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21 CFR Parts 210/211 (use current title)
(b) Copies of Records
Part 101 - Food Labeling
Guidelines for good clinical practice (2005/28/EC)
Health Canada SOR 98-282 Canada Medical Device Regulations
GLP Manufacturing Handbook - 4.5x7.5 58 21 CFR Parts 210/211 (useUS FDA Title 21 CFR Parts: 21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Scope & Application 2003 21 CFR Part 58 Good Laboratory Practice for Non Clinical Studies 21 CFR Parts 210 211 Drug GMPs 21 CFR Part 610 General Biological Products Standards 42 CFR Part 493 Laboratory Requirements (HHS) Guidance: EU Annex 1 Sterile Medicinal Products ICH International Council for Harmonisation: ICH Q1A(R2) Stability Testing of New Drugs
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