Address challenges, identify opportunities, and mitigate risk.
For over 40 years, small, medium, and multi-national organizations have hired our experts to provide good manufacturing practices audit/GMP audit services and provide quality control services required for regulated products and activities. Our teams have improved existing pharmaceutical quality management systems and helped to implement quality assurance initiatives. Our experts have a long history of providing economical, efficient, and pragmatic remediation guidance as one of the trusted quality control services and GMP Audit service providers.
GMP Audit and Quality Control Services and Solutions
Our comprehensive suite of quality control and good manufacturing practices audit/GMP audit 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.
Production
- Material Qualification
- Method/Process Validation
- Cleaning Validation
- Computer System Validation
- Facility Qualification
Documentation Services
- Technical Writing
- Standard Operating Procedures (SOPs)
- Stability Program Design & Management
- Quality Manuals & 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 QMS Program
- Release / Reject Program
- Importer Quality Assurance Person (QAP)
- Distributor QMS Programs
Post Market Services
- Post-Market QMS Programs
- Recall Management
- Ongoing Stability
- Self Inspections
- Vendor Qualifications
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.
Audits and Remediation
A comprehensive GMP audit with a certified GMP auditor can identify GMP compliance gaps and quality issues well before they become business risks. With certified GMP auditors, we provide a thorough evaluation of all mission-critical operations and associated documentation processes that span the entire production process from material receipt to release, distribution and post-market surveillance. At every step along the way we provide economical, efficient and pragmatic recommendations for improvement to enhance your quality management system.
- Health Canada Inspection and NHP Inspection Program* (Virtual and Onsite Hosting & Support)
- Health Canada NHP Inspection Program
- The GMP Gap Analysis
- Third Party Onsite Audits (Foreign & Domestic)
- QAR
- Remediation Plans
*Health Canada site license inspection pilot program
Training
- Good Manufacturing Practices (GMP) – Basics & Applied
- Deviation, OOS Investigation and CAPA
- Change Control
- Pharmaceutical Process and Cleaning Validation
- Stability (Shelf-life, On-Going, Accelerated and Freeze-Thaw)
- Complaint Handling
GMP audits and inspections in the food industry
Ensuring compliance with Good Manufacturing Practices (GMP) is critical in the food industry. GMP audits and inspections in the food industry play a vital role in maintaining high standards by providing thorough evaluations of production processes. As a leading GMP audit company, we offer specialized expertise to conduct GMP audits and perform GAP assessments for facilities involved in food production, handling or storage, ensuring that all regulatory requirements are met.
MCS is recognized as one of Canada’s premiere GMP audit companies. We have helped many organizations optimize their operational robustness through regular GMP audit assessments. Comprehensive GMP audits and inspections in the food industry represent an essential part of overall approach to product quality and safety.
What license do you need to sell supplements?
A comprehensive pharmaceutical quality management system (QMS) is crucial for maintaining high standards in the manufacturing, packaging, labeling, and/or importing of natural health products or dietary supplements. By designing a robust quality management system, companies can ensure compliance with regulatory expectations, improve their overall quality assurance processes and ensure long-term viability in the marketplace. One essential aspect of this system includes conducting regular GMP audit assessments to verify adherence to Good Manufacturing Practices. For businesses wondering what license do you need to sell supplements, a NNHPD-issued Site License is required. It is important to note that a robust quality management system is required before a license is issued. Our comprehensive GMP audit services ensure your firm complies with the government’s expectations. These quality control services help identify potential areas for improvement and ensure that all regulatory standards are consistently met, thereby safeguarding product quality and consumer safety, and business longevity. The reason why we are one of the most trusted GMP audit companies is due to our certified GMP auditors heavily review and examine your business to ensure you are adhering to regulatory requirements.
FAQ’s
Think of it as a health check. A good manufacturing practices audit goes deeper than a simple clipboard exercise; it is a full evaluation of your entire quality management system to ensure what you’re making is safe, compliant, and ready for the shelf. Why does this matter? Because fixing issues now is cheap. Fixing them later is a nightmare. If you wait for a regulator to find a gap, you could be facing recalls or shutdowns, but catching those issues early keeps your business safe. You need that protection. By bringing in professional quality control services, you aren’t just ticking boxes you are optimizing your whole operation. It ensures your QMS quality management system is not just paperwork, but a living system that ensures business continuity.
It comes down to one thing. Are they just identifying problems, or are they helping you fix them? While many firms treat a good manufacturing practices audit like a simple checklist, handing you a report and walking away, MCS operates differently. We don’t just find the gaps. We help you bridge them with effective, practical corrective and preventative actions. With over 40 years of experience, our team provides practical, cost-effective guidance to resolve the issues we find, rather than just adding to your to-do list. It is a partnership. We back our audits with deep, supportive quality control services that improve your entire operation. This ensures your QMS quality management system isn’t just a set of binders on a shelf, but a robust system that keeps your business compliant and efficient for the long haul.
We cover the full spectrum. Because the regulations for a heart valve aren’t the same as the regulations for a protein bar, we don’t believe in a one-size-fits-all approach.
Every field is different. A generic inspection just won’t suffice; you need a good manufacturing practices audit that is relevent ot the standards that govern your business. We tailor the solution to your firm. By taking advantage of our deep experience, we ensure you aren’t wasting time on irrelevant tasks. This guarantees your QMS quality management system isn’t just a generic set of templates, but a custom-built shield designed to future-proof your specific business.