QCS-014 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 75

SOP No. QCS-014.00 Effective date: mm/dd/yyyy
Approved by:

l. Reports of the product which has potentials to extend or reduce the shelf life or requires

any adjustment in excesses are to be forwarded to the director quality assurance
quarterly. It consists of product name, batch number, date of commencement, date of
completion, and reason for study.

Note: After the completion of the stability testing period, the remaining samples of that particular
batch should be removed to avoid unnecessary congestion at the respective stations.

14.6.1 c olor
A product on stability can undergo two types of color changes:

1. If the product is changed from the original color to another color, for example, from red to
yellow or from blue to purple, the analyst should describe the color change as mentioned
in the above example.

2. If the product maintains the original color but with lighter or darker shade of that color,
there could be three types of changes, that is

Insignificant: A change which is not readily noticeable

Significant: A change which is readily noticeable

Severe: 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 to

a lighter shade of the color.

Darkening of color: This term will be used to indicate the change from the original to

a darker shade of the color.

14.6.2 o dor
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.

14.6.3 t aSte
The following phrases will be used to describe the changes in taste:

Characteristic taste: Represents the original taste of the product
Off taste: If the taste has changed from the original characteristic taste to other taste

The term off taste will be used with the adjectives such as insignificant, significant, and severe to
indicate not readily noticeable, readily noticeable, or gross change, respectively.