SOP for Overprinting of Batch Details on Cartons and Catch Covers

1.0 OBJECTIVE

To lay down the procedure for overprinting of batch details on cartons and catch covers.

2.0 SCOPE

This SOP shall be applicable for all the batch overprinting operations carried out in Packing Department.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 Production person shall ensure that the printing area and printing machine are cleaned. Cartons / Catch covers of the previous product are removed; stereos of the previous product are removed and destroyed.
5.2 Before starting the operation production person get the line clearance from Q.A person by writing the status label with Product Name, batch Details to equipment & area and record the same in BMR.
5.3 Packing pharmacist should display the status label in front of overprinting machine and also give the instruction with batch details which are to be overprinted to the overprinting operator as per the BPR requirement.
5.4 Bring the cartons/ catch covers issued for the batch to be overprinted, inside the printing area. Count the cartons/ catch covers before starting the printing.
5.5 Obtain the overprinted rubber stereos required for the batch from the pharmacist and set the overprinted matter as per the instructions are given by the pharmacist.
5.6 First two overprinted cartons/ catch covers should be signed and approved by:

• Overprinting Operator
• Two Packing Pharmacist
• Q.A. Person

5.7 Attach specimen samples to BPR (Batch Packing Record) and retain one sample in the department for reference which should be destroyed after 3 months.
5.8 Before printing the sticked cartons should be separated and then taken for printing. The overprinted carton should be checked for any mixed up for the unprinted carton.
5.9 Good overprinted cartons/ catch covers should be collected and arranged in drum or cage trolley and should be labeled accordingly.
5.10 Quantity of printed cartons / catch covers and rejected quantity along with the number of unprinted cartons, if any, should be recorded in the batch document as well as printing record.

5.11 Quantity of rejected cartons/ catch covers recorded in a register and these cartons / catch covers should be destroyed by tearing into pieces in presence of Q.A. person followed by transfer into scrap yard for further destruction by burning/shredding.
NOTE: If there should be any break then, In case of carton/catch cover the first printed carton/ catch cover specimen should be Checked & Signed by the Operator, Concerned Pharmacist & Q.A. Person. In case of printed foil, after the change of every printed roll the foil specimen to be attached in the respective BMR signed by Operator, Concerned Pharmacist & Q.A. Person.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department

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