Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-013.00 Effective date: mm/dd/yyyy
Approved by:
3. Taste
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 is changed from the original characteristic taste to other taste.
• The term “off taste” will be used with adjectives such as insigniicant, signiicant, and
severe to indicate not readily noticeable, readily noticeable, and gross change,
respectively.
4. Clarity
Clarity can be described as follows:
•
Clear:
If the liquid contains no undissolved or insoluble matter.
•
Suspended particle:
If there is a separation of some insoluble material but not in the
form of precipitates.
•
Precipitates:
If there is a substantial separation of insoluble matter. There can be some
sedimentation also.
•
Cloudy precipitate:
If the precipitates are very fine and give the appearance of a cloud.
In this case, there can be some sedimentation.
•
Heavy precipitate of fine particles:
Generally no sedimentation is observed.
•
Sedimentation:
When the supernatant liquid is clear but there is some sediment at the
bottom. The terms mentioned above will be used with adjectives such as insignificant,
significant, and severe, to indicate not readily noticeable, readily noticeable, and gross
change, respectively.
5. For the required tests of any product, the stability staff should follow the specifications at
the end of the shelf life based on the finished product specifications.
32.4.11 a
dditional
r
eQuirementS
for
the
S
taBility
t
eSting
of
anda P
roductS
The following topics are included:
A. Handling stability failures for products marketed in the United States
• The stability protocols will be established in coordination with the contracting party
and will be followed.
• Ongoing stability testing will include one batch per year in accordance with the protocols.
B. Trend analysis of stability data
• The PDL manager will review the batches kept at stability on an ongoing basis as per
the protocols. At the end of the year a trend report will be published.
C. Change of supplier(s) of the active pharmaceutical chemical will require the generation of
new stability data
• If the change of the supplier of the active material is unavoidable, the protocols will be
prepared in coordination with the contracting party.
D. Registration documents for countries other than the UAE
• The registration of the products in other countries will be the responsibility of the
Julphar registration manager.
E. Fluctuation of the stability data
• Investigations will be performed to acertain the luctuation in the stability data of
ANDA-related products.
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