Buildings and Facilities Sec. 211.42
Buildings and Facilities Sec. 211.42 The design and construction of buildings and facilities play a critical role in the pharmaceutical manufacturing process, …
Drug product salvaging.Sec. 211.208
Current good manufacturing practices for finished pharmaceutical 21CFR 211. The pharmaceutical industry operates under stringent regulations to ensure the safety, …
Lyophilizer cleaning validation
Lyophilizer cleaning validation is paramount for lyophilized drugs in the pharmaceutical industry. Contamination in the lyophilizer not only wastes resources …
Freeze Drying Capacity Calculator
Freeze Drying Capacity Calculator Choosing the right freezer for your needs can be a complex process, especially when you need …
Freeze Dryer Condenser Capacity test
The Freeze Dryer Condenser Capacity Test is a crucial procedure to evaluate the maximum ice-holding capacity of a freeze dryer’s …
Functional test of the Media fill process
The functional test of the Media Fill process is a critical validation step in pharmaceutical manufacturing, ensuring that the process …
Functional test of the filter integrity test (WIT)
The Functional Test of the Filter Integrity Test (WIT) is a critical component in validating the performance of filters used …
Lyophilizer Qualification Guidelines
Lyophilizer Qualification Guidelines” article provides an in-depth exploration of lyophilization, also known as freeze-drying, a critical process for enhancing the …