WHO Revises Guidance on QMS Requirements for National Inspectorates

The guidances that health authorities adopt for themselves can tell us much about what they think is important. WHO recently revised the Guidance on QMS for National Inspectorates to align with international standards and the latest quality management system (QMS) principles and to expand the document’s scope. This guidance is pretty much saying “Get with the times.”

Nothing here is that unfamiliar to folks who are familiar with IS 9001 or most other standards. There are sections on management, management system planning, resources, personnel, infrastructure and documentation. There is a section on a section on operational planning and performance evaluation. WHO states inspections, should be planned in advance and risk management principles should be established for prioritizing inspection.

The document is in it’s comment period through September.

FDA draft guidance – Continuous Manufacturing

The FDA published today a new draft guidance “Quality Considerations for Continuous Manufacturing Guidance for Industry.” Which, together with ICH plans continues to demonstrate the emphasis on continuous manufacturing.

More a set of questions than anything else, this is a good document for those who are grappling with the challenges of continuous manufacturing.

Data Integrity and the Role of Guidances

Interesting piece over at FDALawBlog on the new data integrity guidance “New Data Integrity Guidance Imposes Significant Burdens, Yet FDA Claims It Does Not Regulate by Guidance.”

I find it interesting to read a different perspective. I tend to be a big fan of guidances (they always need work) as they help lay down how we can get better and improve. Being on the front line of regulatory inspections probably more than a group of lawyers, I recognize the differences in how guidances are treated differently than regulations, and how the agencies apply very long lead times on how inspections treat this material. And frankly, the 483s and Warning Letters we are seeing coming out of data integrity scare the beejeezus out of me. There is also a need for the FDA to ensure it’s thinking on matters is aligned with our European and rest-of-world counterparts, especially in this day of mutual recognition agreements.

Regulatory and administrative law is definitely continually evolving. It is important to be aware of a variety of perspectives  on the subject.