Process Validation

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.
Aug 01, 2017
Pharmaceutical Technology
Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
Jul 02, 2017
Pharmaceutical Technology
FDA’s process validation guidance has evolved and the current lifecycle approach has profoundly influenced validation practice.
Jun 02, 2017
Pharmaceutical Technology
The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.
May 15, 2017
Pharmaceutical Technology
Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.
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