Resources

The main regulatory standard for ensuring pharmaceutical quality is 21 Code of Federal Regulations (CFR) Parts 210 and 211, collectively referred to as the current good manufacturing practice (CGMPs) regulation...

A well-written and well-implemented quality risk management plan is an integral element of an effective quality system. During the development of your total quality strategy, the bottom line is that...

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. Q: Do I need to comply with all aspects of the various...

Subject matter experts from Regulatory Compliance Associates® Inc. discuss how too many organizations scramble when an FDA inspection occurs because they fail to be adequately prepared. True inspection preparedness, however,...

When it comes to pharmaceutical manufacturing, ensuring a strong quality culture is one way to avoid recurring GMP issues, such as data integrity. Susan Schniepp, Distinguished Fellow at Regulatory Compliance...

Susan J. Schniepp, Distinguished Fellow at Regulatory Compliance Associates, answers some commonly asked questions about aseptic processing and environmental controls. Q. What is aseptic processing? A. Aseptic processing is a...