Indent, Approval and Destruction of Rubber Stereos

In this post Standard Operating Procedure Indent, Approval and Destruction of Rubber Stereos in Pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for indent, approval and destruction of rubber stereos for overprinting of batch details on printed packaging material.

2.0 SCOPE:

This procedure is applicable to production department.

3.0 RESPONSIBILITY:

Officer, Executive – Production Department

Officer, Executive – Quality Assurance Department

Head Production - shall ensure compliance of the SOP.

4.0 DEFINITION(S):

5.0 PROCEDURE:

5.1 Rubber Stereos required for the overprinting is to be indented in duplicate copy one copy shall go to supplier and other preserve in to indent book as per Annexure- I.

5.2 Before indenting stereo, properly check the M.L.No., B. No., MFD., EXP., M.R.P. from BMR/BPR/B. No. Log and standard pricelist by production officer and approved by department head

5.3 After receipt of stereos, enter receipt details in stereo impression and destruction format (Annexure-II)

5.4 Impression of each stereo shall be cross checked with the details given in indent and as per BMR/BPR.

5.5 Impression of stereo is checked by the production(sign/Date) and verified by Quality Assurance (Sign/Date). Each impression shall be numbered.

5.6 Incase the impression is improper, make a new impression and cut the previous Impression with signature, write invalid (incase, the coding details are wrong or improper, the impression shall be cut with remark ‘’not OK.”

5.7 After approval, the stereos are stored under lock and key with specified location in stereo cupboard. Key of the cupboard shall be in the custody of production Officer/In- charge.

5.8 All the incorrect and improper stereos shall be destroyed

5.9 Issued the required number of stereos for packing and record in to stereo impression and destruction format as per Annexure-II.

5.10 After completion of batch collect all stereos that shall be same no. stereos issued and record in to stereo register.

5.11 After completion of batch destroy the stereo by cutting into pieces and record the destruction details in Annexure-II. Destruction details shall be verified by Quality assurance.

5.12 If there is change in the production plan (cancelled / Postponed), the stereos procured during the period/plan shall be destroyed, and record in remark column in to Annexure-II

6.0 ABBREVIATION(S):

BMR : Batch Manufacturing Record

BPR : Batch Packing Record

B. No. : Batch number

MFD. : Manufacture Date

EXP. : Expiry

M.R.P. : Maximum Retail Price

M.L. No. : Manufacture License Number

7.0 RERERENCE(S):

8.0 ANNEXURE(S):

Annexure – I : Stereos indent format

Annexure – II : Stereo impression and destruction format