No, GMP is not a QMS, but rather a part of a Quality Management System. GMP ensures products are consistently produced and controlled according to quality standards, while a QMS encompasses the overall organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.
In short, GMP is integrated into the QMS, providing the specific requirements for manufacturing.
GMP as Part of QMS
Good Manufacturing Practices (GMP) are focused on the production and control aspects of quality. They provide a detailed set of guidelines and regulations that must be followed during the manufacturing process to ensure that products meet defined quality standards.
QMS Overview
A Quality Management System (QMS) is a more holistic system that includes:
- Organizational structure.
- Responsibilities.
- Procedures.
- Processes.
- Resources for quality management.
QMS is a broader concept than GMP. According to the provided reference, Good Manufacturing Practices (GMP) is a part of the Quality Management System that helps ensure products are produced and controlled according to quality requirements.
| Feature | GMP | QMS |
|---|---|---|
| Scope | Manufacturing processes and quality control. | Entire organization and all activities impacting quality. |
| Focus | Ensuring products are consistently produced to quality standards. | Creating a system for continuously improving quality across the organization. |
| Implementation | Detailed guidelines and regulations for manufacturing. | Framework for implementing and maintaining quality standards, which includes GMP, where applicable. |
In other words, GMP is a subset within the larger QMS framework.
