What are the GMP quality assurance principles for Quality Management?

1 Principle 1: Quality by Design

Quality by design means that quality is planned and built into every stage of the product lifecycle, from development to distribution. It involves identifying the critical quality attributes of the product, the potential risks and sources of variation, and the control measures and specifications that ensure the product meets the intended use and customer expectations. Quality by design also requires a systematic approach to documentation, validation, and change management, as well as continuous improvement and learning from feedback and data.

2 Principle 2: Quality Control

Quality control refers to the activities and tests that verify and monitor the quality and conformity of the product and its components throughout the production process. It includes sampling, inspection, analysis, and release of raw materials, intermediates, and finished products, as well as calibration, maintenance, and cleaning of equipment and facilities. Quality control also involves recording, investigating, and correcting any deviations, errors, or non-conformities that may occur, as well as implementing corrective and preventive actions to prevent recurrence.

3 Principle 3: Quality Assurance

Quality assurance encompasses the overall management and oversight of the quality system and its implementation. It ensures that the quality policy, objectives, and responsibilities are defined, communicated, and followed by all staff and stakeholders. It also ensures that the quality system is aligned with the regulatory requirements, industry standards, and customer needs. Quality assurance also involves conducting audits, reviews, and assessments to evaluate and improve the effectiveness and efficiency of the quality system and its processes.

4 Principle 4: Quality Culture

Quality culture is the shared values, beliefs, and behaviors that foster a commitment to quality and excellence in the organization. It involves creating a positive and supportive environment where staff are motivated, empowered, and accountable for their actions and results. It also involves fostering a culture of transparency, collaboration, and feedback, where staff can communicate openly, learn from mistakes, and share best practices. Quality culture also involves engaging and satisfying the customers and stakeholders, as well as complying with the ethical and social responsibilities of the organization.

5 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?