Quality

LexaMed has a mature robust Quality Management System (QMS) under which it operates. The QMS is based on a risk-based process approach involving a system of interrelated processes.  The system is monitored for effectiveness and process improvements in accordance with the requirements of ISO 13485, ISO 17025, 21 CFR Part 820, 21 CFR Parts 210/211 and 21 CFR Part 58.  Quality System procedures define the criteria and methods needed to ensure that the operation and control of the quality system processes are effective. 

Performance of quality system processes is monitored through internal quality audits, external audits (including client and regulatory audits), and customer feedback (including complaints).  The monitoring of the quality system allows for identification of the effectiveness of quality system processes and for continual improvement.

In addition to FDA and ISO requirements, LexaMed also complies with the following documents:                                                                                                                    

• 21 CFR Part 11
• EU GMP, Chapters 1-9, Annex 1
• ICH Q7 – GMP for APIs
• ICH Q8 – Pharmaceutical Development
• ICH Q9 – Quality Risk Management
• ICH Q10 – Pharmaceutical Quality System
  
  

Quality Policy

• Continually monitoring turnaround times to ensure on time delivery of our products and services.
• Providing accurate, error-free work.
• Conducting testing using state of the art methods and equipment that meets or exceeds regulatory requirements.
• Offering consulting services that provide competent assistance and timely solutions.
• Maintaining a professionally trained staff and providing on-going training programs to ensure that our scientists are experts in their fields