• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

Outsourced QA

ServicesMultination MAH/MAAOutsourced QA

When a company plans to establish or is establishing a quality system and the quality management department, maybe they don’t have sufficient experience or manpower to manage the relevant quality activities. Or when products are in the early clinical stage, maybe the quality activities appear volatility and the overall workload is not so high, it may be costly to have a quality team in place. gempex can provide QA related services to support the customer in managing and executing the related responsibilities and tasks until the customers can carry out the activities independently after having the sufficient resources.

Service Advantage

Technical expert team with professional background in pharmaceutical, biological and other fields
Support many domestic enterprises for quality system operation and maintenance services
Covers quality agreement review, management of suppliers, and others
advantage

The Service Contents

1.  Maintain and manage the new established quality management system
2.  Prepare training plan and implement training
3.  Execute internal audits
4.  Provide supplier management (audit execution for suppliers)
5.  Provide orreview quality agreements
6.  Review records related to system operation (changes, deviations, batch records, etc.)
7.  GMP compliance support for the routine activities
8.  Update GMP regulatory
9.  Provide training and compliance support
  • MAH related regulations training
  • MAH preparation for inspection
  • Training on various topics of the quality system
  • Data integrity, qualification and validation concepts training, etc.
  • Other topics training