Quality Assurance

Our industry-experienced experts have implemented dozens of quality systems within the biopharmaceutical, pharmaceutical, medical device, and combination product industries. We assist with organizational activities, plans, policies, procedures, and processes and provide the resources to design, implement, and maintain a quality system that delivers quality, compliant drug products.

We develop quality systems in accordance with: 
  • Current Good Manufacturing Practices (21 CFR 210 and 211, 600, 601, 610, 820 and 1271)
  • Combination Products GMPS (21 CFR 4)
  • Pharmaceutical Development (ICH Q8)
  • Risk Management (ICH Q9)
  • Quality Systems (ICH Q10),
  • Good Manufacturing Practices for Active Pharmaceutical Ingredients (ICH Q7A)
  • EU Good Manufacturing Practices (Eudralex Volume 4)
  • Australia’s PIC/S Guide to Good Manufacturing Practices
Establishing Quality Management Systems Excellence

Our team designs and implements quality system procedures and instructions in line with client objectives and the requirements of the leading regulatory bodies. Elements of our quality management system programs include the establishment and/or management of:

  • Document control system
  • Electronic document management system
  • CAPA and deviations SOPS
  • External audit SOP
  • Performance of GMP and GLP audits
  • Establish phase-appropriate training SOP and program
  • Vendor qualification, audits, and materials management programs
  • Change control
  • Quality risk management (e.g., microbial control, quality risk assessment, etc.)
Global FDA/EMA Remediation Projects

Leveraging decades of experience, BioTechLogic supports comprehensive global inspection readiness remediation projects.

  • Quality plans for Six-System inspection readiness
  • Remediation team leadership
  • Conduct mock inspections
  • Provide remediation services for all GMP departments
  • Reorganization and establishment of a high-performance management team
  • On-site support and team augmentation

Other Areas of Focus

BTL Experts in

Quality Assurance

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