CMC: Quality Assurance

Overview

The Rondaxe Quality Team is focused on providing the highest level cGMP Quality Assurance strategy for development and manufacturing stage projects. The Quality team is a staff of high-level pharmaceutical industry professionals, each with years of industry experience. Our team is well experienced in API and Drug Product cGMP compliance for both small and large molecules, and medical device GMP. We have strong technical skills in aseptic processing and sterile products manufacturing. The team brings its extensive experience in analytical chemistry and microbiology laboratory operations to support the client’s needs.

Quality Assurance

• Preparing and managing required SOPs for cGMP compliance
• Training staff in following the policies and general cGMP compliance
• Preparing and executing Quality Agreements on a client’s behalf with contract manufacturers
• Serve as the Release Authority on behalf of the client

cGMP Auditing

• Assess compliance of manufacturers
• Provide written gap analysis
• Propose compliance improvement opportunities

cGMP Remediation & Compliance Improvement

• We work directly with the manufacturer’s quality unit to implement improvement programs:
  • Define required CAPA
  • Establish missing or incomplete quality systems
  • Prepare needed SOPs
  • Train both manufacturing and quality unit staff

Manufacturing Operations

• Review and recommend opportunities for improvement of batch records and other operations
  documentation to improve shop floor and QA release efficiency
• Advise on suitability of facilities for API, large molecule and sterile product manufacturing to ensure
  GMP compliance
• Advise on design and operation of environmental monitoring systems for “clean rooms” and other
  controlled manufacturing facilities
• Provide an organizational strategy for conducting and reporting sterility failure investigations to
  assess root cause and define corrective action and preventative actions

Validation

• Help create the critical process parameter analysis experimental plan to be consistent with Quality
  by Design concepts
• Draft the process validation protocol to be consistent with Quality by Design concepts
• Help organize the process validation plan or validation data

Preparation for Agency Inspection (FDA PAI)

• Train Quality staff to manage a regulatory authority inspection, specifically:
  • Assist in selection of subject matter experts (SME)
  • Train SMEs on proper procedures for responding to investigator questions
  • Set up documentation (“war room”)
  • Ensure all previously identified CAPA are complete
  • Perform final housekeeping inspection to ensure a facility is fully prepared
  • Organizing daily de-briefing and assignment of follow-up duties
  • Advising on response to any inspection observations

Benefits

• Prevention of Compliance problems
• Maintaining GMP Compliance
• Cost Effectiveness
• Efficient preparation for regulatory agency inspection
• Rapid response and remediation planning post inspection