QUALITY ASSURANCE
We can assist you with the implementation, training and audit of your Quality Assurance (QA) Program.
GMP / cGMP: Good Manufacturing Practices
An overriding set of principals which govern the quality of every aspect of making a drug. It is a set of regulations, mandated by Health Canada's Therapeutic Products Program (TPP), that ensures that the product (drug) offered for sale to the public is fit for its intended use and is safe.Facility design and construction oversight services to GMP standards
Ensures that your proposed production facilities are designed and constructed in a manner that will comply with the GMP requirements.GLP: Good Laboratory Practices for clinical laboratories
A set of internationally harmonized regulations, mandated by the Environmental Directorate of the Organization for Economic Cooperation and Development (OECD).Clinical Trial Applications (CTAs)
Our service package Includes:determining the scope of the trials, identifying target population, identifying the number of patients required, etc.HACCP Hazard Analysis and Critical Control Point (HACCP) for food production
HACCP (Hazard Analysis and Critical Control Point) is a scientific system used in food production, to prevent problems, by applying controls at points in a food production process, where hazards could be controlled, reduced, or eliminated.ISO 9000 for manufacturing and services companies
This is a system to effectively manage your business, in order to provide your product or services to your clients, in a consistent, accountable, and traceable manner.ISO 13485 / 13488 for medical devices
This standard is presently regulated by Health Canada's "Therapeutic Products program" (TPP) and is similar to the European Union's EN 46000 Standard. It is soon to be a requirement in Canada, in order to harmonize with other parts of the world. ISO 13488 is the same as ISO 13485, with the exclusion of the requirements for "Design Control".ISO 14000 Environmental Management System (EMS)
A set of internationally created and recognized guidelines (EMS) that allow companies to address the environmental impact of their products, services and business practices. Its focus is on prevention and continuous improvement.ISO 17025 for testing and calibration labs
This standard was developed specifically to give guidance to lab managers on both quality management and the technical requirements for the proper operation of a laboratory. Thus, ISO 17025 can be thought of as the technical compliment to ISO 9000. As a matter of fact, any organization who meets the requirements for ISO 17025 automatically is ISO 9000 compliant (but the converse is not true).Validation service
This is the documented act of demonstrating that any of your critical procedures, processes, equipment, materials, activities, or systems will consistently lead to expected results.Stability
Stability Protocol is mandated by Health Canada's Good Manufacturing Practices (GMP). It is to determine the normal shelf life of the product under recommended storage conditions.GMP and security requirements for narcotics and controlled substances
Under Renovation....Training courses
ICS offers a variety of Quality Management System training courses in various formats.Internal audits/ Third-party audits
We provide an objective and unbiased review, to help you assess your conformance with applicable regulations.
Gap analysis
This provides a quick snapshot of the overall status of your QA program in relation to GMP.
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