Back in October, FDA announced that it submitted a proposal to the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for the development of common global standards for generic drugs.
— Read on www.fdalawblog.net/2018/11/international-plan-of-mystery-ich-guidelines-for-generic-drugs/
Interesting blog post on FDA’s thoughts on the ICH creating some standards on generics.
FDA’s position that it may regulate device as drugs is plainly not authorized under the FDCA. To the contrary, if a product is within the definition of a device, Congress has decreed that it must be regulated under the device authorities.
— Read on www.fdalawblog.net/2018/11/may-fda-regulate-medical-devices-as-if-they-were-drugs/
Interesting ideas here. The boundaries between a device and a drug are becoming more and more blurred, and frankly I am not sure if this is the right way to move forward, but this is good reading.
PIC/S Meetings in Chicago (United States)
— Read on www.picscheme.org/newsletters/5bcdb563efcf6
Deeper connections and alignments between the FDA and PIC/S is a good thing.
The Indian regulatory authority CDSCO (Central Drugs Standard Control Organization) has published a 21-page draft on Good Distribution Practices (GDP) for pharmaceutical products.
The draft covers topics that are well aligned to other good distribution practices, and is aligned to the ICH framework.
It is good to see India moving ahead in adopting best practices. This is a huge market, a growing source of production and it will be a huge center of innovation in the near future. It is important for CDSCO to continue to push forward in a better regulatory regime and to tighten their quality practices.
The guidance contains some of my favorite themes of GDP (and other pharma) practices, including::
The responsible person/quality person model is one of the more problematic aspects of our field. Yes, there is someone who is responsible for quality, its called the officers of the company. But this idea that one person sits on the top of the pyramid and makes ALL the best decisions is a problematic thing that regulations tend to enshrine.
The Pfizer McPherson site has been under a great deal of regulatory scrutiny, and as a result there is a lot we can learn from their findings.
In July the MHRA stated the following:
There is a lot to unpack here, and for most of it I can pull up some previous postings to start with:
Breaking down change controls is both a necessity and a difficulty. I talked about the need for a change strategy when breaking up changes. This connective tissue will help with issues like 2.4.1.1 above and can also serve as a good playbook for discussing the changes with an inspector. This is especially important when you find you need to implement related changes at different times. I talked about the various implementation dates in some detail.
Risk assessments are only getting more important, and for a company with international distribution it is important to consider the risks inherent to your regulatory strategy and distribution strategy and mitigate.
If you have changes that will have long tails of regulatory approvals, then your change control needs to have the right controls to ensure appropriate and safe supply.
Build your actions to address all risks and impacts and ensure they are appropriately carried through.
Finally ensure your change control process has a way to revise the plan and ensure all stakeholders are included in the decisions.
Investigations of a Dog 