ABL has a dedicated Quality Assurance Unit (QAU) committed to a quality-based, systematic approach to the development of products and services to our customers. The responsibilities of the QAU encompass GCLP and cGMP activities conducted at ABL, as well as oversight of contracted or subcontracted GXP activities that are conducted under the contractor’s quality systems.  The QAU is headed by the Director of Quality Assurance and is independent of Manufacturing, Project Management, Research & Development and other operations of the business, reporting directly to the ABL’s CEO.

The QAU is responsible for the following activities:

• Review and approve all quality-related documents including but not limited to master and batch records, change control requests, standard operating procedures, validation protocols and reports, stability protocols and reports material and product specifications, and document archiving
• Ensure that vendors and subcontractors are qualified
• Identification and other required testing are performed on critical components
• Release manufacturing suites for cGMP operations
• Issue production batch records and laboroatory records for examination
• Review completed batch production records and laboratory control records of critical process steps before release of bulk drug substance and drug product
• Ensure the environmental monitoring, equipment maintenance, and calibration programs are effective
• Perform internal audits of ABL operations
• Review study reports to assure the report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of a GCLP laboratory study, including preparation of a compliance statement to be included with the final study report
• Review and approve deviations and other investigations
• Release or reject all final lots of drug substance or product and issue a Certificate of Compliance, as per contractual arrangement
• Provide Chemistry, Manufacturing and Controls (CMC) supportive documentation for regulatory submissions to clients, and coordinate activities with client QA, and/or regulatory affairs personnel
• Establish quality agreements with subcontractors
• Archive all quality related documents
• Investigate and resolve compliants
• Issue and reconcile final product labels