QAS-005 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 227

abc Pharmaceutical comPany

LEVEL-3
SOP No.: QAS-005
Issued on:
Revision No.:
Initiator name:

Decision: The product shall be completely recalled from all the distribution points, including indi-
vidual consumers in a minimal time. Also use telecommunication resources.

Class II: Major (Possible Reasons)
Product defects which may not cause adverse health consequences but will impair efficacy or
usefulness.
The intensity of the problem shall be evaluated using military standards 105 E. Tightened sam-
pling plan shall be used to reach the final conclusion.

Mix-Ups

1. Inactive ingredients (e.g., mix-up of compatible excipient, only affecting the therapeutic
values)

The sampling and testing shall be performed at 0.65% acceptable quality level (AQL)
single sampling using level S-3; otherwise the batch shall be recalled from the market.

Impurities

1. Nonpathogenic microorganisms in excess of tolerance limits

2. Excessive amounts of physiologically harmless materials

Deviations/Changes

1. Perceptible changes in appearance, odor, color, taste, physicals, etc. of the product (1)

2. Deviations in packaging components (e.g., only leaflet change) (1)

3. Expiration date (1)

4. Product that would impair usability (e.g., broken tablets)

5. Defects in packaging components that would impair usability (e.g., leaks, pinholes, func-
tional defects)

6. Missing labels

7. Empty packages

8. Underfilling, in terms of volume, weight, or quantity, and overweight (2)

9. Labels peeled off cartons, missing insert (2)

Remarks

1. Major in the sense that it could result in misinterpretation and uncertainty on the part of
the consumer.

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

Class III: Minor (Possible Reasons)

Product's defects which will cause no adverse health consequences and/or effect on product
efficacy.