Quality System Model
Maintaining a top-functioning Quality System in a regulated environment can add serious problems to the company’s bottom line. Nevertheless, the Return On Investment (ROI) can be significant with solutions that automate routine and administrative tasks related to Quality System maintenance.
Within the pharmaceutical industry, it is not easy to find a Quality System model that offers a meeting point for agreement, be it direct or indirect, with the FDA’s cGMP initiative.
However, in the ‘Quality Systems Approach to Pharmaceutical cGMP Regulations’[1] support document, the FDA introduces a potential Quality Systems model that could offer the elements that pharmaceutical companies require to start, or keep growing a top-functioning Quality System capable of meeting the institution’s regulations and requirements.
This guidance is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the Agency's current good manufacturing practice (cGMP) regulations (2l CFR parts 210 and 211). The guidance describes a comprehensive quality systems (QS) model, highlighting the model's consistency with the cGMP regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. Submitted by The Food and Drug Administration (FDA)
The quality systems model proposed by the FDA is divided into four major categories:
1. Management responsibilities - Modern robust quality systems models call for management to play a key role in the design, implementation, and management of the quality system.
2. Resources - Appropriate allocation of resources is key to creating a robust quality system and complying with the CGMP regulations.
3. Manufacturing operations - Significant overlap exists between the elements of a quality system and the CGMP regulation requirements for manufacturing operations.
4. Evaluation activities - Quality systems call for continually monitoring trends and improving systems. This can be achieved by monitoring data and information, identifying and resolving problems, and anticipating and preventing problems.
The central goal of a quality system is the consistent production of safe and effective products and ensuring that these activities are sustainable. Easily broken down into three items:
1. Upholding customer safety
2. Abide by regulatory body regulations
3. Strive for continuous improvement
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