Quality/GMPs

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

PDA's strategic plan calls for maintaining valuable relationships with global regulators.

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

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

Manufacturers and regulators struggle to control phony versions of crucial medicines.

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

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

After a series of government reforms, the Japanese pharma market is making a comeback.

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

Import controls and risk strategies aim to promote quality and spur new drug development.

Current expectations in bioprocessing and a framework for using NMR to enhance a QbD approach.

The author describes a methodology for developing a per product qualitative and semi-qualitative business case for applying QbD to a biopharmaceutical product.

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

A report from the European Commission shows that fake pharmaceuticals were the top articles detained by European-Union customs in 2011.

Guide helps companies meet CGMP requirements.

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.

Multiple initiatives are moving forward to maintain US leadership in biopharm R&D.

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

The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

FDA Updates List of Warning Letters

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

European and US associations call for continued vigilance against the threat of counterfeit medicines.

BIO is calling for a more patient-centric approach to user-fee reauthorization.

Implementing quality by design makes the determination of quality metrics across CMOs and sponsors essential.

A review of new biologic drug approvals over the years, featuring highlights from 2010 and 2011.

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.