A surge of interest in data integrity in recent years has caused the regulators to issue new or updated guidance on the requirements and expectations with regards to achieving and demonstrating compliance in respect to data integrity.
To achieve the necessary level of control the cleanroom is designed and constructed in a manner to minimize the introduction, generation, and retention of particles inside the room.
An SOP can guide your Master Validation Plan, and are fundamental to explaining how your departments operate. Available for instant download is this Master Validation SOP template, along with an approval form template.
The challenges and risks of microbiological analyses and their impact on product quality and patient safety is underestimated or overlooked. Dr. Saha directs your focus.
This article discusses the need for procedures regarding objectionable organisms as well as methods to determine the organisms that should be on this listing.
This article reviews the evidence and factors for temperature in hot circulating pharmaceutical water systems and examines the case for operating such systems at temperatures below the previously uncontested cut-off temperature of 80oC.