SOP for Approval of shipper label

1.0 OBJECTIVE:

To describe the procedure for Approval of shipper label generated through Software.

2.0 SCOPE:

This SOP covers the procedure for Approval of shipper label generated through Software in production department at [Company Name].

3.0 RESPONSIBILITY:

3.1 Production department to give Shipper Label to IPQA for approval.

3.2 IPQA to verify the details of label as per procedure.

3.3 QC department to verify barcode against the number given below the Bar Code  

3.4 Head QA to ensure the compliance.

4.0 PROCEDURE:

4.1 Collect the 1 Specimen Shipper labels generated through Software from production department duly signed by production head / designee for approval purpose and record the details in annexure I for receipt of label. For approval

4.2 Verify the details as follows by IPQA person.

Refer the Numbered details given in Example Label with the help of below Table.

4.3 Verify the Number given below respective Barcode as follows

4.3.1 There shall be two type of Bar i.e. Primary Bar and Secondary 

4.3.2 The Primary barcode contains the NDC/ UPC number and case size (the case size can be from 2 to 5 digits) using code 128 format and just the NDC/ UPC number using the Interleaved 2 of 5 format.

4.3.3 The Secondary barcode contains the case size, expiration date and lot number using the Code 128 format. 

4.3.4 The coding technique is as follows :

4.3.5 Primary Barcode : Either interleaved 2 of 5 or Code 128 format 

01PUUNNNNNNNNNNX30CCCCC

(Here, the quantity can be anywhere from 2 to S digits in length)

4.3.6 Secondary Barcode : Code 128 format

22QCCCCCMMYYLLLLLLLLLLZ

Where meaning of characters in primary and secondary Barcode is as follows: 

P=Packaging level indicator (Use 3 if it is not known) 

U=UCC Prefix (generally 03 if your NDC number is preceded by a 3) 

N=NDC or UPC number (10 digits) 

X=Mod 10 Check digit on the NDC or UPC number 

Q=8 indicates a 2 digit case quantity; 9 indicates a 5 digit case quantity 

C=Case quantity (in eaches – either 2 or 5 digits based upon the value of Q above)

M=Expiration date month (2 digit month) 

Y=Expiration date year (2 digit year) 

L=Lot number (State the maximum number of characters / digits in your lot number) 

Z=Link Character (which has the same value as “X” – Mod 10 check digit on the NDC / UPC number) 

If the item does not have an expiration date, then fill the date with ‘0000’. 

4.4 After verification by IPQA person, IPQA person shall sign on label and send to QC for verification of Barcode and respective number corresponding to Barcode mentioned below barcode respectively by using Barcode scanner. And after verification and found OK by QC person, QC person shall sign on label and this label shall consider as approved label for respective batch.

4.5 Send above approved label to production department for verification of other labels and Production head/ designee shall be verify all other labels need to use for same batch and sign on all verified labels for their use.

4.6 The approved label shall be stick in Batch Packing record.

5.0 ANNEXURES : 

Annexure I Approval Detail of Shipper label Generated using Software

Sr. No

Date

Batch No

Item Code

Labels received by QA for verification

Found OK/ Not OK

Verification in QC 

Done By

Found OK/ Not OK

Label received by / Date (Production)