Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-019.00 Effective date: mm/dd/yyyy
Approved by:
38.1 PurPose
The purpose of this SOP is to
a. Identify the department responsible for carrying out the labeling at particular steps.
b. Describe the policy and procedure for labeling of incoming materials, quarantined materi-
als, and in-process and finished product.
c. Describe the number and position of the labels on a lot or a batch, especially in case of
incoming raw material and packaging materials.
38.2 resPonsibility
It is the responsibility of production, QC, packaging, materials planning department, maintenance,
and QA to carry out the agreed-upon procedure of labeling. The QA manager will be responsible for
the SOP compliance.
38.3
general instructions for Pasting labels
38.3.1 P recaution
Never fix labels on the lid or bottom of the container.
38.3.2
P rocedure
1. Labels will be printed on the ABC printer using the QA release labeling system
2. Labels printed will be checked against the information of lot in the system
3. All labels will be signed and dated and one label will be kept in a record file for future
reference
a.
Peal off the label from the sheet and apply very gently on the surface
b.
Press from one end to the other with a thumb to remove air gaps
c.
Press overturned corners if visible
d.
Fix label on the body of the container only
38.3.3 l aBelS
The following labels are being used to indicate the status of the item:
1. Production (computer-printed labels): yellow, blue, and white
a.
Yellow label : To indicate complete processed bulk product/finished bulk (specimen
attached)
b.
Blue label : To indicate in-process product (specimen attached)
c.
White label (printed) : To indicate rework product (specimen attached)
2. Production (printed labels)
a.
Clean label (white) : To indicate the cleanliness of the equipment/area
b.
Undercleaning label (white) : To indicate the undercleaning status of the area/equipment
c.
Production ID : To indicate the stage of production
d.
Sterile : To indicate the cleaning status of the equipment used in the sterile area
3. Store
a. Yellow label : On incoming lot of raw material and packaging materials (receiving
computer labels printed)
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