
GMP consultation & validation
Austar has abundant experience on GMP requirements. We have a number of qualified GMP experts, who acted as major roles respectively in the international pharmaceutical companies and authorized drug administrations, with rich practical experience and cooperation relationship with relevant foreign consultant agencies abroad.
We will try our best to provide below consultation or service according to current GMP of China, US and EU:
Validation service
- Writing of VMP(Validation Master Plan)
- Qualifications of HVAC, Process water system and Production equipments
- Cleaning Validation and Analytical method validation
- GMP compliance consultation
GMP site audit
- Writing and registration of DMF
- Writing and registration of COS
- Supporting to build an integrated Quality Assurance System
- Training of special subject

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