https://owl.unipharm.com/mediawiki/index.php?action=history&feed=atom&title=Distribution_Centre%3AHealth_Canada_Regulations_%26_Guidelines 2026-09-01T11:45:46Z Revision history for this page on the wiki MediaWiki 1.35.4 https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11249&oldid=prev 2018-03-02T19:36:04Z

<p><span dir="auto"><span class="autocomment">Other Resources</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 19:36, 2 March 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 98:</td> <td colspan="2" class="diff-lineno">Line 98:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/guidelines-active-pharmaceutical-ingredients-0104.html Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API)] '''GUI-0104'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/guidelines-active-pharmaceutical-ingredients-0104.html Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API)] '''GUI-0104'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">−</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/publications/healthy-living/loss-theft-controlled-substances-precursors.html Reporting of loss or theft of controlled substances and precursors]</div></td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">*</ins>[https://www.canada.ca/en/health-canada/services/publications/healthy-living/loss-theft-controlled-substances-precursors.html Reporting of loss or theft of controlled substances and precursors]</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <!-- diff cache key wikidb:diff:wikidiff2:1.12:old-11248:rev-11249:1.11.0 --> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11248&oldid=prev 2018-03-02T19:35:43Z

<p><span dir="auto"><span class="autocomment">Other Resources</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 19:35, 2 March 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 97:</td> <td colspan="2" class="diff-lineno">Line 97:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-manufacturing-practices-positiron-emitting-radiopharmaceuticals.html Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)] '''GUI-0071'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-manufacturing-practices-positiron-emitting-radiopharmaceuticals.html Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)] '''GUI-0071'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/guidelines-active-pharmaceutical-ingredients-0104.html Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API)] '''GUI-0104'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/guidelines-active-pharmaceutical-ingredients-0104.html Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API)] '''GUI-0104'''</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/publications/healthy-living/loss-theft-controlled-substances-precursors.html Reporting of loss or theft of controlled substances and precursors]</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <!-- diff cache key wikidb:diff:wikidiff2:1.12:old-11233:rev-11248:1.11.0 --> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11233&oldid=prev 2018-02-28T23:55:44Z

<p><span dir="auto"><span class="autocomment">Good Manufacturing Practices (GMP)</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 23:55, 28 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 53:</td> <td colspan="2" class="diff-lineno">Line 53:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==Good Manufacturing Practices (GMP)==</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==Good Manufacturing Practices (GMP)==</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html Good Manufacturing Practices (GMP) Guidelines] '''2009 Edition, Version 2, issued Feb. 28, 2018, GUI-0001'''.</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html Good Manufacturing Practices (GMP) Guidelines] '''2009 Edition, Version 2, issued Feb. 28, 2018, GUI-0001'''.</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/risk-classification-drug-gmp-observations-0023/document.html Risk classification guide for drug good manufacturing practices observations] '''GUI-0023'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>===GUI-0069===</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>===GUI-0069===</div></td> </tr> <!-- diff cache key wikidb:diff:wikidiff2:1.12:old-11232:rev-11233:1.11.0 --> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11232&oldid=prev 2018-02-28T23:53:23Z

<p><span dir="auto"><span class="autocomment">Good Manufacturing Practices (GMP)</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 23:53, 28 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 52:</td> <td colspan="2" class="diff-lineno">Line 52:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==Good Manufacturing Practices (GMP)==</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==Good Manufacturing Practices (GMP)==</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html Good Manufacturing Practices (GMP) Guidelines] '''2009 Edition, Version 2, issued Feb. 28, 2018, GUI-0001'''.</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>===GUI-0069===</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>===GUI-0069===</div></td> </tr> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11231&oldid=prev 2018-02-28T23:53:11Z

<p><span dir="auto"><span class="autocomment">GMP Inspection</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 23:53, 28 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 67:</td> <td colspan="2" class="diff-lineno">Line 67:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==GMP Inspection==</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==GMP Inspection==</div></td> </tr> <tr> <td class="diff-marker">−</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/good-manufacturing-practices-guidelines-2009-edition-version-2-0001.html Good Manufacturing Practices (GMP) Guidelines] '''2009 Edition, Version 2, GUI-0001'''.</div></td> <td colspan="2" class="diff-empty">&#160;</td> </tr> <tr> <td class="diff-marker">−</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"></td> <td colspan="2" class="diff-empty">&#160;</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/inspection-policy-canadian-drug-establishments.html GMP Inspection Policy for Canadian Drug Establishments] '''POL-0011'''.</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/inspection-policy-canadian-drug-establishments.html GMP Inspection Policy for Canadian Drug Establishments] '''POL-0011'''.</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <!-- diff cache key wikidb:diff:wikidiff2:1.12:old-11230:rev-11231:1.11.0 --> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11230&oldid=prev 2018-02-27T19:49:47Z

<p><span dir="auto"><span class="autocomment">Medical Device Inspection</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 19:49, 27 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 46:</td> <td colspan="2" class="diff-lineno">Line 46:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.html How Health Canada inspects medical device establishments].</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/medical-devices/inspects-medical-device-establishments-0064.html How Health Canada inspects medical device establishments].</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>'''Note:'''</div></td> </tr> <tr> <td class="diff-marker"><a class="mw-diff-movedpara-left" title="Paragraph was moved. Click to jump to new location." href="#movedpara_3_2_rhs">&#x26AB;</a></td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><a name="movedpara_2_0_lhs"></a>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/guidance-investigation-reported-medical-device-problems-0065.html Guidance on Investigation of Reported Medical Device Problems].</div></td> <td colspan="2" class="diff-empty">&#160;</td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*An inspection takes place if you have a medical device establishment licence (MDEL) and are a distributor (Class I-IV medical devices). Regular inspections are every '''5 years'''.</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker"><a class="mw-diff-movedpara-right" title="Paragraph was moved. Click to jump to old location." href="#movedpara_2_0_lhs">&#x26AB;</a></td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><a name="movedpara_3_2_rhs"></a>[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/guidance-investigation-reported-medical-device-problems-0065.html Guidance on Investigation of Reported Medical Device Problems]<ins class="diffchange diffchange-inline"> provides an overview of procedures if there is a problem with a product such as risk management (roles and responsibilities of distributors), problem investigation (documenting, implementing, and evaluation)</ins>.</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==Good Manufacturing Practices (GMP)==</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==Good Manufacturing Practices (GMP)==</div></td> </tr> <!-- diff cache key wikidb:diff:wikidiff2:1.12:old-11229:rev-11230:1.11.0 --> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11229&oldid=prev 2018-02-27T18:24:59Z

<p><span dir="auto"><span class="autocomment">Other Resources</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 18:24, 27 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 92:</td> <td colspan="2" class="diff-lineno">Line 92:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[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 Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs)] '''GUI-0027'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[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 Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs)] '''GUI-0027'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-manufacturing-practices-positiron-emitting-radiopharmaceuticals.html Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)] '''GUI-0071'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-manufacturing-practices-positiron-emitting-radiopharmaceuticals.html Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)] '''GUI-0071'''</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/guidelines-active-pharmaceutical-ingredients-0104.html Good Manufacturing Practices (GMP) Guidelines for Active Pharmaceutical Ingredients (API)] '''GUI-0104'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <!-- diff cache key wikidb:diff:wikidiff2:1.12:old-11228:rev-11229:1.11.0 --> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11228&oldid=prev 2018-02-27T18:08:37Z

<p><span dir="auto"><span class="autocomment">GMP Inspection</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 18:08, 27 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 75:</td> <td colspan="2" class="diff-lineno">Line 75:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>::4. Quality Control</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>::4. Quality Control</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>::5. Records</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>::5. Records</div></td> </tr> <tr> <td class="diff-marker">−</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div><del class="diffchange diffchange-inline">A</del> observation of risk will be assessed and a rating will be given (more <del class="diffchange diffchange-inline">info</del> on the Risk Classification of GMP Observations: [https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/risk-classification-observations-0023.html '''GUI-0023''')].</div></td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div><ins class="diffchange diffchange-inline">An</ins> observation of risk will be assessed and a rating will be given (more <ins class="diffchange diffchange-inline">information can be found</ins> on the Risk Classification of GMP Observations: [https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/risk-classification-observations-0023.html '''GUI-0023''')].</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>'''Tip:'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>'''Tip:'''</div></td> </tr> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11227&oldid=prev 2018-02-27T17:58:39Z

<p><span dir="auto"><span class="autocomment">Other Resources</span></span></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 17:58, 27 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 89:</td> <td colspan="2" class="diff-lineno">Line 89:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002.html Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees] '''GUI-0002'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002.html Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees] '''GUI-0002'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/drug-good-manufacturing-practices-establishment-licensing-enforcement-directive-0004.html Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive] '''POL-0004'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/drug-good-manufacturing-practices-establishment-licensing-enforcement-directive-0004.html Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive] '''POL-0004'''</div></td> </tr> <tr> <td class="diff-marker">−</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html Compliance and Enforcement Policy] '''POL-0001<del class="diffchange diffchange-inline">'</del>'''</div></td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html Compliance and Enforcement Policy] '''POL-0001'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[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 Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs)] '''GUI-0027'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[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 Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs)] '''GUI-0027'''</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-manufacturing-practices-positiron-emitting-radiopharmaceuticals.html Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)] '''GUI-0071'''</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-manufacturing-practices-positiron-emitting-radiopharmaceuticals.html Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)] '''GUI-0071'''</div></td> </tr> <!-- diff cache key wikidb:diff:wikidiff2:1.12:old-11226:rev-11227:1.11.0 --> </table>

Mikeg https://owl.unipharm.com/mediawiki/index.php?title=Distribution_Centre:Health_Canada_Regulations_%26_Guidelines&diff=11226&oldid=prev 2018-02-27T17:42:03Z

<p></p> <table class="diff diff-contentalign-left diff-editfont-monospace" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #202122; text-align: center;">Revision as of 17:42, 27 February 2018</td> </tr><tr> <td colspan="2" class="diff-lineno">Line 85:</td> <td colspan="2" class="diff-lineno">Line 85:</td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==CAPDM - Safe and Secure Practices==</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>==CAPDM - Safe and Secure Practices==</div></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>Please see person in charge for more information.</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>Please see person in charge for more information.</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>==Other Resources==</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/guidance-drug-establishment-licences-drug-establishment-licensing-fees-0002.html Guidance on Drug Establishment Licences and Drug Establishment Licensing Fees] '''GUI-0002'''</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/directives-guidance-documents-policies/drug-good-manufacturing-practices-establishment-licensing-enforcement-directive-0004.html Drug Good Manufacturing Practices (GMP) and Establishment Licencing (EL) Enforcement Directive] '''POL-0004'''</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/policies-standards/compliance-enforcement-policy-0001.html Compliance and Enforcement Policy] '''POL-0001''''</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*[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 Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines Schedule D Drugs (Biological Drugs)] '''GUI-0027'''</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>*[https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/annex-manufacturing-practices-positiron-emitting-radiopharmaceuticals.html Annex to the Good Manufacturing Practices Guidelines Good Manufacturing Practices (GMP) for Positron Emitting Radiopharmaceuticals (PERs)] '''GUI-0071'''</div></td> </tr> <tr> <td colspan="2" class="diff-empty">&#160;</td> <td class="diff-marker">+</td> <td style="color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td> </tr> <tr> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; color: #202122; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[[Category: Health Canada]]</div></td> <td class="diff-marker">&#160;</td> <td style="background-color: #f8f9fa; 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Mikeg