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Change control
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== Regulatory environment == In a [[good manufacturing practice]] regulated industry, the topic is frequently encountered by its users. Various industrial guidances and commentaries are available for people to comprehend this concept.<ref name=giqs>{{cite web | last = | first = | title = Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations | publisher = [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] | date = September 2006 | url = https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070337.pdf | archive-url = https://web.archive.org/web/20090709193336/http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070337.pdf | url-status = dead | archive-date = July 9, 2009 | doi = | access-date = 12 July 2009 }}</ref><ref name=cccr>{{cite web |last = Infusion |title = Challenges of Change Control in a Regulated Industry |publisher = |date = |url = http://www.infinityqs.com/asset-library/articles/ChangeControlChallenges.pdf |format = |doi = |access-date = 28 April 2009 }}{{Dead link|date=November 2018 |bot=InternetArchiveBot |fix-attempted=yes }}</ref><ref name=gmpg>{{cite web | last = ICH | author-link = International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use | title = Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients | publisher = | date = | url = http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q7/Step4/Q7_Guideline.pdf | format = | doi = | access-date = 20 April 2011 }}</ref> As a common practice, the activity is usually directed by one or more [[Standard operating procedure|SOP]]s.<ref name=ccss>{{cite web | last = GMP Online Consultancy | title = Change control system: Standard Operating Procedure | publisher = | date = | url = http://www.gmp-online-consultancy.com/e/html/301_direct_order/210_standard-operation-procedures_detail.php?docIndex=60 | format = | doi = | access-date = 28 April 2009 }}</ref> From the [[information technology]] perspective for [[clinical trial]]s, it has been guided by another U.S. [[Food and Drug Administration]] document.<ref name=gics>{{cite web | last = | first = | title = Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS | publisher = [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] | date = April 1999 | url = https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/guidance-industry-computerized-systems-used-clinical-trials | doi = | access-date = 13 May 2021 }}</ref>
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