Process and Scaling

June 18, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

June 17, 2014

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

June 06, 2014

Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.

May 19, 2014

Hospira has recalled one lot of labetalol hydrochloride injection, USP, due to visible particulates.

May 02, 2014

Laser Diffraction Software Supports Analytical QbD

April 02, 2014

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

March 06, 2014

Agencies extend successful pilot program to further harmonization of QbD topics.

February 25, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Daiichi Sankyo announced suspension of API shipments from Ranbaxy's Toansa and Dewas plants; issues apology to stakeholders.

February 01, 2014

Traditional project decision-making is compared with a QbD approach.

January 24, 2014

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location