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QA
Our Quality Assurance (QA) staff has expertise in the guidelines of current Good Manufacturing Procedures, in particular their application to the manufacture of biologic agents. QA staff ensures that standard operating procedures, batch records, sampling plans and shipping are coordinated and appropriately controlled.
Appropriate quality systems are in place to maintain compliance and safety of all products. They include:
- Validation Master Plan
- Standard Operating Procedures (SOP) and Batch Records
- SOP's for Change Control, Calibration, Validation (Process, Cleaning and Analytical), Corrective and Preventive Action, Deviation Control
- Training
- GMP Compliant Analytical Systems
Quality Assurance provides the following services:
- Quality Assurance of manufacturing and controls meeting the cGMPs
- Training and education in cGMP related to product development,
production, analysis and quality systems
- Release of Bulk Drug Substance by Qualified Person
- cGMP and regulatory support including ready-to-file regulatory documents
- Preparing for, hosting and responding to various inspections
- Commissioning, qualification and validation of facilities and processes
- Facility, process and systems audit
- Out-Of-Specification guidance and investigations
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