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Global Compliance

Product quality drives our operational philosophy. AccelPharma’s process and facilities are designed to meet the regulatory requirements of the CFDA, US FDA and EMA for clinical and commercial supplies.

Mission Statement and Vision Quality policy
Global Compliance

Total Quality Management (TQM) - Today's most effective Quality Management Systems (QMS)

Full compliance with FDA cGMP

Based on the following key standards and guidelines:

  • Customer-centric focus and “exceeding customer expectations” are the primary focus of our quality management system
  • We commit to "Total Employee Involvement" via training, communication, empowerment, rewards, and recognition to positively impact quality results.
  • Our process-centered approach a core principle of ISO quality management systems with increased impact on pharmaceutical QMS.
  • Our integrated Quality Management System consists of a framework for the governance of interrelated processes. Transparency throughout the product lifecycle is necessary to TQM.
  • AccelPharma's strategic and systematic approach to leadership is integral to our quality-driven organization. Our management team is fully responsible for defining our organization's vision, clarifying paths to success, and encouraging employees to deliver quality.

Based on the following documentation hierarchy:

documentation hierarchy

Facility / Process Implementation Strategy

AccelPharms's facilities and processes will implement using a QbD risk-based approach (FDA Process Validation 2011, ICH Q8, ICH Q9, ICH Q10, GAMP, ISPE Commissioning & Qualification Baseline, 21 CFR 211 and EU GMP regulations) within a Defined Life Cycle (ASTM E2500) for implementation, qualification and validation of process and facilities.

This approach uses the highest quality and compliance standards. The facility and process implementation, qualification, validation, and revalidation are based on the following hierarchy:

process implementation
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Please do not hesitate to contact us with any inquiries

Head Office
AccelPharma, LLC
c/o 853 Camino Del Mar #201
Del Mar, CA 92014
Manufacturing Facility
AccelPharma, LLC
710 N Woods Dr.
Fountain Inn, South Carolina 29644