Health Canada Oos Guidance

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Guide to validation – drugs and supporting activities (GUI-0029)

(2 days ago) WEB2004 (revised 2009) Health Canada document to provide guidance to the pharmaceutical industry in dealing with validation issues for sterile and non-sterile …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/validation-guidelines-pharmaceutical-dosage-forms-0029.html

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Guidance Documents – Applications and submissions - canada.ca

(2 days ago) WEBProduct Vigilance. Veterinary Drugs Application and Submission Guidance Documents. Date modified: 2024-01-02. Health Canada guidance documents to assist in the …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents.html

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Specifications: Test Procedures and Acceptance Criteria …

(4 days ago) WEBHealth Canada is pleased to announce the adoption of the ICH guidance document Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/specifications-test-procedures-acceptance-criteria-new-drug-substances-new-drug-products-chemical-substances-topic.html

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Clinical Practice Guidelines Resources – Ontario Osteoporosis …

(4 days ago) WEBGuide to Osteoporosis Management and Fracture Prevention. Osteoporosis Canada 2023 Guideline – Your updated resource for optimizing bone health and preventing fractures …

https://osteostrategy.on.ca/new-management-guidelines/

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Guidance Document

(6 days ago) WEBGuidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance …

https://www.publications.gc.ca/collections/collection_2021/sc-hc/H164-277-2021-eng.pdf

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Investigating Out-of-Specification (OOS) Test Results for

(4 days ago) WEBThis guidance for industry provides the Agency’s current thinking on how to evaluate out-of- specification (OOS) test results. For purposes of this document, the …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision

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Occupational Health Evaluation Standard

(8 days ago) WEBThere are three categories of health evaluations: 6.1.1. Category 1: A confidential personal health declaration completed by the employee and reviewed by an appropriate …

https://www.publications.gc.ca/collections/collection_2018/sct-tbs/BT43-145-2013-eng.pdf

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Guidance Document

(2 days ago) WEBHealth Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613‐957‐2991 Toll free: 1‐866‐225‐0709 Fax: 613‐941‐5366. TTY: 1‐800‐465‐7735. E‐mail: …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-eng.pdf

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FDA Updates Guidance on Investigating Out-of-Specification …

(5 days ago) WEBIn May 2022, the U.S. Food and Drug Administration (FDA) has published a new version (Revision 1) of its Guidance for Industry on Out-of-Specification (OOS) Results. The …

https://www.gmp-compliance.org/gmp-news/fda-updates-guidance-on-investigating-out-of-specification-oos-test-results-for-pharmaceutical-production

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Annex 4 to the current edition of the good manufacturing

(2 days ago) WEBOn March 25, 2024, the Health Product Compliance Directorate posted the following guidance document: Annex 4 to the current edition of the good manufacturing practices …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/annex-4-good-manufacturing-practices-guidelines-veterinary-drugs-gui-0012.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 Guidance 5. Regulations—Raw Out Of Specification 31 8. Foreign sites 9. Sterile …

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

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Canadian Centre for Occupational Health and Safety

(1 days ago) WEBIn our 2021-2022 Departmental Plan, the Canadian Centre for Occupational Health and Safety (CCOHS) will continue to respond to the changing needs of workers and …

https://www.publications.gc.ca/collections/collection_2021/cchst-ccohs/CC271-7-2021-eng.pdf

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Guidance for Industry - U.S. Food and Drug Administration

(Just Now) WEBOffice of Training and Communication Division of Drug Information HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane …

https://www.fda.gov/media/71001/download

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Guidance document : preparation of regulatory activities in the

(1 days ago) WEBGuidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format.: H164-293/2019E-PDF "This guidance document …

https://publications.gc.ca/site/eng/9.882674/publication.html

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Health Canada Implementation of ICH Q12: CMC Changes

(Just Now) WEBHealth Canada is partially aligned • Concept is well understood –we have our CPID (Certified Product Information Document) • Concept of PLCM has been introduced …

https://www.casss.org/docs/default-source/cmc-strategy-forum-north-america/2021-cmc-na-speaker-presentations/hamel-hugo-health-canada-2021.pdf?sfvrsn=9db6e87d_8

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Health Canada Draft Revised Guidance Documents on Post-NOC

(7 days ago) WEBOn August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder …

https://capra.ca/en/blog/health-canada-draft-revised-guidance-documents-on-post-noc-changes-quality-for-consultation-2021-09-30

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Guidance Document

(2 days ago) WEBGuidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance …

https://publications.gc.ca/collections/collection_2023/sc-hc/H164-305-2023-eng.pdf

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Health Canada updates guidance on nitrosamine impurities in …

(4 days ago) WEBHealth Canada has updated the Guidance on nitrosamine impurities in medications. Updates to general and quality-related topics include the following: when …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/drug-establishment-licensing-bulletin/health-canada-updates-guidance-nitrosamine-impurities-medications.html

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