QA/QCQuality Systems Experts

 

Accredited quality professionals with over 20+ years of experience

Our experts are proven and experienced in Quality Systems for Materials Management applying GAMP, GDP, 21 CFR Parts 11, 210, 211 & 820, GCP/ICH to the management of high value samples, including infectious materials, finished pharmaceuticals, and investigational drugs and/or components. We operate an audited cGMP facility & can assist you with review, development, and implementation of sound compliance strategies for your organization.

 
investigations manual 2009

Accredited quality professionals

Coldchain's team of accredited quality professionals have 20+ years of experience, Audit Experience & Paticipation Includes: US Food & Drug Administration (direct audit), Wyeth, Johnson & Johnson, Sanofi Aventis, Cangene, Amgen, Human Genome Sciences, MedImmune, Biogen, BioReliance, Pro-Virus, Acambis, Celera Genomics, Bristol-Meyers Squibb, Gene Logic, Searle, Hyclone, TherImmune, Lilly, Life Technologies, SAIC, Elan, Genetic Therapy, and Cell Genesis.

 

Subject Matter Experts

Coldchain Supplies Subject Matter Experts in Contract Compliance and Regulatory Compliance Oversight

We help ensure that your contractors / vendors maintain the standards and benchmarks of your contract with them. In the 3rd Party QA/QC role, we help our clients save costs by avoiding potential deficiencies, provide early communication of project management issues, and ensure completetion of contractual deliverables.

 
the science of compliance
 
 

 
 
cGPM

What is cGMP?

A set of guidelines that addresses the principles required for the proper design, maintenance, and control of operations or facilities involved in the manufacturing and care of products intended for human use and regulated by the FDA.

GMP is a good business tool which will help to refine both compliance and performance at your company. GMP requirements are largely common sense practices which will help your company better itself as it moves toward a quality approach using continuous improvement

US Food & Drug Administration (direct audit), Wyeth, Johnson & Johnson, Sanofi Aventis, Cangene, Amgen, Human Genome Sciences, MedImmune, Biogen, BioReliance, Pro-Virus, Acambis, Celera Genomics, Bristol-Meyers Squibb, Gene Logic, Searle, Hyclone, TherImmune, Lilly, Life Technologies, SAIC, Elan, Genetic Therapy, and Cell Genesis.

 

Good Manufacturing Practice

  1. Detailed step-by-step procedures that provide a roadmap for controlled and consistent performance
  2. Carefully following written procedures to prevent errors
  3. Promptly and accurately documenting work for compliance and traceability
  4. Proving system design by validating work
  5. Integrating productivity, product quality, and employee safety into the design and construction of facilities and equipment
  6. Properly maintaining facilities and equipment
  7. Clearly defining, developing and demonstrating job competence
  8. Protecting product against contamination & promoting cleanliness
  9. Building quality into products by controlling product related processes such as manufacturing, packaging, labeling, distribution, and marketing
  10. Conduct planned and periodic audits for compliance and performance
 
 
Core10 principles
 
 

 
standard operating procedure

Is Your Quality Team Unpopular with Operations?

Your Master Quality Plan, Policies, Procedures, and Protocols should work together to deliver value greater than the sum of their parts.  Let us help you develop a Quality System that helps reveal value rather than limit your abilities.

 

Pharma, Biotech, Health Care, Emergency Preparedness and Drug Dristribution