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SOP on Indent and Approval of Rubber Stereo for Overprinting

1.0 OBJECTIVE: To lay down a procedure for indent and approval of rubber stereo for overprinting of batch details on printed packaging material.
2.0 SCOPE: This procedure is applicable to indenting and approval of stereo for overprinting of packing material in the production department.
3.0 RESPONSIBILITY: Officer, Executive – Production Department
Manager – Production Department

4.0 PROCEDURE:
4.1 Stereo required for the overprinting is to be indented as per Annexure- I.
4.2 Before indenting stereo, properly check the B. No. , MFD., EXP., M.R.P., and M.L. No. of particular batch through BPR and B.No. Log and standard price Approved list from QA by production officers and approved by the department head.
4.3 After receipt of stereo, enter receipt details in a stereo Logs.
4.4 Impression of each No. of stereos taken in Annexure-II stereo impression format
4.5 In case the impression is improper, make a new impression and cut the previous impression with a signature.

4.6 Impression of each stereo shall be cross-checked with the indent.
4.7 Impression of stereo is checked by one production officer and cross-checked by a second production officer.
4.8 After approval from the IPQA person, the stereos are stored under lock and key in a specified location in the stereo cupboard. The key to the cupboard shall be in the custody of the production Officer / Executive.
4.9 If the matter of the Rubber Stereo procured is incorrect or improper, then the stereos shall be returned back to the supplier or destroyed as per stereo as per the SOP “Destruction of rubber stereos” and new stereos are to be indented as per the format given in Annexure-I.

4.10 Issued the required number of stereos to the production officer/operator and recorded them into the stereo register as per Annexure-III
4.11 After completion of batch collect all Rubber Stereo that shall be the same no. stereos issued and record into the stereo register.
4.12 After completion of the batch destroy the Rubber Stereo as per the SOP “Destruction of rubber stereos” and record the destroyed details in a stereo register.

Read Also: SOP On Change of Aluminum Foil During Packing

5.0 ABBREVIATION(S):
BMR: Batch Manufacturing Record
B. No. : Batch number
MFD.: Manufacture Date
EXP.: Expiry
M.R.P.: Maximum Retail Price
M.L. No. : Manufacture License Number

6.0 ANNEXURE(S):
Annexure –I: Stereos indent format.

annexure 1 Rubber Stereo

Annexure – II: Rubber Stereo impression format.

annexure 11 Rubber Stereo

Annexure – III: Stereo impression format.

annexure 111 Rubber Stereo
    by
  • Naresh Bhakar
    (Author)

    Naresh Bhakar is the Founder and Author at Pharmaguddu.com, bringing his extensive expertise in the field of pharmaceuticals to readers worldwide. He has exprience in Pharma manufactring and worked with top Pharmaceuticals. He has rich knowledge and provides valuable insights and data through his articles and content on Pharmaguddu.com. For further inquiries or collaborations, please don't hesitate to reach out via email at [email protected].

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