Conducting an Inspection
Basically, an inspection looks at how a company has established it will do something, and compares it to how it is in compliance with good manufacturing practices.
Current good manufacturing practices have been mentioned many times. To give a little background, cGMPs come from section 501(a)(2)(B) of the FD&C. In an effort to create a more defined framework for the cGMPs, FDA added a "c" before GMP to indicate current.
FDA receives its regulations from Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211. These have the force and effect of law and outlines what FDA expects from companies. These regulations are used to determine cGMP compliance. All companies are held to the same standards. The cGMP can be found at:
Lesson status: Incomplete (0% done)
Topic: page 1 of 3 (Lesson: page 18 of 35)