Interpreting Process Controls - 21 CFR Part 820.70(a)

[Mark Meer]

I've got several points of confusion regarding requirements of 21 CFR 820.70(a) (General production & process controls).

Any guidance to any of the points below would be much appreciated:

1. "Where deviations from device specifications could occur as a result of the manufacturing process..."
Are there any examples of devices NOT subject to this criteria? It seems to me that ALL devices would meet this criteria, and hence be subject to all the requirements that follow...

2. "Monitoring and control of process parameters and component and device characteristics during production;"
Assuming there are no quantifiable/measurable "parameters", would it be sufficient just to document in-process acceptance activities at different stages of production to fulfill this?

3. "Compliance with specified reference standards or codes;"
I'm assuming this is mainly applicable to processes like sterilization or clean-room practices for which standards or codes exist? ...but the way the regulation is worded, it appears that this is a requirement regardless (i.e. "Where process controls are needed they shall include:...").

4. "Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples."
By "documented standards", does acceptance criteria (for in-process and finished product), or receiving inspection criteria (for outsourced components) qualify? ...or does "standards" mean an established national or international standard?

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It seems to me that 820.70(a) is already covered by subsequent parts: 820.72 (Equipment), 820.75 (Process validation), and Subpart H (Acceptance activities).

But then, perhaps I'm missing the intent of the regulation here.
(if so, please set me straight)....

 

[Mark Meer]

Re: Help interpreting process controls 820.70(a)

Sorry... perhaps the lengthy post is deterring replies. I'll be more concise:

With respect to 21 CFR 820.70(a) (General production and process controls):

- Do all the subpoints apply to all devices? (the way it's worded it appears so...)
- When it mentions "standards", does this necessarily mean an established national or international standards?

I find this section very difficult to interpret... any help would be greatly appreciated.

 

[Ronen E]

Re: Help interpreting process controls 820.70(a)

- Do all the subpoints apply to all devices?

- When it mentions "standards", does this necessarily mean an established national or international standards?

 

[Mark Meer]

Re: Help interpreting process controls 820.70(a)

Geez, if this is the case, the FDA sure is unnecessarily wordy about it!

"Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:"

could be simply abbreviated to:

"Each manufacturer shall establish and maintain process control procedures to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. These controls shall include..."

And: "Compliance with specified reference standards or codes;" could much better worded as "Compliance with established criteria".

The present wording is almost begging for misinterpretation...

 

[kreid]

For your point 1) Software as a Medical Device (SaMD). The manufacturing process should not/would not impact the design specification for software.

 

[Mark Meer]

Good point! I hadn't considered software stand-alones. Although, I suppose writing software to installation disks could be considered a manufacturing process.

I still am not completely clear what this requirement is trying to accomplish that is not already covered by subsequent requirements (e.g. equipment control, acceptance activities).

The fact is that any manufacturing process has the potential that "deviations from device specifications could occur". So it's unclear to me what the burden of documentation is expected here...

Presently, we maintain:
- Manufacturing work-instructions
- Documented in-process acceptance at delineated stages
- Equipment control procedures (SOPs)
- Documented final acceptance criteria

To me - assuming the wording "standards" can be replaced with "criteria" - this would meet 820.70(a) requirements.

Am I missing something?