Safety GMP certificate in medical devices

K-GMP will try to be more stabilized Medical gmp certification system to be established



GMP


GMP Definition
- Good Manufacturing Practices
- Quality Management System ( ISO9001, 22000, 13485 etc.)
- Quality System Requirement (FDA, CFDA, CE)
K-GMP has been providing companies with RA&QC dispatch work to minimize their financial burden and eventually to help them grow up under well-organized education system.


GMP Documentation

Standard of GMP

Qulity Manual
- Scope
- Qulity policy
- Resposiblity
- Communication Precedure
..

Product Standard
- Document Management
- Facility Management
- Storage Management
..

Sterilization operation guidance
- Cleaning procedure
- Reports of temperature
- Reports of humidify
..


Our Specialties
01. Provide Simultaneous Translation
02. Minimized the possibility to get refusal for GMP
03. Build up Business Network with MFDS
- With simultaneous translation, we help the GMP Audit be conducted more efficiently
- Based on our knowledge of international standards, we will able to provide our expertise to local companies
- We will prepare the audit materials on behalf of MFDS, which help us build up great partnership with them.