GMP Compliance in QC Labs: It Takes a Village
Cookies on PerkinElmer
PerkinElmer uses cookies to ensure that we give you the best experience possible on our website. This may include cookies from third party websites. If you continue without changing your settings, we will assume that you consent to receive cookies from this website. You can change your cookie settings at any time. To learn more, please review our cookie policy, which includes information on how to manage your cookies.

GMP Compliance in QC Labs: It Takes a Village

September 16, 2020

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.

Read More Stories Like This One

Shelf Life: Take Control of Stability Testing

Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated co...