100% bar code verification typically indicates that every code has been graded according to a standard. This is the best way to ensure readability of codes across a supply chain.

Bar code validation can be done utilizing a simple read, and it is useful for ensuring readability of codes within a specified environment. Many in the industry use a hybrid method of bar code validation, which measures readability of codes created based on minimum number of decodes per read cycle.

In order to verify label flatness and integrity, a dark field illuminator should be used to highlight curling or wrinkles. These areas will appear as shadowed or dark in a machine vision image. Acceptable parameters can be based on process control methods utilizing thresholds set for maximum number of pixels.

In addition, a machine vision system can inspect for proper label positioning, proper label content, and color.

21 C.F.R. § 820.80 is related to receiving, in-process, and finished device acceptance. Section 820.80(d) specifically states:

“Final acceptance activities. Each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. Finished devices shall be held in quarantine or otherwise adequately controlled until released. Finished devices shall not be released for distribution until:

(1) The activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated individual(s); and
(4) the authorization is dated. ”

Since the firm’s own SOP also requires that “the QA clerk must check the package labels against the work order and verify that the label is correct” and “after verification, the QA clerk must place his/her initials next to the round barcode labels on the work order,” the company was definitely not following its own SOPs. Label verification using machine vision can, in general, improve the reliability and productivity of manual inspection but would still not satisfy the company’s own SOP or 21 C.F.R. § 820.80 without appropriate signature records on file.

100% inspection refers to the correctness of the label. Specifically, as highlighted in the FDA web site (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm095452.htm), the FDA’s current good manufacturing practice (cGMP) regulations require that “special control procedures be instituted if cut labeling is used in packaging and labeling operations.”

“One of these procedures requires the use of “appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations” (Sec. 211.122(g)(2))”.