Regulatory/GMP Compliance

European Medicines Agency clarifies advanced-therapy medicinal products classification.

Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.

GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.

FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.

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

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

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.

Draft guidance from FDA includes information essential for the completion of ANDA applications.

In legacy facilities and as buildings age, ensuring cGMP compliance can become complex. A review of a facility's gowning operations can bring insight into the current state of cGMP compliance. The author presents characteristics to look for and questions to ask.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

Life-sciences companies can get a jump on potential quality problems by looking at the leading indicators hiding in the document management process further upstream.

The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

New guidance from FDA asks for documentation of CMC postapproval manufacturing changes.

Using best practices for manual or automatic inspection can improve the inspection process.

The root cause of drug shortages is mismanagement of variation.

FDA revises interpretation of the five-year NCE exclusivity provisions for certain fixed-combination drug products.

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

USP's revised Chapters 41 and 1251, which became official in December 2013, have new requirements for weighing, including balance calibration and testing.

EMA releases an update on its flu vaccine guidance.

In first official visit to India, FDA commissioner to discuss ongoing collaboration on drug programs.

The Food and Drug Administration plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

ISPE and PDA take on the challenge of recommending quality metrics.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.

Non-compliance issues show that users find dealing with computer systems challenging.

EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.

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

Online portal accepts nominations for FDA advisory committee membership.