QAS-013 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 301

SOP No. QAS-013.00 Effective date: mm/dd/yyyy
Approved by:

below for accelerated and long-term storage conditions and minimum times. Real-time stability
study will continue until the proposed shelf life has been covered and the results obtained will be
submitted to the registration authority.

Type of Stability
Study

Batch
Number

Temperature and
Relative Humidity

Months

Ten Complete Shelf Life

Long term (a)

(b)
(c)

1st year
0 3 6 9 12

2nd year
18

3rd year
36

4th year
48

5th year
60

30°C ± 2°C with
(60% ± 5% RH)

24

Accelerated or
short term

(d)
(e)
(f)

40°C ± 2°C with
(75% ± 5% RH)

Three
1

(I) 3 6

(II) (g)

(h)
(i)

Two
1 M

50°C ± 2°C

3 M

For products to be
kept refrigerated
for long term

(j)
(k)
(l)

20°C ± 2°C
25°C ± 2°C

Three
1 3 6

32.4.5 l ong -t erm t eSting
Long-term tests must be carried out on representative batches using the type of packages intended
for marketing. A minimum of 12 months long-term stability data will be provided at the time of
submission. In this case, the storage is carried out at 30°C ± 2°C/60% ± 5% RH for the entire shelf
life.
In this type of study, the observations and testing are done first at zero time then every 3 months
during the first year, every 6 months during the second year, and then every year till the end of shelf
life.

32.4.6 S hort -t erm or a ccelerated S taBility t eSting

a. A 6 months stability data at 40°C and/or 3 months data at 50°C will be provided at the
time of submission. The details of the storage conditions for accelerated stability studies
are

40°C ± 2°C/75% RH ± 5% RH
50°C ± 2°C

b. For products to be stored long term under refrigerated condition, the accelerated testing
will be conducted at
25°C ± 2°C
20°C ± 2°C

c. In accelerated stability, testing is done at zero time, 1 month, 3 months, and 6 months for
all required specifications.