Procedure for Terminal Inspection and Transfer of Finished Goods

 

 

Procedure for Terminal Inspection and Transfer of Finished Goods

1.0 OBJECTIVE:
1.1 To lay down a procedure for Terminal Inspection and Transfer of Finished Goods.
2.0 SCOPE:
2.1 This SOP is applicable for Terminal Inspection and Transfer of Finished Goods
3.0 RESPONSIBILITY:
3.1 Officer / Executive- QA
4.0 ACCOUNTABILITY:
4.1 Head – QA
5.0 PROCEDURE:
5.1 During secondary packing of batch, production personnel shall intimate for Terminal Inspection to IPQA.
5.2 Intimation may be raised by production for terminal inspection in case of partial release.
5.3 IPQA person shall receive the intimation from production and select the Nos. of shippers for terminal inspection as per below mentioned criteria including first & last shipper and lower & higher weight shipper. Terminal inspection observation details shall be filled by QA in “Terminal Inspection Check List & record”, as per Annexure-I.


A Selection of Packed Corrugated Boxes
i ) 10 or less 50%
ii) 11 to 100 10 % of total C. boxes but not less than 05 Nos.
iii) More than 100 5 % of total C. boxes but not less than 10 Nos.
B Selection of Shrink Pack
i) Less than 50 20%
ii) Pack of 50 to 100 10% but not less than 10 Nos.
iii) Pack more than 100 5% but not less than 10 Nos.
C Selection of Unit Pack
i) Less than 50 20%
ii) Pack of 50 to 100 10% but not less than 10 Nos.
iii) Pack more than 100 5% but not less than 10 Nos.
D Following Parameters to be Checked, but not limited to:
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 Ampoules / Bottle / Tube per shipper
vi) Quantity of Ampoules / Bottle / Tube per catch cover/carton
vii) BOPP tape printed/ plain
viii) Quality of shipper (5ply/7ply/others)
  • If any Critical defects shall be observed during terminal inspection, hold the batch for 100 % re-checking by production followed by re verification by QA. Details of critical defects are given below, but not limited to:

Critical Defects:

  • Containers without Label /Reverse Label
  • Containers or cartons without Batch Coding / Cut Batch Coding.
  • Cartons without Containers.
  • Containers without Medicine.Crack or broken ContainersObservation of particulate matterSealing defects

    • In case of major defects hold the material and send to production packing department for necessary correction according to identified issue. Details of major defects are given below, but not limited to:

Major Defects:

  • No., Mfg., Exp. and retail price on Carton/Labels is not readable.
  • Weight/volume of drug is not within specified limit in Ampoule / Tube/ bottles.
  • Less or more quantity of unit packed in container.
  • Spreading of ink on label & carton
    • In case of minor defects, solve the problem on-the-spot. Details of minor defects are given below are givenbelow , but not limited to :




Minor Defects:

  • Shipper has dent
  • BOPP tape is not properly placed.
  • Label on shipper is not properly placed.
    • After Corrective action IPQA Officer / Executive shall again check the defect marked and approve the product.
    • IPQA Pack stock inspector shall mention the Inspection details in “Terminal Inspection Check List & record”, as mentioned in Annexure-I
    • Partially batch can be transferred in case of any urgency after verification of complete documents of relevant product.
  • IPQA Officer/Executive shall check the final Terminal Inspection Check List along with respective products BMR/ BPR and after satisfactory review of all required documents, IPQA personnel shall mention their remark in required. column of “Terminal Inspection Check List & record”, and submit to production personnel.
  • After receiving of satisfactory remark from IPQA personnel in “Terminal Inspection Check List & record”, production personnel shall generate the Transfer ticket for the said batch of product and submitted to IPQA Officer/Executive.
  • IPQA Personnel shall check the Transfer .Ticket and match the quantity & other details of  Transfer ticket with “Terminal Inspection Check List & record”,& also with respective product BPR and after satisfactory review of the same, IPQA personnel shall put their signature in Transfer ticket & handover to Production department for transfer of batch to FG warehouse.
  • After receiving of transfer ticket Production personnel shall transfer the batch to FG warehouse area along with Transfer ticket for awaiting of release. Two transfer tickets along with complete terminal inspection report shall be enclosed with respective product BPR.
  • ABBREVIATION:
S. No. Abbreviations used Full form of Abbreviation used
1. QA Quality Assurance
2. SOP Standard Operating Procedure
3. No.                                  Number

 

4. Ltd. Limited
5. FG Finished Goods
6. B. No. Batch Number
7. T.T. Transfer Ticket
8. Qty.                                 Quantity

 

9. Mfg. Manufacturing
10. IPQA In Process Quality Assurance
11. Exp. Expiry
12. BMR Batch manufacturing record
13. BPR Batch packing records

7.0 ATTACHMENTS (ANNEXES) :
7.1 Annex –I : Terminal Inspection Check List and record.

8.0 REFERENCE :

S. No.         Reference Title
1.0           In-house

Annex –I : Terminal Inspection Check List and record

Product Name    Mfg. Date  
Batch Number   Exp. Date  
Batch Size          Date  
Pack Size          
Item Check Parameters Qty. Checked Observation
Corrugated Box Packed shipper shall be checked and ensured that it is intact clean.
No. of Ply shall be checked and it shall be same as mentioned in it’s Specification.
Printed Matter on Packing Slip shall be identical with respect to Product’s BMR/BPR (wherever & whatever is applicable. Total No. of C.B.  :  

 

Checked C.B.  No. with weight
Product Name
Batch No.
Mfg. Date
Exp. Date
Pack Size
Manufactured By
Marketed By  :
Outer Carton /   Shrink Wrapped Carton Printed Matter on all the Outer Carton / Shrink Wrapped Carton shall be identical with respect to Product’s BMR & BPR. Total No. of Shrink Packed  /  Outer Carton Checked:
Additional Inserts
Batch coding information
Batch number
Mfg. Date
Exp. Date
M.R.P. with (I.A.T.)
Ink quality
Inner Carton /Tray/ Label of Container Printed Matter on all the inner Carton / Label of Container / Container as well as it’s Quality shall be identical with respect to Product’s BMR & BPR. e.g. : Total No. of Inner Carton /Container Checked:
Packing  Specification
Additional Inserts
Generic Name
Product Name
Batch number
Mfg. Date
Exp. Date
M.R.P. with (I.A.T.)
Ink quality Ink should not is erase after small rubbing
Labeling Improper labeling not allowed.
Cleanliness Each Unit must be properly cleaned

                                                                                                                                                                                 Checked By:

                                                                                                                                                                                (Sign & Date)

 

Online Rejection in parenteral

Receipt of Batch from Production to Packing Department

sop for for Spillage Handling in parenteral area

sop for calibration of vessels with dipstick

sop for Cleaning of Bins and Containers

cip of mixing vessel and holding vessel

SOP FOR BATCH MANUFACTURING

sop for placebo batch

sop for Cleaning of Ampoule Filling and Sealing Machine

sop for Fogging in Sterile and Non Sterile Area

sop for for Filtration of Bulk Solution

sop for fumigation in production area

sop for post cleaning after media fill

sop for cip of mixing vessel mixing mobile vessel and holding vessel

sop for De-Bagging of Three Piece Vial Dropper Caps

sop for calibration and verification of check weigher

sop for Batch number and Manufacturing and Expiry Date Coding System

sop for Sanitization of Seals

standard operating procedure machine history file

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for for charge hand over between the shifts

Performance requalification report of visual inspectors

sop for Cleaning and operation of ROPP caps inspection table

sop for usage and destruction of filter pad and cartridge filter

sop for cleaning and storage of transfer pipe

sop for Cleaning and operation of labeling machine

Cleaning and operation of the mono block filling and sealing machine

sop for Cleaning and operation of empty bottle inspection table

sop for Cleaning and operation of filter press

sop for cleaning and operation of liquid transfer pump and line

sop for cleaning and operation of storage vessels

sop for cleaning and operation of sugar syrup manufacturing vessel

sop for cleaning issuance and retrieval of accessories and change parts

sop for Cleaning and operation of visual inspection conveyor belt

sop for Cleaning and operation of spray gun and assemble

sop for Fogging in Aseptic and Non Aseptic Area

 

Leave a Comment

error: Content is protected !!