Quality System & GMP
Biote Pharma has an independent quality department, which includes quality assurance and quality control. The quality control laboratory is in charge of and authorizes sampling, testing, approval or rejection of all components, raw materials, in-process materials, packaging materials, and drug products based on the established written methods and procedures. QA is responsible for review of production batch records, laboratory reports, process deviation and out of specification investigations.
The quality department is responsible for establishing a system for approving and issuing all formal written procedures, instructions or specifications to control the identity, strength, quality and purity of the drug product.