Process Validation

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.
Dec 16, 2016
By Pharmaceutical Technology Editors
The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.
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.
Aug 01, 2016
Pharmaceutical Technology
The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \
Jun 02, 2016
Pharmaceutical Technology
This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.
Jun 02, 2016
Pharmaceutical Technology
Experts discuss the key considerations in the development of an autoinjector.
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