Genemed is committed to providing high quality products and services that consistently meet the needs of our customers by maintaining compliance with the applicable quality system and regulatory requirements.
Genemed's quality objective is to work as a team to do things right the first time by maintaining compliance with the applicable quality system and regulatory requirements.
Genemed is committed to providing high-quality products and services that consistently meet the needs of our customers by maintaining compliance with the applicable quality system and regulatory requirements. Genemed’s quality objective is to work as a team to do things right the first time by maintaining compliance with the applicable quality system and regulatory requirements. Through constant monitoring and with a focus on continual improvement, Genemed ensures that clients are satisfied with the service they receive.
Satisfaction with our products and safety are our primary goals. We ensure efficacy of all products by performing QC inspections at each step of the manufacturing process. We strive for on-time shipping and respond quickly to any inquiries or problems with our products. Our customers are our top priority.
Genemed has a flexible, responsive, and quality-minded team that works with customers on their particular needs and timelines. All products, whether for research or manufacturing, are subjected to multiple reviews, and checks. Manufactured products are reviewed and released by our Quality Assurance group, who ensures that all aspects of the product are to specifications and are traceable from the raw materials, through manufacturing, directly to the customer.
Genemed views quality assurance as the natural cornerstone to continuous improvement. By utilizing the data generated by QA indicators, combined with internal and external customer needs assessments, Continuous Quality Improvement (CQI) uses client and employee involvement to improve critical processes. The goal is to define and meet the needs of Genemed’s complex customer requirements. CQI allows Genemed to constantly reevaluate and improve customer service.
• US FDA Registered (Registration Number: 2939340)
• ISO 13485:2003 certified by Underwriter Laboratories (UL) (Link here)
• GMP/ISO compliant facilities for IVD medical device manufacturing
• CE Marked IVD Products for worldwide distribution
• QSR and ISO trained staff
FDA Registered GMP Facility
Genemed is an FDA-registered GMP Facility (Registration Number: 2939340).
• Our 20,000 square foot GMP manufacturing facility includes two cleanroom suites that are ISO Class 8 certified
• Our bulk formulation rooms and filling rooms are ISO Class 5 certified modular enclosures and laminar flow hoods
• Personnel enter the cleanroom suites through ISO Class 8 gowning rooms
• Materials enter the cleanroom suites through ISO Class 8 material passways
• Cleanrooms are certified annually through room air exchange rates, particle counts, HEPA leak tests, and differential pressures.
Environment and Equipment Monitoring
• Our Cleanroom environment is continuously monitored by personnel for nonviable air, viable air, and viable surface
• 24/7 Temperature monitoring is performed by the Rees building management system.
• Rooms, refrigerators, freezers and incubators are monitored and recorded
• Each temperature-controlled unit (CTU) has an upper and lower alarm limit
• Remote alarm notification when a CTU exceeds the temperature limits
• Validated and Temperature Mapped Storage locations
• Class II Biosafety Cabinets are Certified annually
• Autoclaves have validated load configurations for sterilizing containers, tubing, stir bars, and are qualified annually