Prepare yourself for impending Health Canada/FDA/corporate audits and complete your self-inspections with ease by contracting Q&C® to perform your routine and pre-regulator audits.

We will conduct a gap analysis of your Quality Systems. Then we will develop and deliver a prioritized compliance action plan which specifies how to prepare for your impending audit successfully.

Canada is participant to Mutual Recognition Agreements (MRAs) covering drug/medicinal products. The European Community, Switzerland, Iceland, Liechtenstein, Norway and Australia will recognize audits conducted by our company. Protect your licensing and accreditations. Book your facility and subcontractor audits now.


  • Annual self-inspections
  • GMP audits
  • Data Integrity audits
  • Clinical trial/CTA audits
  • Infusion clinic audits
  • Controlled substance audits
  • Quality Assurance Report (QARs) for NHP

Q&C provides GMP auditing of:

  • Fabricators
  • Packagers
  • Labellers
  • Importers
  • Distributors
  • Laboratories
  • Wholesalers
  • Warehouses

Q&C also provides third party supplier/subcontractor audits of:

  • Co-packers
  • API and raw material suppliers
  • Packaging component suppliers
  • Infusion clinics
  • GVP providers

Auditing Standards

Health Canada/MRA

  • Drug Good Manufacturing Practices (GMP)
  • ICH Q7 Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs)
  • Active Pharmaceutical Ingredients GMPs
  • Natural Health Products Good Manufacturing Practices (GMP)
  • Good Pharmacovigilance Practices (GVP)
  • Marihuana for Medical Purposes Regulations (MMPR) (SOR/2013-119)


  • Current Good Manufacturing Practices (cGMPs)
  • Current Good Manufacturing Practices (cGMP) for Dietary Supplements

Recent Auditing Projects


Performed the GMP Gap Analysis audit at a proposed medical cannabis facility located in Brampton.  The audit was to evaluate compliance to the Health Canada (HPFBI) Good Production Practices (GPP) for MMP Regulations.