Regulation and Compliance - BioPharm International

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Regulation and Compliance

European Medicines Agency Reorganizes

September 17, 2013

EMA releases details of restructuring.

FDA Reissues Bioanalytical Method Validation Guidance

September 12, 2013

FDA updates guidance to reflect advances in technology.

The Elements of Training

September 1, 2013

Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.

Europe Calls for Guarantee of GMP Standards

July 2, 2013

Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.

EU Battles Medicine Shortages

July 1, 2013

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

FDA Urges Greater Focus on Contractor Quality

July 1, 2013

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

Congress Considers Legislation to Secure Drug Supply Chain

June 1, 2013

Bills to regulate drug compounding and establish a national track and trace system face political and policy differences.

The Meaning of Metrics

June 1, 2013

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

A Lifecycle Approach to Process Validation

June 1, 2013

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

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