Many products that were traditionally seen as being a drug with a container closure system are now becoming visible as combination products, products like pre-filled syringes, injection devices and inhalers. While this may not seem like a big deal on the surface, in reality it means that product developers are now having, rapidly in some cases, to consider how they address the requirements of 21 CFR 820. Making it more tricky for pharmaceutical developers is that some parts of 820 are in a large part addressed by compliance with 210 and 211. I’m thinking here of topics like document control, production and process controls, CAPA (in part, but usually not covering all aspects of part 820).
If you’re in a similar situation, you may choose to focus your efforts on a few select parts of 820, such as;
- Management Responsibility
- Design Control
- Purchasing Controls
We’ve been helping several clients do just this, leading to successful regulator review and subsequent launch of 3 products already.
What can you do right away?
- Find and focus on key parts to put your effort where it can do most good,
- Get a fresh pair of eyes to look over your approach and documentation,
- Check that existing systems built for pharma continue to meet your needs and those of the QSR / MDD,
- Get in touch (firstname.lastname@example.org) to arrange an impartial and honest review of your readiness.