Links

Good Manufacturing Practices Guidelines, 2009 Edition

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/compli-conform/gmp-bfp/docs/gui-0001-eng.pdf

Evidence for Quality of Finished Natural Health Products

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq_e.html

Laboratory Biosafety Guidelines

http://www.phac-aspc.gc.ca/ols-bsl/lbg-ldmbl/index.html

Good Manufacturing Practices (GMP) Questions and Answers

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/question/gmp-bpf_e.html

Health Canada

Natural Health products

Consumer product safety

Drugs and Health Products

Health Canada, GUIDANCE FOR INDUSTRY, Stability Testing of Existing Drug Substances and Products

FDA

FDA Guidance for Industry, Dissolution Testing of Immediate Release Solid Oral Dosage Forms

http://www.fda.gov/cder/guidance/1713bp1.pdf

FDA, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms

http://www.fda.gov/cder/guidance/3618fnl.pdf

EURO-PHARM International Canada Inc.

 


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