QCS-004 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 10

SOP No. QCS-004.00 Effective date: mm/dd/yyyy
Approved by:
Subject: Checking of Finished Products
4.1 PurPose
To provide written instructions for checking of the finished products.
4.2 resPonsibility
This is the responsibility of all analysts testing the finished products to follow the procedure. The
QC manager is responsible for the SOP compliance.
4.3 Procedure
1. Full analysis for each and every batch will be done on bulk products (before packaging).
2. After full packaging of the batch (finished product), samples are collected from the packag-
ing lines by the process control inspector, who will send samples with complete documents
to the QC receiving room.
3. Samples of each consignee's quantity will be assigned a separate QC reference number.
4. Samples of products will be sent to finished and microbiological laboratories for checking
according to the specification.
5. In the finished products laboratory, samples are checked for
a. Description and appearance (for packaging)
b. Packaging mode
c. Content per pack
d. Printed information (batch no., mfg./exp. dates, special printing as logo of consignee,
agent name, price [where applicable], registration no., telephone No. [where applicable],
etc.)
e. Product description
f. Filling volume or weight (of granules for suspension)
g. Clarity, volume, specific gravity, and refractive index (for solution)
h. Volume and viscosity (for suspension)
6. File documents sent by in-process control inspector will be verified against the accompa-
nied checklist and this checklist will be signed by the finished product analysts.
7. Results of inspection are reported.
8. Microbiologically, the sample will be checked for total aerobic bacterial count, and for the
absence of pathogens.
9. Reports and documents will be submitted to QC assistant manager, and in his/her absence
to the physical laboratory in-charge for evaluation and finished product release.
10. If the finished product does not comply with specifications, the final decision about release
or rejection is made by the QC manager/QA director or the Material Review Board.
4.4 reason for revision
First time issued for your company, affiliates, and contract manufacturers.