Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-008.00 Effective date: mm/dd/yyyy
Approved by:
27.1 PurPose
This SOP outlines the stepwise procedure for auditing and confirming the fill weight and attribute
characteristics of containers, closures, and product and also to check other requirements of the area.
27.2 resPonsibility
The area QAI and officer will be responsible for following the procedure. The QA manager will be
responsible for systems compliance.
27.3 Procedure
In-process audit checks to be carried out on an hourly basis. This procedure is divided into two
portions.
A. Audit checks to be carried out for ensuring the systems and the process
A.1 Equipment and area clearance checks
A.2 Humidity and temperature checks
B. Audit checks to be carried out during filling operations
B.1 Attribute characteristics of containers, closures, and the product
B.2 Fill weight checks
B.3 Removal torque checks
A.1 Equipment and area clearance checks
A.1.1 On the first round of the area, the QAI will check the line clearance granted by the
supervisor.
A.1.2 Confirm that the area and the equipment are clean.
A.1.3 Confirm the cleanliness and proper labeling on the bulk container in which powder
is kept.
A.1.4 Check whether the operator is wearing a mask, gloves, and clogs and the hair is
properly covered.
A.1.5 Tally the product name and the batch number on the bulk container with the Batch
Packaging Record and Master Packaging Instructions requisition.
A.1.6 Check that all the commodities being used in the area are as per the Master
Packaging Instructions requisition and no other commodities are present in the area.
A.1.7 If all the requirements are met, then sign on the line clearance for start-up release.
A.1.8 When the machine is set and the finished product characteristics are found to be as
per specifications, then give the line release by issuing the line release label.
A.2 Humidity checks (by the psychrometer)
A.2.1 Check the relative humidity (RH) of the powder filling area once/shift and at the
start of filling packaging.
A.2.2 RH should be within specified limits.
A.2.3 Temperature: 25°C + 2°C or as specified in the Master Packging Instructions
A.2.4 Record the RH and temperature on the control chart.
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