{"id":"https://openalex.org/W3155155019","doi":"https://doi.org/10.1108/ijppm-09-2020-0472","title":"Application of tools and techniques of quality by design in pharmaceutical process","display_name":"Application of tools and techniques of quality by design in pharmaceutical process","publication_year":2021,"publication_date":"2021-04-07","ids":{"openalex":"https://openalex.org/W3155155019","doi":"https://doi.org/10.1108/ijppm-09-2020-0472","mag":"3155155019"},"language":"en","primary_location":{"id":"doi:10.1108/ijppm-09-2020-0472","doi":"https://doi.org/10.1108/ijppm-09-2020-0472","is_oa":false,"landing_page_url":"https://doi.org/10.1108/ijppm-09-2020-0472","pdf_url":null,"source":{"id":"https://openalex.org/S157600745","display_name":"International Journal of Productivity and Performance Management","issn_l":"0043-8022","issn":["0043-8022","1741-0401","1758-6658","1758-7190"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-b","anvur-class-a","anvur-scientific","cwts-core","fnege-4","jufo-1","norway-1","poland-70","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319811","host_organization_name":"Emerald Publishing Limited","host_organization_lineage":["https://openalex.org/P4310319811"],"host_organization_lineage_names":["Emerald Publishing Limited"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Productivity and Performance Management","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5083718918","display_name":"E.V. Gijo","orcid":"https://orcid.org/0000-0003-0808-2904","observed_orcids":["https://orcid.org/0000-0003-0808-2904"]},"institutions":[{"id":"https://openalex.org/I4405280447","display_name":"Indian Statistical Institute, Bangalore Centre","ror":"https://ror.org/02yqprq16","country_code":"IN","type":"education","lineage":["https://openalex.org/I4405280447","https://openalex.org/I6498739"]}],"countries":["IN"],"is_corresponding":true,"raw_author_name":"E.V. Gijo","raw_affiliation_strings":["SQC and OR Unit, Indian Statistical Institute, Bangalore, India"],"raw_orcid":"https://orcid.org/0000-0003-0808-2904","affiliations":[{"raw_affiliation_string":"SQC and OR Unit, Indian Statistical Institute, Bangalore, India","institution_ids":["https://openalex.org/I4405280447"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5083718918"],"corresponding_institution_ids":["https://openalex.org/I4405280447"],"apc_list":null,"apc_paid":null,"fwci":0.2748,"has_fulltext":false,"cited_by_count":8,"citation_normalized_percentile":{"value":0.60349672,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"71","issue":"7","first_page":"2932","last_page":"2950"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11443","display_name":"Advanced Statistical Process Monitoring","score":0.33500000834465027,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11443","display_name":"Advanced Statistical Process Monitoring","score":0.33500000834465027,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11798","display_name":"Optimal Experimental Design Methods","score":0.2874000072479248,"subfield":{"id":"https://openalex.org/subfields/1803","display_name":"Management Science and Operations Research"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T12905","display_name":"Management Systems and Quality Improvement","score":0.2443999946117401,"subfield":{"id":"https://openalex.org/subfields/1408","display_name":"Strategy and Management"},"field":{"id":"https://openalex.org/fields/14","display_name":"Business, Management and Accounting"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/quality-by-design","display_name":"quality by design","score":0.8399999737739563},{"id":"https://openalex.org/keywords/pharmaceutical-manufacturing","display_name":"pharmaceutical manufacturing","score":0.9419999718666077},{"id":"https://openalex.org/keywords/impurity-reduction","display_name":"impurity reduction","score":0.9679999947547913},{"id":"https://openalex.org/keywords/experimental-design","display_name":"experimental design","score":0.9629999995231628},{"id":"https://openalex.org/keywords/process-capability","display_name":"process capability","score":0.7620000243186951},{"id":"https://openalex.org/keywords/control-charts","display_name":"control charts","score":0.9919999837875366},{"id":"https://openalex.org/keywords/process-optimization","display_name":"process optimization","score":0.9850000143051147},{"id":"https://openalex.org/keywords/drug-quality","display_name":"drug quality","score":0.7289999723434448},{"id":"https://openalex.org/keywords/implementation-barriers","display_name":"implementation barriers","score":0.6970000267028809},{"id":"https://openalex.org/keywords/lessons-learned","display_name":"lessons learned","score":0.671999990940094}],"concepts":[{"id":"https://openalex.org/C204320433","wikidata":"https://www.wikidata.org/wiki/Q7268772","display_name":"Quality by Design","level":3,"score":0.8873695135116577},{"id":"https://openalex.org/C2778938233","wikidata":"https://www.wikidata.org/wiki/Q7180757","display_name":"Pharmaceutical manufacturing","level":2,"score":0.6770956516265869},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.5779253244400024},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.5523725152015686},{"id":"https://openalex.org/C2779652045","wikidata":"https://www.wikidata.org/wiki/Q507443","display_name":"Pharmaceutical industry","level":2,"score":0.5359464883804321},{"id":"https://openalex.org/C90673727","wikidata":"https://www.wikidata.org/wiki/Q901718","display_name":"Product (mathematics)","level":2,"score":0.524217963218689},{"id":"https://openalex.org/C117671659","wikidata":"https://www.wikidata.org/wiki/Q11049265","display_name":"Manufacturing engineering","level":1,"score":0.5180509090423584},{"id":"https://openalex.org/C98045186","wikidata":"https://www.wikidata.org/wiki/Q205663","display_name":"Process (computing)","level":2,"score":0.5079584717750549},{"id":"https://openalex.org/C120823896","wikidata":"https://www.wikidata.org/wiki/Q1043226","display_name":"Product design","level":3,"score":0.4542236626148224},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.44659489393234253},{"id":"https://openalex.org/C19351080","wikidata":"https://www.wikidata.org/wiki/Q1395034","display_name":"New product development","level":2,"score":0.37092119455337524},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.2613421678543091},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.1942925751209259},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.19197747111320496},{"id":"https://openalex.org/C162853370","wikidata":"https://www.wikidata.org/wiki/Q39809","display_name":"Marketing","level":1,"score":0.14352944493293762},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.10950681567192078},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.09115493297576904},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0},{"id":"https://openalex.org/C2524010","wikidata":"https://www.wikidata.org/wiki/Q8087","display_name":"Geometry","level":1,"score":0.0},{"id":"https://openalex.org/C111472728","wikidata":"https://www.wikidata.org/wiki/Q9471","display_name":"Epistemology","level":1,"score":0.0},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.0}],"mesh":[],"locations_count":3,"locations":[{"id":"doi:10.1108/ijppm-09-2020-0472","doi":"https://doi.org/10.1108/ijppm-09-2020-0472","is_oa":false,"landing_page_url":"https://doi.org/10.1108/ijppm-09-2020-0472","pdf_url":null,"source":{"id":"https://openalex.org/S157600745","display_name":"International Journal of Productivity and Performance Management","issn_l":"0043-8022","issn":["0043-8022","1741-0401","1758-6658","1758-7190"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["abdc-b","anvur-class-a","anvur-scientific","cwts-core","fnege-4","jufo-1","norway-1","poland-70","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310319811","host_organization_name":"Emerald Publishing Limited","host_organization_lineage":["https://openalex.org/P4310319811"],"host_organization_lineage_names":["Emerald Publishing Limited"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"International Journal of Productivity and Performance Management","raw_type":"journal-article"},{"id":"pmh:oai:RePEc:eme:ijppm0:ijppm-09-2020-0472","doi":null,"is_oa":false,"landing_page_url":"https://www.emerald.com/insight/content/doi/10.1108/IJPPM-09-2020-0472.html?utm_source=repec&utm_medium=feed&utm_campaign=repec","pdf_url":null,"source":{"id":"https://openalex.org/S4306401271","display_name":"RePEc: Research Papers in Economics","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I77793887","host_organization_name":"Federal Reserve Bank of St. Louis","host_organization_lineage":["https://openalex.org/I77793887"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article"},{"id":"pmh:oai:RePEc:eme:ijppmp:ijppm-09-2020-0472","doi":null,"is_oa":false,"landing_page_url":"https://www.emerald.com/insight/content/doi/10.1108/IJPPM-09-2020-0472/full/html?utm_source=repec&utm_medium=feed&utm_campaign=repec","pdf_url":null,"source":{"id":"https://openalex.org/S4306401271","display_name":"RePEc: Research Papers in Economics","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I77793887","host_organization_name":"Federal Reserve Bank of St. Louis","host_organization_lineage":["https://openalex.org/I77793887"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"article"}],"best_oa_location":null,"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":51,"referenced_works":["https://openalex.org/W152569421","https://openalex.org/W1895993106","https://openalex.org/W1978081096","https://openalex.org/W1978880915","https://openalex.org/W1984940961","https://openalex.org/W1988643997","https://openalex.org/W1991618236","https://openalex.org/W1997187492","https://openalex.org/W1999481657","https://openalex.org/W2012785955","https://openalex.org/W2016251495","https://openalex.org/W2017422800","https://openalex.org/W2018867583","https://openalex.org/W2028749542","https://openalex.org/W2044332466","https://openalex.org/W2050829003","https://openalex.org/W2056972503","https://openalex.org/W2064910951","https://openalex.org/W2066982277","https://openalex.org/W2074679853","https://openalex.org/W2077250336","https://openalex.org/W2084072505","https://openalex.org/W2113155419","https://openalex.org/W2138157712","https://openalex.org/W2146287075","https://openalex.org/W2166269254","https://openalex.org/W2169488774","https://openalex.org/W2214500615","https://openalex.org/W2341458793","https://openalex.org/W2496379660","https://openalex.org/W2586783706","https://openalex.org/W2588259685","https://openalex.org/W2796266569","https://openalex.org/W2801263736","https://openalex.org/W2884827416","https://openalex.org/W2901020484","https://openalex.org/W2901092246","https://openalex.org/W2908815325","https://openalex.org/W2930563084","https://openalex.org/W2934181292","https://openalex.org/W2950479395","https://openalex.org/W2951334332","https://openalex.org/W2966892391","https://openalex.org/W2981205923","https://openalex.org/W2981352503","https://openalex.org/W3006045382","https://openalex.org/W3020834035","https://openalex.org/W3043067223","https://openalex.org/W3048840521","https://openalex.org/W3080957973","https://openalex.org/W4230917442"],"related_works":["https://openalex.org/W4221032980","https://openalex.org/W2909498029","https://openalex.org/W2736006489","https://openalex.org/W4391064964","https://openalex.org/W2995891886","https://openalex.org/W2794326449","https://openalex.org/W2771018726","https://openalex.org/W2505448267","https://openalex.org/W2559382184","https://openalex.org/W2314712860"],"abstract_inverted_index":{"Purpose":[0],"The":[1,137,228],"purpose":[2],"of":[3,11,16,69,77,95,135,166,194,213,218,230,232,239],"this":[4,42,195],"article":[5,153,208],"is":[6,154,177],"to":[7,31,162,199],"demonstrate":[8],"the":[9,12,33,48,65,89,99,108,112,119,124,128,142,152,174,192,210,248,254],"application":[10,238],"tools":[13,66,74,163,215,241],"and":[14,30,37,67,82,107,123,141,164,216,237,242,250],"techniques":[15,68,165,217,243],"Quality":[17],"by":[18,63],"Design":[19,76,231],"(QbD)":[20],"approach":[21],"in":[22,55,61,98,111,168,172,204,221,253],"an":[23],"Indian":[24],"pharmaceutical":[25,186,200,223],"drug":[26,57,103,187,201,224],"product":[27,58,104,113,180,188,225],"manufacturing":[28,59,189,202,226],"company":[29,60],"understand":[32],"challenges,":[34],"managerial":[35],"implications":[36],"lessons":[38],"learned":[39],"while":[40],"implementing":[41],"initiative.":[43],"Design/methodology/approach":[44],"This":[45,207],"work":[46],"adopts":[47],"Action":[49],"Research":[50,148],"methodology":[51,220],"for":[52,88,127,184,234,247],"impurity":[53,109,120,143],"reduction":[54],"a":[56,93,101,157,169,178,222],"India":[62],"using":[64],"QbD":[70,73,96,167,219],"approach.":[71],"Various":[72],"like":[75],"experiments,":[78],"process":[79,235],"capability":[80],"evaluation":[81],"control":[83],"charts":[84],"were":[85,121,131,139,145],"effectively":[86],"utilized":[87],"study.":[90],"Findings":[91],"As":[92],"part":[94],"implementation":[97],"organization,":[100],"specific":[102],"was":[105,114],"identified":[106,122,132,175],"level":[110],"studied.":[115],"Significant":[116],"variables":[117,130],"impacting":[118],"optimum":[125],"levels":[126,144],"significant":[129],"through":[133],"design":[134],"experiments.":[136],"solutions":[138],"implemented":[140],"reduced":[146],"significantly.":[147],"limitations/implications":[149],"Even":[150],"though":[151],"based":[155],"on":[156],"single":[158,170],"case":[159],"study":[160],"related":[161,182],"organization":[171],"India,":[173],"problem":[176],"generic":[179],"quality":[181],"issue":[183],"any":[185],"company.":[190,227],"Hence":[191],"findings":[193],"research":[196],"are":[197,244],"applicable":[198],"industry":[203],"general.":[205],"Originality/value":[206],"illustrates":[209],"systematic":[211],"usage":[212,229],"various":[214],"Experiments":[233],"optimization":[236],"other":[240],"ready":[245],"references":[246],"practitioners":[249],"novice":[251],"users":[252],"field.":[255]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":4},{"year":2024,"cited_by_count":1},{"year":2023,"cited_by_count":2}],"updated_date":"2026-11-07T11:25:07.637180","created_date":"2021-04-26T00:00:00"}