Drug Marketing Holder System/MAH

"The medical device registrant system issued and implemented by the State Drug Administration has solved the actual dilemma of landing products for science and technology start-up enterprises and technology research institutions, solved the problems of idle production sites, equipment and other resources before listing and unsaturated work of professional manufacturing personnel, and avoided the waste of resources caused by the difference between pre-market trial production and post-market mass production scale, and the occupation of a large amount of infrastructure funds before listing approval.

2024

10-25

Medical Device GMP Certification

According to the spirit of the national food and drug supervision and administration and the construction of a clean and honest government on December 26, 2013, China will fully implement the production quality management standard in the medical device industry.

2024

10-25

Plant Verification and Validation

We provide guidance for factories, facilities and equipment suppliers in the whole process of verification implementation in China and Europe and the United States, including verification training, assisting in drafting the verification master plan VMP, verification scheme VP, organizing the implementation and management of the whole verification process (DQ, IQ, OQ, PQ), completing the verification report and evaluation and document standardization, specifically, it includes the verification of plant facilities and three major systems, equipment verification, cleaning verification, method verification, computer software system verification, process verification, etc., to ensure that the latest GMP requirements and global verification guidelines are met.

2024

10-25

CSV Computerized System Validation

1. Computer system verification (CSV verification) is an important part of quality assurance in the pharmaceutical and related industries, and it is the part that must be verified in the 2010 GMP appendix. Durst's validation team has a deep background in the pharmaceutical industry, validation consulting, and a deep understanding of domestic and international GMP regulations and rich practical experience. Can provide you with computer verification services for compliance with GMP requirements such as FDA, EU, TGA, NMPA, etc.

2024

10-25

Utility System Verification and Validation

We provide guidance for factories, facilities and equipment suppliers in the whole process of verification implementation in China and Europe and the United States, including verification training, assisting in drafting the verification master plan VMP, verification scheme VP, organizing the implementation and management of the whole verification process (DQ, IQ, OQ, PQ), completing the verification report and evaluation and document standardization, specifically, it includes the verification of plant facilities and three major systems, equipment verification, cleaning verification, method verification, computer software system verification, process verification, etc., to ensure that the latest GMP requirements and global verification guidelines are met.

2024

10-25

Verification and Validation of Equipment and Facilities

Durst has the CMA qualification of factory inspection. We provide the whole process guidance for factories, facilities and equipment suppliers in China and Europe and the United States, including verification training, assisting in drafting the verification master plan VMP, verification scheme VP, organizing the implementation and management of the whole process of verification (DQ, IQ, OQ, PQ), completing the verification report and evaluation and document standardization, specifically, it includes the verification of plant facilities and three major systems, equipment verification, cleaning verification, method verification, computer software system verification, process verification, etc., to ensure that the latest GMP requirements and global verification guidelines are met.

2024

10-25