Difference between revisions of "Distribution Centre:Health Canada Regulations & Guidelines"

Latest revision as of 12:36, 2 March 2018

Overview

Health Canada is responsible for establishing standards for the safety and nutritional quality of all foods sold in Canada. The department exercises this mandate under the authority of the Food and Drugs Act and pursue its regulatory mandate under the Food and Drug Regulations.

uniPHARM is committed to following Health Canada and other government regulatory body mandates to ensure our company is following all provincial and federal standards, regulations, and laws.

Resources

Narcotic Control

The Narcotic Control Regulations require uniPHARM to be a licensed dealer and have a quality person in charge with certain requirements. More information can be found on the Narcotic Control Regulations webpage

The Directive On Physical Security Requirements For Controlled Substances goes over the licensed dealer's security requirements for the storage of controlled substances. The purpose of this directive is to ensure that minimum security requirements are met to prevent potential theft of controlled substances. More information can be found on the webpage here

Food & Drug

The Food and Drugs Act and the Food and Drug Regulations are mandates provided by the Government of Canada to protect the safety of Canadians from potential risks of certain food or drugs that may or may not follow established guidelines and regulations. More information can be found on the Food and Drugs Act page and the Food and Drug Regulations page.

Benzo's & Targeted Substances

uniPHARM follows the Controlled Drugs and Substances Act to ensure the company complies with all regulations including the proper disposal of controlled substances. More information can be found on the Controlled Drugs and Substances Act webpage.

Further, the Benzodiazepines and Other Targeted Substances Regulations is followed to comply with proper licensing, handling, classification, and destruction of targeted substances. More information can be found on the Benzodiazepines and Other Targeted Substances Regulations webpage.

Precursors

The Precursor Control Regulations are mandated under the Controlled Drugs and Substances Act and provides detailed content on the licensing, handling, transportation, and destruction of Class A and Class B precursors. More information can be found on the Precursor Control Regulations webpage.

Drug Recalls

The Natural Health Products Regulations are located on the Natural Health Products Regulations webpage.

The Recall Policy is located on the Recall Policy webpage.

Visit: Product Recall Procedures to view what is currently required for procedures of product recalls.

Medical Device Recalls

The Medical Device Regulations apply to any medical device sold or advertised to individuals and describes the different types of classifications of medical devices.

The purpose of the Guide to Recall of Medical Devices is to assist in providing knowledge of how to:

keep medical device distribution records
recall medical devices
report medical device recalls to Health Canada
write procedures for distribution record keeping and recall

Medical Device Inspection

How Health Canada inspects medical device establishments.

Note:

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.

Guidance on Investigation of Reported Medical Device Problems 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).

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Version 2, issued Feb. 28, 2018, GUI-0001.

Risk classification guide for drug good manufacturing practices observations GUI-0023

GUI-0069

The mandate of the Guidelines for Temperature Control of Drug Products during Storage and Transportation is to "promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system". This guide goes over the proper distribution, warehousing and storage, transportation, receiving, and documentation.

Specifically applies to storage and inbound/outbound transportation of:

Pharmaceuticals (OTC, Prescription, Category IV, Ethical)
Biologics (Schedule D)
Radiopharmaceuticals (Schedule C)
Narcotics and Controlled Substances
Clinical Trial Drugs
Professional Samples
Natural Health Products intended for export to MRA
For Human and Veterinary Use

GMP Inspection

GMP Inspection Policy for Canadian Drug Establishments POL-0011.

GMP Inspections typically occur every 36 months for Importers, Distributors, and Wholesalers.
Inspections for uniPHARM ("Wholesaler") reviews the:

1. Premises

2. Personnel

3. Manufacturing Control

4. Quality Control

5. Records

An observation of risk will be assessed and a rating will be given (more information can be found on the Risk Classification of GMP Observations: GUI-0023).

Tip:

When expecting an inspection by Health Canada, always ask the Health Canada inspectors who arrive to show their I.D. to ensure they are who they say they are.

CAPDM - Temperature Control Best Practices

Please see person in charge for more information.

CAPDM - Safe and Secure Practices