GMP Certification and GMP Management System

What is GMP?

GMP-Good Manufacturing Practice

It can also be called Current Good Manufacturing Practice(cGMP).

Good Manufacturing Practices refer to the laws and regulations on the production and quality management of food,drugs and medical products.It requires enterprises to meet the sanitary quality requirements in terms of raw materials,personnel,facilities and equipment,production process,packaging and transportation,quality control,etc.according to relevant national laws and regulations,to form a set of operable operation specifications to help enterprises improve the sanitary environment of enterprises,and to find problems in the production process in time for improvement.

The difference between China and most other countries in the world is that human drug use and veterinary drug use are different in China,which adopts human drug use GMP and veterinary drug GMP.Since the implementation of drug GMP certification in China,it has been revised in 2010 and officially implemented the new version of GMP in 2011.The new version of GMP certification puts forward high requirements for the production of sterile preparations and APIs.

So why do many pharmaceutical factories need to pass the GMP certification?

Manufacturers or enterprises with GMP certification receive strict supervision from relevant national departments in a series of processes such as product production and testing.For consumers,it is a barrier to control product quality,and it is also a protection for enterprises themselves,so that their products have a standard to better control product quality.

Enterprises with GMP certification need to establish a GMP quality management system to ensure the integrity and traceability of the enterprise quality,because the enterprise also regularly receives GMP audits from the National Food and Drug Administration every five years to check all the GMP documents and relevant operating history records of the enterprise in the past five years.

As a GMP factory,Hande implements quality management in strict accordance with the requirements of cGMP and the current quality management documents.The Quality Assurance Department supervises the implementation of quality work in all departments,and continuously improves and perfects the company’s quality management system through internal GMP self inspection and external GMP audit(customer audit,third-party audit and regulatory agency audit).