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Good automated manufacturing practice
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<h2 id="gamp-guidance">GAMP guidance</h2> <p>ISPE has published a series of good practice <a href="https://ispe.org/publications/guidance-documents?gad_source=1&gclid=Cj0KCQiA2oW-BhC2ARIsADSIAWr9XfY89cWx_FxOGd5Gm__xb6NOJq6faq91QwnTn5uW-Yjomkho-YsaAsY6EALw_wcB">guides</a> for the industry on several topics involved in drug manufacturing. The most well-known is <i>The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture</i>. The second edition (GAMP5) was released in July 2022.<a class="footnote-ref" id="fnref:2" href="#fn:2"><sup>2</sup></a> </p><p>Other publications in the GAMP series include: </p> <ul><li><i>GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems</i></li> <li><i>GAMP Good Practice Guide: Calibration Management</i></li> <li><i>GAMP Good Practice Guide: Electronic Data Archiving</i></li> <li><i>GAMP Good Practice Guide: Global Information Systems Control and Compliance</i></li> <li><i>GAMP Good Practice Guide: IT Infrastructure Control and Compliance<a class="footnote-ref" id="fnref:3" href="#fn:3"><sup>3</sup></a></i></li> <li><i>GAMP Good Practice Guide: Testing of GxP Systems</i></li> <li><i>GAMP Good Practice Guide: Validation of Laboratory Computerized Systems</i></li> <li><i>GAMP Good Practice Guide: Validation of Process Control Systems</i></li></ul> <h2 id="history">History</h2> <p>GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a> expectations for <a href="/facts/Good_manufacturing_practice/s4sETf1y">good manufacturing practice</a> (GMP) compliance of manufacturing and related systems.<a class="footnote-ref" id="fnref:4" href="#fn:4"><sup>4</sup></a> GAMP published its first guidance in 1994. Soon afterwards the organization entered into a partnership with ISPE, formally becoming part of ISPE in 2000. GAMP has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognised good practice worldwide.<a class="footnote-ref" id="fnref:5" href="#fn:5"><sup>5</sup></a> </p> <h2 id="see-also">See also</h2> <ul><li><a href="/facts/Good_manufacturing_practice/s4sETf1y">Good manufacturing practice</a> covering other industries</li> <li><a href="/facts/Corrective_and_preventive_action/bWydduL4">Corrective and preventive action</a> (CAPA)</li> <li><a href="/facts/Pharmaceutical_Inspection_Convention_and_Pharmaceutical_Inspection_Co-operation_Scheme/6nBoDsUB">Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme</a></li> <li><a href="/facts/Validation_(drug_manufacture)/mUQLLCgT">Validation (drug manufacture)</a></li> <li><a href="/facts/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use/RYUIlU5r">International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use</a> (ICH)</li> <li><a href="/facts/European_Medicines_Agency/h9FTtCYc">European Medicines Agency</a> (EMA)</li> <li><a href="/facts/European_Federation_of_Pharmaceutical_Industries_and_Associations/btMusG9l">European Federation of Pharmaceutical Industries and Associations</a> (EFPIA)</li> <li><a href="/facts/Japan_Pharmaceutical_Manufacturers_Association/SCRI6zRp">Japan Pharmaceutical Manufacturers Association</a> (JPMA)</li> <li><a href="/facts/Pharmaceutical_Research_and_Manufacturers_of_America/Q9vsE54j">Pharmaceutical Research and Manufacturers of America</a> (PhRMA)</li></ul> <h2 id="external-links">External links</h2> <ul><li><a href="http://www.ispe.org">ISPE website</a></li></ul> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP)". International Society for Pharmaceutical Engineering. 25 September 2011. Retrieved 28 February 2012. <a href="http://www.ispe.org/glossary?term=Good+Automated+Manufacturing+Practice+%28GAMP%29" target="_blank">http://www.ispe.org/glossary?term=Good+Automated+Manufacturing+Practice+%28GAMP%29</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>"GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems". International Society for Pharmaceutical Engineering. Retrieved 19 September 2022. <a href="https://www.ispe.org/publications/guidance-documents/gamp-5" target="_blank">https://www.ispe.org/publications/guidance-documents/gamp-5</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>"ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) | GAMP Good Practice Guides". International Society for Pharmaceutical Engineering (ISPE). doi:10.1002/9781946964007 (inactive 1 November 2024). Retrieved 2024-02-18.{{cite web}}: CS1 maint: DOI inactive as of November 2024 (link) <a href="https://guidance-docs.ispe.org/doi/book/10.1002/9781946964007" target="_blank">https://guidance-docs.ispe.org/doi/book/10.1002/9781946964007</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>Smith, Paul (1 December 2008). "20th Anniversary Special Feature: Validation and qualification". Pharmaceutical Technology Europe. 20 (2). Retrieved 28 February 2012. <a href="http://www.pharmtech.com/pharmtech/Validation/20th-Anniversary-Special-Feature-Validation-and-qu/ArticleStandard/Article/detail/574642" target="_blank">http://www.pharmtech.com/pharmtech/Validation/20th-Anniversary-Special-Feature-Validation-and-qu/ArticleStandard/Article/detail/574642</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>DeSpautz, Joseph; Kenneth S. Kovacs; Gerhard Werling (11 March 2008). "GAMP Standards For Validation Of Automated Systems". Pharmaceutical Processing. Retrieved 28 February 2012. <a href="http://www.pharmpro.com/article/2008/03/gamp-standards-validation-automated-systems/" target="_blank">http://www.pharmpro.com/article/2008/03/gamp-standards-validation-automated-systems/</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> </ol>