Here are some of our readers’ thoughts on the January 2008 PharmTech Talk column, “Quality Disconnect”
“Applying quality systems, quality by design, PAT, six sigma, and harmonization is simply a matter of common sense. These principles should be adopted already in all existing businesses in the 21st century. The pharma industry has been lagging behind enormously on such aspects as compared to almost all other industries, perhaps because industry thought GMPs were already covering these issues.
“The various, very complex, strict, and impractical regulatory systems—in particular those in the United States and European Union—that govern the implementation of desirable changes and the authority assessment and approvals that are often needed first, have been the major factor behind the pharmaceutical industry’s inability to bring modern quality management on board. Those regulatory systems made (and are still making) continuous improvement a cornerstone of modern quality management as good as impossible.
“That said, I think that not applying the aforementioned principles will increasingly cease to be a viable option. What FDA proposes is optional so everyone is free to ignore it. But sometimes I indeed get the feeling the initiative is also very much focused on FDA’s own education in this field. It would be helpful if the FDA would start to make haste in clarifying in much more detail what degrees of freedom complying companies will receive. This would quickly take away industry’s ‘What’s it all about?’ feeling.
“After all the recent discussions in Congress on this issue, such concrete measures could free up a large volume of human resources within FDA that may be used to make the needed improvements in FDA’s performance happen.”
--Chris Oldenhof, DSM Anti-Infectives
“Thank you for your column in the Jan issue. I hope this opens up candid discussions.
“One quibble: I think everyone in the industry agrees that quality systems are required, but US regulations are deliberately vague regarding how companies achieve such systems. The good side of this is that it allows flexibility; the bad side is the slack it permits. So when people start discussing quality by design the ambiguities can be formidable.
“A problem, as some both in the regulated industry and Congress have pointed out, is that the agency’s own rule-making sometimes seems to send contradictory messages. Look no farther, e.g., than the proposed rule on mechanical calibration in dissolution testing: 21 USC 501(b) requires compendial compliance and the Guidance acknowledges as much while saying that mechanical calibration is sufficient. What are field inspectors going to do?”
…“I find the whole Quality by Design initiative to be misguided. It seems to me they are creating more complication, with no added value. What is particularly puzzling is that there was – in my view – nothing wrong with the system as is. For example, take the new initiative to set clinically relevant specifications. It seems FDA itself does not have a clear idea how this would be accomplished. The ‘as is’ approach requires setting specifications that are reasonably tight, and requires that companies are using best available technology with respect to both manufacturing and analytical testing. This approach seems entirely valid and logical. Nevertheless, they are asking industry to abandon a system that works well and replace it with something that is not well defined or understood.”