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Control of Medical Device Labels and Labelling Activities - Looking for a procedure

Ajit Basrur

Staff member
Admin
#1
Hi,

I am looking for a procedure which details the labelling activities to include controls on labels, label reconciliation and some do's and dont's regarding the actual labelling operations.

:)
 
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Wes Bucey

Prophet of Profit
#2
Re: Control of Labels and Labelling Activities - Looking for a procedure

Some industries are regulated in terms of labeling. Tell us more details about your situation so we can help you. Otherwise, the topic as you have posed it is way too broad to expect a reasonable answer in this Forum.
 

Al Rosen

Staff member
Super Moderator
#3
Re: Control of Labels and Labelling Activities - Looking for a procedure

I'm betting it's medical devices or pharmaceuticals.
 

Wes Bucey

Prophet of Profit
#4
Re: Control of Labels and Labelling Activities - Looking for a procedure

Al Rosen said:
I'm betting it's medical devices or pharmaceuticals.
Based on the original poster's other posts, that would be good guess. The point is - why should we have to read the poster's mind or guess? What research has the poster done to this date? What were his results? Is he "confused" or just "trying to keep his first source honest?"
 

Ajit Basrur

Staff member
Admin
#5
Re: Control of Labels and Labelling Activities - Looking for a procedure

Hi Wes and Al,

Yes, I am looking for a procedure on labelling and labelling activities for a medical devices manufacturing process, in a regulated industry.
 

Al Rosen

Staff member
Super Moderator
#7
Re: Control of Labels and Labelling Activities - Looking for a procedure

Wes Bucey said:
Based on the original poster's other posts, that would be good guess. The point is - why should we have to read the poster's mind or guess? What research has the poster done to this date? What were his results? Is he "confused" or just "trying to keep his first source honest?"
The thread was originally in the medical devices forum. It's not his fault. BTW, this is a common medical device topic.
 

Wes Bucey

Prophet of Profit
#8
Re: Control of Labels and Labelling Activities - Looking for a procedure

Al Rosen said:
The thread was originally in the medical devices forum. It's not his fault. BTW, this is a common medical device topic.
The move to documentation forum by one of the other moderators might be understandable because the body of the post gave no clue as to the real motive. It also still doesn't answer my query:
What research has the poster done to this date? What were his results? Is he "confused" or just "trying to keep his first source honest?"
I inferred the concept of "medical device labeling" from the poster's other posting activity, but it's still a big topic. If the poster is completely ignorant about labeling, he should say so. If he is looking for a specific facet of medical device labeling, he should say more than
Yes, I am looking for a procedure on labelling and labelling activities for a medical devices manufacturing process, in a regulated industry.
I'd like to know what and why. In fact, the "manufacturing process" doesn't get labeling - the "packaging process" does. The "marketing process" does.
 

Al Rosen

Staff member
Super Moderator
#9
Re: Control of Labels and Labelling Activities - Looking for a procedure

Wes Bucey said:
The move to documentation forum by one of the other moderators might be understandable because the body of the post gave no clue as to the real motive. It also still doesn't answer my query: I inferred the concept of "medical device labeling" from the poster's other posting activity, but it's still a big topic. If the poster is completely ignorant about labeling, he should say so. If he is looking for a specific facet of medical device labeling, he should say more thanI'd like to know what and why. In fact, the "manufacturing process" doesn't get labeling - the "packaging process" does. The "marketing process" does.
You're splitting hairs.

I think Subpart K Labeling and Packaging Control is the FDA Regulation that we're concerned with. It is necessary to know something about the process before writing a procedure since the process usually comes first and then you document it. Please describe your process Qualityalways.
 

Ajit Basrur

Staff member
Admin
#10
Re: Control of Labels and Labelling Activities - Looking for a procedure

Hi Al,

Yes, I am referring to Sec 820.120 "Device Labelling", Subpart K, which talks about Label Integrity, Label inspection, Label Storage and Labelling Operations.

In our operations, we make the molded parts, which after approved by Quality, go to the Assembly area. After the parts are assembled as per the requirements, labels are affixed on the outside of the cartons. These labels are issued by our Sales department.

My question was specifically to address these labelling aspects to be compliant as per Sec 820.120, subpart K, detailing right from the label issue to its reconciliation.

Thus if anyone can help me out with a procedure, that would be great.
 
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