Do Package Inserts Meet the FDA Definition of Cut Labeling?

Do Package Inserts Meet the FDA Definition of Cut Labeling?

  • Yes

    Votes: 0 0.0%
  • No

    Votes: 0 0.0%

  • Total voters
    0
M

maiero

#1
Seeking industry opinions:
Are package inserts held to the following CFR section regarding "cut labeling"?

211.122 (g) If cut labeling is used, packaging and labeling operations shall include one of the following special control procedures:
(1) Dedication of labeling and packaging lines to each different strength of each different drug product;
(2) Use of appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations; or
(3) Use of visual inspection to conduct a 100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling. Such examination shall be performed by one person and independently verified by a second person.
 
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M

maiero

#3
Thanks for the response. To clarify, let's assume that the firm has an adequate incoming inspection and control system for their package inserts. This does not seem to avoid the need for the "special controls" since the regulation simply says, "if cut labeling is used". It does not suggest that the special controls may be bypassed if the firm samples and controls from incoming inspection.

The excerpt from one of the FDA links you provided also seems to suggest that a two-person inspection of package inserts is expected. They seem to be simply agreeing to an alternate method of visual verification using the alignment of the bar-codes.
Is it acceptable for two employees to verify correctness of hand applied
labeling inserts by
inspecting the insert bar codes or bleed lines (for correct alignment)?

HUMAN DRUG CGMP NOTES March, 1995

Yes, as long as the firm can document adequate (representative) sampling
and inspection (proofing) of the incoming lot of inserts to ensure that
the correct inserts had been received. Bar codes on the inserts could
also be scanned using hand or pen type scanners as long as the equipment
is able to create an electronic record of the number of pieces scanned
and this information is archived so that it can be checked against the
packaging records during inspections.
 
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