QAS-019 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 336

SOP No. QAS-019.00 Effective date: mm/dd/yyyy
Approved by:

responsibility Procedure

Materials stores Stores after receiving the packaging or raw materials against the purchase order will paste “Receiving

label” (yellow) on each container or bag or whatever the pack size of the incoming material.
Each receiving label will have the following details:
Raw material receiving label
a. Material name
b. Code No.
c. Container No.
d. Quantity per container
e. ABC Pharmaceutical Company's lot No.
f. Manufacturer's name
g. Manufacturer's lot No.
h. Material receiving date
i. Material expiry date
j. Supplier name
Packaging material receiving label
a. Code No.
b. PO No.
c. Supplier name
d. Quantity
e. Supplier lot No.
f. Receiving date
g. Container No.
h. Lot No.

Quality
assurance

The QAI after taking the sample from incoming supplies will paste the “Sampled” label on the
container from which the sample has been taken. On approval of the lot, the released label (green)
will be pasted on each and every container of raw material by the QA department along with the
receiving label, but on bulk supplies (selected items like sucrose, lactose, mannitol, kaolin, maize
starch, lactose monohydrate, cetostearyl alcohol, glycerol monostearate, citric acid, cetomacrozol,
sodium benzoate, acrosil 200, sorbitol cetyl alcohol) and packaging materials (which are usually
packed in bags or those supplies which are issued in bulk to the production or packaging), only three
labels will be pasted per pallet.
These release labels (printed) will have the following details:
Raw material release label
1. Material name
2. Code No.
3. QC No.
4. PO No.
5. Lot No.
6. Rechecking date
7. Expiry date
8. Release date
9. Signature
Packaging material release label
1. Material name
2. Code No.
3. ABC lot No.
4. PO No.