Regulatory/GMP Compliance

USP revises labeling requirements for Heparin.

This case study describes the process used to transition from a multi-use system to single-use tangential flow filtration for performing final buffer exchange steps.

Insights on single-use systems implementation and exploitation in biopharmaceutical manufacturing and processing, based on a QbD approach.

NIBRT's Jayne Telford provides an overview of biopharmaceutical analytics and their accompanying qualification and validation steps.

Patrick Jackson of Vindon Scientific offers key considerations for choosing an outsourced sample storage facility.

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.

USP Hosts Symposium on Science and Standards

Using a competency-based approach to effectively train biopharmaceutical industry staff.

The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.

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.

Members from an ASQ working group provide analytical methods to enable PAT.

Unnecessary analytical testing can lead to unnecessary costs.

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.

Leading industry collaborators outline top 10 best practices for human error reduction.

In a special anniversary interview, Washington Editor Jill Wechsler speaks with with FDA Deputy Commissioner Deborah Autor about where the agency is headed.

The contract provider needs to know as much as the NDA holder.

A review of key industry shifts and promises for the future.

The authors discuss a new, rapid immunoassay for the detection of biomarkers.

Industry experts discuss significant achievements. Plus: What's in store for the future.

ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.

Manufacturers seek clear path to develop safe-use approaches for more risky OTC therapies.

How to handle and respond to a consent decree.