Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-006.00 Effective date: mm/dd/yyyy
Approved by:
25.1 PurPose
This SOP outlines the stepwise procedure for auditing and confirming the fill weight and physical
attributes of cream and ointment tubes and also to check all other requirements of the area.
25.2 resPonsibility
The QA inspector of the area and the QA manager are responsible to follow up the procedure
whereas the QA director is responsible for the SOP compliance.
25.3 Procedure
In-process audit checks to be carried out on an hourly basis. The following are the checks to be car-
ried out during the cream/ointment filling operation. This procedure is divided into two portions.
A. Checks to be carried out to assure the system and process
A.1 Equipment and area clearance checks
A.2 Line release
B. Checks to be carried out during filling operations
B.1 Physical characteristics of container closures and the products
B.2 Weight variation checks
B.3 Leak test
A.1 Equipment and area clearance checks
A.1.1 During the first round of the area, the QA inspector will check the presence of
equipment and area clearance will be granted by the supervisor.
A.1.2 Check that all packers/operators are properly dressed and their hair are properly
covered.
A.1.3 Check that the operators are wearing masks, gloves, and safety glasses.
A.1.4 Check that no other batch is present in the area except for the batch that is scheduled
for filling.
A.1.5 Ensure that only the respective batch documents are present on the line.
A.1.6 Tally the product's name and batch number on line clearance with product-related
documents.
A.1.7 If all the GMP (good manufacturing practice) requirements and clearance require-
ments are found satisfactory, then allow the process to start and sign off the line
clearance sheet. If any deviation is observed, write in the REMARKS column of the
in-process chart (X & R chart).
A.2 Line release
Once the machine is set, the supervisor will call the QA inspector to check
1. Average weight (filled)
2. Weight variation
3. Leakage
4. Physical attributes
5. Batch engraving on the tubes and boxes
6. Completed packs as per product specification
If found satisfactory, the QA inspector will issue the release label.
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