Analytics

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.

The CPhI Pharma Award for Excellence in Analysis, Testing, and Quality Control went to B&W Tek for its handheld laser induced breakdown spectroscopy (LIBS) analyzer, NanoLIBS, which has been developed for rapid identification of solid materials based on elemental analysis. The instrument features a raster scan using a high repetition rate class 3B laser allowing for detection of elements including C, Li, and Be.

The next decade of drug development will depend on better ways of storing, using, and analyzing data, says CPhI advisor Bikash Chatterjee, president and chief science officer of Pharmatech Associates. But each of the following must be optimized: volume, variety, velocity, veracity, and value.

The agency published a guideline for the implementation of ICH Q3D.

Visual inspection of parenteral vials is the first step in a root cause investigation.

The Chinese facility was cited for data integrity violations.

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Stability testing programs should provide drug owners the information needed to establish the proper handling, shipping, and shelf-life recommendations for drug products.

Multiple methods are required for detecting and removing protein impurities.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.

The draft guidance addresses control of elemental impurities in harmonization with implementation of ICH Q3D guideline.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.

A vessel for the Hanson Research Vision G2 series of dissolution testers is designed to provide more consistent vessel-to-vessel dissolution test results.