Quality Assurance and Regulatory Strategy


Overview

A senior level consulting group focused on providing cGMP Quality Assurance and Regulatory Strategy for development and manufacturing stage projects. Using a systematic approach, combined with depth of knowledge and experience, Rondaxe’s proactive strategies position your company for success.

The Quality team is a staff of 10 former pharmaceutical industry professionals, each with more than 20 years of experience on average. Our group is well experienced in API and Drug Product cGMP compliance for both small molecules and large molecules, and medical device GMP. We have strong technical skills in aseptic processing and sterile products manufacturing. The team brings its in-depth 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 manufacturer’s
  • 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 AND COMPLIANCE IMPROVEMENT


  • Working directly with the manufacturer’s quality unit to implement improvement programs. We will:
    • Define required CAPA
    • Establish missing or incomplete quality systems
    • Prepare needed SOPs
    • Train both manufacturing and quality unit staff
    • Track progress of remediation on planning chart

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

Regulatory Strategy


  • Advice from experienced regulatory affairs experts on manufacturing, analytical, and supply chain issues including starting material selection and change control
  • Identify and document the supply chain
  • Assembly of CMC sections of INDs and NDAs
  • Preparation of DMFs

Preparation for Regulatory Inspection (e.g. FDA PAI)


  • Train Quality staff to manage a regulatory authority inspection, specifically:
    • Assist in selection of subject matter experts (SME)
    • Train SME's on proper procedures for responding to investigator questions
    • Set up documentation ("war room")
    • Assignment of recording duties
    • Arrangement of inspection logistics
    • Ensure all previously identified CAPA are complete
    • Regulatory inspection oversight
    • Perform final housekeeping inspection to ensure a facility is fully prepared
    • Joining the client in "war room" to provide advice to help ensure a successful regulatory authority inspection
    • Organizing daily de-briefing and assignment of follow-up duties
    • Ensuring requested copies of documents are prepared and delivered in a timely fashion
    • Advising on response to any inspectional observations

Benefits


  • Prevention of Compliance Problems
    • Addresses observed deficiencies prior to them becoming an issue with the Regulatory Authority
  • Streamlining Regulatory Filings
    • Prepares CMC documents based on actual production and analytical laboratory demonstrated capabilities and communicates technical information to the Regulatory Authority completely and clearly
  • Maintaining GMP Compliance
    • Provides an independent Quality Assurance audit to ensure operations are fully compliant with GMP
    • Provides an experienced Quality Assurance person, backed by the full Rondaxe pool of experience, in the position of Release Authority
  • Cost Effectiveness
    • Using a realistic and common sense approach, we provide only those services necessary to ensure GMP compliance with flexible billing to consider your budget constraints