Upgrading Systems from CFR 211 to CFR 820 (drug+device combination)


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We are drug development and manufacturing organization and are compliant with all relevant requirements 21 CFR 211, 314, ICH Q8, Q9, Q10 etc.,

Now, we need to update our systems to 21 CFR 820, and here lies the challenges.,

Some systems will be existing, others to be introduced newly.,! and am almost sure, none of existing systems are redundant (cause we require this upgrade for drug+device combination)

I am briefly conversant with 820; request your guidance, references, and best place/way to start on this journey.

Ronen E

Problem Solver

There isn't really that much to it. I recommend that you familiarise yourself with the QSR (part 820) preamble that was published in the FR when the QSR was introduced in 1996. It provides some good insights into the background and reasoning for some of the regulation. Some of it is naturally outdated but still quite a useful and important reading for anyone implementing part 820.

Other than that just follow part 820's text. I would start with a gap analysis laying out all the requirements, noting Applicable / Not-applicable (+rationale), the current state of affairs (existing system) and any gaps that need addressing.

If you come across bits that seem tricky, search for guidance documents. There are some, though I'm not aware of a single go-to reference since the FDA withdrew their very useful Quality Systems Manual guidance (added in edit: you can find it in this thread). There's also good guidance / tutorial material at CDRH-Learn, but it's more basic in nature (still, not bad at all as a starter).

And of course, please do come back here with unsolved issues for more focused Q&A.

Good luck,
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One thing which is inevitable is putting each regulation along side existing systems and practices (ensure the gap assessment - adequacy&traceability) and draw the action plan. (in fact this step will help us represent the compliance and reconcile the 'design and define' aspect of systems & processes)

But, the literature references got us started in right direction., and gives some confidence and direction to progress. Apart from above listed ref., here's few which got me started.

Understanding Medical Device QMS Requirements For Combo Products: Pharma Company Edition
820.20 Management Responsibility
820.30 Design Controls
820.50 Purchasing Controls
820.100 Corrective and Preventive Action
820.170 Installation
820.200 Servicing

Understanding Medical Device QMS Requirements For Combo Products: Medical Device Company Edition
211.84 Testing and approval or rejection of components, drug product containers, and closures
211.103 Calculation of Yield
211.132 Tamper-evident packaging requirements for OTC drugs
211.137 Expiration Dating
211.165 Testing and release for distribution
211.166 Stability Testing
211.167 Special Testing Requirements
211.170 Reserve Samples


  • EAS FDA GMP Side by Side Comparison Chart - D Cirotta 3-4-15.pdf
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  • 21 CFR part 4 cGMPs for combination products.pdf
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Here's the comparative document 21 CFR 211 vs 820 requirements. Hope this to be useful in
* mapping the existing/current practices -
* gap analysis and
* draw action plan relevant to the respective facility/QMS.


  • 21 CFR - 211 VS 820 Gap Assessment Checklist.docx
    84.8 KB · Views: 882


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  • QSIT GUIDE.pdf
    952.4 KB · Views: 160
  • Design Control guidance - FDA.pdf
    178.9 KB · Views: 480
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