Quality Assurance

Integrity Bio’s robust quality organization complies with FDA guidelines to ensure successful manufacture and release of your drug product.

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Production's Systems

  • Document Control
  • Batch Records
  • Training
  • Nonconformance
  • CAPA
  • Change Control
  • Batch Disposition

Laboratory Control System

  • OOS
  • Laboratory Procedures
  • Analytical Methods
  • Sample Management

Facilities/Equipment System

  • Facility Cleaning
  • Equipment Cleaning
  • Environmental Monitoring
  • Water Systems
  • Validation
  • Work Order Program
  • Calibration
  • Facility Monitoring/AEMS

Packaging/Labeling and Raw Material Control

  • Label Control
  • Label Inspection and Packaging
  • Shipping/Distribution
  • Raw Material Program
  • Lot Numbering

QMS

  • Internal Audits
  • Management Review
  • Risk Management
  • Complaint Handling
  • Product Recall
  • Supplier Qualification

What sets us apart?

IBI’s quality management system (QMS) helps ensure the quality of products and process improvements. It enforces compliance with US FDA, current Good Manufacturing Practice (cGMP). The manufacturing of products is maintained at high standards to ensure the quality and purity of the products.

IBI’s QMS complies with ICH Q10 for quality principles to ensure customer focus and process-oriented approach. By achieving excellence in these core quality principles, IBI maintains quality control and promotes the journey of continuous improvement.

Regulations Followed

Current Good Manufacturing Practices (“cGMPs”) – Applicable regulatory requirements with respect to a country or regulatory jurisdiction in the USA as amended from time to time, for the then-current standards under Applicable Law for the Manufacturing, preparation, processing, labeling, packaging, and distribution of pharmaceutical and/or biological products (and components thereof), including as set forth in (a) 21 U.S.C. Section 501(a),21 C.F.R. § 11, 210, 211, and the guidance documents issued by the FDA.

Registrations / Licenses

The company has carried and maintained a Drug Manufacturing License from the State of California Department of Public Health Food and Drug Branch since 2012.

The company is registered on the FDA Drug establishment site. The FDA Facility Establishment Identifier Number (FEIN) for Integrity Bio is: 3006188248.
A member of the IBI staff holds and maintains a Designated Representative License issued by the California Board of Pharmacy.

Quality Systems

Integrity Bio maintains quality systems in accordance with applicable cGMP and regulatory requirements (ICH Q10)
IBI Quality Management Systems consist of a framework for the governance of interrelated processes below: