Agnes Shanley

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

Only half of new drugs make it past Phase III. Adopting best practices and collaborating more closely with contract research organizations can help ensure success.

Despite the move to more strategic partnerships, research shows that tactical outsourcing is still alive and well.

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.

Synthetic biology promises to drive tomorrow’s therapies, while continuous processing is already being used in some new drugs.

With less than two years to meet the US deadline, both manufacturers and CMOs have to move quickly to implement serialization practices.

This month marks the death of a pragmatic, original thinker who helped make PAT and QbD a reality at more pharmaceutical facilities throughout the world.

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

As 3-D screening and lab automation improve lead optimization, open collaborative models are breaking down long-established walls. Will the industry redefine the way it handles R&D?

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.

Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

Closing the summer of 2015, the ChemOutsourcing conference examined contract services from both a sponsor’s and a CMO or CRO’s perspective

The EU has set March, 2016 as a deadline for ensuring excipient supplier GMP compliance, but some manufacturers may still need clarification on how best to do that.

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Contract research, development, and manufacturing organizations (CROs, CDMOs and CMOs) are embracing lean manufacturing, while Big Pharma is applying it, not so much for inventory management, but to improve supply chain visibility and control.

Driven by competitive pressures and using models pioneered in other industries, pharmaceutical companies are extending collaboration efforts well beyond their walls.

Ignoring a contract partner’s ability to handle highly potent APIs (HPAPIs) safely may have serious consequences. Drug owners and contract service providers alike must understand the complexities and liabilities involved in working with HPAPIs.

Cloud computing has made it easier for pharma companies and their contract partners to gain visibility into their combined supply chains.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

Currently, pharma has only scratched the surface of the potential value of repurposing drugs, says consultant Hermann Mucke. Contract service partners are playing a more prominent role, but could play an even larger one in these efforts.

Sponsors and contract partners alike should not assume that upcoming US federal deadlines will be as elastic as California’s were.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

Important research is under way that will help us understand the extent of the presence of substandard, adulterated and counterfeit drugs around the world, and, thus, strengthen enforcement efforts and public outreach programs. Future studies will focus on the API and overall chemical content

An ISPE guidance document, four years in the making, brings risk-based thinking, statistics, and Lean Six Sigma to cleaning validation.