Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-019.00 Effective date: mm/dd/yyyy
Approved by:
4. Weighing area
a.
White label showing the container of a particular lot, which is “in use,” that is, printing
“Some quantity of that container has been issued and container is in use, not intact.”
38.3.3.1
Qc department
a.
Red label
: Indicating that (
rejected
) materials should not be issued/dispensed/distributed.
b.
Green label (material/product release) computer printed
: For packaging commodities and
raw materials (incoming), indicating that these items can be issued, and for bulk product,
indicating that it can be taken up for packing.
38.3.3.2
Quality assurance department
a.
Orange label
: Indicates the containers from which the sample has been withdrawn, sam-
pled whether it be raw material, packaging material, or bulk product.
b.
QA hold labels
: Yellow label with red printed matter. Materials should not be used until the
disposition (GMP deviation observed during inspection) is decided by QA.
c.
“To be sorted” and “to be reworked” labels
: To indicate the disposition of the QC lab or
QA for sorting the batch or reworking a portion.
d.
Green label
: Indicating the area/machine or line is released for processing (area/machine/
line) after inspecting start-up checks (separate for production and packaging area).
e.
Bulk sampling
: In-process labels for containers with bulk product sample having the informa-
tion from where the sample has been taken (process) along with product identification.
38.3.3.3
Packaging department
a.
Semifinished:
: Indicating the product is not completely packed and at least one of the pack-
aging component is missing
b.
Pallet label
: Showing the number of pallets packed of the product and the line boss name
c.
Incomplete pack
: Showing the carton on which it is pasted as not has the complete number
of finished units
d.
Issued packaging material
: Showing packaging material for a particular line to be supplied
after receiving from the store by the packaging department
In addition to these labels, computer-printed labels are used on finished products showing the
product's name, batch number, manufacturing date, and expiry date.
38.3.3.4
maintenance department
a.
White label with red printing
: Showing that the machine/equipment is under maintenance
and not fit for use
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