Audit Clients Click a company logo for a description of some of the tasks performed.
Performed full GMP audit of importation facility for this global medical company specializing in eye care products.
Performed The GMP Gap Analysis™ and self-inspection to identify compliance gaps for HPFBI drug/natural health product GMPs for fabricator.
The Apotex Pharmaceutical Group of Companies develops and manufactures generic pharmaceuticals, researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.
Performed GMP audits of:
• Packaging material suppliers.
• Raw material suppliers.
• Third-party laboratories.
Managed and performed in-house self-inspection audits.
The GMP Gap Analysis™ and self-inspection to Canadian GMPs for importing/distribution operation was performed on this leading supplier of premier makeup, skin care and professional products designed to meet the needs of consumers, dermatologists, aestheticians and plastic surgeons.
Bausch & Lomb's core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products.
Performed The GMP Gap Analysis™ and self-inspection to evaluate compliance to Health Canada drug GMPs at importing/distribution facility.
Biovail Corporation is a specialty pharmaceutical company that applies advanced drug-delivery technologies to improve the clinical effectiveness of medicines. The Company's therapeutic areas of focus are central nervous system (CNS) disorders, pain management and cardiovascular disease.
Performed The GMP Gap Analysis™ to evaluate compliance to FDA cGMPs of potential European contract manufacturer.
Blue-Zone Technologies Ltd., a Canadian Company, specializes in the cost-effective prevention and measurable reduction of greenhouse gas emissions from hospital operating rooms.
Performed The GMP Gap Analysis™ to identify compliance gaps for FDA PAI and HPFBI drug GMPs for fabricator.
Cadbury is a confectionery and beverages company. Today their products include brands such as Cadbury, Schweppes, Halls, Trident, Dr. Pepper, Snapple, Trebor, Dentyne, Bubblicious and Bassett.
Established standards with client.
Performed supplier audits to client-designated standards.
Performed The GMP Gap Analysis™ as a self-inspection to Canadian GMPs for a wholesaling operation.
Performed The GMP Gap Analysis™ on a European sterile facility to evaluate compliance to FDA cGMPs for this specialty pharmaceutical company focusing on the development and commercialization of preventive and curative therapeutics for skin-related problems.
Performed The GMP Gap Analysis™ to evaluate current quality system against Health Canada drug/natural health product importing and distribution requirements, and to meet self-inspection requirements for the world's first company to focus solely on water-based skincare.
Helix is focused on the development and commercialization of innovative medicines in the areas of cancer prevention and treatment. The Company also develops its products for other potential therapeutic applications beyond oncology, and works to expand upon its product development pipeline through its in-house R&D efforts and potential mergers and acquisition activities.
Audited third-party manufacturer of clinical product.
Determined requirements to bring laboratory and quality assurance areas in compliance with GMPs, including validation.
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the Consumer, Pharmaceutical and Medical Devices and Diagnostics markets.
Audited U.S. manufacturer of disinfectant products to Canadian GMPs for product imported/distributed by client.
Audited U.K. manufacturer of disinfectant products to Canadian GMPs to prepare report to be submitted to Health Canada as evidence of GMP compliance.
JohnsonDiversey is a leading global provider of commercial cleaning and hygiene products and solutions for food safety, food and beverage hygiene, floor care, housekeeping and room care, laundry, hand hygiene and industrial cleaning.
Performed self-inspection in accordance with Health Canada drug GMP requirements.
Also performed The Validation Gap Analysis™.
L'Occitane is an international retailer of body, face and home products. The company creates items based on botanicals grown in the tradition of Provence.
Performed The GMP Gap Analysis™ to evaluate compliance to Health Canada drug and natural health product GMPs for importing activities.
An ISO 9002 registered Company, L.V.Lomas Limited is among the leading specialty chemical distributors in Canada.
Performed The GMP Gap Analysis™ as an API supplier qualification to ensure client is compliant with ICH Q7A and Precursor Licensing requirements and to ensure a continual supply of pharmaceutical raw materials to customers.
Performed The GMP Gap Analysis™ to evaluate compliance of U.S. third-party suppliers to Canadian GMPs for the world's leading contract and private label manufacturer of prestige beauty products.
Performed The GMP Gap Analysis™ at two Canadian sites for wholesaler and importer/distributor of drug products to evaluate compliance to Canadian GMPs.
Performed The GMP Gap Analysis™ to evaluate compliance to Health Canada drug and natural health product GMPs as part of self-inspection program to meet importing and distribution requirements for this provider of science based pediatric nutrition products dedicated to providing infants and children with the best start in life.
Performed laboratory facility audit to evaluate compliance to Health Canada drug and natural health product GMPs for this company who specializes in microbiological and analytical testing for cosmetic and pharmaceutical industries.
Northwest Cosmetic Labs is a full service product development and contract manufacturer. They specialize in facial treatment, bath and body, hair care, acne treatment, topical analgesics, antiseptic washes and OTC products.
Performed GMP facility audit to Health Canada and Australian GMP standards.
Novex Pharma is part of the Apotex Group of Companies.
Performed GMP self-inspection audits for sterile drug fabricator:
• Quality control.
• Production (non-sterile and sterile).
• Validation.
• Laboratories.
• Materials management and warehouse.
• Engineering facilities.
• Purchasing.
• Information services.
• Human resources.
Nutrimetics by Avalla
Nutrimetics is one of Australia and New Zealand's leading skincare companies.
Performed general GMP audit for direct-selling skincare and cosmetic importer.
Performed The GMP Gap Analysis™ to evaluate compliance to Canadian and Australian GMPs, and to EU and MRA countries.
Performed The GMP Gap Analysis™ to evaluate compliance to Health Canada GMPs and FDA cGMPs for drug development and contract manufacturing company that specializes in oral dose pharmaceutical products for human consumption.
Performed The GMP Gap Analysis™ to evaluate compliance to Health Canada drug GMPs for two third-party suppliers for this specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients and consumer products.
Performed The GMP Gap Analysis™ on third-party secondary packaging facility in U.S. to evaluate compliance to Canadian GMPs.
Performed The GMP Gap Analysis™ to evaluate compliance to FDA 21CFR Part 11 and PIC/S Annex 11 of Health Canada GMPs for cylinder-filling equipment's software for this global company that supplies atmospheric, process and specialty gases, high-performance coatings, and related services and technologies.
Performed The GMP Gap Analysis™ of importing facility to evaluate compliance to Health Canada GMPs in preparation for expansion into new products of the world's Number 1 in household cleaning (excluding laundry detergents).
Schiff Nutrition International, Inc. develops, manufactures, markets and distributes branded and private label vitamins, nutritional supplements and nutrition bars.
Performed The GMP Gap Analysis™ audit to evaluate compliance to the Health Canada (NHPD) Good Manufacturing Practices (GMP), and prepared a Quality Assurance Report (QAR) for registration with Health Canada.
Smurfit-Image Pac is a national designer and producer of corrugated distribution packaging, specialty retail packaging and creative point-of-purchase solutions.
Performed The GMP Gap Analysis™ to Health Canada GMPs for drug packing facility.
Assisted with audit follow-up activities.
Solvay Pharmaceuticals is a research driven group of companies that constitutes the global pharmaceutical business of the Solvay Group whose aim is to fulfill selected, unmet medical needs in the therapeutic areas of neuroscience, cardiometabolic, influenza vaccines, gastroenterology and men's and women's health.
Performed on-site inspection and prepared gap analysis report for quality assurance and warehousing/distribution activities as per GMP guidelines.
The Body Shop International plc is a global manufacturer and retailer of naturally inspired, ethically produced beauty and cosmetics products.
Performed supplier audits on behalf of client in accordance with Canadian and Australian GMPs, and to EU and MRA countries, for fabricator.
Performed audit of foreign third-party laboratory against Canadian GMPs.
Headquartered in Mississauga, Ontario, Pepsi-QTG Canada is the nation's leader in liquid refreshment, breakfast and wholesome snacking with a roster of Canada's leading brands, including: soft drinks, bottled water, new age healthy refreshment beverages, cold bottled coffee, sports drinks, juices and juice drinks and hot and ready-to-eat cereals, nutrition bars and snacks.
Conducted full audit of US fabricating plant and validation of equipment, process and analytical method.
For over 32 years, Veterinary Purchasing Company Limited has been the leader in the distribution of veterinary supplies, specializing in supplying member veterinarians with the pharmaceuticals, surgical supplies and equipment they need to conduct their business.
A long standing distributor for maxi treat™, Veterinary Purchasing distributes to almost all veterinary hospitals throughout Ontario.
Performed annual self-inspection to evaluate compliance to Health Canada drug GMPs of wholesaling facility.
Provided full GMP audit of fabrication facility for this manufacturer of vitamin products.
Since 1994 Quality & Compliance Services Inc.
(Q&C®) has provided consultation, auditing,
regulatory services, validation, training,
technical writing, Quality Control Officer
services (including product release), and lab
services to a broad range of clients.
Why Hire Us
for Audits?
On completion of Q&C®’s GMP Gap Analysis™ audit,
you will know the compliance gaps, if any, that your processes
and procedures have related to the Health Canada GMP or FDA requirements.
Completing an audit with Q&C® will ensure
you have met Health Canada's self-inspection
requirements. In addition, we will recommend
specific next steps towards compliance for your processes.
An audit with Q&C® will enable you to host
regulatory audits with the confidence that your
systems will comply. You will remove the risk of
losing your Establishment Licence and/or FDA approval.
In some instances, we have assisted in
wide-ranging upgrades of corporate quality and
compliance support systems. In others, we have
helped clients respond to specific regulatory
demands under stringent time constraints. In
all cases, our hallmark has been professional,
timely, and efficient delivery of work that was
both accurate and complete.