1.0       OBJECTIVE:

The objective of this SOP is:

1.1       To lay down a procedure for Operation and Cleaning of sticker labeling machine.

2.0       SCOPE:

3.0       This SOP is applicable for Operation and Cleaning of sticker labeling machine. RESPONSIBILITY:

3.1       The Operator/Officer /Executive Production shall be

3.1.1    Responsible for Operation and Cleaning of sticker labeling machine.

4.0       ACCOUNTABILITY:

Manager Production / Head – Quality Assurance

5.0       PROCEDURE:

5.1       Pre Start up:

5.1.1    Check and ensure that area is cleaned.

5.1.2    Check and ensure that machine is cleaned.

5.1.3    Check and ensure that line clearance is obtained from IPQA.

5.2       Start up:

5.2.1    Switch on the main electric supply of machine.

5.2.2    Set the sticker label roll on the label roller.

5.2.3    Set the cartridge as per product details (B. No., Mfg. Date, and Exp. Date, M.R.P).

5.2.4    Code the label for sample.

5.2.5    Match the over coding on the labeled vials/ampoules as per BPR.

5.2.6    Give the over coded vials / ampoules to packing supervisor for approval from I.P.Q.A.

5.2.7    After approval from I.P.Q.A. start over coding and labeling till batch completed.

5.2.8    Check the over coded labeled vials / ampules frequently for the proper coding.

5.3         Cleaning of sticker labeling  machine

5.3.1    After completion of operation switch off the machine

5.3.2    Remove the leftover sticker labels & verify the quantity and keep in a poly bag.

5.3.3    Clean the machine properly.

5.3.4    Record the operation and cleaning activity of sticker labeling machine.

5.4       Cleaning frequency: Daily after operation activity.