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BATCH MANUFACTURING RECORD (BMR)

BATCH MANUFACTURING RECORD (BMR)

BATCH MANUFACTURING RECORD (BMR)
BMR Title
:
BMR for Tablet
Document No.
:
BMR/TB/001-00
Batch Size
:
 
Page No.
:

 1 of 29

 

Effective Date
:
 
Review Date
:

Product Name                         :

 Generic Name                         :

 Labels Claim)                         : Each ____________coated tablet contains:

Batch No.                                :

Date of Mfg.                           :

Date of Exp.                            :

Shelf Life                                 : 24 months

Mfg. Licence No.                    :

Percentage of Yield                :

Date of Completion                :

BMR Submission Date            :

 TABLE OF CONTENT

Sr.No                                    CONTENT PAGE NO.
1 GENERAL PROCESSING INSTRUCTION
2 LIST OF EQUIPMENTS USED
3 DISPENSING OF RAW MATERIAL
4 GRANULATION
5 COMPRESSION
6 COATING
7 TABLET INSPECTION
8 DOCUMENT RECONCILIATION
9 BMR REVIEW
10 BATCH RELEASE

 1.0 GENERAL PROCESSING INSTRUCTION

  • All the Activity shall be performed as per current SOPs.
  • Follow the GMP compliance throughout the manufacturing process.
  • Check and ensure that the balances are in calibrated state.
  • Ensure that the product is labeled at all applicable stages of manufacturing process.
  • Ensure area (including waste bins), all vessels, machines and equipments are cleaned as per respective SOPs & record the Cleaning details in Equipment Log and affixed with respective STATUS label, before starting process.
  • Avoid direct product contact.
  • Ensure that secondary gowning of the respective areas is followed.
  • Use nose masks and hand gloves during manufacturing process to avoid direct contact to product intermediate.
  • Ensure that Material Dispensing labels and other labels (if applicable) are affixed in the BMR.
  • Checklist and write (Ok) if complies and (Not Ok) if not complies with respective activity.
  • Processing area conditions:
    • Room temperature: NMT 25°C.
    • Relative Humidity: NMT 60 %.
  • Carry out environmental monitoring, during processing operation
  • Integrity of the sieves and screens shall be verified and recorded before and after completion of the operation.
  • Wherever applicable calculate the percentage of yield and record.
  • Do not perform any cleaning activity if manufacturing process is in progress in the area.
  • Take the line clearance from QA before starting the operation during batch to batch product change product change over & record in batch record where applicable.
  • Don’t overwrite the entry, in case there is correction, cancel the entry by single line with sign & date and make correct entry.

2.0 LIST OF EQUIPMENTS USED

S. No. Equipment Name Equipment ID No. Cleaned By/ On Checked By/ On Verified By/ On
1. Weighing Balance        
2. Vibro Sifter        
3. Blender (Double Cone/ Cubic/ Octagonal/      
4. Mass Mixer      
5. Paste Kettle      
6. Planetary Mixture      
7. Rapid Mixer Granulator (RMG)      
8. Multi mill      
9. Fluidized Bed Dryer (FBD)      
10. Tray Dryer      
11. Compression Machine        
12. Coating Machine        
13. Metal Detector        

 

 3.1  Area and Equipment line clearance:
Previous Product Batch No.
Equipments Used  

Dispensing Booth

 

 

 Equipments No. SC/WH/DB/01
Temperature               (Limit: NMT 25°C)   Relative Humidity    (Limit: NMT 60 %)

3.0 DISPENSING OF RAW MATERIAL

  Sr. No. Check points Observations
1. Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2. Cleanliness of floor, ceiling, walls, light fixtures, dustbins, containers, tools, vacuum cleaner.
3. Ensure updation of status board & ‘CLEANED’ label is affixed on Dispensing Booth.
4. Cleanliness of surrounding area of the dustbins, containers, tools and Balances.
5. Ensure the differential pressure of the area is within specified limit
6. Check the proper gowning of personnel
7. Ensure that RLAF is working properly
8. Differential Pressure across HEPA filters are within limits.
9. Ensure that the riser filters are cleaned.
10. Ensure the cleanliness of the container in which the dispensed material is to be kept.
11. Check the raw material for name, appearance, A.R. No., Expiry/retest date etc.
Sign & Date Done by Checked by   Verified by
       

Note: Mark ‘OK’ if complies & mark ‘Not OK’ if does not complies during line clearance. Write NA if not applicable.

 

3.2 RAW MATERIAL ISSUE NOTE:

Sr.No

 

Item Name Actual Qty

(Kg)

 A.R.

No.

Gross Wt. (Kg) Tare Wt. (Kg) Net Wt. (Kg) Weight By Checked By Verified By
Dry mixing
1
2
3
4
Binder preparation
5
6
7
8
9
Lubrication
10
11
12
13
14
Coating
15
16
17
18
19
20

 

4.0 GRANULATION:

4.1  Area and Equipment line clearance:
Previous Product Batch No.
Equipments Used Sifter

Paste Kettle

RMG

FBD

Multi Mill

Mass/Planetary Mixer

Tray Dryer

 Equipments No.
Temperature (Limit: NMT 25°C) Relative Humidity    (Limit: NMT 60 %)

 

  Sr. No. Check points Observations
1. Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2. Cleanliness of floor ceiling, walls, drainage, light fixtures, dustbins, containers, tools, vacuum cleaner.
3. Ensure ‘CLEANED’ label is affixed on each equipment.
4. Check the updation of status board & status label which shows the details of activity.
5. Cleanliness of surrounding area of dustbins, containers, tools.
6. Ensure the differential pressure of the area is within specified limit
7. Check the proper gowning of personnel
8. Ensure the swab/rinse analysis of equipment to be used has passed.
9. Ensure the availability of BMR and filled up to previous stage.
10. Ensure that the equipment Log book is filled up to previous stage.
11. Batch documents are completed up to this stage
Sign & Date Done by Checked by   Verified by
       

Note: Mark ‘OK’ if complies & mark ‘Not OK’ if does not complies during line clearance. Write NA if not applicable.

 

4.2 Affix weighing tags/ labels of Dispensed Raw Materials after addition to batch, for verification.
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 4.3 Sifting:

4.3.1 SIFTING OF INGREDIENTS 
Sieve the Raw Materials with sieve size mentioned in table below as per the product specifications.
S. No. Ingredients Quantity Sieve No. / Mesh # Sieve Integrity Done By Prod. Checked By Prod Verified By/ On (QA)
Before After
OK/Not OK)
1.      
2.      
3.      
4.      
5      
6      
7      
8      

 4.4      Dry Mixing:

Transfer sifted Material of step No.4.3.1 in RMG and Mix the material for _____ minutes with slow /fast speed.

S.No Date Name of Ingredients Qty. Added (Kgs) Specification Starting Time Completion Time Actual Time
1
2
3
4
5
6
7
8

Done By/ On (Production)                       Checked by/ On (Production)                 Verified by/ On (QA)

 

4.5  Binder Preparation
4.5.1 Binder – I  Preparation (Aqueous Binder)
(a) Take and boil the purified water (_______kg) ________at 80 0C in the Paste Kettle (Equipment No. _____________) and cool it till 45 0C temperature and add the materials_____________________________________________________

(b) Meanwhile, separately Take ____________ kg of Purified water in a SS Vessel and add the Starch IP (__________ kg) makes slurry of starch paste.

Add the point no. (a) Into (b) in the Paste Kettle, stirring continuously till a smooth paste is formed.

Starting Time___________________________        Completion Time_____________________________

Done By/ On (Production)                                 Checked by/ On (Production)                Verified by/ On (QA)

 

4.5.2 Binder – II  Preparation (Non Aqueous Binder)
Take______ Lts. of ________________in /SS Container ,Equipment No.___________ Add _____________________ in  Solvent and mix properly

Starting Time___________________________        Completion Time_____________________________

Done By/ On (Production)                                 Checked by/ On (Production)                                Verified by/ On (QA)

 

4.6  WET GRANULATION

Transfer the binder of point no.4.5 in step no 4.4 in RMG/Mass Mixer/SS Container. Mix by running machine at medium speed/ high speed/ manually for ___________ minutes for preparing wet mass of specified properties as per product specifications

 

Equipment Used : RMG/ Mass Mixer/ SS Container               Equipment ID No.: ________________________
Date Start Time (Hrs) End Time (Hrs) Duration of Granulation (Hrs) Done By/ On (Production) Checked by/ On (Production) Verified by/ On (QA)
Remarks (if any): _______________________________________________________________________________

 

4.7 DRYING 

Unload the wet mass of 4.6 and transfer the wet mass into product container of FBD/Tray of tray dryer & dry the wet mass as follow.

First airs dry the granules for _______________ minutes and then at ________________ °C Till the LOD of granules is between _______ to _________ at 105°C by Halogen Moisture Balance.

      Equipment Used: FBD/Tray Dryer                  Equipment ID No.: _____________________

Date Lot No. Drying Temperature (in °C)              Drying time (in mins.) LOD (%) Done By Checked By
Specification Actual Started Completed Specification Actual
I
II

 

4.8 MILLING/ SIZING (AFTER DRYING)

(a) Sieve Integrity checked (Before sifting).

(b) Pass the dried granules of Point No. (4.7) through #__________ sieve fitted on Vibro sifter

(c) Mill the retention of step (b) through Multimill fitted with ________ mm screen at slow speed

(d) Sieve Integrity checked (After sifting).

(e) Collect Granules in Polylined Container.

(f) Record the Dried Granules weight.

Equipment Used : Sifter/ Sieve                Equipment ID No.: SC/PD/MTM/02
Date Lot No. Start Time (Hrs) End Time (Hrs) Milling / Sizing Duration (Hrs) Sieve #/ Screen(mm) Done By/ (Production) Checked by/ (Production) Verified by/ (QA)
I
II
Weight of Dried Granule after Milling/Sizing:


es during line clearance. Write NA if not applicable

 

 

 

4.9.2 Sifting of Lubricants 
1.      Set siffer with #________ sieve and sift of below mentioned Qty in table.

2.      Collect sifted Material in polyline Container.

3.      Check the Sieve Integrity of #____________ after sifting.

 

S. No. Ingredients Quantity Sieve No. / Mesh # Sieve Integrity Done By Prod. Checked By Prod Verified By/ On (QA)
Before After
OK/Not OK)
1      
2      
3      
4      
5      

 

4.9.3 Pre-Blending (without Magnesium Stearate)

Load the material of step 4.8 and Sifted material of 4.9.2 the material in _________________ Blender (Equipment ID.______________) and mix for ________ Minutes at ___________ RPM Speed.

Equipment Used : _________________________          Equipment ID No.: ___________________________   
Date Blender Speed (RPM) Start Time (Hrs) End Time (Hrs) Duration of Mixing (Hrs) Done By/ On (Prod.) Checked by/ On (Prod.) Verified by/ On (QA)
10

4.9.4 Blending (with Magnesium Stearate)

Add the Magnesium stearate in the Pre-blended material of step 4.9.3 in ______________________________Blender (Equipment ID. __________________ and mix for ___________ Minutes at _____________ RPM Speed.

Equipment Used : ______________________ Blender          Equipment ID No.: _____________________ 
Date Blender Speed (RPM) Start Time (Hrs) End Time (Hrs) Duration of Mixing (Hrs) Done By/ On (Prod.) Checked by/ On (Prod.) Verified by/ On (QA)
10

 

Moisture Content of Lubricated Granules Equipment Used Equipment ID No Checked by/ On (QA) Remarks
Moisture balance

 

Bulk Density Tapped Density Compressibility Index Hausner Ratio Checked by/ On (QA) Remarks
________gm/ml ________gm/ml ___________% ___________%

Unload the Lubricated Blend of point No.6.9.4 into Double Polybag in suitable Container. Weigh the material. Affixed the Status Labels on the Container

4.10 WEIGHT OF LUBRICATED GRANULES
Container No. Gross weight (Kg) Tare weight (Kg) Net weight (Kg) Done By/ On (Prod.) Checked by/ On (Prod.) Verified by/ On (QA)
1.
2.
3.
4.
Total weight of Lubricated Granules

4.11   Lubricated Granules Reconciliation:

 

SNo.

Details Quantity

(Weight in Kg)

Done By/ On (Production) Checked by/ On (QA)
A Theoretical Weight of the Lubricated Granules
B Actual Weight of Granules
C Q.C. Sample
D In-Process Check loss
F  Process Loss
E Actual % Yield:(B)x100/A
G Reconciliation % Yield: (B+C+D+E)x100/A

4.12 QC ANALYSIS:

QC Sample Taken By: ___________________________  Qty. of Sample:  _____________________
Analytical result of Blend: Pass/ Fail. A R No.: _____________________ Sign/Date:
The blend is / is not of standard quality and released or not released for compression.

Sign/Date: (Production)                                                             Sign/Date: (QA)

 

5.0   COMPRESSION:
5.1   Area and Equipment line clearance:
Previous Product Batch No.
Equipments Used COMPRESSIO  Equipments No.
Temperature               (Limit: NMT 25°C)   Relative Humidity    (Limit: NMT 60 %)

 

Sr.No Check points Observations
1. Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2. Cleanliness of floor ceiling, walls, light fixtures, dustbins, containers, tools, vacuum cleaner.
3. Ensure ‘CLEANED’ label is affixed on each equipment.
4. Check the updation of status board & status label which shows the details of activity.
5. Cleanliness of surrounding area of dustbins, containers, tools.
6. Ensure the differential pressure of the area is within specified limit
7. Check the proper gowning of personnel
8. Ensure the swab/rinse analysis of equipment to be used has passed.
9. Ensure the availability of BMR and filled up to previous stage.
10. Ensure that the equipment Log book is filled up to previous stage.
11. Batch documents are completed up to this stage
Sign & Date Done by Checked by Verified by
Note: Mark ‘OK’ if complies & mark ‘Not OK’ if does not complies during line clearance. Write NA if not applicable      

 5.2 Initial Check 

Punch Specification Description Observation Checked By Verified By
Upper Punch        
Lower Punch        

 

Product Specification
Description
Weight of 20 Tablets  

_____________ ± 3 % (Limit: ________ gm to ____________ gm)

Average Weight  

____________ mg ± 2 % (Limit : _________ mg to __________ mg)

Individual Tablets Weight Variation Limit  

_________ mg ± 5 % (Limit : _______ mg to __________ mg)

Thickness  

__________ mm ± 0.2 mm  (Limit : __________ mm to___________mm)

Dimension

(LXW)

Length _____________ mm ± 0.2 mm ( Limit: __________ mm to __________ mm)
Width ____________ mm ± 0.2 mm  ( Limit: ___________ mm to ___________ mm)
Hardness NLT __________ kg/cm2
Disintegration NMT 15 min
Friability NMT 1% W/W

 

5.3 Compression Pre-Startup
Equipment Used:    Compression Machine ___________ Station.    Equipment ID No.: _____________________
Date Start Time End Time Duration of Compression Done By/ On Checked by/ On Verified By/ On Remarks

 

Procedure:
1.       Check the dies and punches for compliance with the product specifications.

2.       Adjust the compression parameters as the product specifications.

3.       Reject the first two rounds of tablets at the start of the batch as Recoverable Rejects.

4.       Check for initial round of tablets equal to number of stations, for appearance and Embossing, if any.

5.       The tablets should be free from, picking, chipping and any foreign matter.

6.       Start the compression, if the parameters comply with standards.

 

In-Process Parameter Sample Qty Frequency
Appearance 20 Tabs Every 1hrs
Group Wt. of 20 Tabs (g) _________ ± 3 % (Limit: ________ gm to ________ gm) 20 Tabs Every 1hrs
Average Weight – ____________ mg ± 2 % (Limit : ________ mg to _______ mg) 20 Tabs Every 1hrs
Hardness (NLT ___________ Kg/ cm2) 6 Tabs Every 1hrs
Disintegration time  (NMT __________ Min) 6 Tabs Every 1hrs
Thickness: _____________ mm to______________  mm 6 Tabs Every 1hrs
Friability (%) (NMT _____________%) 6.5 gm Tabs Every 1Hr
Individual Weight Variation Limit______ mg ± 5 % (Limit : ____ mg to _____ mg) 20 Tabs Every 1hrs

 

5.4  In-Process checks Record (Compression)                                     Production (Frequency: Every 1 Hr) 
Date Time Appearance (OK/ Not OK) Wt. of 20 Tabs (g) DT (min) Friability (%) Hardness (Kg / cm2) Thickness (mm) Checked By

 

5.5 In-Process checks Record (Compression)                                                   QA (Frequency: Every 1 Hr )
Date Time Appearance (OK/ Not OK) Wt. of 20 Tabs (g) DT (min) Friability (%) Hardness (Kg / cm2) Thickness (mm) Checked By

 

5.6  Individual Weight Variation                  (Frequency: Every 1 Hr  min alternative Production  person)
Target Av. Weight.: _________ mg   (Limit:   Min: …… mg           Max.  ………. mg)

 

Weight of 20 Tabs: ___________g Weight of 20 Tabs: ___________g Weight of 20 Tabs: ___________g
Date:                Time: Date:                Time: Date:                Time:
1. 11. 1. 11. 1. 11.
2. 12. 2. 12. 2. 12.
3. 13. 3. 13. 3. 13.
4. 14. 4. 14. 4. 14.
5. 15. 5. 15. 5. 15.
6. 16. 6. 16. 6. 16.
7. 17. 7. 17. 7. 17.
8. 18. 8. 18. 8. 18.
9. 19. 9. 19. 9. 19.
10 20. 10 20. 10 20.
Min: ________; Max: _______ mg Min: _______mg; Max: _______mg Min: _______mg; Max:_____  mg
Checked By/On Checked By/On Checked By/On

 

Weight of 20 Tabs: ____________ g Weight of 20 Tabs: ____________ g Weight of 20 Tabs: ____________ g
Date:__________ Time:__________ Date:__________ Time:__________ Date:__________ Time:__________
1. 11. 1. 11. 1. 11.
2. 12. 2. 12. 2. 12.
3. 13. 3. 13. 3. 13.
4. 14. 4. 14. 4. 14.
5. 15. 5. 15. 5. 15.
6. 16. 6. 16. 6. 16.
7. 17. 7. 17. 7. 17.
8. 18. 8. 18. 8. 18.
9. 19. 9. 19. 9. 19.
10 20. 10 20. 10 20.
Min: ________; Max: _______ mg Min: _______mg; Max: _______mg Min: _______mg; Max:_____  mg
Checked By/On Checked By/On Checked By/On

 

5.7  Individual Weight Variation                                      (Frequency: Every 1 Hr  min alternative QA  person)
Target Av. Weight.: __________ mg   (Limit:   Min:…………. mg  , Max……….. mg)

 

Weight of 20 Tabs: ___________ g Weight of 20 Tabs: ____________g Weight of 20 Tabs: __________ g
Date:                 Time: Date:                 Time: Date:                 Time:
1. 11. 1. 11. 1. 11.
2. 12. 2. 12. 2. 12.
3. 13. 3. 13. 3. 13.
4. 14. 4. 14. 4. 14.
5. 15. 5. 15. 5. 15.
6. 16. 6. 16. 6. 16.
7. 17. 7. 17. 7. 17.
8. 18. 8. 18. 8. 18.
9. 19. 9. 19. 9. 19.
10 20. 10 20. 10 20.
Min: ______mg; Max: _____mg Min: ______mg; Max: _____mg Min: ______mg; Max: _____mg
Checked By/On Checked By/On Checked By/On

 

Weight of 20 Tabs: __________ g Weight of 20 Tabs: __________ g Weight of 20 Tabs: ___________ g
Date: _______ Time: __________ Date: ________ Time: ___________ Date: __________ Time: _________
1. 11. 1. 11. 1. 11.
2. 12. 2. 12. 2. 12.
3. 13. 3. 13. 3. 13.
4. 14. 4. 14. 4. 14.
5. 15. 5. 15. 5. 15.
6. 16. 6. 16. 6. 16.
7. 17. 7. 17. 7. 17.
8. 18. 8. 18. 8. 18.
9. 19. 9. 19. 9. 19.
10 20. 10 20. 100 20.
Min: ______mg; Max: _____mg Min: ______mg; Max: _____mg Min: ______mg; Max: _____mg
Checked By/On Checked By/On Checked By/On

 

 5.8            WEIGHT RECORD OF COMPRESSED TABLETS
Sr. No. Gross Weight (kg) Tare Weight (kg) Net. Weight (kg) Weighed by Checked By
1.
2.
3.
4.
Total weight

 

 5.9 RECONCILIATION OF COMPRESSED TABLET

SR.NO. STAGE KGS NUMBERS
A Theoretical
B Weight of granules received for compression
C Weight of Compressed tablets
D Tablets sent to Quality Control
E In process Sample
F Loss during Compression
G Actual Percentage Yield % (C)x100

(A)

H Reconciliation Percentage yield      (C+D+E+F)x100

(A)

Reconciled By (Production)
Send duly filled analysis requisition to Q.C. Department to collect the sample for analysis.
Requisition analysis sheet sent by………….

Date/Sign)

Sampled By…………………

(Date/Sign)

5.10 QC ANALYSIS / SAMPLING:

QC Sample Taken By: ____________________Qty. of Sample:  ________________
Analytical result of Compressed Tablets: Pass/ Fail. A R No.: _____________________Sign/Date:
The Compressed tablet is released or not release for coating

Sign/Date: (Production)                                                             Sign/Date: (QA)

if complies & mark ‘Not OK’ if does not complies during line clearance. Write NA if not applicable

6.2 Sifting Of Coating Material
S. No. Material Name Quantity AR No. Done By/ On Checked By/ On
1.                             
2.                             
3.                             
4.                             
5.                             
6.3 Mixing of Coating material
1.      Mix Material of S. No. ____________________ in S. No. ______________in Purified Water for _________ min. in a mixing vessel.

2.      Add Color ____________________________________________________ in _____________ lt of above prepared solution in Step 1.  Filter the color solution in Step 1.

3.       Keep solution for ______________ min. And proceed for coating process.

4.      Divide the tablets of batch into _______(No.) of lots equally, having Lot size of _________________________Kg.

5.      Set coating parameters as per product specifications.

6.      Pre warm the tablets in coating pan for pre defined time.

7.    After warm up start coating process by starting coating spray from gun & note parameters in Coating details

 

 

6.4   Solution Preparation
Type of Coating: Aqueous/ Non-Aqueous                      Color Name: _____________________________________
Date Lot No. Lot Size Coating Materials Coating Material Qty. Solvent Solvent Qty. Done By/ On Checked by/ On
  I              
  II              
  III              

 

6.5 Coating Pan Setting Details
Date Lot No. No. of Baffles No. of Guns Gun to Gun Distance Gun to Tablet Bed Distance Tab Av. Weight

(uncoated) (mg)

Checked by/ On (Prod.)
  I            
  II            
  III            

 

6.6 Pre-Coating Preparation Details (Lot No. I/ II/ III)
Date Uncoated Tab. Av. Wt. (mg) (pre-warm-up) Warm-up Temp. (OC) Warm-up Time Tablet Av. Wt (After warm-up) (mg) (A) Pan Speed (RPM) Done By/ On (Prod.) Checked By/ On (QA)
  I            
  II            
  III            

 

6.7  Coating Details (Lot No.  I/ II/ III) 
Date Time Inlet Temp. (OC) Tablet Bed Temp. (OC) Av. weight of Tablet (mg) (B) Coating weight gain (%)

({B-A}/A x100)

Done By (Operator) Checked By (Production Officer) Verified By (QA)
                 
                 
                 
                 
                 
                 
                 
                 
                 
Equipment Used : _______________________________                Equipment ID No.: _____________________
Date Lot No. Start Time End Time Duration of Coating Done By/ On Checked by/ On
I
II
III

 

6.8 In process Test for Physical Parameters of Coated Tablets
Test Parameter Lot – I Lot – II Lot – III
Appearance
Group weight of the 20 tablets
Thickness
Disintegration

 

6.9 Individual Weight Variation of Coated Tablet (Production)
Target Av. Weight.: ______________mg   (Limit:   Min: …………… mg ,      Max. ………………… mg)

 

Lot -I Lot -II Lot -III
Weight of 20 Tabs: __________ gm Weight of 20 Tabs: ____________gm Weight of 20 Tabs: ___________gm
Date:__________ Time:_________ Date:___________ Time:_________ Date:___________Time:_________
1. 11. 1. 11. 1. 11.
2. 12. 2. 12. 2. 12.
3. 13. 3. 13. 3. 13.
4. 14. 4. 14. 4. 14.
5. 15. 5. 15. 5. 15.
6. 16. 6. 16. 6. 16.
7. 17. 7. 17. 7. 17.
8. 18. 8. 18. 8. 18.
9. 19. 9. 19. 9. 19.
10 20. 10 20. 10 20.
DT- Thickness – DT- Thickness –
Min: _______mg; Max: _______mg   Min: ________mg; Max: _______mg   Min: ________mg; Max: _______mg
Checked By/On  Checked By/On Checked By/On

 

6.10 Individual Weight Variation of Coated Tablet (QA)
Target Av. Weight.: ______________mg   (Limit:   Min: …………… mg  ,   Max. ………………… mg)
Lot -I Lot -II Lot -III
Weight of 20 Tabs: __________ gm Weight of 20 Tabs: ____________gm Weight of 20 Tabs: ___________gm
Date:__________ Time:_________ Date:___________ Time:_________ Date:___________Time:_________
1. 11. 1. 11. 1. 11.
2. 12. 2. 12. 2. 12.
3. 13. 3. 13. 3. 13.
4. 14. 4. 14. 4. 14.
5. 15. 5. 15. 5. 15.
6. 16. 6. 16. 6. 16.
7. 17. 7. 17. 7. 17.
8. 18. 8. 18. 8. 18.
9. 19. 9. 19. 9. 19.
10 20. 10 20. 10 20.
DT- Thickness – DT- Thickness –
Min: _______mg; Max: _______mg   Min: ________mg; Max: _______mg   Min: ________mg; Max: _______mg
Checked By/On  Checked By/On Checked By/On

 

  6.11 WEIGHT RECORD OF COATED  TABLETS
Sr. No. Gross Weight (kg) Tare Weight (kg) Net. Weight (kg) Weighed by Ckeched By
1.
2.
3.
4.
5.
6.
7.
8.

 

9.
10.
Total weight

 6.12 RECONCILIATION OF COATED TABLET

SR.NO. STAGE KGS NUMBERS
A Theoretical Tablets.
B Weight of Tablet received.
C Weight of Coated tablets.
D Tablets sent to Quality Control.
E In process Sample.
F Loss during Coated.
G Actual Percentage Yield % (C)x100

(A)

H Reconciliation % yield      (C+D+E+F)x100

(A)

Reconciled By (Production)
Send duly filled analysis requisition to Q.A. Department to collect the sample for analysis.
Requisition analysis sheet sent by………….

Date/Sign)

Sampled By…………………

(Date/Sign)

6.13 QC ANALYSIS/SAMPLING

QC Sample Taken By: _______________________________   

Qty. of Sample:  _____________________

Analytical result of Coated  Tablets : Pass/ Fail ________________   

 A R No.: _____________________

Sign/Date:

The Coated tablet is released or not release for tablet inspection.

Sign/Date: (Production)                                                             Sign/Date: (QA)

 

7.0   TABLET INSPECTION
Instructions:

1.            There should not be any variation in the colour of the tablets and tablets should be of smooth surface.

2.            The tablet surface should not have spot & should not be broken.

3.            There should not be any “Blistering” or “Bridging” on the tablets

4.            There should not be any twinning of tablets

 

7.1    Area and Equipment line clearance of Tablet Inspection:
Previous Product Equipments Name Batch No.
Equipments Used  Equipments No.
Temperature               (Limit: NMT 25°C) Relative Humidity    (Limit: NMT 60 %)
Sr.No Check points Observations
1. Ensure the absence of batch documents, labels, materials or any remnants of previous product or batch.
2. Cleanliness of floor ceiling, walls,light fixtures, dustbins, containers, tools, vacuum cleaner.
3. Ensure ‘CLEANED’ label is affixed on each equipment.
4. Check the updation of status board & status label which shows the details of activity.
5. Cleanliness of surrounding area of dustbins, containers, tools.
6. Ensure the differential pressure of the area is within specified limit
7. Check the proper gowning of personnel
8. Ensure the swab/rinse analysis of equipment to be used has passed.
9. Ensure the availability of BMR and filled up to previous stage.
10. Ensure that the equipment Log book is filled up to previous stage.
11. Batch documents are completed up to this stage
Sign & Date Done by Checked by Verified by
Note: Mark ‘OK’ if complies & mark ‘Not OK’ if does not complies during line clearance. Write NA if not applicable      

 

7.2   Challenge Test for Metal Detector

Date Time EQ.ID. Checked By
Ferrous Non Ferrous SS Block
 

 

         
           
           
           
           

 

7.3 Tablet Inspection Record

Cont.No Wt.of Tablets (Kg) Wt. of Tablet After Inspection Rejected Tablet Date Time Inspected By Checked By
Start End
 

 

7.4 RECONCILIATION OF INSPECTED TABLET

Sr.No Stage Number (Total Wt./ Inspected Tab Av. Wt) Kgs Done By Production Checked by (QA) Remarks (if any)
A Theoretical (Standard)
B Tablets Received for Inspection
C Inspected Tablets
D Rejected Tablets
E Actual percentage Yield (C)x100

(A)

                           %      %
F Reconciliation % yield    (C+D)x100

(A)

Reconciled By (Production)
  • DOCUMENT RECONCILIATION:
Sr.No. Description Quantity Production (Sign) QA(Sign)
1. No. of BMR pages      
2. No. of Additional pages      
3. No. of Dispensing  Labels      

  9.0 BMR REVIEW:

BMR Reviewed By

(Manager-Production)

BMR Reviewed By

(Manager-Quality Assurance )

   

 

  10.0     BATCH RELEASE :

All contents of the batch record have been checked, reviewed & found complying/not complying with the proper requirements. As per in process checks record & data submitted by quality control the product complies/does not comply with specifications . Hence the batch can/cannot be released for Packing.

                                                                                                                       QA Head/ (Sign/Date)

 

More Jobs [email protected] http://pharmaguidances.com

 

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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