SOP for Material and Product Labeling in Production Area

1.0 OBJECTIVE

To lay down the procedure for Material and Product Labeling in the production department.

2.0 SCOPE

This SOP shall be applicable for Material and Product labeling in production department so that all Materials & Products must be easily identified & used correctly.

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 affix the “Under process” label on each and every container at every stage. The detailed procedure of labeling is as follows:
5.1.1 “Under process” labels were differentiated on the basis of strength & color.
5.1.2 “Under process” labels were printed in four colors.
5.1.2.1 White Colored Label: Denote that the product comes in one strength only or It is the in the processed lowest strength of active ingredients in its product range if the product is coming in different strength.
5.1.2.2 Yellow Colored Label: On the container denotes that product is having slightly more strength of active ingredients in its product range than the product stored in white under process labels.
5.1.2.3 Light Blue Colored Label: On the container denotes that product is having more strength of active ingredients in its product range than the product stored in yellow colored under process labels.
5.1.2.4 Pink Colored Label: On the container denotes that product is having more strength of active ingredients in its product range than the product stored in Light Blue colored Under process labels.
5.1.3 For the red area the under process label criteria will be different due to same punch size & color of tablet manufacturing in the dedicated red area are as follows (to prevent the chance of mixing of products):
5.1.4 For rest of the products white colored under process labels to be used & in case of the product in range then same criteria for under process label usage to be followed as that of in general area.
5.2 After completion of operation production person shall affix “To Be Cleaned” status label to un-cleaned equipment.
5.3 After cleaning of equipment, production person shall affix “Cleaned” status label & cleaning is valid for 72 hours. If it is to be used after 72 hours, it should be re-cleaned before use & same to be entered in “Equipment Log Book”.
5.4 Production person shall ensure that previously affixed status labels must be removed before affixing the new label.

5.5 Production person shall ensure that the label affixed to the container, not on the lid & it shall easily visible.
5.6 Production person shall ensure that labels must be defaced or removed whenever a container is emptied.
5.7 Production person shall ensure that one label must be inserted into the container (In between Two poly bags) and another label must be affixed outside the body of the container.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure

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