Quality Systems

Articles

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

EMA Relocates Drug Evaluations to EU Member States

The European Pharmacopoeia Commission added 19 new monographs and three new chapters and revised 51 monographs and 15 chapters.

European Pharmacopoeia Gets Updated

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Pharma 4.0 envisions highly efficient automated processes, which could be continuous, batch, or a hybrid of these, driven by an integrated manufacturing control strategy. 

Pharma 4.0

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

EMA Recommends Two Biosimilars, One Orphan Drug, for Approval

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

EMA Releases Relocation Tracking Tool

Russell E. Madsen is the former senior vice-president of science and technology at PDA, and is a current member of Pharmaceutical Technology's editorial advisory board.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing.  The authors included a brief summary of the comments developed on the draft document.  This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft. 

Annex 1 Misses the Mark–Expanded Version

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

EMA Advises Recall of AbbVie, Biogen MS Drug

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the  United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

How to Achieve Pharmaceutical Dust Control

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. 

A New Method for Risk Assessment of Pharmaceutical Excipients

The agency met to discuss its new temporary and permanent premises in Amsterdam.

Regulatory/GMP Compliance, Europe