Auditing

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.

Audits

  • 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)

US FDA

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

Recent Auditing Projects

Medical-Marihuana-Audit

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