QCS-014 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 76

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

14.6.4 c larity
Clarity can be described as follows:

Clear If the liquid contains no 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

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 the adjectives such as insignificant, significant, and
severe to indicate not readily noticeable, readily noticeable, and gross change, respectively.

1. For the required tests of any product, the stability staff should follow the specification at
the end of the shelf life based on the finished product specification.

2. For registration, follow documentation as under:

a. The protocol of both long-term and accelerated stability studies for any drug products

should be in the original application files.

Analytical test procedures should be stability-indicating (i.e., detects active as well as
level of degradation components) and should be fully validated.

b. The incomplete results from long-term stability can be submitted along with the com-

pleted short-term (accelerated) results; then the remaining results for long-term stabil-
ity will be accepted after completion and will be added to the product original file after
the approval of abbreviated new drug application (ANDA).

c. Specification at the end of the shelf life should be included.

d. The first page: authorization person for signature, brand name, and strength.

e. The second page: for protocol index only, batch number, storage conditions, and pack-

ing material (PM).

f. The third page and inverse should be arranged to include the following:

− Experimental, detailed
− Results with tables and graphs

14.7 reason for revision
First time issued for your company, affiliates, and contract manufacturers.