Drugsformulations
| 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.
- Critical Defects:
- 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)
