Quality Systems

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.

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

This article takes a statistical look at the calibration requirements for a UV spectrometer.

Abrams Royal Pharmacy is recalling all unexpired lots of sterile products dispensed in the US.

USP is developing and revising distribution standards in response to changes in the global supply chain.

FDA and EMA launch initiative to share bioequivalence inspection information.

FDA has issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water.