Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-007.00 Effective date: mm/dd/yyyy
Approved by:
7.1 PurPose
To provide written instructions for checking the finished products.
7.2 resPonsibility
It is the responsibility of all analysts testing the finished product to follow up the procedure. The QC
manager will be responsible for the SOP compliance.
7.3 Procedure
1. A full analysis for each and every batch will be done on bulk product (before packaging).
2. After full packaging of the batch (the finished product), samples are collected from the
packaging lines by the in-process control inspector, who will send samples with full docu-
ments to the QC receiving room.
3. Samples of each consignee's quantity will be given 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 (for PPS)
g. Clarity, volume, specific gravity, and RI (for solution)
h. Volume and viscosity (for suspension)
6. File documents sent by the in-process control inspector will be verified against the accom-
panied 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 the QC assistant manager, and in his/her
absence to the physical laboratory in-charge for evaluation and release of the finished
product.
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.
7.4 reason for revision
First time issued for your company, affiliates, and contract manufacturers.
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