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Management’s Role in Developing a cGMP-compliant QS

Creating an effective quality system (QS) requires a significant investment of time and resources. This requires more than just participation from staff. Management's involvement is key to setting up and maintaining a robust QS. 

Both senior management and employees must dedicate time and effort to develop, implement, and manage a quality system. An effective QS can help manufacturers comply with cGMP regulations while improving the company's reputation and streamlining its profitability. 

Let's take a closer look at management's role in developing an effective and cGMP-compliant quality system. 

  1. Provide Leadership

Leadership is among the most important functions of management since strives to maximize the manufacturer's efficiency and helps it achieve set goals. When it comes to quality systems, senior management must immerse itself in the development process to ensure the right degree of control, initiate action, provide guidance, and demonstrate commitment. 

To support the quality system, management can: 

  • Participate in the QS design, implementation, and monitoring. 
  • Oversee the system review. 
  • Find and commit the necessary resources.
  • Encourage improvement of QS operations.
  • Be proactive in implementing changes.
  • Understand the external environment fluctuations and react to them.
  • Develop trust across all levels of the organization.
  • Develop and deliver the necessary training for the QS staff 

It's up to management to maintain a healthy quality system by providing all the necessary resources and support. Managers should foster open, honest, and detailed internal communication on quality issues across all levels and related departments within the organization. 

  1. Structure the Organization

To make sure a robust quality system is developed, implemented, and maintained in the most efficient way possible, management must create an appropriate environment. Managers have to structure the organization, so the quality system can work according to rules, regulations, and the manufacturer's goals. 

The organization should be structured to support actions necessary to produce quality products. Otherwise, the staff would need to struggle to implement an effective system. Senior management is also responsible for ensuring that the organization's structure is documented properly. 

It's up to management to make sure that: 

  • All organizational elements required to develop and implement a properly functioning quality system are in place. 
  • The organizational structure is clearly defined and documented. 
  • Proper resources are allocated to meet the needs of QS personnel and structure. 
  • Establishment of appropriate monitoring and controls 

Team members who are responsible for implementing the system and maintaining product quality must know their responsibilities. To ensure this, management should communicate employee roles within the system in a transparent manner. 

  1. Build Your QS to Meet Requirements

By implementing an effective quality system, management can ensure compliance with cGMP regulations. While a robust QS is designed with compliance in mind, it's up to management to make sure that the system provides transparent guidance to the staff. 

Managers should control the development of: 

  • QS design 
  • Risk management framework
  • Documentation management system 

One of the most important responsibilities of management is to structure QS documentation. To comply with cGMP regulations, it's important to establish and follow written controls for plans, specifications, and procedures that help implement and maintain a robust quality system. 

It's also up to management to communicate the importance of meeting QS requirements while assigning responsibilities for the system's reporting, documentation, and control. 

  1. Establish Policies, Objectives, and Plans

Policies, objectives, and plans are the tools that management uses to communicate its commitment to quality. It's up to the managers to develop a quality policy that aligns with the organization's mission. Senior management should commit to meeting QS requirements and ensuring compliance while proposing objectives to maintain the quality policy. 

  • Quality policy — a document that aligns the organization's purpose and direction and provides a framework for quality objectives. 
  • Quality objective — a measurable goal aimed at improving customer satisfaction. These objectives can be established for any process relevant to the quality system. 
  • Quality plan — documents that define the quality standards for a product and provide information on how these quality standards should be achieved. 

It's management's responsibility to: 

  • Communicate the quality policy and quality system plans to the staff and ensure a full understanding of how they align with strategic and quality goals. 
  • Establish metrics and targets by which the performance of the QS will be assessed. 
  • Define the quality objectives identified for quality policy implementation. 
  • Ensure the creation of quality objectives through a formal quality planning process. 
  • Support quality objectives with necessary resources. 
  • Monitor quality objectives regularly. 

Managers should use quality planning to find resources and define activities for meeting quality objectives. 

  1. Review of the System

Management's role doesn't end with the design and implementation of the quality system. It's up to the managers to ensure the system's integrity and effectiveness throughout its lifecycle. Top managers must arrange regular reviews of the quality system and related metrics to make sure it's working according to plans, requirements, and schedule. 

During the review, management should assess the quality system's metrics, performance, and its effectiveness for the quality of the product. 

For new systems, such reviews should be more frequent than for mature QS. They can help establish the right processes and adjust plans and policies according to the organization's needs with cGMP requirements in mind. 

Besides scheduled internal reviews, management should arrange periodic reviews by qualified external sources. These reviews can be highly useful for QS evaluation that can provide valuable insight into the manufacturing process, resource allocation, and quality-related procedures. 

The Takeaway 

Occasional monitoring and superficial control aren't sufficient to ensure effective design, implementation, and maintenance of a quality system. To achieve your organization's goals and develop a cGMP-compliant QS, it's imperative for management and executives to proactively involve themselves in the process. 

From committing the necessary resources to arranging in-depth system reviews, managers must invest a substantial effort in keeping the quality system in top shape. To improve your quality system and ensure compliance, it may be necessary to rethink management's responsibilities. 

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