Inventory, Storage, Issuance, Withdrawal, Destruction and Reconciliation of Rubber Stereo

Inventory, Storage, Issuance, Withdrawal, Destruction and Reconciliation of Rubber Stereo

Objective

  • To lay down a procedure for Inventory, Storage, Issuance, Withdrawal, Destruction, and Reconciliation of Rubber stereos used on packing / overprinting machines.

Scope

  • This SOP is applicable for placing orders, receiving, checking of impression, issuance, usage, withdrawal, and destruction of rubber stereos used for all packing / overprinting machines at pharma industries.

Responsibility

  • Production Operator/ Technician/Printing In-charge shall be responsible for following the procedure mentioned 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.

Accountability

  • Department Head and QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • QA:            Quality Assurance
  • BMR:            Batch Manufacturing Record

Procedure

Order, Receipt & Issuance of Stereos

  • 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.
  • Every stereo record shall have a serial number as described below: MMM/XXX/YY, where, MMM means the 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 2014 it would be 14 and so on…
  • The number of stereos shall be ordered as per printing requirement and quantity shall be mentioned in Annexure-III.
  • After receiving the stereos, printing In-charge personnel shall check whether these are as per Stereo Order and shall check the delivery challan.
  • 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.
  • If the impression of stereo is not clear or any type of discrepancy is observed then the respective stereo shall be destroyed by responsible Production Personnel in presence of QA personnel.
  • Impression of the next stereo shall be taken as per Annexure-II. The previous impression shall be diagonally cut and signed by printing In-charge.
  • If rejection of impression shall repeat
  • After completion of impression printing In-charge shall hand over the stereos to Production Department. Production personnel shall enter the details in Annexure-III.
  • Production personnel shall keep the stereos in the designated area under lock & key.

Issuance of Stereos:

  • 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.
  • In the case of foil, stereo shall be issued to individual section heads by responsible production personnel in presence of QA personnel as per Annexure-III.

Usages of Stereos:

  • After setting a 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).
  • After verifying the impressions, a sample of verified impressions duly signed by concerned personnel shall be attached as a specimen to the BMR. This specimen is known as ‘Initial Proof’.
  • After verification processing of batch shall be started.
  • During the batch run, if any stereo or the full set of stereos shall change
  • After completion of the batch, the operator shall take the impression of the stereos on foil/cartons/label. This impression shall be verified by Production Personnel and counter-checked by QA Personnel. This is kept in the BMR as the ‘Final Proof.
  • After verification of the completed batch, all the used stereos shall be handed over to the responsible Production Personnel.

Withdrawal of Stereos:

  • If the batch is suspended halfway, 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 the suspended batch in lock & key and subsequently shall be re-issued from responsible production personnel as per Annexure-III, when the remaining quantity of suspended batch is to be packed.
  • Take the line clearance from QA Personnel before packing of remaining quantity of the suspended batch.
  • 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.
  • Meanwhile, coding/ printing, if the stereo gets a smudge or damage the same, shall be replaced by reissuing a new one and the proof shall be again checked by Production and QA personnel. Record the re-issuance in Annexure-III.
  • Stereo shall be withdrawn after cleaning by using thinner.
  • The exact number of stereos shall be returned by operator/ Printing In-charge and withdrawn by production personnel as per Annexure-III.
  • Withdrawal of stereo shall be done in presence of QA personnel. Rubber Stereo

Destruction of Stereos:

  • Ensure that after the usage of the stereos of the previous batch/product is removed and handed over to Production personnel in presence of QA personnel as per annexure-III.
  • Production Personnel shall destroy the used stereos in presence of QA personnel by cutting them into pieces across the letters using scissors and disposing of the destructed stereo to scrap room in a polythene bag.
  • Destruction details shall be recorded in Annexure-III.

Forms and Records (Annexures)

  • Stereo Order –           Annexure-I
  • Stereo Checking Record –           Annexure-II
  • Stereo Reconciliation Record –           Annexure-III

Distribution

  • Master copy        –    Quality Assurance
  • Controlled copies –     Quality Assurance, Production & Quality Control

History

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Annexure -I

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

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

S.

No.

ProductB. No.Stereo forQty. of Stereo IndentedQty. of stereo

Received

Impression Cheeked

(Yes/No)

Rejected

(If any)

Total Good Stereos received

by/ On

Qty. IssuedIssued

By/On

Stereo received

By Prod./On

Balance Qty.Verified

By QA/On

Re-issued

By QA/On

Balance Qty.

after re-issuance

Qty. returnedReturned By/OnReceived By/OnVerified

 By QA/On

Destroyed Qty.Destruction

Done By

Destruction

Checked By

(Prod.) /  On

Destruction

verified By

(QA) / On

   Foil                  

 

  
Inner Carton
Outer Carton
Label
Other:
Foil
Inner Carton
Outer Carton
Label
Other:

 

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About ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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