Quality Assurance

BioStem Life Sciences' Quality Assurance team is committed to ensuring that all operations within our facility meet the highest quality standards outlined in our Quality System. Our team of QA specialists make certain that both production and final product output are in compliance with FDA and other regulatory agency requirements.

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 BioStem 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

Have Questions? Reach out to us

If you have questions about the company, our lab, our scientific team or anything else, please feel free to contact us.

Contact Us

Contact Information

info@biostemlife.com
(954) 380-8342

Location

2836 Center Port Circle
Pompano Beach, FL 33064

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