Regulatory/GMP Compliance

The author describes an equation that can be used to define the Quality relationship between a contract manufacturing organization and a client, including how to factor in both party's needs and regulatory commitments.

Challenges of vaccine development include regulatory, technical, and manufacturing hurdles in translating a vaccine candidate into a commercial product.

Does global development have to entail multiple comparability studies?

Social media use raises questions about applying old standards to new information technology.

Key business considerations when developing biosimilar products virtually.

Has the long-awaited guidance answered all of the industry's questions?

The authors compare the exposure risk from viable particles from the air supply in four well-established aseptic filling technologies.

Focusing on how risk affects the entire organization can improve the business bottom line.

Key technical considerations when developing a clinical project in the biotech world.

New educational programs are key to the industry's future and to safe, available drugs.

Strategies for transfer of the manufacturing process.

A Risk-Management Case Study.

This article is the second in a two-part series on extractables and leachables.

Introducing a new way to think about sharing information in a patent-driven industry.

More collaboration and expanded oversight aim to compel manufacturers to follow GMPs.

Contract organizations must have highly organized teams and plans to accommodate today's audits.

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

Government plans require investment, partnership, and industry collaboration.

Pressure to approve new user fees opens the door to action on drug shortages, prices, and regulation.

Greater emphasis on focus and efficiency for companies as market demands value in 2012.

Political leaders need to consider the impact of the biopharmaceutical industry on the economy.

Added responsibilities and outside concerns prompt overhaul of agency's structure.

Clamor mounts over compromised care and rising costs due to lack of crucial therapies.

In a culture of quality, it is important that employees adopt this mindset, not because they have to, but because they understand the importance.

Developing a quality agreement template for single-use systems.