QCS-014 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 74

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

5. Details of packaging commodities

6. Date of commencement

7. Date of completion

8. Stations

9. Intervals

a. After the protocol is finalized, samples of 30, 40/50°C are arranged in a basket and
kept in respective ovens and mentioned in the computer list. For any deviation or
variation from the protocols, permission should be taken from the director quality
affairs.

b. Raise the stability card and enter the following:

i. Product name

ii. Batch number

iii. Initial results with manufacturing excess

iv. Testing intervals and stations

v. Date of commencement

vi. Date of completion

vii. Details of packaging commodities

c. By the last day of each month, the computer list for products falling for testing next

month is provided by the stability lab officer for daily planning purpose.

d. On the due date, the analysis is done and the results are entered on the stability card.

e. The analyst will also mention STM No., TIME, and REF.REC.

f. Calculation for rate of degradation:

initial result result (specified)
months

−

% Degradation month =

For example, at 3 months

1 2 98 0 −

= = 1 33 month . % /

3

g. If any abnormal behavior is observed, it should be discussed and brought to the knowl-

edge of the R&D manager and the director quality affairs without any delay.

h. Stability cards will be reviewed by the designated stability officer/PDL manager every

month.

i. Any alteration in the test interval will be done if necessary by the stability officer with

consultation of the director quality affairs.

j. Any abnormality observed by the stability officer that could affect the shelf life should

be considered important and should be communicated immediately to the R&D man-
ager and the director quality assurance.

k. If the stability data fall outside the specifications, established for the previously

approved expiration dating period, the applicant should perform an investigation to
determine the probable cause of the failure if it is determined that the storage condition
is the cause for stability failure; the applicant may shorten the expiration dating. Other
measures (e.g., more protective container/closure or product reformulation) may be
considered through prior approval supplement.