The FDA conducted an inspection of a manufacturing facility located in the US and found significant violations of Current Good Manufacturing Practice (CGMP) regulations. The violations identified include the following: The FDA requested the following actions in response to the identified violations: Recommendation: The firm should consideration of engaging a qualified consultant to assist in…
The U.S. Food and Drug Administration (FDA) recently inspected a US drug manufacturing facility and identified several significant cGMP violations, resulting in a Warning Letter (#649198). The violations include: Here are five remediation actions that the company should take: Cleaning and Maintenance Procedures: Investigations and Deviations: Production and Process Control Procedures: Contamination Prevention: Independent Assessment:…
Q1. Do the CGMP regulations require a firm to retain the equipment status identification labels with the batch record or other file? The CGMP regulations for finished pharmaceuticals require the retention of cleaning and use logs for non-dedicated equipment. But no similar requirement exists for retaining what are intended to be quick reference or temporary…
GMP and cGMP are two common terms in pharmaceutical manufacturing. In this article we try to find out the differences between GMP and cGMP in pharma industry. “c” in cGMP “c” in cGMP stands for current, requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and…
GMP stands for Good Manufacturing Practices. It is a set of guidelines and regulations to ensure that pharmaceutical products are consistently produced and controlled to the quality standards appropriate for their intended use. This includes guidelines for the design, monitoring, and control of manufacturing processes, as well as quality control testing procedures. GMP compliance is…