Guides: Biotechnology: Standards & Regulations

Standards

US Pharmacopeia National Formulary (USP-NF)
Access the United States Pharmacopeia (USP) and the National Formulary (NF). Contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. Register to create an Access Point user account using a valid @dcmail or @durhamcollege.ca email address: USP Access Point Registration
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CSA On Demand
Search by standard title, standard number or click My Library to access the full collection of standards and browse by subject. Access full text using the View Online option. PDF download is not available with our subscription.

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Techstreet Standards
This resource is no longer available. Please use Intertek i2i for access to our custom collection of Standards.
Simultaneous access to standards in electronic format. This custom collection is curated by the Library. To request a standard for electronic access, please contact library.resources@durhamcollege.ca. To open PDF downloads you must install FileOpen
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CCOHS - Canadian Centre for Occupational Health and Safety
Collection of databases focusing on chemicals highlighting their properties, uses, hazards, and availability - Includes MSDS (Material Safety Data Sheets) and associated Ontario and federal legislation and standards. Includes selected CGSB and CSA standards.
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Regulatory Bodies - Canada

Canadian Food Inspection Agency (CIFA)
The Canadian Food Inspection Agency is dedicated to safeguarding food, animals and plants, which enhances the health and well-being of Canada's people, environment and economy.
Canadian Biosafety Standards & Guidelines
Safe handling of human and animal pathogens, toxins and plant pests in laboratories and containment zones.
Canadian Institutes for Health Research (CIHR): Guidlines for Biotchnology Research Funding
Search for relevant guidelines.
Government of Canada Workplace Hazardious Materials Information System (WHMIS)
Provides information about WHMIS with some examples of safety data sheets.
Health Canada - Good Manufacturing Practices & Good Laboratory Practice
To view Good Manufacturing Practices choose
drugs and health products / compliance & enforcement-drug and health products / good manufacturing practices and Covid-19 / Guidance documents-good manufacturing practices / good manufacturing practices guide for drug products
(GUI-0001) - Summary

To view good laboratory practices choose
product safety / consumer products and cosmetics / reports and publications-consumer product safety / pesticides and pest management reports and publications / policies and guidelines.
Public Agency of Canada: Biosafety & Biosecurity
Biosafety training, pathogen hazards, exposure reporting, licences, regulating laboratories or containment zones
Safe Foods for Canadians Regulations
Canadian Dairy Commission Act; Consumer Packaging And Labelling Act; Controlled Drugs And Substances Act; Criminal Code; Customs Tariff; Food And Drugs Act; Feeds Act; Health Of Animals Act; Safe Food For Canadians Act; Seeds Act; CIHR Guidelines

Regulatory Bodies - United States of America

Food and Drug Admistration (FDA):Guidance, Compliance, & Regulatory Information
Guidance documents describe FDA’s interpretation of our policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. Guidance documents are not regulations and alternative approaches may be chosen to comply with laws and regulations.
NIH Biosafety, Biosecurity, & Emerging Biotechnology
The Biosafety, Biosecurity, and Emerging Biotechnology Policy Division focuses on the development and implementation of policies that promote the responsible conduct and oversight of life sciences research. Specific areas of focus include the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), dual use research of concern (DURC), and the NIH Stem Cell Registry.

Regulatory Bodies - International

Good Laboratory Practice: Organization for Economic Cooperation & Development (OECD)
The Organisation for Economic Co-operation and Development (OECD) is an international organisation that works to build better policies for better lives. Our goal is to shape policies that foster prosperity, equality, opportunity and well-being for all. We draw on 60 years of experience and insights to better prepare the world of tomorrow.
HAACP Certification
Demonstrate your commitment to food safety through HACCP certification or a GMP audit.