Blister Pack line validation Report
Blister Pack line validation Report – ALU/PVC
- Objective:
To validate the packing process of __________________________________
- No. ________________________ Batch size _________________ & pack size _________________________________ on the Blister Pack line.
- Scope:
Applicable to Blister Packing of tablets.
- Justification:
___________________________________________________________
- Site of study:
Packaging Department I
- Responsibility:
Production : ___________
Quality Assurance : ___________
Engineering : ___________
(Individuals to be named )
- Description of equipment to be used:
BLISTER PACK MACHINE
Code No. : ______________
Equipment Qualification done on: _______________
CARTONATOR
Code No. : ______________
Equipment Qualification done on: _______________
INKJET PRINTER / CONDOT PRINTER
Code No. : ______________
Equipment Qualification done on: _________________
Reviewed by sign and Date : _______________
CHECK WEIGHER
Code No. : ______________
Equipment Qualification done on: _________________
SHRINK WRAPPING MACHINE (if applicable)
Code No. : ______________
Equipment Qualification done on: _________________
SHIPPER WEIGHING BALANCE
Code No. : ______________
Equipment Qualification done on: _________________
- Standard Operating Procedure (SOP) to be followed :
Packing of the product done as per SOP No. :
- Standard Operating Procedures (SOP) for operating Operation of the Blister pack machine.
SOP No. : __________
- Standard Operating Procedures (SOP) for operating Cartonator :
SOP No. : __________
- Standard Operating Procedures (SOP) for operating Inkjet / Condot Printer.
SOP No. : __________
- Standard Operating Procedures (SOP) for Check Weigher :
SOP No. : __________
- Standard Operating Procedures (SOP) for Shrink Wrapping Machine (if applicable):
SOP No. : __________
- Standard Operating Procedures (SOP) for Shipper Weighing balance:
SOP No. : __________
Reviewed by sign and Date : _______________
- Batch packing record (BPR) to be followed:
- Record pack code as per BPR
Pack code : ______________
- Controls: Requirements :
- Blister Pack Machine:
- Blister Pack machine speed.
Machine speed : _______________ Limit : _______________
- Temperature Range of Film Heater : ___________ to ___________ and Blister Sealing roller : __________ to __________
- Ambient temperature under which packing operation of the product under study is carried out should 220C ± 30C
Ambient Temperature : ________________
- Calibration :
Calibrated Vacuum Pressure gauge. Code No. _______________
Calibration of Vacuum pressure gauge done on : ______________
Calibration of Vacuum pressure gauge due on : _______________
- Cartonator :
- Working of Carton Level Detector, Enclosure Detector and Product Sensor.
- Vacuum pressure should be NLT 50 Psi,
- Functioning of Pharma code reader.
- Ink Jet Printer / Condot Printer:
- The printer must be adapted to production line.
- The printer must be initialized.
- Access Code.
- Sensor for sensing the carton should be kept “ON”.
Reviewed by sign and Date : ____________
- Check Weigher System :
- Sufficient compressed air pressure should be kept at carton blow station. (NLT4 bar).
- Conveyor speed.
- During validation ensure that pack with improper content should be rejected and same should be ensured.
- Optical Sensor to Detect the product.
- Pressure switches to ensure that Machine does not Operate in case of low pneumatic pressure.
- Shrink Wrapping Machine:
During validation it is ensure that wrapping of shrink must be done properly.
- Shipper Weighing Balance :
During validation ensure that shipper with improper count should be rejected and same should be ensured.
- Calibrations:
Equipment | Code No. | Calibration done | Calibration due |
Reviewed by sign and Date : ____________
- Training:
Training details of personnel involved in validation.
Name | Training status | Training report availability | Checked by |
- Precautions:
Safety aspects while operation of equipments and process must be ensured.
- Validation Procedures:
Packing Process Flow Diagram :
Blister packing
Cartonator |
Cartons Cartonating
Ink Jet Printer / Condot printer |
Carton Overprinting
[
Check Weigher |
Weighing of Carton
Shrink Wrapping Machine |
Shrink Wrapping (if Applicable)
Outer carton
Shipper Packing
Reviewed by sign and Date : ____________
Department : | |
Product : | |
Batch No : | |
Date of Validation : |
Equipment : | Blister Pack machine |
Code No: | |
Make :. |
Equipment : | Cartonator |
Code No: | |
Make :. |
Equipment : | Ink Jet / Condot Printer |
Code No: | |
Make :. |
Equipment : | Check Weigher System |
Code No: | |
Make :. |
Equipment : | Shrink Wrapping Machine (As applicable) |
Code No: | |
Make :. |
Equipment : | Shrink Wrapping Balance |
Code No: | |
Make :. |
Reviewed by sign and Date : ____________
- Acceptance criteria:
- Blister Pack Machine:
- Leak test observed should be NIL.
- Temperature of film Heater.
For EPI 2500:
- Temperature of film heater for PVC film should be between 140 – 1700
- Temperature of film heater for PVC /PVDC or PVC / PE / PVDC should be between 150 – 1600
- Temperature of Sealing Roller 170 – 2100C
- Cartonator :
- Only set size Blister should be released in the Blister cell.
- Carton and leaflet should not be released by the respective sensors.
- No Blister :
- Carton sensor should not release the carton.
- No Carton :
- Pusher should not come out.
- Removal of carton after closing of flap Cartons flap (front and rear) should get closed properly.
- Ensure that Inter Locks are available for Emergency off, Guards open, Hand wheel, Loading safety, Motor overload, No carton, No Product, No leaflet & Low air pressure pusher overload.
- Quality of carton should comply as per product specification after closing of flap for Embossing, Printing, Insertion of Leaflet (if any).
- System Should not Accept Incorrect Password.
- Leaflet and Carton should Recognized as “ERROR” and machine must stop.
- Carton sensor should not release the carton.
- Ink Jet Printer / Condot Printer :
- System should not accept incorrect password.
- The overprinted details on carton should match with that of BPR entries.
Reviewed by sign and Date : ____________
- Check Weigher System :
Carton with target should pass through the Check Weigher System and under and over weight cartons should be rejected along with the LED indicator by the Check Weigher System.
- Shrink Wrapping Machine : (if applicable)
During validation it is observed that wrapping of shrink must be done properly.
- Shipper Weighing Balance :
The alarm should be actuated whenever count is less or more than the standard fill value of the shipper.
- Non Compliance:
- Details of Deviations :
Deviation Report dated | Checked by |
- Details of OOS Results :
OOS Report dated | Checked by |
Reviewers Comments / Remarks
- Type of Validation :
Concurrent Validation:
- Frequency :
- Concurrent Validation: Three successful validation exercises.
- Re-validation (After major change.)
Reviewed by sign and Date : _______________
- Results:
- Blister Pack machine :
Date/ Time | Temperature of film Heater/platen heater Range:
___ to ___ |
Temperature of Sealing Roller | Leak Test NIL | Checked by |
Reviewed by sign and Date : _______________
II.
Date/ Time | Pin Holes | Knurling Uniformity | Wrinkles | Break Test (for Combipack / Scoring) | Embossing / Overprinting | Checked by |
Reviewed by sign and Date : _______________
- Camera Challenge:
- Remove One Tablet
Date | Time | Audio alarm for sensing missing tablets
Yes/No |
Non filled pack Rejected / Passed | Filled pack Rejected / Passed | Checked by |
Reviewed by sign and Date : _______________
- Insert Half Tablet
Date | Time | Audio alarm for sensing missing tablets
Yes/No |
Non filled pack Rejected / Passed | Filled pack Rejected / Passed | Checked by |
Reviewed by sign and Date : _______________
- Empty blister
Date/ Time | Audio alarm for sensing missing tablets
Yes/No |
Non filled pack Rejected / Passed | Filled pack Rejected / Passed | Checked by |
Reviewed by sign and Date : _______________
- Observation at lower speed: ____________
Condition | Date | Time | Temperature of film heater
______ to _______ |
Temperature of Sealing roller
_____ to_____ |
Knurling Uniformity
|
Checked by |
Lower Temp. | ||||||
Higher Temp. |
Condition | Date | Time | Leak Test | Wrinkles | Pin Holes | Break Test (for combipacks) | Perforation (if applicable) | Checked by |
Lower Temp. | ||||||||
Higher Temp. |
- Observation at Higher speed: ____________
Condition | Date | Time | Temperature of film heater
______ to _______ |
Temperature of Sealing roller
_____ to_____ |
Knurling Uniformity
|
Checked by |
Lower Temp. | ||||||
Higher Temp. |
Condition | Date | Time | Leak Test | Wrinkles | Pin Holes | Break Test (for combipacks) | Perforation (if applicable) | Checked by |
Lower Temp. | ||||||||
Higher Temp. |
Reviewed by sign and Date : _______________
- Observation at Optimum speed: ____________
Condition | Date | Time | Temperature of film heater
______ to _______ |
Temperature of Sealing roller
_____ to_____ |
Knurling Uniformity
|
Checked by |
Lower Temp. | ||||||
Higher Temp. |
Condition | Date | Time | Leak Test | Wrinkles | Pin Holes | Break Test (for combipacks) | Perforation (if applicable) | Checked by |
Lower Temp. | ||||||||
Higher Temp. |
- Cartonator:
Date | Time | Tests | Acceptance Criteria | Observation |
Set size of blister to be released from the blister cell. | Only Set size of blister should be released in the blister cell. | |||
No blister in the blister cell | Cartons and leaflet should not be released. | |||
Leaflet below sensor level in the leaflet magazine box. | Machine should stop with proper justification on monitor. | |||
Carton below sensor level on the packing line. | Machine should stop with proper justification on monitor. |
Reviewed by sign and Date : _______________
Date/ Time | Tests | Acceptance Criteria | Observation | ||||
— | — | — | 1 | 2 | 3 | 4 | 5 |
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. |
Reviewed by sign and Date : _______________
Date/ Time | Tests | Acceptance Criteria | Observation | ||||
— | — | — | 1 | 2 | 3 | 4 | 5 |
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. | |||||||
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. |
Reviewed by sign and Date : _______________
Date/ Time | Tests | Acceptance Criteria | Observation | ||||
— | — | — | 1 | 2 | 3 | 4 | 5 |
Remove the carton after closing of flap,
Check the quantity of carton at the end for proper closing, embossing/printing and insertion of Enclosure. |
i. Cartons flap (front and rear) should get closed properly. | ||||||
ii. Cartons flap should get properly embossed or printed. (if applicable) | |||||||
iii. filled blister and enclosure should be present in the carton printing should done properly. |
Check the interlocking of following:
Tests | Acceptance Criteria | Observation | |
Emergency off | Interlock should be available for these. | ||
Guards open | Interlock should be available for these. | ||
Hand wheel | Interlock should be available for these. | ||
Pusher Overload | Interlock should be available for these. | ||
Motor overload | Interlock should be available for these. | ||
No carton | Interlock should be available for these. | ||
No leaflet | Interlock should be available for these. | ||
Quantity of carton after closing flap for proper closing. Embossing / printing, number of blisters, insertion of leaflet | Pack should comply with the standard pack specification | Initial | End |
Reviewed by sign and Date : _______________
Pharmacode system :
Date / Time | Checks | Acceptance Criteria | Observation |
Password verification for editing product:
Enter incorrect password for editing the set product parameters. |
System should not accept the incorrect password. | ||
Access code verification for Adjustment Menu:
Enter incorrect access code to enter into adjustment menu. |
System should not accept the incorrect password | ||
Access code verification to advanced configuration option:
Enter incorrect access code to enter into configuration option. |
System should not accept the incorrect password | ||
Password verification for editing product:
Enter incorrect password for editing the set product parameters. |
System should not accept the incorrect password. | ||
Access code verification for Adjustment Menu:
Enter incorrect access code to enter into adjustment menu. |
System should not accept the incorrect password | ||
Access code verification to advanced configuration option:
Enter incorrect access code to enter into configuration option. |
System should not accept the incorrect password | ||
Password verification for editing product:
Enter incorrect password for editing the set product parameters. |
System should not accept the incorrect password. | ||
Access code verification for Adjustment Menu:
Enter incorrect access code to enter into adjustment menu. |
System should not accept the incorrect password | ||
Access code verification to advanced configuration option:
Enter incorrect access code to enter into configuration option. |
System should not accept the incorrect password |
Reviewed by sign and Date : _______________
Date / Time | Checks | Acceptance Criteria | Observation |
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. | ||
Prepare a leaflet by adding a bar code to the code on the front side. | Cartonator must stop. |
Reviewed by sign and Date : _______________
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. | ||
Add an additional bar code to the code on the carton flap. | Cartonator must stop. |
Reviewed by sign and Date : _______________
- Ink Jet Printer:
- Enter Incorrect password for printer
Observation :
_________________________________________________________
- Enter correct password for printer
Observation :
__________________________________________________________
III. Product details fed in the Ink Jet Printer /condot Printer/stereo printing.
Carton _________________________________
_________________________________
_________________________________
_________________________________
Date / Time | Overprinting Details Observation |
Reviewed by sign and Date : _______________
Date / Time | Overprinting Details Observation |
Reviewed by sign and Date : _______________
- Check Weigher System:
Date / Time | Count shown | LED indicator | Observations | Checked by | ||||
1 | 2 | 3 | 4 | 5 | ||||
Carton with one more enclosure | Y | |||||||
Carton without enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more Blister. | Y | |||||||
Carton without Blister. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more enclosure | Y | |||||||
Carton without enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more Blister. | Y | |||||||
Carton without Blister. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more enclosure | Y | |||||||
Carton without enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G |
Note : 1) Y & R – Rejected 2) G – Passed
Reviewed by sign and Date : _______________
Date / Time | Count shown | LED indicator | Observations | Checked by | ||||
1 | 2 | 3 | 4 | 5 | ||||
Carton with one more Blister. | Y | |||||||
Carton without Blister. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more enclosure | Y | |||||||
Carton with out enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more Blister. | Y | |||||||
Carton with out Blister. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more enclosure | Y | |||||||
Carton with out enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more Blister. | Y | |||||||
Carton with out Blister. | R | |||||||
Carton with standard fill value (as per specification) | G |
Note : 1) Y & R – Rejected 2) G – Passed
Reviewed by sign and Date : _______________
Date / Time | Count shown | LED indicator | Observations | Checked by | ||||
1 | 2 | 3 | 4 | 5 | ||||
Carton with one more enclosure | Y | |||||||
Carton with out enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more Blister. | Y | |||||||
Carton with out Blister. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more enclosure | Y | |||||||
Carton with out enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more Blister. | Y | |||||||
Carton with out Blister. | R | |||||||
Carton with standard fill value (as per specification) | G | |||||||
Carton with one more enclosure | Y | |||||||
Carton with out enclosure. | R | |||||||
Carton with standard fill value (as per specification) | G |
Note : 1) Y & R – Rejected 2) G – Passed
Reviewed by sign and Date : _______________
- Shrink Wrap Machine: (if applicable)
Date / Time | Test | Observation | Checked by | |||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking |
Reviewed by sign and Date : _______________
Date / Time | Test | Observation | Checked by | |||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking | ||||||
Sealing | ||||||
Wrapping | ||||||
Shrinking |
Reviewed by sign and Date : _______________
- Set the temperature – Lower temperature ___________ 0
Date / Time | Test | Observation | Checked by | |||
Sealing | ||||||
Wrapping | ||||||
Shrinking |
- Set the temperature – Higher temperature __________ 0
Date / Time | Test | Observation | Checked by | |||
Sealing | ||||||
Wrapping | ||||||
Shrinking |
- Set the temperature – at optimum temperature ___________ 0
Date / Time | Test | Observation | Checked by | |||
Sealing | ||||||
Wrapping | ||||||
Shrinking |
Reviewed by sign and Date : _______________
- Shipper Weighing balance:
Date / Time | Count shown | Observation Alarm | Checked by | |
Actuated | Not Actuated | |||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) |
Reviewed by sign and Date : _______________
Date / Time | Count shown | Observation Alarm | Checked by | |
Actuated | Not Actuated | |||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) |
Reviewed by sign and Date : _______________
Date / Time | Count shown | Observation Alarm | Checked by | |
Actuated | Not Actuated | |||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) | ||||
Shipper with one carton more. | ||||
Shipper with one carton less. | ||||
Shipper with standard fill value (as per specification) |
Reviewed by sign and Date : _______________
17.Summary of finding of validation (inference):
18.Recommendation:
19.Team Approval:
_____________ _______________ _____________
Production Quality Assurance Engineering
Date:
Reviewed by sign and Date : _______________
- Review: (Inclusive of follow up action, if any):
- Approved by:
_______________ ___________
Quality Assurance Plant Head
Date:
- Annexures :
- Abbreviations:
NFD : Non Filled Detection
PVC : Polyvinyl Chloride
PVDC : Polyvinyl Dichloride
PE : Polyethylene
0C : Degree Celsius
SOP : Standard Operating Procedure
QA : Quality Assurance
No. : Number
NLT : Not Less Than
PSI : Per Square Inch
LED : Light Emitting Device
Mins. : Minutes
Kg./Sq.cm : Kilogram per Square Centimeter
Reviewed by sign and Date : _____________