Address challenges, identify opportunities, and mitigate risk.
For over 40 years, small, medium, and multi-national organizations have hired our experts to provide 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 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 bring 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.