1.0 Objective
To lay down a procedure for Inventory, Storage, Issuance, Withdrawal, Destruction and Reconciliation of Rubber stereos used on packing / overprinting machines.
2.0 Scope
This SOP is applicable for placing order, receiving, checking of impression, issuance, usage, withdrawal and destruction of rubber stereos used for all packing / overprinting machines at pharmaceutical formulation plant.
3.0 Responsibility
Production Operator/ Technician/Printing In-charge shall be responsible for follow the procedure mention in the SOP.
Production Officer/ above shall ensure the proper usage, withdrawal and destruction of rubber stereos used on all packing/ overprinting machines.
Head & QA Personnel shall be responsible for proper compliance of SOP.
4.0 Accountability
Department Head and QA Head shall be accountable for implementation of this SOP.
5.0 Abbreviations and Definitions
QA : Quality Assurance
BMR : Batch Manufacturing Record
6.0 Procedure
6.1 Order, Receipt & Issuance of Stereos
6.1.1 As per the production planning the order of the required stereos should be placed to the party by Printing In-charge duly checked by the Production Officer and verified by QA Personnel as per Annexure-I. The details shall be overprinted with the proper instructions regarding the type of stereos, stereo size and the quantity shall be mentioned with instructions.
6.1.2 Every stereo record shall have a serial number as described below:
MMM/XXX/YY, where, MMM means first three letters of the current month e.g. Sep for September, XXX means serial number e.g., 001,002,003 and so on…, and YY means last two digits of the current year e.g., for 2017 it would be 17 and so on….
6.1.3 Number of stereo shall be ordered as per printing requirement and quantity shall be mentioned in Annexure-III.
6.1.4 After receiving the stereos, printing In-charge personnel shall check whether these are as per Stereo Order and shall check the delivery challan.
6.1.5 Printing Operator shall take the stereo impression which shall be checked by printing In-charge and counter checked by production and further verified by QA as per Annexure-II.
6.1.6 If impression of stereo is not clear or any type of discrepancy observed then respective stereo shall be destroyed by responsible Production Personnel in presence of QA personnel.
6.1.7 Impression of next stereo shall be taken as per Annexure-II. Previous impression shall be diagonally cut and signed by printing In-charge.
6.1.8 If rejection of impression shall repeat then step no. 6.1.6 and 6.1.7 shall be followed.
6.1.9 After completion of impression printing In-charge shall handover the stereos to Production Department. Production personnel shall enter the details in Annexure-III.
6.1.10 Production personnel shall kept the stereos in designated area under lock & key.
6.2 Issuance of Stereos:
6.2.1 In case of printing of outer carton, inner carton and label stereo shall be issued to printing In-charge by responsible production personnel in presence of QA personnel as per Annexure-III.
6.2.2 In case of foil stereo shall be issued to individual section head by responsible production personnel in presence of QA personnel as per Annexure-III.
6.3 Usages of Stereos:
6.3.1 After setting standard number of stereos on the packing / overprinting machine, the operator shall give the impression of the stereos on foil / cartons / label etc. for checking by the Production and verified by QA Personnel. (In case of carton / label Printing In-charge and Quality Control Personnel shall also check the impression).
6.3.2 After verifying the impressions, sample of verified impressions duly signed by concerned personnel shall be attached as specimen to the BMR. This specimen is known as ‘Initial Proof’.
6.3.3 After verification processing of batch shall be started.
6.3.4 During the batch run, if any stereo or full set of stereos shall change, then shall be followed by step no. 6.3.1 to 6.3.2.
6.3.5 After completion of the batch, the operator shall take the impression of the stereos on foil / cartons / label. These impression shall be verified by Production Personnel and counter checked by QA Personnel. This is kept in the BMR as the ‘Final Proof.
6.3.6 After verification of the completed batch, all the used stereos shall be handed over to the responsible Production Personnel.
6.4 Withdrawal of Stereos:
6.4.1 If the batch is suspended half way, the final specimen of the impression shall be maintained with BMR and stereo shall be handed over to responsible production personnel before packing of the next batch. Preserve the stereos of suspended batch in lock & key and subsequently shall be re-issued from responsible production personnel as per Annexure-III, when remaining quantity of suspended batch is to be packed.
6.4.2 Take the line clearance from QA Personnel before packing of remaining quantity of suspended batch.
6.4.3 Production Officer shall check the initial proof of stereo impression and counter checked by QA Personnel before starting the packing of remaining quantity of suspended batch.
6.4.4 Meanwhile coding/ printing if the stereo get smudge or damage the same shall be replaced by reissuing new one and the proof shall be again checked by Production and QA personnel. Record the re-issuance in the Annexure-III.
6.4.5 Stereo shall be withdrawal after cleaning by using thinner.
6.4.6 The exact number of stereos shall be returned by operator/ Printing In-charge and withdrawal by production personnel as per Annexure-III.
6.4.7 Withdrawal of stereo shall be done in presence of QA personnel.
6.5 Destruction of Stereos:
6.5.1 Ensure that after the usage of the stereos of previous batch / product are removed and hand over to Production personnel in presence of QA personnel as per Annexure-III.
6.5.2 Production Personnel shall destroy the used stereos in presence of QA personnel. by cutting them into pieces across the letters using scissor and disposed off the destructed stereo to scrap room in polythene bag.
6.5.3 Destruction details shall be recorded in Annexure-III.
7.0 Forms and Records (Annexures)
Stereo Order – Annexure-I
Stereo Checking Record – Annexure-II
Stereo Reconciliation Record – Annexure-III
8.0 Distribution
Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production & Quality Control
9.0 History
| Date | Revision Number | Reason for Revision |
| – | – | New SOP |
Annexure-I
Stereo Order
Sr. No._________ Date: ______________
To,
______________________
Product Name:- _______________________________ B. No.:_____________________
Type of Stereo for Foil: – Flat / Grooved
Stereo Size:-
Qty. Required:-
Type of Stereo for carton / Others (Specify)………………….: – Flat
Stereo Size:-
Qty. Required:-
Stereo Detail for Foil:-
Stereo Detail for Carton / Others (Specify)………………………:–
| Prepared By
(Printing In-charge) |
Checked By
(Production) |
Verified By
(QA) |
Annexure-II
Stereo Checking Record
| Date | |||
| Product Name | B. No. | ||
| Batch Size | Mfg. Date | ||
| Exp. Date | M.R.P. | ||
Impression of Stereos:
| Done By
(Operator) |
Checked By
(Printing In-Charge) |
Counter Checked By
(Production) |
Verified By
(QA) |
Annexure-III
Stereo Reconciliation Record
