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Commitment to Quality

Bio-Tech Pharmacal, Inc. complies with all applicable US Food and Drug Administration (FDA) regulations and follows Good Manufacturing Practices (GMPs) that are designed to ensure that our products meet the highest quality standards.

Formulation Philosophy

  • Utilization of pure, bio-available vitamin and mineral forms
  • Avoidance of added colors and flavors.
  • Minimal fillers.  We use only pharmaceutical-grade cellulose and silica when needed.
  • Encapsulation in Kosher and Halal-certified all-beef (non-pork) gelatin capsules or Kosher and Halal-certified cellulose-based vegetarian capsules.
  • Use of two-piece encapsulation technology eliminates the need for the binders, lubricants, coatings, and disintegrants that are used in tablets.

Our products start with quality ingredients.

We work to build long term relationships with suppliers that consistently deliver high quality ingredients.  With trustworthy suppliers as a foundation, we test ingredients for identity (correct ingredient), strength (quantity of active component), and contamination(limits on components such as heavy metals, pathogenic organisms, yeast and mold, pesticides, and solvents).  We utilize scientifically valid methods and modern analytical technologies in testing.  Only those ingredients that meet our strict quality requirements are used to manufacture finished products.

Our products are manufactured in a controlled environment with modern equipment.

Our manufacturing facility includes physical separation between different manufacturing areas and a logical workflow to prevent cross contamination and mix-ups.  Manufacturing areas are highly controlled and require personnel to wear protective clothing, masks, and gloves.  We also use properly designed, qualified, and maintained equipment in manufacturing, packaging, and labeling.

Our manufacturing process is guided by procedures and production records.

Standard operating procedures are the foundation of GMP manufacturing and assure that all tasks are completed correctly and consistently.  We have over 100 standard operating procedures that include instructions for the operation of equipment, weighing, blending, encapsulating, packaging, labeling, laboratory testing, and cleaning.  Production records are created for every unique Bio-Tech formula and provide the step-by-step instructions needed to manufacture a specific product with batch-to-batch uniformity.

Our people are dedicated to the principles of GMP.

All Bio-Tech employees receive recurrent instruction in the principles of GMP and are trained to understand the procedures that impact their role.  Every employee must recognize the importance of their job, have a commitment to absolute integrity, accept responsibility for their function, and work as a team.

Learn more about GMP and our commitment to quality in our series of Quality Matters articles.

Partnership with the medical community

Bio-Tech Pharmacal, Inc. products are being used in clinical studies by the following institutions and organizations:

  • Autoimmunity Centers of Excellence
  • Center for Autism and Related Disorders
  • Charles Drew University of Medicine and Science
  • Children’s Hospital of Philadelphia
  • Cleveland Clinic
  • Cystic Fibrosis Therapeutics Foundation
  • Emory Global Health Institute
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Feinstein Institute for Medical Research
  • Jewish Home, San Francisco
  • Mayo Clinic
  • Medical College of Georgia
  • Medical College of Wisconsin
  • Medical University of South Carolina
  • Memorial Sloan-Kettering Cancer Center
  • Mount Sinai School of Medicine
  • National Center of Tuberculosis and Lung Diseases
  • National Heart, Lung, and Blood Institute (NHLBI) AsthmaNet
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institute of Mental Health (NIMH)
  • National Institute on Aging (NIA)
  • National Institute on Drug Abuse (NIDA)
  • National Jewish Health
  • National Kidney Foundation
  • Oregon Health and Science University
  • Pennsylvania State University College of Medicine
  • Republic of Georgia National Tuberculosis Program
  • Rollins School of Public Health
  • Rutgers University
  • The University of Chicago Medical Center
  • Tufts University – Jean Mayer USDA Human Nutrition Research Center on Aging
  • University Hospital Case Medical Center
  • University of California, San Diego
  • University of Colorado Integrative Physiology of Aging Laboratory
  • University of Florida College of Medicine
  • University of Kansas Medical Center
  • University of Michigan Medical Center
  • University of Minnesota – Clinical and Translational Science Institute
  • University of North Carolina School of Medicine
  • University of Rochester Medical Center
  • University of Wisconsin – Madison

The Vitamin D Council is a nonprofit organization whose mission is to end the worldwide epidemic of vitamin D deficiency.

The Vitamin D Council and its founder, Dr. John Cannell, feel that too many people worldwide are needlessly ill and dying due to the numerous diseases and health conditions related to vitamin D/sunlight deficiency.

Grassroots Health.net – Vitamin D Action is a 501c3 Nonprofit Consortium of Scientists, Institutions and Individuals Committed to Solving the Worldwide Vitamin D Deficiency Epidemic through education and blood testing.

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