Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-013.00 Effective date: mm/dd/yyyy
Approved by:
d. For some dosage forms, especially liquid and semisolid, the study may also need to con-
sider low temperature, that is, freezer (-10°C to -20°C) and refrigerator (2-8°C).
However, usually, accelerated studies are less suitable for semisolids and heterogeneous
formulations, for example, emulsion.
e. Other storage conditions in stability studies are allowable if justified. The heat-sensitive
drug products must be stored under alternative lower-temperature conditions, if justified by
the manufacturer, which will eventually become the designated long-term storage tem-
perature. Studies at a low temperature that affects and changes the finished product's prop-
erties should be avoided.
f. For products such as solutions and suspensions contained in packs designed to provide a
permanent barrier to water loss, specific storage under high relative humidity condition is
not necessary.
32.4.7 P
roduction
f
formula
and
/
or
P
roceSS
c
hange
Stability samples are required from first product lot following a formula or manufacturing process
change, which may have stability significance.
32.4.8 P
ackaging
m
aterialS
The testing must be carried out in the final packaging proposed for marketing. Additional testing of
unprotected drug product can form a useful part of the stress testing and pack evaluation, as can
studies carried out in other related packaging materials in supporting the definitive pack(s).
32.4.9 e
valuation
A systematic approach will be adopted in the presentation evaluation of the stability information,
which should cover, as necessary, physical, chemical, biological, and microbiological quality char-
acteristics, including particular properties of the dosage form (e.g., dissolution rate for oral solid
dosage forms).
Significant changes at the accelerated conditions are defined as
a. A 5% potency loss from initial assay value of a batch. All obtained values for all batches
should be combined and treated by appropriate statistical tests at 95% confidence limit.
b. Any specific degradation exceeding the product's specification limit.
c. Exceeding the pH limits.
d. Dissolution exceeding the specification limits for 12 capsules or tablets.
e. Failure to meet specifications for appearance and physical properties like
i Color
ii. Phase separation
iii. Resuspendability
iv. Delivery per actuation
v. Caking
f. Microbiological specification limit.
32.4.10 S
taBility
P
roductS
/e
xecution
After the product is selected, the stability analyst will initiate the stability protocol and enter the
following information:
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