{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,30]],"date-time":"2026-07-30T14:03:55Z","timestamp":1785420235374,"version":"3.56.0"},"reference-count":20,"publisher":"American Society for Microbiology","issue":"9","license":[{"start":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T00:00:00Z","timestamp":1757462400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T00:00:00Z","timestamp":1757462400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"HHS | NIH | Clinical Center | Intramural Research Program"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["J Clin Microbiol"],"published-print":{"date-parts":[[2025,9,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>Product sterility testing requests are becoming increasingly common in clinical microbiology laboratories due to the rapid development of advanced therapies. Most laboratory directors are hesitant to bring on such tests because they fall under current Good Manufacturing Practices (cGMP) regulated by the United States Food and Drug Administration (FDA), where expectations differ from clinical requirements (regulated by the Centers for Medicare and Medicaid Services). When considerations are made for cGMP testing in the clinical lab, most focus is placed on analytical test validation. In this mini-review, we provide an overview of one critical element within the cGMP quality system\u2014validation of equipment, software, and systems through installation, operational, and performance qualification (IQ, OQ, and PQ or IOPQ). This terminology is not common in clinical laboratories, and the IQ and OQ portions are often overlooked, not performed, and\/or not documented, although phase II CAP requirements exist (COM.30550 and COM.30575). This mini-review will provide an overview of the IOPQ framework, what is included and how it differs from CAP requirements, important considerations for an IOPQ, and a summary of FDA citations relating to equipment validation. We provide examples using blood culture systems, controlled temperature units (CTUs; e.g., incubator), and the laboratory information management system, given their likelihood for use in cGMP activities in the clinical lab. Importantly, the IOPQ requirements summarized here would have also been relevant to laboratory-developed tests (LDTs) classified as \u201cdevices\u201d prior to the March 31, 2025, annulment of the ruling.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1128\/jcm.01477-24","type":"journal-article","created":{"date-parts":[[2025,8,11]],"date-time":"2025-08-11T13:28:34Z","timestamp":1754918914000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":2,"title":["All you need to know about equipment validation for sterility testing"],"prefix":"10.1128","volume":"63","author":[{"given":"James E. T.","family":"Gebo","sequence":"first","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01cwqze88","id-type":"ROR","asserted-by":"publisher"}],"name":"Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health","place":["Bethesda, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayla M.","family":"Feehely","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01cwqze88","id-type":"ROR","asserted-by":"publisher"}],"name":"Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health","place":["Bethesda, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chase E.","family":"Lattimore","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01cwqze88","id-type":"ROR","asserted-by":"publisher"}],"name":"Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health","place":["Bethesda, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dylan P.","family":"Mogavero","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01cwqze88","id-type":"ROR","asserted-by":"publisher"}],"name":"Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health","place":["Bethesda, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8205-9978","authenticated-orcid":true,"given":"Anna F.","family":"Lau","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/01cwqze88","id-type":"ROR","asserted-by":"publisher"}],"name":"Sterility Testing Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health","place":["Bethesda, USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_3_2_2","unstructured":"United States Food and Drug Administration. 2025. Approved cellular and gene therapy products on united states food and drug administration. Available from: https:\/\/www.fda.gov\/vaccines-blood-biologics\/cellular-gene-therapy-products\/approved-cellular-and-gene-therapy-products"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1038\/d41573-024-00094-4"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.01654-22"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinmicnews.2021.10.001"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.01492-19"},{"key":"e_1_3_3_7_2","volume-title":"Guidance for industry sterile drug products products by aseptic processing - current good manufacturing practice","author":"United States Food and Drug Administration","year":"2004","unstructured":"United States Food and Drug Administration. 2004. Guidance for industry sterile drug products products by aseptic processing - current good manufacturing practice. United States Food and Drug Administration, White Oak, MD."},{"key":"e_1_3_3_8_2","volume-title":"PDA technical report no.56 (TR 56): application of phase-appropriate quality system and cGMP to the development of therapeutic protein drug substance (API or biological active substance)","author":"Parenteral Drug Association","year":"2016","unstructured":"Parenteral Drug Association. 2016. PDA technical report no.56 (TR 56): application of phase-appropriate quality system and cGMP to the development of therapeutic protein drug substance (API or biological active substance). Parenteral Drug Association, Bethesda, MD."},{"key":"e_1_3_3_9_2","doi-asserted-by":"crossref","unstructured":"DeMarco E. 2015. Contamination scare at NIH leaves clinical trial subjects with tough choice. American Association for the Advancement of Science Washington DC.","DOI":"10.1126\/science.aac6803"},{"key":"e_1_3_3_10_2","unstructured":"United States Food and Drug Administration. 2025. Facts about the current good manufacturing practice (CGMP) on United States food and drug administration. Available from: https:\/\/www.fda.gov\/drugs\/pharmaceutical-quality-resources\/facts-about-current-good-manufacturing-practice-cgmp"},{"key":"e_1_3_3_11_2","volume-title":"Guidance for industry quality systems approach to pharmaceutical CGMP regulations","author":"United States Food and Drug Administration","year":"2006","unstructured":"United States Food and Drug Administration. 2006. Guidance for industry quality systems approach to pharmaceutical CGMP regulations. United States Food and Drug Administration."},{"key":"e_1_3_3_12_2","unstructured":"United States District Judge (Sean. D. Jordan). 2025. American clinical laboratory association et al v. U.S. food and drug administration et al (civil no. 4:24-CV-479-SDJ); association for molecular pathology et al v. U.S. food and drug administration et al (civil no. 4:24-CV-824-SDJ). United States Court Eastern District of Texas Sherman Division"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1001\/jamahealthforum.2024.2917"},{"key":"e_1_3_3_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.01488-23"},{"key":"e_1_3_3_15_2","unstructured":"The Pew Charitable Trusts. 2021. The role of lab-developed tests in the in vitro diagnostics market. Available from: https:\/\/www.pewtrusts.org\/en\/research-and-analysis\/reports\/2021\/10\/the-role-of-lab-developed-tests-in-the-in-vitro-diagnostics-market#:~:text=In%202014%2C%20FDA%20estimated%20that develop%20such%20tests%20did%20so.&text=CLIA%20standards%20differ%20from%20those%20applied%20during%20FDA%20premarket%20review"},{"key":"e_1_3_3_16_2","volume-title":"Guidance for industry process validation: general principles and practices","author":"United States Food and Drug Administration","year":"2011","unstructured":"United States Food and Drug Administration. 2011. Guidance for industry process validation: general principles and practices. United States Food and Drug Administration, Silver Spring, MD."},{"key":"e_1_3_3_17_2","unstructured":"United States Pharmacopeia. 2022. USP <1223> validation of alternative microbiological methods. Rockville MD United States Pharmacopeia"},{"key":"e_1_3_3_18_2","unstructured":"United States Centers for Medicare & Medicaid Services. 2025. Individualized quality control plan (IQCP) on United States centers for medicare & medicaid services. Available from: https:\/\/www.cms.gov\/medicare\/quality\/clinical-laboratory-improvement-amendments\/quality-control"},{"key":"e_1_3_3_19_2","unstructured":"United States Pharmacopeia. 2017. USP <1058> analytical instrument qualification. Rockville MD United States Pharmacopeia"},{"key":"e_1_3_3_20_2","unstructured":"American Society for Quality. 2025. FMEA. 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Available from: https:\/\/www.fda.gov\/medical-devices\/ivd-regulatory-assistance\/overview-ivd-regulation"}],"container-title":["Journal of Clinical Microbiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01477-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/jcm.01477-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T13:01:03Z","timestamp":1757509263000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/jcm.01477-24"}},"subtitle":[],"editor":[{"given":"Romney M.","family":"Humphries","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,9,10]]},"references-count":20,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2025,9,10]]}},"alternative-id":["10.1128\/jcm.01477-24"],"URL":"https:\/\/doi.org\/10.1128\/jcm.01477-24","relation":{},"ISSN":["0095-1137","1098-660X"],"issn-type":[{"value":"0095-1137","type":"print"},{"value":"1098-660X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,10]]},"assertion":[{"value":"2025-08-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01477-24"}}