Quality Assurance and Regulatory Support

The Quality Assurance group at Waisman Biomanufacturing is committed to ensuring that all operations within the facility meet the highest quality principles. Our QA specialists are responsible for overseeing Waisman standard operating procedures that guide the manufacture and testing of products for use in IND-enabling animal studies and phase I/II human clinical trials and certifies compliance with US FDA and global regulatory agency requirements as applicable. Quality Assurance responsibilities are listed below.

Batch Release:

Review/approval of documents associated with all phases of CGMP production including:

• Standard Operating Procedures
• Master Production/Control Records
• Batch Production Records
• Quality Control Specifications
• Oversight of Raw Materials including acquisition and release of materials used in production lots
• Review of Quality Control testing and release of manufactured Drug Substance and Drug Product
• Issuing Certificates of Analysis and Certificates of Compliance

CGMP Documentation:

• Issuance and control of CGMP documentation
• Management of raw materials and batch record archives
• Maintenance of training files for all WB personnel
• Oversight of equipment calibration/maintenance and associated documentation archives
• Oversight of facility maintenance/cleaning and associated documentation logs
• Oversight of equipment installation, qualification, and maintenance

Audit Facilitation:

• Surveillance of vendors and contracted services, specifically execution of audits (on-site and by mail) of suppliers and contract testing laboratories
• Primary contact for audits requested by potential clients including interacting with auditor(s) throughout the process and ensuring a timely response to all resulting observations
• Investigations and CAPAs
• Oversight of internal investigations including assigning, monitoring and approving CAPAs with the goal of a thorough and timely completion, as well as adequate close-out and effectiveness

Regulatory Support:

• QA-audited batch records, Quality Control test records, raw material documentation
• Drafting Chemistry, Manufacturing, and Controls (CMC) Investigational New Drug Application sections (Module 3 eCTD)
• Letter of authorization to cross-reference the Waisman Biomanufacturing Type V Facility Master File that has been submitted electronically to FDA CBER/CDER.