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Process qualification
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<h2 id="see-also">See also</h2> <ul><li><a href="/facts/Installation_qualification/hgqysrzb">Installation qualification</a></li> <li><a href="/facts/Design_qualification/hgqysrzb">Design qualification</a></li> <li><a href="/facts/Performance_qualification/hgqysrzb">Performance qualification</a></li> <li><a href="/facts/Process_validation/KBylubUB">Process validation</a></li></ul> <h2 id="external-links">External links</h2> <ul><li><a href="https://www.slideshare.net/shettyuc/process-validation-for-beginners">Drugregulations.org</a></li></ul> <h2 id="references">References</h2> <ol> <li id="fn:1"><p>"Process Qualification". Atris Information Systems. Retrieved November 17, 2014. <a href="http://www.atris-systems.com/cms/index.php?id=215" target="_blank">http://www.atris-systems.com/cms/index.php?id=215</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li> <li id="fn:2"><p>"Guidance for Industry Process Validation: General Principles and Practices" (PDF). Food and Drug Administration. Retrieved November 17, 2014. <a href="https://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf" target="_blank">https://www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li> <li id="fn:3"><p>"Process Validation A Lifecycle Approach" (PDF). Food and Drug Administration. Retrieved November 17, 2014. <a href="https://www.fda.gov/downloads/aboutfda/centersoffices/cder/ucm255585.pdf" target="_blank">https://www.fda.gov/downloads/aboutfda/centersoffices/cder/ucm255585.pdf</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li> <li id="fn:4"><p>"PROCESS QUALIFICATION (P2Q)". validation-online.net. Retrieved November 17, 2014. <a href="http://www.validation-online.net/process-qualification.html" target="_blank">http://www.validation-online.net/process-qualification.html</a> <a href="#fnref:4" class="footnote-back-ref">↩</a></p></li> <li id="fn:5"><p>"DIRECTIVE 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use" (PDF). European Commission. Retrieved November 17, 2014. <a href="http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf" target="_blank">http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf</a> <a href="#fnref:5" class="footnote-back-ref">↩</a></p></li> </ol>