Good Manufacturing Practice Quality Assurance
The GMP QA Leadership Group was formed in September 2011. Our mission is to help shape and influence development and commercial GMP regulations and bring innovation to the quality arena through collaboration with other IQ Leadership Groups.
The GMP QA LG was formed with the specific objectives of:
- Aligning GLP and GMP QA requirements
- Collaborating with FDA and other regulatory agencies on new QA based GMP guidance documents
- Developing industry white papers, publicize and promote findings
- Providing resources and subject matter experts to various IQ teams
The first activity undertaken by the GMP QA LG is the establishment of its Working Group on practical implementation of ICHQ10 concepts.