1.0   OBJECTIVE:

1.1 Objective is to record the findings of qualification study executed as per pre-approved protocol and to show that the digital weighing balance stands qualified for routine use.

2.0  SCOPE:

2.1 The scope of this report is limited to Digital Weighing Balance having Id No. XYZ

3.0 RESPONSIBILITIES:

Maintenance Officer/Executive: To prepare qualification protocol, report and co-ordinate the entire qualification activity.

Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.

Production Officer/Executive: To execute qualification study in co-ordination with other departments.

Head Maintenance: To review the qualification documents.

Head Quality Assurance: To approve the qualification documents.

4.0 BALANCE DESCRIPTION:

Sr. No.	ID. No.	Capacity	Least   count	Location	Make	Model No.	Serial No.
1	XYZ	Max. : 50.00 Kg Min. : 0.50 Kg	0.01 Kg	Packing Hall	Mettler Toledo	NA	Example: ABCD

5.0 ACCEPTANCE CRITERIA:

Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

5.1 Installation Verification Report

Sr. No.	Check points	Acceptance criteria	Observations	Checked by sign/date
1	Check the levelling of the equipment on level indicator.	Air bubble shall be at centre position of level indicator.
2	Placing location	1. Bench top or floor shall be steady and even surface. 2. Location shall be free from heat, vibration and moisture.

5.2 Multimeter Calibration Verification Report

Sr. No.	Measuring Device	Acceptance Criteria	ID. No.	Calibration  done On & due on	Observation	Checked by Sign/ Date
	Multimeter	It shall be calibrated for its performance.

5.3 Calibration Status of Standard Weights

Sr. No.	Standard Weights	Acceptance criteria	Observation	Checked by sign/date
1	Check the calibration of standard weights.	Standard weights should be calibrated for its performance.

5.4 Operational Verification Report

Sr. No.	Check points	Acceptance criteria	Observations	Checked by sign/date
1	Press ‘Φ’ button.	Balance should turn ON.
2	Press ‘T’ button.	Balance should tare (zero – setting).
3	Press ‘Φ’ button.	Balance should turn OFF.

5.5 Utility Verification Report

Sr. No.	Utility	Acceptance criteria	Observation	Checked by sign/date
1	Electricity	Single phase, 230 + 10% V AC and 50 + 5% Hz

 5.6 Eccentricity Test Report

5.6.1 Procedure

Eccentricity test is carried out by placing 1/3 rd weight of maximum capacity i.e. 20.00 Kg on weighing platform at 5 different locations (four corners & center) and Values displayed by Balance against standard weight are recorded in a following table.

Location ID	Standard Weights	Observation/Weight Displayed	Checked by sign/date
1	20.00 Kg
2	20.00 Kg
3	20.00 Kg
4	20.00 Kg
5	20.00 Kg

• Acceptance Criteria: 19.18 Kg to 20.02 Kg

• Remark: ______________________________________________________________________________________________________________________________________________________

5.7 Linearity Test Report

5.7.1 Procedure

Linearity test is carried out by placing 4 different standard weights i.e. 0.50 Kg, 15.00 Kg, 30.00 Kg and 50.00 Kg one by one on weighing platform in ascending order and by removing the placed standard weights in descending order. Values displayed by Balance against standard weights area recorded in a following table

Sr. No.	Standard Weights	Observation/Weight Displayed	Checked by sign/date
A	Ascending order
1	0.50 Kg
2	15.00 Kg
3	30.00 Kg
4	50.00 Kg
B	Descending  order
1	50.00 Kg
2	30.00 Kg
3	15.00 Kg
4	0.50 Kg

• Acceptance Criteria:     0.49 Kg to 0.51 Kg for 0.50 Kg

   14.98 Kg to 15.02 Kg for 15.00 Kg

   29.97 Kg to 30.03 Kg for 30.00 Kg

   49.95 Kg to 50.05 Kg for 50.00 Kg

• Remark: ________________________________________________________________________________________________________________________________________________________________________________________________________

5.8 Repeatability Test Report

5.8.1 Procedure:

Repeatability test is carried out by placing minimum i.e. 0.50 Kg, optimum i.e. 25.00 Kg and maximum i.e. 50.00 Kg weight of capacity of balance 5 times on weighing platform and values displayed by Balance against standard weight are recorded in a following table.

Sr. No.	Standard Weights	Observation/Weight Displayed	Checked by sign/date
1	0.50 Kg
2	0.50 Kg
3	0.50 Kg
4	0.50 Kg
5	0.50 Kg
6	25.00 Kg
7	25.00 Kg
8	25.00 Kg
9	25.00 Kg
10	25.00 Kg
11	50.00 Kg
12	50.00 Kg
13	50.00 Kg
14	50.00 Kg
15	50.00 Kg

• Acceptance Criteria:     0.49 Kg to 0.51 Kg for 0.50 Kg

                                                 24.97 Kg to 25.02 Kg for 25.00 Kg

                                                 49.95 Kg to 50.05 Kg for 50.00 Kg

• Remark: ______________________________________________________________________________________________________________________________________________________

6.0 DEVIATION REPORT:

Sr. No.	Deviation (s)	Justification for acceptance criteria	Impact on installation, operation and performance

7.0 CHANGE CONTROL:

8.0 LIST OF ANNEXURE:

9.0 SUMMARY AND CONCLUSION OF QUALIFICATION

10.0 CERTIFICATION OF QUALIFICATION:

        Qualification is satisfactory.                                     Yes/No

        Hence Balance can be used for routine use.             Yes/No

                                                                                                            Head- Q.A.

1.0   OBJECTIVE:

Objective of this report is to provide documented evidence through the verification of  installation, operation &  performance of Tablet Friability Tester to show that the instrument  installed, operated and consistently performed according  to predetermine specifications.

2.0   SCOPE :

The scope of this Report is limited to Id No. XYZ

3.0  QUALIFICATION TEAM AND RESPONSIBILITIES:

DEPARTMENT	NAME & SIGNATURE	RESPONSIBILITY
Maintenance		To prepare qualification report. To co-ordinate the entire qualification activity.
Quality Assurance		To execute qualification study in co-ordination with other departments.
Production		To execute qualification study in co-ordination with other departments.
Maintenance		To review the qualification documents.
Head – Quality Assurance		To approve qualification protocol & report.

4.0    INSTRUMENT DESCRIPTION:

  For instrument description, should match as per re qualification protocol

 5.0   ACCEPTANCE CRITERIA:

Qualification of  the instrument shall be in accordance with the parameters given in Annexures – A, B, C, D, E, F, G, H, I & J of this report.

 6.0   OBSERVATIONS:

 Qualification shall be executed using following forms:

• Installation verification checklist – Refer Annexure – A.
• Calibration of measuring device– Refer Annexure – B.
• Site inspection checklist – Refer Annexure – C.
• Utility verification checklist – Refer Annexure – D.
• Technical specification checklist – Refer Annexure – E.
• Drum specification checklist – Refer Annexure – F.
• Operation verification checklist – Refer Annexure – G.
• Parameter challenge study –  Refer Annexure – H.
• Power failure challenge study – Refer Annexure – I.
• Performance of instrument –   Refer Annexure- J.

Annexure- A

INSTALATION VERIFICATION CHECK LIST

Sr. No	Checks to be performed	Acceptance criteria	Observation	Checked by/Date
1	Check for the receipt of the consignment.	It shall be received in good condition.
2	Check for any scratches on the machine body and drums.	It shall not have any scratches on machine body and drums.
3	Check  for  electrical connection	It shall not observed a loose or damage connection.
4	Check for levelling of the platform.	Air bubble of level indicator should be at centre.
5	Check both drums are properly locked with knob on the shaft.	Both drums should be properly locked with knob on the shaft.

Annexure- B

CALIBRATION OF MEASURING DEVICES

Sr. No.	Measuring devices	Acceptance criteria	Observation	Checked by/Date
1	Vernier Calliper	It   should   be calibrated within calibration period.
2	Thermometer	It   should   be calibrated within calibration period.
3	Stopwatch	It   should   be calibrated within calibration period.
4	Multimeter	It   should   be calibrated within calibration period.

Annexure- C

SITE INSPECTION CHECKLIST

Sr.No.	Parameter	Acceptance criteria	Observation	Checked by/ Date
1	Room Temperature	15 to 30°C
2	Room Humidity	40 to 70 % RH
3	Room environmental checks	– Away from direct sunlight. – Free from vibration. – No corrosive gases. – Free from excess dust and moisture.
4	Table space	Width :15” Length : 18” Height :  20”

Sr.No.	Parameter	Acceptance criteria	Observation	Checked by/ Date
5	Point for electrical connection	Single phase of 230 V AC 50 Hz
6	Base/table level	Levelled sturdy, with no vibration.
7	Earthing	Shall be provided.

Annexure- D

UTILITY VERIFICATION CHECKLIST

Sr.No	Parameter	Acceptance criteria	Observation	Checked by/Date
1	Phase Voltage:	Single Phase, 220/230 VAC, 50/60 Hz.

Annexure- E

TECHNICAL SPECIFICATION CHECKLIST

Sr. No.	Test	Acceptance criteria	Observation	Checked by/ Date
1	Speed	25 Revolutions per minute (RPM)
2	Speed Accuracy	± 1 RPM
3	Time range	01 Sec. to 09 Hrs.59 Min. 59 Sec.
4	Count Range	01 to 99999 revolutions.
5	Motor	DC Stepper Motor of 3.5 KgCm Torque, 6 Volts
6	Type of the Drum	Electrolab AD Drum and Abrasion Drum.
7	Power Supply	Single Phase, 220/230 V AC, 50/60 Hz
8	Fuse Rating	T 160 mAmp – (For I/P Supply as 220/230 V AC, 50/60 Hz)
9	Dimension	350mm (L) X 310mm X 430mm (H)
10	Weight	12 Kg. (approx.)
11	No. of Drums	02 Nos.
12	No. of Discharge Trays	02 Nos.

Annexure- F

DRUMS SPECIFICATION CHECK LIST

Sr. No.	Name	Acceptance criteria (As per USP General Chapter – 1216)	Observation	Checked by / Date
1	Drums	– One side removable.
—	—	—	Drum 1 and Drum 2	—
–	Material	Transparent synthetic polymer with polished internal surfaces.
–	Inside Radius of Curved Projection	80.5 ± 5.0 mm.
–	Diameter of Central Hole	10.0 ± 0.1 mm.
–	Diameter of Central Ring	25.0 ± 0.5 mm.
–	Inside Diameter of Drum	287.0 ± 4.0 mm.
–	Outside Diameter of Drum	302.5 ± 4.0 mm.
–	Depth  of Drum	38.0 ± 2.0 mm.
–	Tablet Dropping Height	156.0 ± 2.0 mm.
–	–	–	–

Annexure- G

OPERATIONL VERIFICATION CHECKLIST

Sr. No.	Operation	Acceptance criteria	Observations	Checked by/ Date
1	Switch ‘ON’ the power switch.	– The drum shall initialize itself to the  loading position. – The display shall now show ‘Start”
2	a) Press ‘TIME’ key to select the “TIME MODE”.	– The MODE indicator LED shall     indicate the “TIME MODE”. -The display shall show the previous time values.
	b) Enter the desired value by using numerical keys. Press ‘ENTER’ key to register the value.	The display shall show ‘00’.
	c) Press ‘RUN/HALT’ key.	– The drum shall start rotating in forward direction. – The display shall show elapsed time. – When the test is over the drum shall rotate in reverse direction for discharging the tablets into the tray. – Indication of test over shall show by an audible beep. – The display shall show “END”.
	d) Press ‘RESET’ key.	The instrument shall initialize and will stop at the loading position.
3	a) Press ‘COUNT’ key to select the “COUNT MODE”.	– The MODE indicator LED shall    indicate the “COUNT MODE”. – The display shall show the previous count values.
	b) Enter the desired value by using numerical keys. Press ‘ENTER’ key to register the value.	The display shall show ‘00’.
	c) Press ‘RUN/HALT’ key.	– The drum shall start rotating in forward direction. – The display shall show elapsed count. – When the test is over the drum shall rotate in reverse direction for discharging the tablets into the tray. – Indication of test over shall show by an audible beep. – The test over shall show “END”.
	d) Press ‘RESET’ key.	The instrument shall initialize and the will stop at the loading position.

POWER FAILURE CHALLENGE STUDY (Annexure- I)

Sr.No	Test procedure	Acceptance criteria	Observation	Checked by/Date
1	Start the instrument.	Instrument shall run.
2	Turn main power to the instrument OFF.	The instrument shall get OFF.
3	Turn Power ON.	Instrument should not start spontaneously.
4	Start the instrument.	Instrument should resumes from the stop condition with all the parametrs found as before POWER – OFF.

PERFORMANCE OF INSTRUMENT (Annexure- J)

1.0  Procedure:

Performance of instrument is checked by taking different size or shape of tablets   ( different size or shape of tablets causes a regular and irregular tumbling). Initially weighed tablets are transferred gently into the drum from the side slit provided on the drums. The TIME mode is set for 4 minute i.e. 100 rotations. Calculated the friability and result is recorded in following tables.

 a) For regular tumbling, set the instrument at normal position, as there is no any irregular tumbling of tablets.

b) For irregular tumbling, set the instrument with 10° tilt with the bench top to prevent any irregular tumbling of tablets.

 1.1    Acceptance criteria:  Performance of instrument shall be found satisfactory.

 1.2   For Normal Position: 

 Product Name: 

 Batch No.:

Sr. No.	Time Set in Minute	Initial weight	Final weight	Friability	Checked by/Date
1
2
3

1.3   For 10° Tilt Position: 

Product Name: 

Batch No.:

Sr. No.	Time Set in Minute	Initial weight	Final weight	Friability	Checked by/Date
1
2
3

7.0 DEVIATION REPORT:

Sr. No.	Deviation (s)	Justification for acceptance criteria	Impact on installation, operation and performance

8.0   CHANGE CONTROL:

9.0   LIST OF ANNEXURE:

10.0   SUMMARY AND CONCLUSION OF QUALIFICATION:

11.0   CERTIFICATION OF QUALIFICATION:

        Qualification is satisfactory                                          Yes/No

        Hence instrument can be used for routine use.           Yes/No                                            

1. OBJECTIVE:

Objective of this report is to check and provide documented evidence of its performance as per the predetermined acceptance criteria.

Refer working and principle of RMG https://pharmaceuticalupdates.com/2020/04/27/working-and-principle-of-rapid-mixer-granulator-rmg/

2.   SCOPE:

The scope of this report is limited to equipment ID No. XYZ.

3. QUALIFICATION TEAM AND RESPONSIBILITIES:

DEPARTMENT	NAME AND SIGNATURE	RESPONSIBILITY
Quality Assurance		To prepare performance qualification protocol and report. To co-ordinate the entire qualification activity.
Production		To execute qualification study in co-ordination with other departments.
Quality Assurance		To execute qualification study in co-ordination with other departments.
Maintenance		To review the qualification documents.
Head – Quality Assurance		To approve qualification protocol & report.

4. EQUIPMENT DESCRIPTION:

Equipment description shall be match as per design qualification protocol.

5.  ACCEPTANCE CRITERIA:

Performance Qualification of the equipment shall be in accordance with the parameters given in FORM – A of this report.

6.  PROCEDURE:

Perform the qualification as per following form,

Performance of Equipment

PERFORMANCE OF EQUIPMENT

Performance of the equipment is verified by simulating the normal operation for dry mixing, granulation and milling of the ingredients. While doing the exercise consideration is given to the operational range of the equipment that is at minimum level (20% of capacity), optimum level (50% of the capacity) and maximum level (80% of the capacity). At the end of the granulation process wet mass is checked for its physical appearance.

  1.0 Minimum Level: (20 % of capacity)

Product Name              :

Batch No.                     :

 Theoretical Batch Size  :

Practical Batch Size      :

1.1 Dry Mixing:

Uniform mixing of raw materials i.e. active and inactive materials is checked by collecting samples from 10 different locations for blend uniformity test. The result of blend uniformity test, process parameters of equipment i.e. mixer speed, chopper speed and end point ampere reading are recorded in following tables.

1.1.1 Acceptance Criteria:     

Mixing of active material shall be uniform.

  Blend Uniformity: 90.0 % to 110.0 %

  % RSD: NMT 6.0 %

1.1.2 Process Parameters Data:

sr no.	Step	Mixer Slow	Mixer Fast	Chopper Slow	Chopper Fast	End Point  Ampere	Observation entered by/date
1	Dry mixing cycle

1.1.3 Blend Uniformity Test Result:

Sr. No.	Locations	Assay in %	Result  entered by/date
1	Left – Top
2	Left – Bottom
3	Right – Top
4	Right – Bottom
5	Middle – Top
6	Middle – Bottom
7	Front – Top
8	Front – Bottom
9	Back – Top
10	Back – Bottom
	Minimum
	Maximum
	Average
	% RSD

1.2 Wet Mixing (Binder Addition):

After addition of binder solution, checked the wet mass, process parameters of equipment i.e. binder solution temperature, mixer speed, chopper speed and end point ampere reading. The observations are recorded in following tables.

1.2.1 Acceptance Criteria:  Wet mass shall be coherent.

 1.2.2 Process Parameters Data:  

              Binder solution temperature:

Sr No.	Steps	Mixer Slow	Mixer Fast	Chopper Slow	Chopper Fast	End Point  Ampere	Observation entered by/date
1	During binder solution addition.
2	After completion of binder solution addition.
3	Additional purified water, if added. Quantity :

1.2.3 Physical Appearance of Wet Mass:

Sr.No.	Test	Observation	Checked by/date
1	Physical appearance

1.3 Wet Mass Milling:

The wet mass after granulation is passed though the cone mill and the same is checked visually for its size and uniformity.

1.3.1 Acceptance Criteria:  Wet granules size shall be uniform.

1.3.2 Physical Appearance of Wet Mass:

               Sieve details:

Sr.No.	Test	Observation	Checked by/date
1	Visually check wet granules for its size.

Repeat the above mentioned process for optimum level (50% of the capacity) and maximum level (80% of the capacity).

7. Deviation Report:

Any deviation reported during process with respect to acceptance criteria shall be justified and it’s it’s impact on equipment qualification shall be evaluated.

8. CHANGE CONTROL:

Change control number shall be mentioned.

9. List of Annexures:

Annexures shall be attached to the PQ Report.

10. Summary and Conclusion of Performance Qualification:

The results and final conclusion shall be mentioned that the equipment performance is found satisfactory at load condition and analytical and physical parameters performed at different capacities are found satisfactory.

11. Certification of Performance Qualification:

Performance Qualification is satisfactory Yes/No

Hence equipment can be used for routine use Yes/No.

Certification shall be taken from Quality Assurance before use.