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Setting up a New GMP Facility 04.23: Due to the very high interest this workshop will be held in 2012. Learn more about the content and make your pre-reservation.

Successful Expert Seminar09.19: Our first GMP expert seminar held in shanghai was a full successful activity.

US, EU GMP Requirements, Inspections 10.18: Do you still suffer with the differences of chinese GMP compared to western GMP? come to our seminar.

What is GMP?

: GMP is a term that was introduced in 1962 by the US Food and Drug Administration (FDA). The term is synonymous for a collection of behaviour measurements and instructions that have to be taken into consideration during the...Read more >>

About us

Wellcome to our booth, E1C18
ShangHai CPhI, June 26-28th, 2012

The international GMP requirement is more and more strict, how to pass the EU/FDA authorities' inspection or fulfill their requirement, still a big issue in china. in order to help you for solving these problems, we will arrange foreign experts to meet with you on our booth to give answer to your questions and provide individual GMP consultancy to you. We will also give showcase during CPhI for free.

Want to arrange a special meeting between you and my Germany expert? pls contact our staff directly.

Services Packages

: DMF/ASMF/CEP; - CTD Training
- Instruction "how to do"
- On-site assistance
- Review & compliance check
- Authority filing & communication
- Be the representative
- Customer sourcing; Read more >>

Gap Analysis

- GMP system check
- documentation review

- design review (old & new

facilities)

- on-site interviews
- improvement plans
- analysis reports

Qualification

- Qualification of equipment

- Qualification of rooms &

premises

- Training & Templates

GMP Training

- Fundamentals of GMP

- GMPs for Importers

&Distributors

- Risk Management
- Validation & Qualification
- Building of GMP facilities
- Preparing for a RegulatoryInspection
- Procedure Writing (SOPs)
- Preparing for GMP Audits

: Audit Assistance; - Pre-audit auditing
- Compliance audit
- Self-Inspections
- Third-Party Supplier Audits
- API Audits
- Follow-up audits
- Audit Assistant; Read more >>

Process Validation

- Validation Master Plan

- Process Risk assessment

- Validation Protocols (templates)

- Statistical Evaluation