Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-019.00 Effective date: mm/dd/yyyy
Approved by:
(continued)
responsibility
Procedure
5. QC No.
6. Release date
7. Signature
In case the incoming supply is rejected, rejection label will be pasted 100% and the lot will be kept in
the rejection area.
Weighing area
At the time of dispensing of released raw material, the dispensing officer will paste the issuance label
(white computer-printed or labels filled in by hand) on the portion dispensed with the following details:
a. Material name
b. Code No.
c. QC No.
d. Lot No., batch No.
e. For which product and batch No. it is being used
f. Quantity dispensed
g. Tare weight
h. Dispensing person's signature
i. Date and time of dispensing
At the time of pasting of these labels, the dispensing officer/issuing personnel will make sure that there
is no other label on the dispensed quantity. If present, he will either remove it or deface it before
pasting the dispensing labels.
Production
To indicate different stages during manufacturing, the production will use “blue label” for proper
identification and status. The status of material will be mentioned on the label against process status,
e.g., compressed tablet, blended granules, dried granules, for drying, etc.
Likewise, on completion, the production department will use a yellow label with the following details:
1. Product name
2. Code No.
3. Process status
4. Batch No.
5. Gross weight
6. Net weight
7. No. of containers
8. Date and signature
These labels will be pasted 100% on each container of the batch.
While taking the sample from the bulk product, the QAI will paste the “Sampled” label on each
container from which the sample has been taken out.
Production ID (white label with blue printed matter) labels used for the identification of the
manufacturing and finishing process. Labels have the following details:
Product:
Batch no.:
Status:
Date:
Signature:
Sterile labels are used to identify the cleaning status of the equipment/container and is to be used in
injectables. The label has the following information:
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