GMP Compliance in QC Labs: It Takes a Village
Meeting standards for Good Manufacturing Practice (GMP) compliance is increasingly difficult for pharma labs. Regulatory bodies around the globe enforce these standards. In the U.S. alone, the FDA’s Office of Manufacturing Quality issued 81 warning letters to manufacturers of finished products in the fiscal year that ended in September 2019.
Forming a partnership with third party QA/QC providers can be what manufacturers need: expert help that can quickly discover where QA/QC assistance is needed. They also provide a wealth of knowledge that may surpass the experience of internal teams.
If an audit turned up an observation, for example, it may be a truly beneficial time to bring in fresh eyes to help you meet GMP compliance requirements. Not only can third-party providers aid with responding to observations or warnings, they can proactively help internal teams to comply with regulatory standards.
For more signs that it’s time to talk to a QA/QC compliance provider, read our checklist here.