Process Validation

May 15, 2018
Pharmaceutical Technology
Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
May 15, 2018
Pharmaceutical Technology
Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?
Apr 02, 2018
Pharmaceutical Technology
Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy.
Mar 01, 2018
Pharmaceutical Technology
Can an Irish analytics company and its CEO bring pharma closer to 21st-century practice?
Dec 02, 2017
Pharmaceutical Technology
Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.
Nov 02, 2017
Pharmaceutical Technology
The revised Akers-Agalloco aseptic risk assessment and mitigation method includes two sub-methods that can be used independently for risk assessment.
Oct 02, 2017
Pharmaceutical Technology
Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.
Sep 08, 2017
Six years after the guidance, it’s time to change our quality assurance vocabulary.
Sep 01, 2017
Pharmaceutical Technology
The industry needs a single standard cleaning limit at 25 mg/m2.
Aug 02, 2017
Pharmaceutical Technology
The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
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