SOP on Destruction of Rubber Stereos

1.0 Objective

The objective is to lay down a procedure for the destruction of rubber stereos after the overprinting of a batch is completed. The procedure makes sure that no stereo carrying old batch details remains available for printing on another batch.

2.0 Scope

This procedure applies to the destruction of rubber stereos in the Production department. It covers stereos used on the carton overprinting machine for printing the batch number, manufacturing date (MFD), expiry date (EXP), maximum retail price (MRP) and manufacturing licence number. Stereos are issued under the companion SOP on indent and approval of rubber stereo for overprinting, and this SOP continues from the point where that issue ends.

3.0 Responsibility

Officer or Executive, Production: collects and counts the stereos, destroys them, and makes the entries in the stereo register and the BPR.

Quality Assurance (QA): reviews the completed record. QA also witnesses the cutting where the plant has added this step.

Manager, Production: makes sure that the procedure is followed and that any count mismatch is reported as a deviation.

4.0 Definitions

Rubber stereo: a rubber printing block that carries the variable batch details. It is fixed on the block of the carton overprinting machine and may be grooved (G) or flat (F).

Stereo register: the record that shows, for each product and batch, the number of stereos received, issued, returned and destroyed, together with the names of the persons involved.

5.0 Procedure for the SOP on Destruction of Rubber Stereos

Stereos are issued at line clearance, and the first overprinted carton is authorised by the production officer and the QA officer. Destruction follows only after the batch is completed.

5.1 The production officer collects the used stereos after packing of the batch is completed and counts them. The count must be equal to the quantity issued, as entered in the stereo register.

5.2 The issued stereos and the retained stereos are then collected together. Their combined quantity is verified against the quantity received.

5.3 When the quantities agree, each stereo is cut into small pieces, so that no legible batch characters remain.

5.4 The destruction details are recorded in the stereo register (destroyed by, remarks) and in the BPR of the respective batch, with the date and signature.

5.5 When the production plan changes, or the batch is cancelled or postponed, the stereos are not destroyed. In the reference SOP, a postponement of about one month leads to storage in the stereo cupboard with a proper storage label. The period is defined by each plant.

5.6 A stereo with incorrect or improper matter is returned to the supplier or destroyed under this SOP. New stereos are then indented under the indent SOP.

5.7 Some plants add an independent witness, for example an in-process quality assurance (IPQA) officer, who verifies the cutting. This step is a plant decision and is not a requirement of the reference SOP.

Related packing material, such as printed cartons and leaflets, is reconciled and destroyed under the SOP on reconciliation and destruction of packing materials. Rejected tooling follows the SOP for destruction of rejected dies and punches.

6.0 Precautions

6.1 Stereos must never be destroyed until the returned count matches the stereo register. A short count must be reported as a deviation, and the investigation must be completed before the BPR is closed. The batch packing should be held and the line should not be released until the quantities are reconciled.

6.2 Each stereo must be cut so that the batch details cannot be read or reused. The date and the name of the person who destroyed it must be recorded.

6.3 Retained stereos should be kept separate from used stereos, so that the two lots are not mixed during counting. Stereos of a postponed or cancelled batch must carry a storage label and must be kept in the locked stereo cupboard. The key stays with the production officer or executive. A used stereo must never be reused for another batch, because it can reprint old batch details and cause a mix-up.

6.4 The regulatory basis is the control of labeling. 21 CFR Part 211 requires that all excess labeling bearing lot or control numbers is destroyed, and plants apply the same principle to the printing stereos.

7.0 Records and Formats

7.1 The stereo register (Annexure III of the indent SOP) has these columns: product or batch number, type (G or F), supplier or receiving date, total number of stereos, number issued, number received, issued by, submitted by, destroyed by, and remarks. The BPR carries the destruction entry of the batch.

8.0 Annexures: the stereo indent format (Annexure I), the stereo impression format (Annexure II) and the stereo register (Annexure III) belong to the indent SOP.

9.0 Revision card: each revision must be recorded in the table below. The SOP header also carries the SOP number, the supersedes number, the page number, the issue, effective and review dates, and the prepared, checked and approved signatures. SOP numbers are assigned by each plant.

Sr. No.	Revision No.	Revision date	Details of revision	Reason for revision

10.0 Abbreviations

BPR: Batch Packing Record

QA: Quality Assurance

IPQA: In-Process Quality Assurance

SOP: Standard Operating Procedure

G: Grooved, F: Flat

MFD: Manufacturing Date, EXP: Expiry Date, MRP: Maximum Retail Price

7.0 References

1. 21 CFR 211.125 Labeling issuance, eCFR, US Government Publishing Office
2. Destruction of Rubber Stereos, production SOP, and Indent and Approval of Stereo, production SOP, internal plant library (private)