Large Compliance Project Consulting Clients Click a company logo for a description of some of the tasks performed.
Performed/co-performed/observed supplier audits to mentor-train client on cGMP auditing.
Organized QA files and implemented quality systems (e.g., document review and approval,
vendor audit programs, etc.) for this biopharmaceutical company focused on the discovery,
development and commercialization of therapies for the treatment of inflammatory diseases
and bacterial infections
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.
Provided temporary full-time on-site microbiologist to assist with R&D and validation activities.
Reviewed facilities calibration / preventative maintenance (PM) records for GMP compliance.
Completed Change Control checklists, flowcharts and SOPs to assist in the review of Change Control Forms.
Identified the operating range of manufacturing instrumentation and ensured the equipment has been calibrated over the operating range.
Performed GMP Consulting for the Validation Services and Facility departments.
Developed and put in place record management system (including physical infrastructure) by which training records for 1,600 employees are organized and managed.
Established associated policies and procedures.
Developed and put in place procedures meeting GMP requirements for evaluation of training effectiveness.
Reviewed evidence to support vendor certification programs.
Developed system and implemented procedure for assessing accuracy of batch records for this, one of the largest pharmaceutical companies in the world, and is a research-oriented company spanning six therapeutic areas: cardiovascular, gastrointestinal, oncology, respiratory, neuroscience and infection.
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.
Developed a plan to transition an R&D drug product development site to a GMP facility.
Implemented GMP quality system to successfully pass an Establishment Licence inspection.
Identified gaps in quality system, developed full quality plan to implement GMPs; overseeing completion of plan.
Performed full range of interim on-site quality control activities and regulatory activities for independently owned Canadian Private Label manufacturer of OTC, prescription, narcotics, and herbal products.
Set up full quality systems to ensure GMP compliance for phase 2 oral-dose insulin products for Generex, leader in drug delivery for metabolic diseases through the inner lining of the mouth and in the research and development of novel immunomedicines.
GSK produces medicines for five major disease areas - respiratory illness, diabetes, virus control, infections and central nervous system disorders. In addition, they are a leader in vaccines, and are developing new treatments for cancer.
Evaluated the accuracy and adequacy of master records on all pharmaceutical and consumer health products imported by client for sale in Canada. Designed and implemented new, more useful and productive database structure.
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.
Identified gaps in QA activities and created processes and SOPs where needed.
Provided guidance to fabricator and contract lab in becoming compliant to GMPs.
Iovate Health Sciences, Inc. manufactures natural health products and dietary supplements. The company is based in Oakville, Canada.
Analyzed the annual requirements for Natural Health Products (NHPs). Implemented and streamlined the finished product testing and annual confirmatory testing programs.
Ongoing quality work.
Provided GMP guidance on an as-needed basis to this 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.
Provided ongoing QA services and performed GMP compliance activities for a biopharmaceutical company specializing in the research, development, and commercialization of pharmaceutical products and technologies for the management of cancer.
Identified gaps in quality system, developed full quality plan to implement GMPs; oversaw completion of plan.
An ISO 9002 registered Company, L.V.Lomas Limited is among the leading specialty chemical distributors in Canada.
Prepared SOP for Precursor A drug products in preparation for licensing.
Updated warehouse SOPs to ensure product stored at correct temperature.
Set up quality system to ensure continual supply of API materials to customers in compliance with ICH Q7A.
Mead Johnson Nutritionals has a heritage of developing scientifically-based nutritional products and a vision to being the world's leading provider of science based pediatric nutrition products dedicated to providing infants and children with the best start in life.
Provided guidance regarding supplier audit and Establishment Licence amendment.
Ensured compliance with Health Canada regulations in transferring fabrication of a number of drug products from a foreign site to a Canadian fabricating facility.
Implemented GMP quality system at facility for contract secondary and specialty packager.
Sanofi Pasteur is the country's largest vaccine company with a proud heritage and commitment to public health. They provide important and superior vaccines for the prevention and treatment of infectious diseases, common illnesses and cancers.
Assisting with implementation of best practices to ensure production areas meet site requirements for Global Quality Directives.
Assisted with backlog of non-conformances and customer complaints.
Assisted with backlog of batch production records, reviewed for product release.
Determined maximum holding times for various intermediates.
Implemented protocol for a Historical Data Analysis.
Expedited the investigation, documentation, and closure of Process Deviation Reports (PDRs).
Consolidated process validation and bacteriology/bioburden compliance information for verification reports.
Organized, reviewed and verified stability data for Research & Development department; prepared detailed stability reports.
Prepared GMP quality manual for this national designer and producer of corrugated distribution packaging, specialty retail packaging and creative point-of-purchase solutions.
Transition Therapeutics Inc. is a biopharmaceutical company with a proprietary state-of-the art drug discovery engine and extensive drug development program exploring novel therapeutics in multiple disease indications.
Evaluated third party compliance with ICH Q7A.
Reviewed batch documentation to support CTA Part 2 (Quality & Manufacturing) specifications and technical information.
Developed, implemented and coordinated corporate quality system and GMP functions with third party fabricators, testing laboratories, storage sites and clinical sites.
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.
Designed and implemented full Quality System in preparation for new product launch.
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.
Acted as quality control advisor for veterinary wholesaler:
• Performed GMP self-inspection to address Health Canada
audit finding.
• Developed and implemented corrective actions.
• Wrote/revised SOPs.
• Performed GMP training, mentored client for performance of
ongoing training.
Virox Technologies Inc. has pioneered the broader acceptance of Hydrogen Peroxide based products with a patented technology known as Accelerated Hydrogen Peroxide (AHP). AHP is a synergistic blend of commonly used, safe ingredients that when combined with low levels of hydrogen peroxide produce exceptional potency as a germicide and performance as a cleaner.
Identified corrective actions required by initial Health Canada findings of GMP compliance gaps.
Coached client staff representative on interpretation of Health Canada and FDA regulations, implementation of GMP compliant systems, drafting of required documentation, and creation of required training materials.
Saw client through to full GMP compliance.
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 Large
Compliance Project Consulting?
Employing Q&C® as your QA personnel will allow
you to focus on your day-to-day activities with
the assurance your quality system is being
maintained in a compliant manner.
As we are a full-service company, we can provide
expertise and assistance with all aspects of
quality and compliance, including auditing,
validation, Quality Control Officer, technical
writing, GMP training, regulatory, and lab
services.
We tailor our services using our proven processes
and templates to provide a practical, efficient and
cost-effective approach to your project.
We employ a team approach to fully address your
needs. We have many highly qualified full-time
consultants/associates; your staff will benefit
from their broad-based knowledge and
experience in quality control and quality
assurance, GMP/NHP/cGMP, and technical
documentation.
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.