GMP Requirements for Freeze Drying: Essential Guide for Compliance
Good Manufacturing Practice (GMP) requirements for freeze-drying set strict quality standards to ensure that pharmaceutical and food products are produced …
Process Performance Qualification (PPQ)
Process performance qualification
Process performance qualification (PPQ) is the second stage of process validation. FDA Guidance 2011, Process Validation: General Principles and Practice …
Lyophilizer Qualification: Ensuring Freeze-Dryer Quality
Did you know a single mistake in a lyophilized drug can cause a recall? This recall can cost pharmaceutical companies …