Regulation and Compliance - BioPharm International

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Regulation and Compliance

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.

Should Regulation of Combination Products Become More Centralized in Europe?

May 1, 2013

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Regulatory Convergence Sought for Global Pharma Market

May 1, 2013

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

Extractables and Leachables: Best Practices to Ensure Patient Safety

May 1, 2013

The author presents best practices for extractables and leachables.

Navigating Emerging Markets — Latin America

April 1, 2013

Latin America's diverse growing market seeks regulatory harmonization.

State of Quality and Compliance in the Biopharmaceutical Industry

April 1, 2013

Have FDA initiatives improved manufacturing quality?

Manufacturers Under Pressure to Manage Painkillers

April 1, 2013

Opioid abuse generates calls for efforts to curb distribution.

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