GMP QMS Establishment

ServicesPlant QMSGMP QMS Establishment

A good quality management system is crucial to ensure product safety, effectivity and quality, and is also the key aspect of all authority inspections. How to build a quality management system that can meet the management requirements of the target regulatory market, at the same time be smart not too complex, in addition be pragmatically fit to enterprise routine operation, becomes the focus and expectation. Especially for new set-up companies, causing by various issues, such as insufficient resources, project time pressure, or experience limitations, etc., the system establishment becomes a problem.

gempex has an efficient system establishing method accumulating from project experience and professional knowledge. We deeply understand the situation of customers, can effectively combine the requirements of regulations, and optimize the quality management process to provide customers with customized management processes. We believe that a document is not just a document, but more of a process. We commit ourselves to providing optimal management solutions with high compliance by good design.

Service Advantage

One-stop solutions, bilingual in Chinese and English

Customized system, executable and direct to use after delivery

Coverage of multi-field customers (chemical drugs, biological drugs, raw materials and package materials, medical devices, etc.)


The GMP QMS Establishment Services Common Modules

1. Quality assurance system

2. Laboratory management system

3. Production management system

4. Facilities and equipment management system

5. Materials and supply management

6. Packaging and labeling

7. Specific subject

  • Contamination and Cross Contamination Control Strategy (CCS)
  • Computerized system management
  • Qualification and validation system
  • Data integrity, etc.

Service Workflow