":0.9580000042915344},{"id":"https://openalex.org/keywords/niosh-recommended-exposure-limit","display_name":"NIOSH recommended exposure limit","score":0.9990000128746033},{"id":"https://openalex.org/keywords/ispe","display_name":"IspE","score":0.6759999990463257},{"id":"https://openalex.org/keywords/regulatory-harmonisation","display_name":"regulatory harmonisation","score":0.8510000109672546},{"id":"https://openalex.org/keywords/biomonitoring","display_name":"biomonitoring","score":0.6759999990463257},{"id":"https://openalex.org/keywords/occupational-safety","display_name":"occupational safety","score":0.5450000166893005},{"id":"https://openalex.org/keywords/cross-contamination","display_name":"cross-contamination","score":0.6140000224113464}],"concepts":[{"id":"https://openalex.org/C2992558043","wikidata":"https://www.wikidata.org/wiki/Q30671664","display_name":"Health surveillance","level":2,"score":0.6187000274658203},{"id":"https://openalex.org/C187155963","wikidata":"https://www.wikidata.org/wiki/Q629029","display_name":"Occupational safety and health","level":2,"score":0.6083999872207642},{"id":"https://openalex.org/C108170787","wikidata":"https://www.wikidata.org/wiki/Q3951828","display_name":"Agency (philosophy)","level":2,"score":0.6051999926567078},{"id":"https://openalex.org/C2781195946","wikidata":"https://www.wikidata.org/wiki/Q17072363","display_name":"Occupational exposure limit","level":3,"score":0.5878000259399414},{"id":"https://openalex.org/C2780182762","wikidata":"https://www.wikidata.org/wiki/Q1630279","display_name":"Guideline","level":2,"score":0.49630001187324524},{"id":"https://openalex.org/C99454951","wikidata":"https://www.wikidata.org/wiki/Q932068","display_name":"Environmental health","level":1,"score":0.48539999127388},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.4756999909877777},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.46399998664855957},{"id":"https://openalex.org/C2987845665","wikidata":"https://www.wikidata.org/wiki/Q17072363","display_name":"Occupational exposure","level":2,"score":0.45399999618530273},{"id":"https://openalex.org/C2778421134","wikidata":"https://www.wikidata.org/wiki/Q628764","display_name":"Occupational medicine","level":3,"score":0.37860000133514404},{"id":"https://openalex.org/C2779709869","wikidata":"https://www.wikidata.org/wiki/Q1292017","display_name":"Good manufacturing practice","level":3,"score":0.3774999976158142},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.3605000078678131},{"id":"https://openalex.org/C2994410616","wikidata":"https://www.wikidata.org/wiki/Q189603","display_name":"Health protection","level":2,"score":0.3366999924182892},{"id":"https://openalex.org/C12174686","wikidata":"https://www.wikidata.org/wiki/Q1058438","display_name":"Risk assessment","level":2,"score":0.3328999876976013},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.3206000030040741},{"id":"https://openalex.org/C2779652045","wikidata":"https://www.wikidata.org/wiki/Q507443","display_name":"Pharmaceutical industry","level":2,"score":0.31279999017715454},{"id":"https://openalex.org/C124056412","wikidata":"https://www.wikidata.org/wiki/Q3320364","display_name":"Scientific evidence","level":2,"score":0.3122999966144562},{"id":"https://openalex.org/C57827392","wikidata":"https://www.wikidata.org/wiki/Q3143849","display_name":"Occupational hygiene","level":3,"score":0.3052999973297119},{"id":"https://openalex.org/C2778917124","wikidata":"https://www.wikidata.org/wiki/Q7309705","display_name":"Regulatory science","level":2,"score":0.3043000102043152},{"id":"https://openalex.org/C3019398576","wikidata":"https://www.wikidata.org/wiki/Q1639780","display_name":"Regulatory agency","level":2,"score":0.2978000044822693},{"id":"https://openalex.org/C2776676706","wikidata":"https://www.wikidata.org/wiki/Q8035062","display_name":"Medical surveillance","level":2,"score":0.27649998664855957},{"id":"https://openalex.org/C2781342390","wikidata":"https://www.wikidata.org/wiki/Q17146321","display_name":"Under-reporting","level":2,"score":0.27309998869895935},{"id":"https://openalex.org/C2984618805","wikidata":"https://www.wikidata.org/wiki/Q2284929","display_name":"Health risk","level":2,"score":0.2720000147819519},{"id":"https://openalex.org/C3020026551","wikidata":"https://www.wikidata.org/wiki/Q110315","display_name":"Lead exposure","level":3,"score":0.25870001316070557},{"id":"https://openalex.org/C2780765947","wikidata":"https://www.wikidata.org/wiki/Q12033531","display_name":"Administration (probate law)","level":2,"score":0.2547999918460846},{"id":"https://openalex.org/C198408306","wikidata":"https://www.wikidata.org/wiki/Q4008388","display_name":"Exposure assessment","level":2,"score":0.2542000114917755}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.18311/jeoh/2026/24904","doi":"https://doi.org/10.18311/jeoh/2026/24904","is_oa":true,"landing_page_url":"https://doi.org/10.18311/jeoh/2026/24904","pdf_url":null,"source":{"id":"https://openalex.org/S2764950255","display_name":"Journal of Ecophysiology and Occupational Health","issn_l":"0972-4397","issn":["0972-4397","0974-0805"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4323972300","host_organization_name":"Informatics Publishing Limited","host_organization_lineage":["https://openalex.org/P4323972300"],"host_organization_lineage_names":["Informatics Publishing Limited"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Ecophysiology and Occupational Health","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.18311/jeoh/2026/24904","doi":"https://doi.org/10.18311/jeoh/2026/24904","is_oa":true,"landing_page_url":"https://doi.org/10.18311/jeoh/2026/24904","pdf_url":null,"source":{"id":"https://openalex.org/S2764950255","display_name":"Journal of Ecophysiology and Occupational Health","issn_l":"0972-4397","issn":["0972-4397","0974-0805"],"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/P4323972300","host_organization_name":"Informatics Publishing Limited","host_organization_lineage":["https://openalex.org/P4323972300"],"host_organization_lineage_names":["Informatics Publishing Limited"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Ecophysiology and Occupational Health","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.9391000270843506,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":12,"referenced_works":["https://openalex.org/W1988567392","https://openalex.org/W2025299658","https://openalex.org/W2053220606","https://openalex.org/W2061112276","https://openalex.org/W2076188045","https://openalex.org/W2107153099","https://openalex.org/W2128844659","https://openalex.org/W2148575930","https://openalex.org/W2155035234","https://openalex.org/W2159790322","https://openalex.org/W2488130514","https://openalex.org/W2897965015"],"related_works":["https://openalex.org/W7120725705","https://openalex.org/W3182073664","https://openalex.org/W2006912213","https://openalex.org/W1986731218","https://openalex.org/W7164324798","https://openalex.org/W2182772107","https://openalex.org/W647197492","https://openalex.org/W39778200","https://openalex.org/W63716861","https://openalex.org/W4237513019"],"abstract_inverted_index":{"Active":[0],"Pharmaceutical":[1],"Ingredients":[2],"(APIs)":[3],"pose":[4],"a":[5],"significant":[6],"occupational":[7,56,108,144,259,293],"health":[8,109,148,260,270,322],"challenge":[9],"in":[10,19,284],"pharmaceutical":[11,55,258],"manufacturing":[12],"and":[13,24,65,78,85,105,124,132,150,168,174,224,269,288,298,320],"healthcare":[14],"settings,":[15],"where":[16,247],"workers":[17,41],"involved":[18],"synthesis,":[20],"formulation,":[21],"packaging,":[22],"dispensing,":[23],"administration":[25],"may":[26],"be":[27],"exposed":[28],"to":[29,54,138,274],"pharmacologically":[30],"potent":[31],"substances.":[32],"Occupational":[33,63,76,236],"Exposure":[34,70,82,237],"Limits":[35,71,83],"(OELs)":[36],"are":[37,211,250,272],"essential":[38],"for":[39,75,92,107,179,187,291],"protecting":[40],"from":[42,136],"unintended":[43],"biological":[44,318],"effects.":[45],"This":[46],"review":[47],"critically":[48],"evaluates":[49],"four":[50],"regulatory":[51,125,151,230],"frameworks":[52,161,281],"relevant":[53],"exposure:":[57],"ICH":[58,170],"Q3C":[59,171],"on":[60,222],"residual":[61,180],"solvents,":[62],"Safety":[64,77],"Health":[66,79],"Administration":[67],"(OSHA)":[68],"Permissible":[69],"(PELs),":[72],"National":[73],"Institute":[74],"(NIOSH)":[80],"Recommended":[81],"(RELs),":[84],"the":[86],"European":[87],"Medicines":[88],"Agency":[89],"(EMA)":[90],"guideline":[91],"health-based":[93],"exposure":[94,145,177,267,316],"limits":[95,178,198],"(HBELs).":[96],"Their":[97],"scientific":[98,163,208,289],"foundations,":[99],"derivation":[100],"methodologies,":[101],"applicability,":[102],"legal":[103,286],"status,":[104,287],"implications":[106],"surveillance":[110,271,323],"were":[111,153],"compared.":[112],"A":[113],"literature":[114],"search":[115],"was":[116,158],"conducted":[117],"using":[118],"PubMed,":[119],"Scopus,":[120],"Web":[121],"of":[122,234],"Science,":[123],"databases,":[126],"including":[127,241],"OSHA,":[128],"NIOSH,":[129,297],"EMA,":[130],"ICH,":[131],"ISPE,":[133],"covering":[134],"publications":[135],"1990":[137],"2024.":[139],"Studies":[140],"addressing":[141],"OEL":[142],"derivation,":[143],"assessment,":[146,317],"worker":[147,276,311],"outcomes,":[149],"compliance":[152],"narratively":[154],"synthesised.":[155],"Considerable":[156],"heterogeneity":[157],"identified":[159],"among":[160],"regarding":[162],"basis,":[164],"methodology,":[165],"update":[166],"frequency,":[167],"enforceability.":[169],"provides":[172],"classifications":[173],"permitted":[175],"daily":[176],"solvents":[181],"but":[182,195,210,305],"is":[183,192,232,325],"not":[184,201],"specifically":[185],"designed":[186],"API":[188,292],"dust.":[189],"OSHA":[190],"PELs":[191],"legally":[193],"enforceable":[194],"include":[196],"numerous":[197],"that":[199],"have":[200],"been":[202],"comprehensively":[203],"updated.":[204],"NIOSH":[205],"RELs":[206],"incorporate":[207],"evidence":[209],"generally":[212],"advisory.":[213],"EMA":[214,295],"HBEL":[215],"methodology":[216],"offers":[217],"an":[218],"API-specific":[219],"approach":[220],"based":[221],"pharmacological":[223],"toxicological":[225],"evaluation,":[226],"although":[227],"its":[228],"primary":[229],"purpose":[231],"prevention":[233],"cross-contamination.":[235],"Banding":[238],"(OEB)":[239],"approaches,":[240],"ISPE":[242,299],"systems,":[243],"provide":[244,302],"practical":[245],"support":[246],"substance-specific":[248],"OELs":[249],"unavailable.":[251],"Overall,":[252],"no":[253,306],"single":[254,307],"framework":[255,308,324],"fully":[256,309],"addresses":[257,310],"needs.":[261],"Greater":[262],"international":[263],"harmonisation,":[264],"periodic":[265],"review,":[266],"monitoring,":[268,319],"needed":[273],"strengthen":[275],"protection.":[277,312],"Major":[278],"Findings:":[279],"Regulatory":[280],"differ":[282],"substantially":[283],"scope,":[285],"basis":[290],"exposure.":[294],"HBEL/PDE,":[296],"OEB":[300],"approaches":[301],"complementary":[303],"tools,":[304],"An":[313],"integrated":[314],"OEL/OEB-based":[315],"proportional":[321],"proposed.":[326]},"counts_by_year":[],"updated_date":"2026-10-28T10:33:24.094632","created_date":"2026-10-09T00:00:00"}