QAS-002 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 143

Attach. No.: QAS-002
Revision No.:
Issued on:
Initiator Name:

Class III—MINOR

Product defects which will cause no adverse health consequences and will not impair efficacy
usefulness.

Complaint

1. Minor deviations from product standards (e.g., in terms of color, odor, taste,
shape or occurrence of spots)

2. Standard deviations from packaging component standards (e.g., color, occa-
sional illegible printing of lot number, inconsequential misprints or misprints
or mislabeling, such as outdated registration numbers, nomenclatures, etc.) #

3. Packaging defects, such as crooked labels, rubbed-off print, hard to open or
loose caps

4. Any other:

Remarks :

QA director/QA manager

# Major in the sense that it could result in misinterpretation or uncertainty on the part of the consumer.

* The extent of the defect is to be considered here. Under certain circumstances, it could be classified as a Class E defect.

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