Validation and compliance

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.
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.
Nov 02, 2016
Pharmaceutical Technology
A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.
Nov 02, 2016
Pharmaceutical Technology
The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
Aug 02, 2016
Pharmaceutical Technology
Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.
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