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Quality Control
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.
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.
Quality Control
Since 1985, Bio Tech Pharmacal has operated with the formulation philosophy of quality first. This includes the utilization of bio-available forms of vitamin and minerals. We also avoid the use of dyes, talc, fillers, binders and excipients. Our use of two-piece encapsulating technology eliminates the need for lubricants, coatings and disintegrants that are commonly used in nutritional products offered in tablet form.
GMP Standards
Our products are manufactured under FDA regulations at 21 CFR part 111 and comply with dietary supplement current Good Manufacturing Practices (cGMP). The GMP standards are applied to a wide variety of procedures associated with our manufacturing facility.
Ingredient Standards
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 contaminants (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.
Operating Standards
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, blending, encapsulating, packaging, laboratory testing, and sanitation. 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. Employee training programs coupled with detailed risk management protocols lend confidence that our staff is equipped with the necessary tools to meet operating standards.
Certifications
GMP registered, Kosher Certified (product dependent), Halal Certified (product dependent), FDA registered/FFRM license number: 16678614978
Contact Quality Control | Read This First
Our dietary supplements are intended to support a healthy diet and provide wellness related nutritional benefits for the body. We do not manufacture or distribute any product intended to diagnose, treat, cure, or prevent any disease condition. We recommend that all questions concerning any medical condition you may have be directed to your health care provider for guidance. This includes medication interaction as well as dosing recommendations outside of what appears on our labels
We will not reply to inquiries for medical advice or that otherwise do not follow the above guidelines.