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Quality Management, Assurance, Control, and Engineering

We cover the whole gamut: management, assurance, control, and engineering.

Quality Management

Sovereign maintains an excellent relationship with the FDA, DEA, and local health and regulatory agencies. Sovereign adheres to strict cGMP compliance with all our products and processes. Sovereign's Quality Management is considered to have three main components - Quality Assurance, Quality Control and Quality Engineering. Quality Management is focused not only on product quality but also the means to achieve it. Quality Management uses quality assurance and control of process and products to achieve to achieve more consistent quality. Quality Management coordinates activities to direct and control an organization with regard to Quality.

  • Conducts regular reviews of the quality management system
  • Ensures adequate resources are available
  • Communicates the organizational structure to staff
  • Informs staff of the importance of ensuring the quality system is effective and continually improved

Quality Assurance

The Quality Assurance Department (QA) is responsible for managing and providing oversight for the quality systems at Sovereign Pharmaceuticals. Each batch manufacturing cycle begins and ends with QA, but depends on each department following the quality systems and maintaining cGMPs to produce quality products. QA issues the manufacturing lot numbers and the appropriate record, reviews/approves each executed record, the analytical data and stability reports.

Based on these documents QA makes the final disposition decision for each component, raw material, and drug product. QA has the primary responsibility of managing and maintaining master documents such as: manufacturing records, packaging records, analytical procedures, specifications, and SOPs. Additionally, QA maintains original data generated from the master documents. To facilitate these functions QA is organized into groups for Component Release, Document Control, Label Control, In-process Inspections, and Production Release. To facilitate company compliance with cGMPs, QA provides ongoing training and assists in new employee orientation.

Quality Control

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.

QC ensures that all raw materials, in-process batches and finished products are in specifications and are of highest pharmaceutical quality. During manufacturing, each process is monitored by our knowledgeable staff. Overall lab operations are under the direct supervision and control of our experienced laboratory director. The lab employs the most technologically advanced equipment, such as, off-hours auto sampling and analysis, HPLC analysis, disintegration and dissolution apparatus, UV spectrophotometers, stability chambers and other sophisticated analytical equipment.

QC inspects and samples all incoming shipments of raw materials and packaging components. QC personnel perform cleaning inspections of production equipment and rooms prior to a production run to assure batch integrity from lot to lot. This department conducts in-process testing and sampling of in-process intermediates and finished dosage forms to assure product quality and safety. QC maintains the calibration schedule for all electronic equipment used in production to assure consistent results during the manufacturing processes. QC performs facility walkthroughs on a daily basis to address any cGMP issues.

QC is also responsible for maintaining the raw material and packaging component shelf life program at Sovereign. QC verifies every shipment of finished product to assure lot numbers, count, and customer are correct immediately before shipping.

QC is a full service analytical laboratory with the most advanced instrumentation commercially available. The following is a partial listing of instrumentation in our laboratory:

  • Waters Empower Enterprise Software
  • High Performance Liquid Chromatographs (HPLC) equipped with U.V. and Photodiode Array Detectors
  • U.S.P. Dissolution Apparatus
  • U.S.P. Disintegration Apparatus
  • Gas Chromatographs equipped with Flame Ionization and Electron Ionization Detectors
  • Infrared Spectrophotometer and Horizontal Attenuated Total Reflectance Accessory
  • Ultraviolet Spectrophotometer and Integrating Sphere Accessory
  • Mass Spectrometer
  • Colorimeter
  • Potentiometric Titrator
  • Specific Gravity Meter
  • Reverse Osmosis Deionized Water System
  • Refractometer Karl Fischer Titrator
  • Auto Polarimeter
  • Friabilator
  • Automatic Melting Point Apparatus

Quality Engineering

The Quality Engineering Department (QE) is responsible for Process Validation, Equipment Qualification, and Cleaning Validation. QE generates and executes validation protocols to demonstrate that process, equipment, and system consistently produce products or results that meet pre-approved specifications. The QE group also performs engineering studies to support the proposed changes to process or procedures toward optimization and/or improvements, and supports continuous improvement activities to validation program to ensure efficiency, effectiveness, and compliance

QE provides a leadership to effective in-depth investigations related to incident, deviation and failure including root cause analyses and risk assessments, and to reduce non-conforming issues and implement preventive measures through an effective CAPA system.

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We've got facilities we're incredibly proud of, and a team that will put your company first. Stop by anytime.

54k sq ft
cGMP Production Facility
14.5k sq ft
cGMP R&D/QC Facility
100k sq ft
Warehouse & Expansion
5.4k sq ft
Storage / Stability Space