Analytics

This discussion aims to outline an approach to metal contamination prevention that should achieve a level of control acceptable to all stakeholders.

Using an alternate moisture-generation method may provide more accurate data for regulatory submissions.

The authors describe a process for generating high affinity, fully human antibodies in culture.

This article focuses on the growing need for effective data management in the life sciences industry-especially among smaller pharmaceutical manufacturers.

Developing analytical methods and performing related testing is crucial for ensuring the quality of a pharmaceutical product.

Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation.

The author discusses current expectations in bioprocessing and lays a framework for using NMR to enhance a QbD approach.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2012 edition from UFP Technologies and Mettler Toledo.

Managing risk in biopharmaceutical operations is of utmost importance for patient protection.

New European Pharmacopoeia chapter aims to resolve problems with applying the harmonized UDU test to large sample sizes.

The authors describe how traditional approaches to analytical method and validation may benefit from alignment with quality-by-design concepts.

Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications.

Real-time experimentation may offer continuous process improvement.

New product reviews for October 2012, featuring analytical equipment.

International trade can be great for business, but breaking border laws can put one in hot water.

Industry experts share perspectives on analytical instrumentation, methods, and data analysis.

MIT survey results address product and site characteristics that statistically correlate with quality performance.

The authors describe a QbD study that was performed to optimize a coating system.

New product reviews for August 2012.

The author discusses how to manage pending pharmacopeial changes.

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

Meticulous system configuration can prevent machines from taking over.

The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.

Cleaning validation provides assurance that the quantity of residual substances collected from equipment surfaces are within permissible limits, helping to ensure quality control and safety in pharmaceutical manufacturing facilities. Three different cleaning validation methods for measuring the carbon in residual samples of various pharmaceutical substances were compared.

Experts share insights into analytical tools and techniques.

We have developed an in-house broth to neutralize a preservative for traditional microbiological testing following USP <61> Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests. We would like to use a rapid method to release product faster, but is there a broth that will be effective on our products?

Industry experts share their insight on solid-dosage and sterile manufacturing.

IQ Consortium representatives explore industry approaches for applying GMPs in early development.

Careful attention to detail will help to prevent valuable assets from "melting" away.

An industry roundtable on how users and makers can best assess and manage black specks.