Comprehensive Quality Management System

Our Quality unit encompasses Quality Assurance, Regulatory support, and Validation. Our FDA-registered facilities produce API, adjuvants, and intermediates that meet the relevant cGMP requirements of 21 CFR Part 210 and 211, and ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients. A dedicated Quality Assurance representative ensures that all applicable regulatory and quality standards and requirements are met throughout your project.

Demonstrated compliance

Nitto Avecia takes a proactive approach to assuring quality and regulatory excellence. Our facilities have a successful track record of FDA and QP inspections. In addition, we have been audited and client-approved by most leading pharmaceutical companies with outsourced oligonucleotide programs, undergoing 10 to 15 such audits annually.

Regulatory compliance

Our Quality Assurance team works with all Nitto Avecia departments to ensure compliance with applicable U.S. regulations and internationally recognized ICH guidelines, including:

  • Current Good Manufacturing Practices (cGMP) per USFDA 21 CFR Parts 210 and 211
  • ICH Guidelines:
    • Q7 Good Manufacturing Guidance for Active Pharmaceutical Ingredients (API)
    • Q8 Pharmaceutical Development
    • Q9 Quality Risk Management
    • Q10 Pharmaceutical Quality System
    • Q11 Development and Manufacture of Drug Substance
    • Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management

As a company offering global solutions to your oligonucleotide manufacturing needs, we work with you to accommodate your region-specific Quality and Regulatory requirements.

Time-saving services

We help reduce administrative burdens on customers with a range of added services, including review of Chemical, Manufacturing and Controls (CMC) sections for INDs, CTAs, NDAs, etc., as well as offering prepared templates for ease of establishing Quality Agreements. Avecia also maintains an eCTD-compliant Facilities Master File that may be cross-referenced to support your regulatory filings.