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 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
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 operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
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