Overview

MCS Consultants play key roles in both Quality Control & Assurance



Once a business is involved with a regulated product the operations of that business become subject to certain standards. These standards are embodied in the Canadian Food and Drug Act and are assessed by Canadian Health Authorities.

The Act provides the foundation for the regulations that govern licensable products and activities.  The regulations are then distilled down from legal language into everyday language in the form of guidance documents.

Standard Operating Procedure s (SOPs) are derived for you business from these guidance documents. These SOPs are the tools to monitor your firm’s Quality Programs.

MCS Associates consult for many companies to develop, implement, and monitor the SOP process. MCS Associates also provides full support training to all of your employees.

SOP’s provide the essence of Good Manufacturing Practices

GMP provide an effective and comprehensive approach to product quality control and risk management.

Good Manufacturing Practices cover
Quality Control Quality Assurance Accredited Personnel Operations
Product Specifications Equipment & Premises Sanitation and Cleaning programs Sterile Products
Samples Stability Records Recall Reporting

We work with your company to design a GMP program for each facility based on your firm’s particular products and activitiesMCS can also develop corresponding training programs for your staff to ensure that the program is properly implemented.

MCS Consultants conduct on-site audits recognized by Health Canada to ensure that all steps in your manufacturing and operating practices, comply with current Good Manufacturing Practices.



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Regulated Products require regulatory compliance at every stage;
  • fabrication
  • packaging
  • labeling
  • wholesaling
  • testing
  • distributing
MCS Associates has expertise in all of these areas.
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