General Instruction for Packing of Water for Injection

December 13, 2022February 11, 2023 Alvina

General Instruction for Packing of Water for Injection

BATCH PACKING ACTIVITIES

Line Clearance for Dispensing of secondary packing material
Dispensing of secondary packing material
Line Clearance for secondary Packing Area
Label Specimen Checks
Visual Inspection & labeling
In- process Check during visual inspection
In- process Check during labeling
Final packing
In- process Check during packing
Fill-weight Corrugated box
Terminal Inspection
Reconciliation of Batch Yield

Document Title

Bill of packing material generated by SAP/ERP
Total qty. of specimen corrugated box label
Additional sec. packing material Dispensing slip
Packing Material return note
Finished Good Transfer ticket
Sample intimation Slip
A terminal inspection report in BPR
Preventive or breakdown maintenance repair report
Batch Packing Record (Stage batch Yield) Batch reconciliation generated by SAP/ERP
Finish Goods Release note
Finish COA
Deviation & change control record (if any)

GENERAL INSTRUCTIONS:

Warehouse personnel to check the release status of packaging materials
Material Requisition generated by SAP/ERP.
Production to fill the column of Quantity required while the rest of the columns are to be filled.
An Approved copy of SAP/ERP for executed Packaging Material Requisition is to be retained by the Transfer of the issued material to the respective areas for usage.
Printed Packaging Material Specimen shall be attached with the Batch Packaging Record & duly signed & checked by production & IPQA person.
Carry out the packaging operation as per the package specification and packaging arrangement mentioned in the BPR and record the operational details.
Carry out the in-process check and record it in the Batch Packaging Record.
Return the unused packaging material to the warehouse through Material Return Note (MRN).
Destroy the rejected packaging material and record it in the Batch Packaging Record.
Reconciliation of the packaging material after completion of the packaging for batch.
Perform pre-dispatch inspection before the transfer of finished goods to FGS.
Transfer finished goods to FGS.

DISPENSING:

DATE (Date required in case of LC to be done in shift change or day of working change).
BPR is available with an approved Standard bill of material.
Verification of cleaning of light fixtures, and return air risers of secondary packing room. The waste bin is emptied out and cleaned.
Check the availability of the concern-approved secondary packing materials.
Check the cleanliness of the packing material container.
All packing material is approved by QC.
The equipment used for weighing and transferring the material is cleaned and dried.
Check whether the packing material requisition sheet is ready and signed by an authorized person.
Check whether the Relative Humidity: is NMT 55 % & Room Temperature: is NMT 27 0C.

General instructions for dispensing secondary packing material:-

If the batch is split into two or more pack sizes then the split quantity for the respective packing shall be mentioned. In such cases, BOM quantity shall be revised as per packing batch size.
Line clearance shall be performed before starting dispensing of secondary packing material.
The store supervisor shall arrange the secondary packing material as per the standard bill of packing material.
The store supervisor shall check the coding details on the container label (i.e. Batch No., Mfg. Date, Exp. Date, AR No.) of all materials.
QA person shall verify the above-mentioned information prior to dispensing.
Secondary packing material should be protected & arranged on SS pallets or racks.
Printed packing material should be stored in a lock & key & only authorize persons of the store or QA can open the lock.
All material should be issued by FEFO/FIFO.
Instruction for issuance of secondary packing material shall follow relevant SOP.
The environmental conditions should be maintained at Temperature NMT 27°C, and RH NMT 55% during dispensing.

In-process Specification & check frequency-

Sr. No.	Parameter	Specifications	Frequency
Ampoules:
1.	The physical condition of Ampoules	Deforming the shape of ampoules is not permitted	Initial & after every hrs.
2.	Foreign Particles	No visible particle should be present inside the Ampoule.	Initial & after every hrs.
3.	Coding on Label	B.No., Mfg. date, Exp. date, MRP, etc. should be clear & legible	Initial & after every hrs.
4.	Labeling	The label should be in the correct direction & affixed firmly.	Initial & after every hrs.
Corrugated Box:
5.	C. Box arrangement & Ampoule Qty. in C. box	Qty. of Ampoule should be exactly the same as specified in C. Box & C. Box properly arrange.	Initial & At every 2 Hrs.
6.	Corrugated Box closing with BOPP tape pattern	“C” Type	Initial & At every 2 Hrs.
7.	Corrugated Box label	Coding is neat & legible	Initial & At every 2 Hrs.

VISUAL INSPECTION, LABELLING & FINAL PACKING OF AMPOULES:

Activities

The packing room should be clean & free from previous products or other product traces.
The equipment should be clean & free from previous or other product traces.
Sanitation & hygiene are maintained in the area.
Proper line clearance should be taken.
The physical condition (shape, size, engraved number) of the ampoule should be proper.
Deform, surface particles/Rough surface ampoules should be rejected online.
Any visual particle (black & white) should not be present inside the ampoule or container.
Visually inspect each leak-tested ampoule.
The in-process check is to be carried out at the required frequency as per BPR.
Environmental conditions should be maintained at T (°C) NMT 27, RH (%) NMT 55 during secondary packing activities in the packing room.
Packing details & operations clearly communicated to the packaging personnel before starting operation.
Non-compliances are properly evaluated & closed with CAPA.

In-process checks record of filled ampoules for physical condition, foreign particles, labeling & coding:- (Frequency: every hour)

Acceptance Criteria: (Take 16 ampoules for each observation)

Ampoules should not deform in shape.
No visible particle was present when observed against white/black surface under adequate light.
The label direction should be correct. Batch coding details should be clear & legible.
The label should not be torn & printing matter should be readable.

Batch Release Checklist (BMR)

Issuance of BMR and Label claim is proper.
All the pages are available in compliance with the index.
Manufacturing and expiry are correctly allotted.
Dispensing is carried out on calibrated balances.
SAP BOM for RM is available.
SAP BOM for primary packing material is available.
Line clearance is taken prior to all dispensing and manufacturing activities
The raw material assessment sheet is available
All dispensing labels are properly affixed.
Environmental conditions comply during all the manufacturing steps.
No overwriting is observed and all wrong entries have been strikeout and signed.
The actual equipment used is as specified.
The manufacturing process follows as per BMR and is recorded.
The yield reconciliation of filling is within the acceptable limit.
QC Bulk report is available.
In-process checks are performed at a defined frequency and recorded.
NVPC report is available.
CIP/SIP graph or printout of mfg. tank & FFS machine available.
Filter integrity report of product filter available.
Filter integrity report of vent/air filter available.
Terminal sterilization graph of each lot available.
Vacuum leak test of each lot available.
Finish product intimation for sterility is available.
AQL is Performed for a batch before packing.
Is there any deviation during the process and deviation is raised and approved?
Is any deviation, incident, or change control raised related to the batch, attached with BMR?
Deviation, incident, and change control are closed before the release of the batch.
Issuance of BPR and Label claim is proper.
All the pages are available in compliance with the index.
Manufacturing and expiry are correctly allotted.
SAP BOM for PM is available.
Line clearance is taken prior to all packing activities
No overwriting is observed and all wrong entries have been strikeout and signed
Environmental conditions comply during primary packing.
In-process checks are performed at a defined frequency and recorded
All the in-process results comply with the specified limit
Specimen of labels and shipper labels are affixed.
The finished goods transfer note is affixed.
MRN is affixed.
The finished product release is affixed.
Additional material slip is affixed.
The finished product QC report is affixed.
Reconciliation of material is performed and is correct.
PDI was performed and attached with BPR.
The yield reconciliation of the finished product is within the acceptable limit.
Is there any deviation during the process and deviation is raised and approved?
Is any deviation, incident, or change control raised related to the batch, attached with BMR?
Deviation, incident, and change control are closed before the release of the batch.

Rejection analysis & reconciliation of ampoules after visual inspection

Rejection type Rejection Category
Dirty ampoule (Critical)
Deep line (Major)
Neck problem (Minor)
Black particle on the surface of the ampoule (Major)
Black particle in solution (Critical)
White particle on the surface of the ampoule (Major)
White particle in solution (Critical)
Low Volume (Major)
High Volume (Major)
Twist problem (Minor)
Extra plastic (Minor)
Rough surface (Minor)

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General Instruction for Packing of Water for Injection

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