Quality Control/Quality Assurance

Companies can use metrics as a tool to help drive positive change and quality process improvements.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

KR Karu from Sparta Systems spoke with BioPharm International about the importance of having an enterprise quality management system.

Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.

Reduced carryover risk and close attention to particulate control result in greater patient safety through the use of single-use systems.

Have FDA initiatives improved manufacturing quality?

This article examines the options to best match needs and spending for quality and regulatory leadership.

BioPharm International spoke with industry experts about the effect FDA's 2011 process validation guidance has had on industry.

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

FDA talks about the changing scope of regulatory science.

A recent ISPE guidance provides a baseline for the design of quality laboratory facilities.

This month, Sharon Strause, an industry consultant, provides a look back at "Computer System Validation Part I: Testing and Verification of Applications Software" by Leonard J. Goren.

USP revises labeling requirements for Heparin.

Understanding overall supplier capability versus the critical-to-quality attributes of your product can reduce both risk and cost.

New US Pharmacopeial Convention (USP) standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.

USP optimizes identification tests and impurities procedures.

Anne Marie Dixon of Cleanroom Management Associates, gives us an update on her 1988 article, "Clean Room Management."

USP Hosts Symposium on Science and Standards

Brazil's regulatory health authority, Anvisa, plans to establish quality requirements for locally produced pharmaceutical excipients, Anvisa told BioPharm International.

A one-day sign off for batch records is considered a best practice in the industry.

Recently developed immunoassay technology platforms reduce sample volume requirements and improve cycle times.

Unnecessary analytical testing can lead to unnecessary costs.

Although FDA cannot do anything to stop drugs from being discontinued, it can do something about supply and quality problems that lead to shortages.