Is a Packaging line Check-Weigher a GxP system

GOOD MANUFACTURING PRACTICE (cGMP) RISK ASSESSMENT
1

Dear experts,

I’d like to ask you about Packaging line check-weigher that is used to weigh the final Carton Box pack to check for missing blisters or pamphlets. Is this system a GxP system ? and If not , Why do we need to have 21 CFR p11 documentation for it knowing that it is not GxP system ? .

Thank you all in advance for your support.

Waleed

2

The answer is YES. I assume that the checkweigher was installed as a control to ensure complete and accurate contents are enclosed in the packaging. The checkweigher provides quality data (output) as an inspection mechanism to determine conformity to your specification for packaging fill. I hope and assume that the checkweigher data is documented as an inspection pass/fail result on your batch record. Because the data is used to make a final quality decision for compliance, it is therefore part of the GxP system. I hope this help.

[quote=waleedMakarem]Dear experts,

I’d like to ask you about Packaging line check-weigher that is used to weigh the final Carton Box pack to check for missing blisters or pamphlets. Is this system a GxP system ? and If not , Why do we need to have 21 CFR p11 documentation for it knowing that it is not GxP system ? .

Thank you all in advance for your support.

Waleed[/quote]

3

Depends what decision you make on the checkweigher -

  1. if the package is with a specific tolerance then - you release it
  2. Or you just like to weigh boxes of stuff with a cool machine.

If the answer is 1 then we presume that if the weights were incorrect patients health could be put at risk due to insufficient tablets in the blister pack…so it would be GxP

but - if there is a manual check further down the line, then you can ignore the check weigher as the actual quality check is done as a manual process and as we all know, we can’t validate people so we don’t care about the machine anymore.

4

All

I question the statement, “… if the weights were incorrect patients health could be put at risk due to insufficient tablets in the blister pack.” If the context was the incorrect volume in an injectable or incorrect active ingredient in a tablet where the patient is not getting the required amount of drug when taken, then I can see the point. But to say that an incomplete fill in a blister card or a missing blister card could affect patient health (to me) seems a stretch. I would consider this a business risk at best.

5

[quote=PCB]All

I question the statement, “… if the weights were incorrect patients health could be put at risk due to insufficient tablets in the blister pack.” If the context was the incorrect volume in an injectable or incorrect active ingredient in a tablet where the patient is not getting the required amount of drug when taken, then I can see the point. But to say that an incomplete fill in a blister card or a missing blister card could affect patient health (to me) seems a stretch. I would consider this a business risk at best.[/quote]

I agree with your comment PCB, that statement made me re-read again the post about the process. maybe he was just making a point based on the impact any other process could have as evaluated in its own context.

We have a checkweigher in our process and it was indeed validated as Quality System GxP since we do make reject decisions based on its results.

i dont think of anyone validating these type of equipment just because they would “… like to weigh boxes of stuff with a cool machine…” not even putting an additional full inspection afterwards.