cGMP Quality Systems

Implementation of a comprehensive quality systems model for human and veterinary pharmaceutical products, including biological products, are crucial components to comply with FDA’s cGMP requirements.  The central goal of a quality system is (1) the consistent production of safe and effective products and (2) ensuring that these activities are sustainable.  Good intentions alone will not ensure good products, so a quality system must be written, followed, and documented.  Creating a pharmaceutical manufacturing Quality System that is compliant with CGMP regulations will require a significant investment of time and resources, but is not only necessary but will provide long-term organizational value, if implemented correctly.

Desired Outcomes for a Pharmaceutical cGMP Quality System

A robust quality system will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions.  Specifically, successful quality systems share the following characteristics:

  • Decisions based on an understanding of the intended use of a product
  • Proper identification and control of areas of potential process weakness
  • Responsive deviation and investigation systems that lead to timely remediation
  • Science-based approaches
  • Sound methods for assessing and reducing risk
  • Supportive management (philosophically and financially)
  • Systems for careful analysis of product quality; and
  • Well-defined processes and products, starting from development and extending throughout the product life cycle.

Modern Pharmaceutical cGMP Quality System Concepts

Both good manufacturing practice and good business practice require a robust quality system. When fully developed and effectively managed, a quality system will lead to consistent, predictable processes that ensure that pharmaceuticals are safe, effective, and available for the consumer.  Every pharmaceutical product has established identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness.  A robust quality system is the only means of achieving these characteristics for a product.

The modern quality system includes the following concepts:

  • CAPA (Corrective and Preventive Action) – Root cause analysis with Corrective Action and Preventive Action to avert recurrence of a similar potential problem;
  • Change Control –  managing change to prevent unintended consequences;
  • Quality – Achieving identity, strength, purity, and other quality characteristics designed to ensure the required levels of safety and effectiveness for the product;
  • Quality by Design and Product Development – developing a product and manufacturing processes to ensure the product consistently attains a predefined quality;
  • Quality Risk Management – assess and mitigate risk or evaluate acceptable levels of risk;
  • Quality Unit (QU)- usually quality control (QC) and quality assurance (QA)- regulations expressly assign the QU the authority to create, monitor, and implement a quality system.

Model Pharmaceutical cGMP Quality System Activities

The model Quality System is typically implemented with an emphasis on four major factors, with key initiatives under each:

  • Evaluation Activities
    • Analyze Data for Trends
    • Conduct Internal Audits
    • Quality Risk Management
    • Corrective Action
    • Preventive Actions
    • Promote Improvement
  • Manufacturing Operations
    • Design, Develop, and Document Product and Processes
    • Examine Inputs
    • Perform and Monitor Operations
    • Address Nonconformities
  • Management Responsibilities
    • Provide Leadership
    • Structure the Organization
    • Build Your Quality System to Meet Requirements
    • Establish Policies, Objectives, and Plans
    • Review the System
  • Resources
    • General Arrangements
    • Personnel Development
    • Facilities and Equipment
    • Control Outsourced Operations

Robert P. Mino, PA, can help your firm implement a plan to create, a status review, or an audit of your firm’s quality system.  Either directly, or through our network of experienced consultants, we can offer you opportunities to improve your quality system in each of the above areas.