Quality Management & Certifications

Good Laboratory Practice US-FDA
Good Clinical Practice VICH GL9
Aquatic Containment Level 2 In vitro Canadian Food Inspection
Aquatic Containment Level 3 In vivo Canadian Food Inspection
Closed Premises for Domestic
Movement of Fish & Samples
Canadian Food Inspection
Good Animal Practice Canadian Council
on Animal Care
Good Manufacturing Practices EU – LAVES
Veterinary Biologics QC Testing Canadian Food Inspection
Risk Group II Pathogens
& Toxins License
Public Health Agency
of Canada

Certification overview:

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. GCP provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are respected and protected.

Source: NCBI

GLP is a quality system of management controls that applies to non-clinical studies conducted for the assessment of the safety or efficacy of products in development (including pharmaceuticals) for man, animals, and the environment. The principles of GLP aim to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing. GLP is not limited to chemicals and also applies to medical devices, food additives, food packaging, colour additives, animal food additives, other non-pharmaceutical products or ingredients, biological products, and electronic products.

Source: FDA

The Canadian Council on Animal Care (CCAC) is a Canadian organization that is responsible for "setting and maintaining standards for the care and use of animals in science" within the country. The organization provides ethical standards for the usage of nonhuman animals in laboratories. Its goal is to prevent harmful conduct on animals.

An institution's animal ethics and care program (GAP) is certified every three years based on its compliance with CCAC policies and guidelines and other CCAC-recognized standards.

Source: CCAC

The CFIA movement permit contains conditions that control disease risks associated with the aquatic animal or thing to be shipped or received, and the water, ice, or other medium, materials, equipment and conveyances used during the shipment.

It is required if the declared aquatic animal or thing is moving from:

  • a declared infected area to a declared buffer area, provisionally-free area or free area
  • a declared buffer area to another declared buffer area, provisionally-free area or free area
  • a declared provisionally-free area to a declared free area

Source: CFIA

Veterinary biologic means a thing that is manufactured, sold or represented for use in restoring, correcting or modifying organic functions in animals or for use in the diagnosis, treatment, mitigation or prevention of disease.

VB products include, but are not limited to, vaccines, bacterins, bacterin-toxoids, subunit protein vaccines, plasmid DNA vaccines, replicons, antibody products for administration to animals, immunomodulators, allergenic extracts and diagnostic kits.

Source: CFIA

In AQC2 in vitro facilities, containment is achieved through facility design, operational procedures and the use of specialized equipment. An autoclave or other proven technology must be available to treat solid waste and wastewater. Containment is achieved primarily through operational practices including training in biosafety and containment precautions, limiting access to authorized personnel, use of protective clothing, effective sanitation and housekeeping, and the use of good microbiological laboratory practices. All AQC1 physical and operational requirements also apply to this containment level.

Key additional physical requirements include:

  • on-site autoclave or other proven means of waste treatment;
  • chemical and heat resistant surfaces in accordance with laboratory function.

Key additional operational practices include:

  • use of primary containment devices;
  • use of dedicated or disposable laboratory clothing;
  • appropriate decontamination of solid and liquid waste;
  • designation of a person (e.g. Biosafety Officer (BSO)) to oversee biosafety and
  • biosecurity practices.

Source: CFIA

AQC3 containment is achieved through highly specialized facilities, stringent operational procedures and the use of specialized equipment. All AQC2 physical and operational requirements also apply to this containment level.

Key additional physical requirements include:

  • restricted access through controlled access system;
  • entry provided via an anteroom;
  • dedicated anterooms with change areas;
  • penetrations on containment perimeter must be sealed;
  • inward directional airflow from "clean" to "dirty" areas;
  • drains and associated piping connected to an effluent treatment system;
  • effluent treatment system to have redundancy;
  • electronic data transfer and communication capability; and
  • emergency power for critical equipment and containment systems.

Key additional operational practices include:

  • restricted access with a sign-in log for personnel and visitors entering the facility;
  • full clothing change before entry.

Source: CFIA