Quality Assurance

The Quality Assurance group at Waisman Biomanufacturing is committed to ensuring that all operations within the facility meet the highest quality principles. Responsible for overseeing Waisman policies that guide the manufacture and testing of products for use in animal studies and phase I/II human clinical trials, our team of QA specialists makes certain that both production methods and final products are in compliance with US FDA and global regulatory agency requirements.  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
  • Master Specifications

Certificates of Analysis:

  • Oversight of Raw Materials including acquisition and release of materials used in production lots
  • Review of QCS testing and release of manufactured final product

cGMP Documentation:

  • Issuance and control of GMP 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 IQ, OQ and PQ executions for equipment related to GMP work

Audit Facilitation:

  • Surveillance of vendors and out-sourced services, specifically execution of audits (on-site and by mail) of suppliers and contract testing laboratories
  • Primary contact for internal 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