Quality Systems

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

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.

FDA urges manufacturers to examine how shape, size, and color may affect patient safety and enhance treatment adherence.

High technology assessments are having an impact on biosimilars development in Europe.

PDA works with FDA to create pharmaceutical quality metrics.

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.

The biopharmaceutical industry contemplates product innovation within the changing landscape of healthcare.

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

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

Regis Technologies passes a recent FDA audit with no Form 483 observations.

Some recent high-profile cases of quality issues at Indian manufacturers have given reason to examine manufacturers more closely.

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

NCI launches trial to assess the utility of genetic sequencing to improve patient outcomes.

India has a name when it comes to generic drug development. According to a recent research on patent applications carried out by Withers & Rogers, innovation by Indian pharmaceutical companies has increased over the past few years; however, the quality did not match the standard seen in Europe.

Products enable testing in accordance with methods described in new USP monograph.

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.

USP opens expanded Shanghai facility to enhance quality standards for medicines and food ingredients.

A packaging defect has led to Merck voluntarily recalling all lots of Liptruzet tablets in the United States.

A survey of BioPharm International readers found that single-use systems and other technologies are driving process efficiencies in biomanufacturing, but there is room for improvement.

USP announced the approval of General Notices section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements with an official date of Dec. 1, 2015.

FDA releases guidance on the qualification of drug development tools.

FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.

EMA has launched a new version of the EudraGMDP database, which includes the publication of statements of non-compliance with good manufacturing practice.

Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator.

Regulators work with manufacturers to improve systems for measuring product performance and manufacturing reliability.

Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed.

Kurt Lumden, Director, Client services at PAREXEL's Perceptive Informatics, discusses the management of investigational product temperature excursions.