April 2012 Issue
The big picture has changed very little in ten years. While pointing out root causes, observers also see reasons for optimism.
Highlights of current industry issues and reasons why the manager is no longer the manager.
New research indicates that biopharma manufacturers have a desire for operational excellence but are not using sophisticated methods that are commonplace in other industries.
Can drug manufacturing reach its potential without standards, science and an admission that theres a need for improvement?
Trade show consolidation can be a good thing, at least when it gives smaller innovator companies room to grow.
Standard work definitions, and recognized standards, will improve drug manufacturingnot nostalgia, or the insistence that pharma is different.
Using the instrument makers tolerance, there is often a higher risk of an Out of Tolerance appearing on a calibration certificate; this costs money.
Does Pharma have a place on Pinterest?
As conventional ways of making drugs give way, we will seek out these people and value their brilliance.
A Framework for Technology Transfer to Satisfy the Requirements of the New Process Validation Guidance: Part 1
A risk-based model allows the manufacturer to fully consider process and product design at the outset of tech transfer.