Insider Solutions

Key talks from the recent PDA/FDA regulatory conference highlight room for improvement.

The contract provider needs to know as much as the NDA holder.

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

Why SOPs are rarely followed, often cited, and in need of follow-through.

What to do when your CMO changes the manufacturing equipment line.

Drug manufacturers have to be more than just "audit ready."

Before embarking on an outsourcing relationship, it's important to be aware of FDA's expectations.

We never thought implementing complex changes could become more cumbersome.

With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.

Determined to prevent further supply-chain breaches, industry takes charge, offers proposals.

Standards data is helpful, but FDA needs to apply its information across the board. This article contains bonus online-exclusive material.

The USP public-comment process exists for a reason. Industry needs to take advantage. This article contains bonus online-exclusive material.