{"id":1092,"date":"2020-03-20T10:56:32","date_gmt":"2020-03-19T23:56:32","guid":{"rendered":"http:\/\/paulyeatman.net.au\/?p=1092"},"modified":"2020-03-21T10:02:44","modified_gmt":"2020-03-20T23:02:44","slug":"question-regarding-making-cephalosporin-and-cytotoxic-drugs-in-the-same-building","status":"publish","type":"post","link":"https:\/\/paulyeatman.net.au\/index.php\/2020\/03\/20\/question-regarding-making-cephalosporin-and-cytotoxic-drugs-in-the-same-building\/","title":{"rendered":"Question Regarding Making Cephalosporin and Cytotoxic Drugs in the Same Building"},"content":{"rendered":"

The Question posed on <\/strong><\/a>LinkedIn:<\/strong><\/h4>\n

“Dear Experts: Is it possible to make Cephalosporin and Cytotoxic drug in a same building considering Risk Assessment ?<\/span>“<\/h4>\n

<\/p>\n

My reply was this:<\/h4>\n

“Hi Saiful. <\/span><\/p>\n

This would suggest yes. <\/span>https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC6776210<\/a>\/ <\/span><\/p>\n

This FDA related article (an old one) indicates yes: <\/span>https:\/\/pink.pharmaintelligence.informa.com\/PS012026\/CEPHALOSPORINS-MAY-REQUIRE-SEPARATE-MANUFACTURING-FACILITIES<\/a> <\/span><\/p>\n

I have worked at sites where different classes of drugs were made under the same roof but in segregated facilities. Such a setup is supported by this guidance for industry: <\/span>https:\/\/www.gmp-compliance.org\/gmp-news\/new-fda-guidance-for-the-prevention-of-cross-contamination-of-beta-lactam-antibiotics<\/a> <\/span><\/p>\n

Kind Regards<\/span><\/p>\n

Paul<\/span>“<\/p>\n

The other replies all said no.\u00a0 I asked one of the other ‘experts’ if that was no to same roof or non segregated production so I could update my knowledge.<\/p>\n

The answer from one with better knowledge than me was..<\/p>\n

“there is of course a wide range of technical solutions available, how ‘segregation’ or ‘dedication’ of production facilities may be realised – including walls and full separation of airflows within one and the same building. In the case of sensitizing substances with no defined threshold dose or concentration, however, I would be very cautious because the closer two productions are (production \/ engineering & QA staff, flow of materials and waste, air, utilities, QC labs, sanitary and social areas, …), the more scenarios of potential cross-contamination are generated which need to be controlled (with virtually zero tolerance for failures) –> frequently the technical risk assessment will show that this is almost impossible to achieve. Scientific or risk considerations apart, you should also expect that certain GMP supervisory authorities will not be prepared to enter into a detailed assessment of your specific technical and organizational solution but simply (and possibly rightfully) just expect adherence to general principles with regard to dedication of production facilities.<\/span>“<\/p>\n

I think a risk assessment would show risk of stuff up: low to medium, impact of stuff up: large.\u00a0 Result – segregate.<\/p>\n","protected":false},"excerpt":{"rendered":"

The Question posed on LinkedIn: “Dear Experts: Is it possible to make Cephalosporin and Cytotoxic drug in a same building considering Risk Assessment ?“<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21,5],"tags":[12,66],"class_list":["post-1092","post","type-post","status-publish","format-standard","hentry","category-advice-provided","category-documentation","tag-guidelines","tag-manufacturing"],"_links":{"self":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1092","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/comments?post=1092"}],"version-history":[{"count":6,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1092\/revisions"}],"predecessor-version":[{"id":1106,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/posts\/1092\/revisions\/1106"}],"wp:attachment":[{"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/media?parent=1092"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/categories?post=1092"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/paulyeatman.net.au\/index.php\/wp-json\/wp\/v2\/tags?post=1092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}