Quality Control Services

Pharmaceutical & Health Product Quality Control Services in Canada & the United States

At MCS Associates, we offer comprehensive quality control services tailored to the unique compliance requirements of pharmaceutical, natural health product, dietary supplement, food, cosmetics, cannabis, and medical devices manufacturers. With a deep understanding of Good Manufacturing Practices (GMP) and Pharmaceutical Quality Management Systems (PQMS), we support companies in both Canada and the United States in meeting regulatory expectations with confidence and precision.

A Quality Management System (QMS) is a formalized framework of procedures, processes, and responsibilities that ensures consistent delivery of products and services that meet regulatory, customer, and internal quality standards. In regulated industries such as pharmaceuticals, natural health products, dietary supplements, cosmetics, foods, medical devices, and cannabis a robust QMS is not just a best practice it is a compliance requirement.

At MCS Associates, we help companies across Canada and the United States design, implement, and maintain compliant and effective QMS programs aligned with Health Canada regulations, FDA requirements (21 CFR Parts 210, 211, 820, 111), and international standards like ISO 13485 and ICH Q10.

Core Elements of a Robust QMS

A well-structured QMS includes several interrelated components. The key elements include:

1. Quality Manual and Quality Policy

• Defines the scope of the QMS and overall quality objectives.
• Establishes a management commitment to continuous improvement and regulatory compliance.

2. Document Control System

• Ensures all standard operating procedures (SOPs), work instructions, and records are accurate, up-to-date, reviewed, and approved.
• Prevents use of obsolete or uncontrolled documents.

3. A Risk Management System

• Identifies and mitigates quality risks using tools such as Failure Mode and Effects Analysis (FMEA), risk matrices, and Corrective Actions/Preventative Actions trend analysis.
• Integral to product development, process changes, and post-market surveillance.

4. Training and Competency Programs

• Ensures all personnel are qualified by education and experience and are continuously trained on relevant processes, procedures, and regulations.
• Tracks training records for audit readiness.

5. Change Control

• Manages changes to materials, equipment, processes, or documentation in a controlled and traceable manner.
• Evaluates the potential risk of a proposed change and provides consistent and complete communication to all stakeholders.
• Prevents unintended impact on product quality or compliance.

6. Corrective and Preventive Actions (CAPA)

• Investigate deviations, non-conformances, and customer complaints.
• Implements data-driven corrective actions to prevent recurrence and improve system performance.

7. Internal Audits

• Verifies that processes are compliant, efficient, effective and continually improving.
• Identifies gaps and opportunities ahead of regulatory inspections.

8. Supplier Qualification and Quality Agreements

• Ensures third-party vendors, contract manufacturers, and testing labs meet regulatory and internal quality standards.
• Includes audits, technical agreements, and performance monitoring.

9. Deviation and Investigation Management

• Systematic evaluation of unexpected events, OOS/OOT results, or process failures.
• Root cause analysis and data trending ensure systemic resolution.

10. Management Review

• Regular evaluation of QMS performance metrics, audit findings, and improvement plans.
• Demonstrates top-level commitment to quality culture.

Key Considerations for Implementing a Strong QMS

When building or upgrading a Quality Management System, organizations must consider the following:

• Regulatory Alignment: Ensure your QMS is built to satisfy the regulatory requirements specific to your product category (e.g., 21 CFR 211 for pharmaceuticals, Part 111 for supplements, or ISO 13485 for medical devices).
• Scalability: Design systems that are flexible enough to grow with your business without compromising compliance.
• Integration: Your QMS should integrate seamlessly with manufacturing, quality control, R&D, and regulatory affairs functions.
• Audit Preparedness: Ensure your QMS is inspection-ready at all times, with properly maintained records, traceability, and audit trails.
• Digitalization and Automation: Consider electronic QMS (eQMS) platforms to improve efficiency, reduce human error, and enhance traceability.

Whether you are developing a new therapeutic or entering the North American market with a natural product or medical device, MCS Associates delivers precision, compliance, and peace of mind through every step of your product lifecycle.

Our comprehensive suite of quality control services are designed to help improve your operational reliability, reduce costs, mitigate risks, and ensure compliance with ever increasing regulatory demands. As one of Canada’s leading GMP quality control services provider, we provide extensive expertise and personalized service to meet your specific needs.

Manufacturing Solutions

• Facility Qualification
• Material Qualification
• Method/Process Validation
• Cleaning Validation
• Computer System Validation

Documentation Services

• Technical Writing
• Standard Operating Procedures (SOPs)
• Stability Program Design and Management
• Quality Manuals and Policies
• Finished Product Specifications
• Work Instructions
• Quality Agreements

Our comprehensive suite of quality control services ensure that all critical production and associated processes adhere to the highest standards, maintaining compliance and fostering an environment of continuous improvement.

Importation and Distribution Support

• Importer Quality Management System (QMS) Program
• Release / Reject Program
• Importer Quality Assurance Person (QAP)
• Distributor Quality Management System (QMS) Programs

Post Market Services

• Post-Market QMS Programs
• Recall Management
• Ongoing Stability
• Self Inspections
• Vendor Qualifications
• Audits

Our comprehensive quality control services support importation, distribution, and post-market activities to ensure continuous compliance and risk mitigation to protect your brand and business for the long term. Our team includes certified GMP auditors that assess pharmaceutical quality management systems using a risk-based approach.