Appropriate allocation of resources is key to creating a robust quality system and complying with the CGMP regulations.
The organization shall determine and provide the resources needed in order to implement, maintain and continuously improve the quality system to achieve customer requirements.
Resource requirements and management are critical to support your quality management system and produce quality products:
(1) ensuring that personnel performing work affecting quality is competent;
(2) the organization infrastructure (buildings, workplace, facilities, equipment and machinery, associated utilities, etc) is adequate;
(3) the Work environment is capable to support the quality journey
Therefore RESOURCES Requirements and Management is divided into:
1) Human Resources
2) Facility & Equipment,
3) Out-sourcing Resources