Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-013.00 Effective date: mm/dd/yyyy
Approved by:
1. Product name
2. Batch number
3. Manufacturing date
4. Expiry date
5. Shelf life
6. Reason for stability study
7. Details of packaging component
8. Testing stations
9. Intervals
• If any abnormal behavior is observed, it must be discussed and brought to the knowl-
edge of the department's manager and QA director without any delay.
• Any alteration in the test interval will be done if necessary with the consultation of the
QA director.
• Any abnormality observed which may affect the shelf life will be considered impor-
tant and must be communicated to the department manager and the QA director
immediately.
• Any abnormality which can seriously affect the performance of the product either in
the market or which has been planned for marketing should be brought to the knowl-
edge of the managing director by the QA director (or by the department's manager in
the absence of the QA director) so that necessary actions can be taken immediately.
1. Color
A product on stability can undergo color changes and may be described as follows:
a.
If there is a change in the product's original color to another color, the analyst must
describe the color change in detail.
b.
If the product maintains the original color but with lighter or darker shade of that color.
In this case, there could be three types of changes, that is
Insignilficant:
The change that is not readily noticeable
Significant:
The change that is readily noticeable
Major:
A gross change
The lighter or darker shade can be described as follows:
Fading of color:
This term will be used to indicate the change from the original
shade to a lighter shade of the color.
Darkening of color:
This term will be used to indicate the change from the original
shade to a darker shade of the color.
2. Odor
The following phrases will be used to describe the change of odor:
Characteristic odor: Represents the original odor of the product
Faint characteristic odor: If the odor is less intense than usual
Off odor: If the odor is different from the characteristic original odor
• Off odor can be subdivided into three types of description depending upon the degree
of intensity, insignificant, significant, and severe, to indicate not readily noticeable,
readily noticeable, and gross change, respectively.
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