Recent 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.

Performed The Gap Analysis of a medical devices facility to evaluate compliance to the Health Canada Medical Device Regulations. The audit was to determine Gaps and Risk Assessment for an upcoming Health Canada MDEL Inspection.

Performed 14 supplier audits for a customer, which included visits to facilities in India, Italy, Germany, Austria, Poland, Portugal and Belgium.

Our team performs annual audits on over 15 infusion clinics which deliver drugs for treating multiple sclerosis and Crohn's disease.

Performed a Self-Inspection Mock Audit at a drug fabrication facility to evaluate compliance to the Health Canada (HPFBI) Good Manufacturing Practices (GMP) in preparation for a Health Canada Inspection.

Provided the lead auditor with technical expertise, as we assisted a multinational pharmaceutical company in auditing a supplier providing fabricating, packaging and testing. The audit was to evaluate compliance to Health Canada GMPs as well as the customers manufacturing audit expectations.

Validated an off-the-shelf Warehouse Management System for a privately owned Canadian importing and distributing company.

Qualified and mapped a stability chamber for storage of drug products by a Canadian subsidiary that manufactures and markets products that save and sustain the lives of people with hemophilia, kidney disease or other immune disorders or compromises.

Executed a shipping study for Canada’s largest national distributor of pharmaceuticals and health care products.

Our team has performed seasonal temperature mapping studies for regulated product storage facilities for several of Canada's largest importers and distributors, as well as at many of the smaller companies.

Qualified packaging equipment at a Canadian contract packager of drug and natural health products.

Remediated and re-qualified the water system at a Canadian manufacturer of drug, natural health products and medical devices.

Successfully negotiated a plan of corrective actions for a medical device and infection control fabricator that received a Non-Compliant rating from Health Canada.

Worked with a respected fabricator of veterinary products to get them back into compliance following a Non-Compliant rating from Health Canada.  Stepping in as the company's interim Quality Control management, we hosted a successful audit after some minor corrective actions and received a compliant rating.

Created the processes for the stability program development, and the finished product specification development for Canada's largest manufacturer of vaccines for the prevention and treatment of infectious diseases, common illnesses, and cancers.

Successfully implemented a plan of corrective actions for a drug importer that received a Non-Compliant rating from Health Canada inspection focused on data integrity.  Following the corrective actions, the American multinational received a compliant rating and has been returned to the regular audit cycle.

After being hit with a Non-Compliant rating from Health Canada, this importer of prescription drugs and Natural Health Products (NHPs) needed to quickly review their Quality Control procedures.

Q&C has had the pleasure of working with this well known British Cosmetic and Skin Care company which has made themselves a fixture at nearly every shopping mall across Canada.

This on-going project involves importing large volumes of over 100 different Over-The-Counter (OTC) pharmaceuticals and Natural Health Products (NHP) for resale at several of Canada's biggest brands including WalMart, Loblaws and Shoppers Drug Mart.

Set up and operated the importing department for a newly formed Canadian pharmaceutical company specializing in legacy pharmaceuticals. Our company acted as their narcotic AQPIC while they grew their internal full-time employee base, eventually taking on all responsibilities themselves.

Our specialist team was contacted by this European multinational pharmaceutical importer that has become a household name, to validate a corporate Quality Assurance spreadsheet and information tool for their internal Quality Assurance to sign-off on it.

Brought in to help this Canadian multinational pharmaceutical fabricator complete their data integrity checks, our team was right at home working with SAP to validate the custom electronic controls in their manufacturer ERP system.

A Canadian API fabricator contacted our team regarding an application and hardware validation of their operations. We set to work and our team qualified their IT network infrastructure, deployed and validated a new corporate backup solution, and provided documented associate procedures for system use.

Our team was asked by this Canadian API fabricator to design and deploy an Empower CDS instrumentation system. This entailed qualifying the infrastructure, followed by validating the laboratory instrumentation and computerized system controls for their intended use.

We were approached by this American multinational pharmaceutical fabricator with the request to develop and deliver a module-based technical training program which would educate their personnel on several aspects of regulatory requirements. We were thrilled to help.