Process Validation

3M Launches Production-Scale Sizes of its Upstream Purifiers

July 14, 2015

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

Getting Scientific About Cleaning Validation

July 01, 2015

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.

Natrix Introduces New Disposable mAb Purification Column

June 29, 2015

The new column features Natrix’s signature macroporous hydrogel.

Microbiologists Contribute to a Quality Culture

June 17, 2015

Equipment and Processing Report

Presenters at IVT's Microbiology Week discussed best practices and recent guidance publications for microbial control in sterile and non-sterile pharmaceutical processes.

Compliance and Technology for Track and Trace

May 22, 2015

Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.

Medicago Plans Vaccine Facility In Quebec City

May 21, 2015

Medicago's new production facility will make plant-based vaccines and therapeutics.

Evaluating Disinfectant Efficacy of a Silver-Based Disinfectant

May 02, 2015

The author reports results of evaluations and concludes that a disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.

US Marshals Seize Unapproved Drugs

April 16, 2015

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

MHRA Revises Data Integrity Guidance

April 15, 2015

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

EMA Releases Medication Error Guidelines

April 14, 2015

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.