Procedure For Terminal Inspection

by
STANDARD OPERATING PROCEDURE
Title : Procedure For Terminal Inspection 
Department
:
Quality Assurance

 OBJECTIVE

    • To lay down the procedure for Terminal Inspection.
  • SCOPE
    • This procedure is applicable for terminal inspection and transfer of finish goods activities during processing of product.
  • RESPONSIBILITY
    • Officer-Production
    • Officer-IPQA/QA
  • ACCOUNTABILITY
    • Manager-Production
    • Manager-Quality Assurance
  • PROCEDURE
    • Terminal inspection procedure includes the verification of the product quality defects related to the packaging of the product by ensuring the proper packing of the Bottle/ Tube foil/carton/ Tin/ shipper through random check of the total batch packed.
    • Inspection of the packed shippers is carried out online, on the initiation of the secondary packing of the product, by the IPQA Executive/Designee.
    • On initiation of the secondary packing, the first three shippers & last two shipper packed are to be verified for the pack stock.
    • After the pack stock inspection of the initial three shippers, if all the parameters are found complying, the packing process will continue.
    • In case when any of the parameters stated in the pack stock does not comply, the chemist on the line will take proper corrective action and after that will take the secondary line clearance as per SOP – Line Clearance .
    • Depending upon the observations of initial pack stock, selection of the Corrugated box inspection of the further stock is done as per the Table No.1
    • QA person will do the terminal inspection as per below mentioned procedure and observation details will filled by QA personnel in “Terminal Inspection Check List”, as per Format No.————-.
      • Firstly QA Person will check relevant documents for the said batch and then select the samples to verify different parameters given as under:-

Table No. 01
A Selection of Packed Corrugated Boxes
i ) 10 or less 100%
ii) 11 to 50 20% of total Corrugated boxes but not less than 10 Nos. or as per party specification.
iii) More than 50 10% of total C. boxes but not less than 50 Nos. or as per party specification.
D Parameters to be Checked
i) No. of shipper received
ii) Name of the product
iii) B. No., Mfg., Expiry, Retail. Price
iv) Spreading of ink on label
v) Quantity of unit pack Tablet/Capsule/Bottle/Tube/ Vial/ Tin per shipper
vi) Quantity of Tablet/Capsule/Bottle/ Tube/ Vial/ Tin per catch cover/carton
vii) BOPP tape printed/ plain
viii)

Quality of shipper (5ply/7ply/others)
  • In Case of Critical defects packed corrugated box will be kept on Hold, Production Personnel will be informed for 100 % checking and other corrective action.
    • Critical Defects:
      • Containers without Label /Reverse Label.
      • Containers or cartons without Batch Coding / Cut Batch Coding.
      • Cartons without Containers / SWFI etc.
      • Containers without Medicine/ empty packet/ torn blister/ drug content in pocket spilled from tablet or capsule/ cut pocket/ Leakage Problem/ Dented Bottle/ Dented Cap.
      • Crack or broken Containers.
  • In case of major defects (as defined under) observed in shipper first will check pre & post shipper against observed shipper, if same is found observation in pre & post shipper then batch will be check 100% ,and hold the material and send to production for necessary checking/ action.
  • Major Defects:
    • No, Mfg., Exp. and retail price on Carton/ Label/ Tube/ Bottle is not readable.
    • Weight of drug is not within specified limit.
    • Less or more quantity of unit packed in container.
    • Spreading of ink on label/ Tube & Carton.
    • Notch capsule/ tablet in pocket.
    • In case of minor defects, solve the problem on-the-spot.
  • Minor Defects:
    • Shipper has dent.
    • BOPP tape is not properly placed.
    • Label on shipper is not properly placed.
  •  After corrective action, Q.A Officer will again check the defect marked and   approve the Product.
    • Manager Q.A. will finally check the final Terminal Inspection Check List and releases the product for it’s transfer inside the Finished Goods Store at specified area looking to it’s Testing status from QC.
    • Partially batch can be transferred in case of any urgency after verification of complete documents of relevant product.
    • After Terminal inspection IPQA personnel will put their details in “Terminal Inspection Checklist”
    • In case of corrective action suggested by QA, production personnel will perform the required corrective measures.
    • After receiving satisfactory QA remark production personnel will generate FGTN for the said batch of product and send it to QA department.
    • QA personnel will check the FGTN and match the details with “Terminal Inspection Intimation Report” for the same put his observation details along with signature and return it to production.
    • Production personnel will send the said FGTN to the FG store.
    • FG Warehouse personnel will receive QA signed FGTN check the packed product’s Qty. and if it is same as mentioned in the FGTN, it will be transferred in FG Warehouse inside the quarantine area.

 ABBREVIATIONS

SOP       –    Standard Operating Procedure

QA        –    Quality Assurance

FGTN     –    Finish Goods Transfer Note

IPQA     –    In-process Quality Assurance

 Attachments

Sr. No. Title Attachments
Terminal Inspection Intimation Report Attachment
Terminal Inspection Checklist Attachment

DISTRIBUTION LIST

Sr. No. Copy No. Department
Quality Assurance
Quality Control
Quality Control – Microbiology
Production
VP-Plant & Operations

Attachment –I

Terminal Inspection Checklist

Product Name   
Batch Number   Mfg. Date  
Batch Size          Exp. Date  
Pack Size           Date  
Total no. Of Packed Shippers :
Item Check Parameters Qty. Checked Shipper No.’s Inspected Terminally Remark
                                       
Corrugated Box

 

 

 Packed shipper will be checked and ensured that it is intact clean & un-mutilated.  

 
No. of Ply will be checked and it will be same as mentioned in it’s Specification.
Check Parameters Qty. Checked Shipper No.’s Inspected Terminally Remarks
Packing Slip must be checked and ensure that it is Pasted on the outer surface of all the C. Box.
Printed Matter on Packing Slip will be identical with respect to Product’s BMR/BPR (wherever & whatever is applicable)

 

Check Parameters Qty. Checked Shipper No.’s Inspected Terminally Remarks
Packing Slip must be Pasted properly at fixed specified Place on each C. Box.
Batch Details Batch No.
Mfg. Date
Exp. Date
Pack Size
Manufactured By
Mfg. Lic. No.
Manufactured under
Marketed By

 

Product Name   
Batch Number   Mfg. Date  
Batch Size          Exp. Date  
Pack Size           Date  
Total No. of Shrink Wraps  /  Outer Carton / Inner Carton/ Container packed :
Item Check Parameters Qty. Checked Shrink Wraps  /  Outer Carton / Inner Carton/ Container Inspected Terminally Remark
                                       
Outer Carton /   Shrink Wrapped Carton Printed Matter on all the Outer Carton / Shrink Wrapped Carton will be identical with respect to Product’s BMR & BPR.  

 

  

 

 

 

 

 
Additional Inserts
Item Check Parameters Qty. Checked Shrink Wraps  /  Outer Carton / Inner Carton/ Container Inspected Terminally Remarks
Inner Carton / Label of Container Printed Matter on all the inner Carton / Label of Container / Container as well as it’s Quality will be identical with respect to Product’s BMR & BPR.
Additional Inserts
Packing  Specification Packing Material
Generic Name
Product Name
Batch number
*M.R.P.
Item Check Parameters Qty. Checked Shippers/ Shrink Wraps/  Outer Carton/ Inner Carton/ Container Inspected Terminally Remarks
Ink quality Ink should not erase after small rubbing .
Labeling Improper labeling not allowed
Cleanliness Each unit must be properly cleaned
Denting/ Leakage problem Each unit must be properly check.
Total no. of shippers packed in batch:
Total shipper checked in the batch:
Defects (if any):
Total No. of defects:

Action plan for defects:
Corrective Action and Preventive Action:
Total replaced units (If any):
Done By:
Checked by:
QA Remark: The Product Packed is / is not of Standard Quality and hence it May / May not be Transferred to Finished Goods Store in “Under Test” / “Approved” Area.                                                                                                                                                                        

QA Executive / Designee (Sign & Date):          Manager – QA (Sign & Date):

 

Attachment-II

Terminal Inspection Intimation Report

Date
Section
Product Name Batch Size
Batch No. Mfg. Date Exp. Date
Intact Packed Qty. Details Loose Packed Qty. Details
Total Packed Qty. Total No. of Packed C.B.
Product Type Sales / PS
Manufactured Under:
Manufactured For:

Production Executive:                                                                             Manager Production:

(Sign/date)                                                                                                         (Sign/date)

Date
Intact  Packed Qty. Loose Packed Qty.:
Total Packed Qty.: Total No. of Packed C.B.

QA Remark: The Product Packed is / is not of Standard Quality and hence it May / May not be Transferred to Finished Goods Store in “Under Test” / “Approved” Area

 

QA Executive / Designee                                                                                                                               Manager – QA

(Sign/date)                                                                                                                                                          (Sign/date)

 

NORFLOXACIN & LOPERAMIDE CAPSULE

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