| Department | Packaging | Document no | MAN-125 | ||
| Title | Component return procedure from packaging floor | ||||
| Prepared by: | Date: | Supersedes: | |||
| Checked by: | Date: | Date Issued: | |||
| Approved by: | Date: | Review Date: | |||
Document Owner
Production Manager
Purpose
This procedure describes the steps to be followed when there are packaging components to be returned to the warehouse after the packaging operation has been completed.
Scope
This procedure defines how to return all surplus packaging components to the Warehouse on completion of a Packaging lot. SOP for Reconciliation of Packaging Components details the procedure to be followed for Finished Goods, Samples and Reject Material.
Responsibility
It is the responsibility of the Packaging Manager to ensure that this procedure is followed and used appropriately.
4.1 Quality and GMP
Adherence to this procedure is a GMP requirement.
All relevant GMP rules must be followed; this includes correct documentation practices. Any deviation from this procedure is to be reported to Packaging Manager and Quality Team.
4.2 Safety
Correct lifting / manual-handling methods should be used at all times. If you have not been trained in manual handling, advise your supervisor or Manager.
Procedure
5.1 Determining Quantities
5.1.1 All surplus packaging components returned to the warehouse are to be placed on a clean pallet and the pallet moved away from the packaging line, to allow line clearance to commence.
5.1.2 Ensure each full container or roll of return components is identified and clearly labelled with its Quantity, Component Item Code and Delivery Number or laboratory batch number.
5.1.3 Check all component Item Codes and Delivery Numbers against the Packaging Instruction to ensure they correspond.
5.1.4 Count and/or weigh all complete, loose or bagged return components as per SOP
Reconciliation of Packaging Components
5.1.5 Record details of full, loose or bagged return components on the Form-125 Batch Reconciliation Sheet for Tablet Packing.
5.1.6 If components are left on line during a campaign, quantities must be documented on Form-125 Batch Reconciliation Sheet for Tablet Packing and/or on Batch Production Number (BPN) if instructed. Transaction is to be completed in site ERP system by packaging warehouse staff.
5.2 Labelling
5.2.1 Ensure any components that have been batch coded are removed from return components and rejected before being returned to the warehouse.
5.2.2 Each packaging component for return is to be identified by use of a green and white “Returned” label. Each container / roll or box of components must contain a “Returned” label.
5.2.3 Each “Returned” label must document the Component Item Code, Delivery Number, Quantity and the Batch Production Number (BPN) from which the component is being returned; and a Signature / Initials and Date.
5.2.4 Packaging Operators must apply the “Returned” label to each component.
5.3 Documentation
5.3.1 Using Form-125 Batch Reconciliation Sheet for Tablet Packing, document the following details for all material to be returned to Warehouse: Component Item Code, Delivery Number and Quantity.
5.3.2 On the same form, document the following details for all material remaining on the packaging line (Batch to batch transfers) if applicable: Component Item Code, Delivery Number, Quantity and From / To Batch Production Numbers.
5.3.3 Ensure that all the sections of the form are completed including Batch Production Numbers, Date and Time and Signature.
5.3.4 The pallet/s of returned components is/are all to have Form-125 Batch Reconciliation Sheet for Tablet Packing attached and must be returned to the packaging warehouse and stored in the “Returned Goods” section of the packaging staging area.
5.4 Handling of Defective Packaging Components
5.4.1 Any defective components found on the Packaging Floor should be referred to the Packaging Manager or Delegate and must be reported as per Form-125 Batch Reconciliation Sheet for Tablet Packing.
5.4.2 If any packaging component is deemed defective or unusable, apply a red “Reject” sticker on each container and complete section “Defective Components” on Form-125 Batch Reconciliation Sheet for Tablet Packing.
Definition
| Component | Materials issued to a batch according to the Bill of Materials |
| Item Code | Component or Material Identification Code |
| Delivery Number | Component Delivery number or Laboratory Batch number |
| BPN | Batch Production Number |
Related Documents
| Form-125 | Batch Reconciliation Sheet for Tablet Packing |
Summary of Changes
| Version # | Revision History |
| MAN-125 | New. |
Form: Coponent Return
| Product Description: | BPN: | Code: | Line: | Date: | ||
| Retention Samples: | Total Pack Quantity: | |||||
Rejects and Returns:
| Packaging | Warehouse | ||||||
| Material Code | Lab. Batch Number/Delivery Number | Received Qty | Rejected Qty | Returned Qty | Location | Pallet No. | |
| Tablets | |||||||
|
PVC Film/Cold form film | |||||||
|
Printed Foil | |||||||
|
Cartons | |||||||
|
Leaflets | |||||||
| Bottles | |||||||
| Caps | |||||||
| Slip Sheet | |||||||
| Shippers | |||||||
| Shipper Labels | |||||||
Defective Components:
| Packaging use only | ||||
| Material Code | Lab. Batch Number/Delivery Number | Quantity | Rejected label applied by | Date |
Return Completed:
| Warehouse sign | Date |
Component Transfer:
| Material Code | Lab. Batch Number/Delivery Number | Quantity | |||||||
| From BPN | To BPN | ||||||||
| Completed by | Date | Time | |||||||
| Tablets Reconciliation | Cartons Reconciliation | ||
| A. No. of Tablets Received | A. No. of Cartons Received | ||
| No. of Tablets Packed | No. of Cartons Packed | ||
| No. of Tablets Sampled | No. of Cartons Sampled | ||
| No. of Tablets Rejected | No. of Cartons Rejected | ||
| No. of Tablets Returned | No. of Cartons Returned | ||
| B. Total Tablets Used | B. Total Cartons Used | ||
| (B/A) x 100 = Tablets Yield | (B/A) x 100 = Cartons Yield | ||
| Leaflets Reconciliation | Labels Reconciliation | ||
| A. No. of Leaflets Received | A. No. of Labels Received | ||
| No. of Leaflets Packed | No. of Labels Packed | ||
| No. of Leaflets Sampled | No. of Labels Sampled | ||
| No. of Leaflets Rejected | No. of Labels Rejected | ||
| No. of Leaflets Returned | No. of Labels Returned | ||
| B. Total Leaflets Used | B. Total Labels Used | ||
| (B/A) x 100 = Leaflets Yield | (B/A) x 100 = Labels Yield | ||
| To calculate reject tablets | Floor | Machine | In Process | Total |
| A. No of reject blisters | ||||
| B. Weight of 1 empty blister | ||||
| C. Total Weight of empty blisters | ||||
| D. Total Weight of Tablets and blisters containing tablets | ||||
| E. Total Weight of reject tablets | ||||
| F. Weight of 1 single tablet | ||||
| A x B = C D – C = E
E ÷ F = No of Reject Tablets |
|
Note:
1) The amount recorded in the “quantity column” is to equal the amount recorded on the pallet ID card for all pallets.
2) The operator must check and sign for the correct quantity of each pallet before booking out the pallet.
3) Record quantity on pallet ID card without lab samples.
4) GBS stands for Goods Booking Slip #
| PALLET No | LAST SHIPPER LABEL Number | Pallet QTY | SIGN | GBS | PALLET No | LAST SHIPPER LABEL Number | Pallet QTY | SIGN | GBS | ||||
| 1 | 11 | ||||||||||||
| 2 | 12 | ||||||||||||
| 3 | 13 | ||||||||||||
| 4 | 14 | ||||||||||||
| 5 | 15 | ||||||||||||
| 6 | 16 | ||||||||||||
| 7 | 17 | ||||||||||||
| 8 | 18 | ||||||||||||
| 9 | 19 | ||||||||||||
| 10 | 20 | ||||||||||||
| Comments | |||||||||||||
| Name: | Sign: | Date | |||||||||||