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Good manufacturing practices guide for drug products …

(5 days ago) WEBGood manufacturing practices guide for drug products (GUI-0001) - Summary. These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, …

https://open.canada.ca/data/en/dataset/03ad7152-47b1-4319-a89b-414c0e0c6f7c

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Good manufacturing practices guide for drug products.

(1 days ago) WEBCanada. Health Canada, issuing body. Title : Good manufacturing practices guide for drug products. Publication type : Monograph : Language [English] Other language editions

https://publications.gc.ca/site/eng/9.886144/publication.html

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Good manufacturing practices guide for drug products GUI …

(2 days ago) WEBGUI-0001 Health Canada Issued 28 Feb 2018 Implementation 01 Oct 2018.Rx-0.org This summary was prepared by the Rx-360 Monitoring and Reporting Working Group which …

https://rx-360.org/wp-content/uploads/2018/08/GMP-Guide-for-Drug-Products-GUI-001-Canada.pdf

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Guidance Document - Annex 13 to the Current Edition of the …

(6 days ago) WEB2009 Health Canada guidance document providing guidance relevant to the fabrication, packaging and labelling of drugs intended for use in human clinical trials

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/annex-13-good-manufacturing-practices-guidelines-drugs-clinical-trials-0036.html

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Drug Establishment Good Manufacturing Practices - canada.ca

(Just Now) WEB2011 Health Canada pre-application package to assist in preparing for an initial drug Good Manufacturing Practices inspection (GUI-0001) version 2 as …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/application-package-importers-distributors-wholesalers.html

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Annex 11 to the Good manufacturing practices guide …

(3 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/Annex-11-to-the-Good-Manufacturing-Practices-Guide-Computerized-Systems-(GUI-0050)-ENG-.pdf

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Annex 2 to the Current Edition of the Good Manufacturing …

(7 days ago) WEBThe guidance included in this Annex when placed in context with the "Good Manufacturing Practices (GMP) Guidelines (GUI-0001)", should facilitate compliance …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-2-current-edition-guidelines-schedule-drugs-biological-drugs-0027.html

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Good manufacturing practices guide for drug products (GUI-0001

(8 days ago) WEBThese guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. Guidance documents like this one are meant to help …

https://open.canada.ca/data/en/info/03ad7152-47b1-4319-a89b-414c0e0c6f7c/resource/a3d8e7c0-cc15-4b4c-b787-916e1a2e5eeb

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Risk classification guide for drug good manufacturing practices

(2 days ago) WEBThis guidance document is based on the current edition of the Good manufacturing practices guide for drug products (GUI-0001) and the Good Manufacturing Practices …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/risk-classification-drug-gmp-observations-0023.html

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Guidance: How to demonstrate foreign building compliance

(Just Now) WEB2003 (revised 2009) Health Canada guidance document. 2003 (revised 2009) Health Canada guidance document. Skip to main content; Skip to "About government" …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guidance-evidence-demonstrate-drug-compliance-foreign-sites-0080.html

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Good manufacturing practices guide for drug products

(8 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. We assess the safety of drugs and many consumer …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/gui-0001-eng.pdf

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Good manufacturing practices for active pharmaceutical …

(9 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/guidelines-active-pharmaceutical-ingredients-0104/pub1-eng.pdf

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POL-0011: Good manufacturing practices inspection policy for …

(1 days ago) WEBHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of …

https://publications.gc.ca/collections/collection_2022/sc-hc/H139-39-2022-eng.pdf

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Canadian GMP Guidelines GUI-0001 July 1, 2020 - GMP Publications

(4 days ago) WEBCanadian GMP Guidelines GUI-0001 July 1, 2020. 978-1-935131-03-8. This guideline on Good Manufacturing Practices (GMP) pertain to Division 2, Part C of the …

https://www.gmppublications.com/canadiangmpdetails.htm

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Canada Revised versions of drug good manufacturing practices

(5 days ago) WEBGUI-0001, GUI-0023, and GUI-0031 are revised versions of currently posted documents and GUI-0119 is a new document to replace the sterile products section of GUI-0001. …

https://prais.paho.org/en/canada-revised-versions-of-drug-good-manufacturing-practices-gmp-documents-are-available/

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