<\/p>\n
Big Idea 1 \u2013 GMPs, Regulations and Quality Systems \u2013 <\/span><\/p>\n What do I need to cover in this Big Idea:<\/span><\/p>\n <\/span><\/p>\n Big Idea 5 \u2013 Cleanrooms \u2013 400 words<\/span><\/u><\/b><\/p>\n <\/span><\/p>\n Conclusion \u2013 200 words <\/span> <\/span><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":" Big Idea 1 \u2013 GMPs, Regulations and Quality Systems \u2013 400 words What do I need to cover in this Big Idea: (Major Supporting Point a) Good Manufacturing Practices \u2013 200 words Describe the content of a typical GMP, and identify some regulatory agencies that issues them (e.g. ISO, FDA, etc.). (Major Supporting […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","template":"","meta":[],"disciplines":[713],"paper_types":[],"tagged":[],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/questions\/30336"}],"collection":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/questions"}],"about":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/types\/questions"}],"author":[{"embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/comments?post=30336"}],"version-history":[{"count":0,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/questions\/30336\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/media?parent=30336"}],"wp:term":[{"taxonomy":"disciplines","embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/disciplines?post=30336"},{"taxonomy":"paper_types","embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/paper_types?post=30336"},{"taxonomy":"tagged","embeddable":true,"href":"https:\/\/www.goodacademic.com\/blog\/wp-json\/wp\/v2\/tagged?post=30336"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
\n400 words<\/span><\/u><\/b><\/p>\n\n
\n Supporting Point a) Good Manufacturing Practices \u2013 200 words
\n <\/span><\/b>Describe the content of a typical GMP, and identify
\n some regulatory agencies that issues them (e.g. ISO, FDA, etc.).
\n
\n <\/span><\/li>\n
\n Supporting Point b) Quality Systems Approach to cGMP Regulations \u2013 200 words
\n <\/span><\/b>Describe a quality system model focusing on the
\n management responsibilities, resources, manufacturing operations, and
\n evaluation activities, and how they relate to GMPs.<\/b><\/span><\/li>\n<\/ul>\n
\nWhat do I need to cover in this Big Idea:
\n
\n<\/span><\/p>\n\n
\n <\/span><\/b>Describe a
\n cleanroom configuration from the perspective of airflow direction, filter
\n arrangements, cleanroom gowning, and personnel and material flows – <\/span>to both contain high potency medicines
\n from escaping into the environment, as well as preventing their contamination
\n from external sources.
\n
\n <\/span><\/li>\n
\n Protection & Monitoring \u2013 200 words<\/span><\/b>
\n Discuss the range of airlock configurations typically used to maintain the
\n critical environmental zones of cleanrooms, their impact on controlling the
\n risk of contamination, and how they maintain product quality. In addition,
\n discuss the relationship between the physical tests used to monitor
\n cleanroom environments (e.g. pressure differentials, airflow velocity, etc,)
\n to the GMPs required to consistently manufacture safe medicines, vaccines
\n and medical devices.<\/span><\/li>\n<\/ul>\n
\n<\/span><\/u><\/b><\/div>\n