Bio-Tech Pharmacal Inc. 4.15

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 two piece hard shell capsules. This 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.