Quality Management, Assurance, Control, and Validations

Quality Management, Assurance, Control, and Validations
Product Description

Sovereigns provides oversight for the quality systems. We issue the manufacturing lot numbers and appropriate records, review/approve each executed record, and analytical data and stability reports. Sovereign will:

  • MAINTAINS an excellent relationship with the FDA, DEA, and local health and regulatory agencies 
  • CONDUCTS regular reviews of the quality management system 
  • ENSURES adequate resources are available 
  • MAINTAINS experienced staff 
  • TRAINS STAFF in the importance of ensuring the quality system is effective and continually improved
The Quality Control Department (QC) is composed of a team of dedicated and hardworking degreed professionals who are highly trained in pharmaceutical analysis and cGMP regulations. The QC Laboratory is responsible for testing of both raw materials and finished products. This effort extends to stability, in-process, process validation, and microbial samples. Our state-of-the-art QC lab is dedicated to maintaining stringent quality. For you, it means the confidence in knowing that your products are manufactured to the industry's strictest guidelines. Our capabilities include meticulous monitoring of each stage of production by our chemists and ensuring the finest pharmaceutical quality for all raw materials, in-process batches and finished products manufactured to exact customers' specifications. Every aspect of our lab operations are under the direct control of our highly experienced lab director.

Sovereign Pharmaceuticals, LLC

  • US
  • 2017
    On CPHI since
  • 250 - 499
    Employees
Company types
Manufacturer/Innovator

Sovereign Pharmaceuticals, LLC

  • US
  • 2017
    On CPHI since
  • 250 - 499
    Employees
Company types
Manufacturer/Innovator

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    Product High Potency Pharma Suite

    Launched in 2020, our high-potency suite is designed to ensure the safety of highly potent APIs from development through production. 

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    Product Pharma Product Development

    We develop oral tablet formulations, oral powder-filled capsule formulations, oral and topical solutions, and oral suspension formulations. 

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    Product Packaging and Serialization

    Sovereign offers packaging for: • liquids • tablets and capsules 


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