Properly validated drugs are safe drugs and safe drugs mean safe patients. That is why the journals on IVT Network have been dedicated to the best thought leadership from the best researchers and scientists in the field.
During the past 30 years, there has been a move from product control (finished product sampling and testing) to process control.
The presence of endotoxin in sterile pharmaceutical products presents a significant risk to patients. The primary source of endotoxin is pharmaceutical grade water, due to the potential for Gram-negative bacteria to be present in the water system or outlets.
Must penicillin be manufactured in a separate CGMP manufacturing facility?
Why are you writing a Business Continuity Plan (BCP)? In our case, a client auditor reviewing our quality systems for cGMP compliance noted that while we had SOPs in place on Disaster Recovery, Backup Power Generation, Preservation of Raw Data, Safety and others to deal with adverse events that can disrupt the business of the laboratory, we did...
Medication errors entail several concurrent impacting situations many necessitating a deeper level of investigation. Human error is inevitable. However, we can understand and strive to reduce the frequency of human error through proactive approaches.