Process Validation

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 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.
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.
Apr 02, 2017
Pharmaceutical Technology
The primary impact of using the covalidation model is the expedited analytical method qualification of both the transferring and receiving laboratories.
Mar 02, 2017
The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.
Feb 15, 2017
PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
Nov 15, 2016
Pharmaceutical Technology
The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.
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