BATCH MANUFACTURING RECORD (BMR)
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
- GENERAL PROCESSING INSTRUCTION
- LIST OF EQUIPMENT USED
- DISPENSING OF RAW MATERIAL
- GRANULATION
- COMPRESSION
- COATING
- TABLET INSPECTION
- DOCUMENT RECONCILIATION
- BMR REVIEW
- 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 EQUIPMENT USED
- Weighing Balance
- Vibro Sifter
- Blender (Double Cone/ Cubic/ Octagonal/
- Mass Mixer
- Paste Kettle
- Planetary Mixture
- Rapid Mixer
- Granulator (RMG)
- Multi mill
- Fluidized Bed Dryer (FBD)
- Tray Dryer
- Compression Machine
- Coating Machine
- Metal Detector
Dispensing Area and Equipment line clearance:
Previous Product Batch No.
Equipment Used Equipment No.
Temperature (Limit: NMT 25°C) Relative Humidity (Limit: NMT 60 %)
DISPENSING OF RAW MATERIAL CHECKPOINTS
- Ensure the absence of batch documents, labels, materials, or any remnants of previous products or batches.
- Cleanliness of floor, ceiling, walls, light fixtures, dustbins, containers, tools, and vacuum cleaners.
- Ensure updation of the status board & ‘CLEANED’ label is affixed on Dispensing Booth.
- Cleanliness of the surrounding area of the dustbins, containers, tools, and Balances.
- Ensure the differential pressure of the area is within the specified limit
- Check the proper gowning of personnel
- Ensure that RLAF is working properly
- Ensure that RLAF is working properly
- Differential Pressure across HEPA filters is within limits.
- Ensure that the riser filters are cleaned.
- Ensure the cleanliness of the container in which the dispensed material is to be kept.
- Check the raw material for name, appearance, A.R. No., Expiry/retest date, etc.
Note: Mark ‘OK’ if complies & mark ‘Not OK’ if does not comply during line clearance. Write NA if not applicable.
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
GRANULATION:
Area and Equipment line clearance:
Previous Product Batch No.
Equipment Used Equipment No.
Temperature (Limit: NMT 25°C) Relative Humidity (Limit: NMT 60 %)
LINE CLEARANCE CHECKPOINTS FOR GRANULATION
- Ensure the absence of batch documents, labels, materials, or any remnants of previous products or batches.
- Cleanliness of floor ceiling, walls, drainage, light fixtures, dustbins, containers, tools, and vacuum cleaners.
- Ensure the ‘CLEANED’ label is affixed on each piece of equipment.
- Check the updation of the status board & status label which shows the details of the activity.
- Cleanliness of the surrounding area of dustbins, containers, and tools.
- Ensure the differential pressure of the area is within the specified limit
- Check the proper gowning of personnel
- Ensure the swab/rinse analysis of the equipment to be used has passed.
- Ensure the availability of BMR and filled up to the previous stage.
- Ensure that the equipment Logbook is filled up to the previous stage.
- Batch documents are completed up to this stage
Note: Mark ‘OK’ if complies & mark ‘Not OK’ if does not comply during line clearance. Write NA if not applicable.
Affix weighing tags/ labels of Dispensed Raw Materials after addition to batch, for verification.
SIFTING OF INGREDIENTS
Sieve the Raw Materials with the sieve size as per the product specifications.
Check Sieve Integrity – Before and After
Dry Mixing:
Transfer the sifted Material for dry mixing in RMG and Mix the material for _____ minutes with slow /fast speed.
Binder Preparation
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 a slurry of starch paste and add point no. (a) Into (b) in the Paste Kettle, stirring continuously till a smooth paste is formed
Starting Time______________ Completion Time_________________
Binder – II Preparation (Non-Aqueous Binder) (If required)
Take______ Lts. of ________________in /SS Container ,Equipment No.___________ Add _____________________ in Solvent and mix properly
Starting Time_______________ Completion Time________________
WET GRANULATION
Transfer the binder of point no.4.5 in step no 4.4 in RMG/Mass Mixer/SS Container. Mix by running the machine at medium speed/ high speed/ manually for ___________ minutes for preparing a wet mass of specified properties as per product specifications.
DRYING
Unload the wet mass of 4.6 and transfer the wet mass into the 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.: _____________________
The drying Parameter shall be controlled and Monitor
- Drying Temperature (in °C)
- Drying time (in mins.)
- LOD (%)
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 a Polylined Container.
(f) Record the Dried Granule’s weight.
The Milling/Sizing Parameter shall be controlled and Monitor
- Milling / Sizing Duration (Hrs)
- Sieve #/ Screen(mm
Weight of Dried Granule after Milling/Sizing:__________________________
Sifting of Lubricants
- Set siffer with #________ sieve and sift of below mentioned Qty in the table.
- Collect sifted Material in polyline Containers.
- Check the Sieve Integrity of #____________ after sifting.
Pre-Blending (without Magnesium Stearate)
Load the Milled material and Sifted lubricants_________________ Blender (Equipment ID.______________) and mix for ________ Minutes at ___________ RPM Speed.
Blending (with Magnesium Stearate)
Add the Magnesium stearate in the Pre-blended material in ___________Blender (Equipment ID. ______________ and mix for ___________ Minutes at _____________ RPM Speed.
Moisture Content of Lubricated Granules:____________________
The Following Parameter of Blended material shall be controlled and Monitor
- Bulk Density
- Tapped Density
- Compressibility Index
- Hausner Ratio
Unload the Lubricated Blend into Double Polybag in a suitable Container. Weigh the material. Affixed the Status Labels on the Container
Lubricated Granules Reconciliation:
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
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)
COMPRESSION:
- Ensure the absence of batch documents, labels, materials or any remnants of previous products or batches.
- Cleanliness of floor ceiling, walls, light fixtures, dustbins, containers, tools, and vacuum cleaner.
- Ensure ‘CLEANED’ label is affixed on each equipment.
- Check the updation of status board & status label which shows the details of activity.
- Cleanliness of surrounding area of dustbins, containers, tools.
- Ensure the differential pressure of the area is within specified limit
- Check the proper gowning of personnel
- Ensure the swab/rinse analysis of equipment to be used has passed.
- Ensure the availability of BMR and filled up to the previous stage.
- Ensure that the equipment Logbook is filled up to the previous stage.
- Batch documents are completed up to this stage
Initial Check
Punch Specification
- 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 ________ Width________Diameter________
- Hardness -NLT __________ kg/cm2
- Disintegration NMT 15 min/NMT 30 min/NMT 01 Hours.
- Friability-NMT 1% W/W
Compression Pre-Startup
Procedure:
- Check the dies and punches for compliance with the product specifications.
- Adjust the compression parameters to per the product specifications.
- Reject the first two rounds of tablets at the start of the batch as Recoverable Rejects.
- Check for the initial round of tablets equal to the number of stations, for appearance and Embossing, if any.
- The tablets should be free from, picking, chipping, and any foreign matter.
- Start the compression, if the parameters comply with standards.
In-Process Parameter
- Appearance – Every 30 Minutes
- Group Wt. of 20 Tabs (g) _________ ± 3 % (Limit: _____ gm to _____ gm) – Every 30 Minutes
- Average Weight – ____________ mg ± 2 % (Limit : ________ mg to _______ mg) – Every 30 Minutes
- Hardness (NLT ___________ Kg/ cm2) – Every 01 hrs
- Disintegration time (NMT __________ Min) – Every 01 hrs
- Thickness: _____________ mm to______________ mm – Every 01 hrs
- Friability (%) (NMT _____________%) – Every 02 hrs
- Individual Weight Variation Limit – ______ mg ± 5 % (Limit : ____ mg to _____ mg) – Every 01 hrs
WEIGHT RECORD OF COMPRESSED TABLETS
- Sr. No.
- Gross Weight (kg)
- Tare Weight (kg)
- Net. Weight (kg)
- Weighed by
- Total weight
RECONCILIATION OF COMPRESSED TABLET
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)
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 released for coating
Sign/Date: (Production) Sign/Date: (QA)
if complies & mark ‘Not OK’ if does not comply during line clearance. Write NA if not applicable
Sifting Of Coating Material
- S. No.
- Material Name
- Quantity
- AR No.
- Done By/ On
Mixing of Coating material
- Mix Material of S. No. _______in S. No. ________in Purified Water for _______ min. in a mixing vessel.
- Add Color ___________ in __________lt of the above-prepared solution.Filter the color solution.
- Keep the solution for ______________ min. And proceed with the coating process.
- Divide the tablets of batch into _______(No.) of lots equally, having Lot size of ___________Kg.
- Set coating parameters as per product specifications.
- Pre-warm the tablets in a coating pan for a predefined time.
- After warm-up start the coating process by starting the coating spray from the gun & note the parameters in the Coating details.
Solution Preparation
- Type of Coating: Aqueous/ Non-Aqueous
- Color Name:__________________
Coating Pan Setting Details
- No. of Baffles
- No. of Guns
- Gun-to-Gun Distance
- Gun to Tablet Bed Distance
- Tab Av. Weight (uncoated) (mg)
Pre-Coating Preparation Details
- 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)
- Inlet Temp. (_______________OC)
- Tablet Bed Temp. (___________OC)
- Av. weight of Tablet (mg) (B)
- Coating weight gain (%) ({B-A}/A x100)
RECONCILIATION OF COATED TABLET
- A-Theoretical Tablets.
- B-Weight of the 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)
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 released for tablet inspection.
Sign/Date: (Production) Sign/Date: (QA)
TABLET INSPECTION
Instructions:
- There should not be any variation in the colour of the tablets and tablets should be of smooth surface.
- The tablet surface should not have spot & should not be broken.
- There should not be any “Blistering” or “Bridging” on the tablets
- There should not be any twinning of tablets
Area and Equipment line clearance of Tablet Inspection:
- Ensure the absence of batch documents, labels, materials, or any remnants of previous products or batches.
- Cleanliness of floor ceilings, walls, light fixtures, dustbins, containers, tools, and vacuum cleaners.
- Ensure the ‘CLEANED’ label is affixed on each piece of equipment.
- Check the updation of the status board & status label which shows the details of the activity.
- Cleanliness of the surrounding area of dustbins, containers, and tools.
- Ensure the differential pressure of the area is within the specified limit
- Check the proper gowning of personnel
- Ensure the swab/rinse analysis of the equipment to be used has passed.
- Ensure the availability of BMR and filled up to the previous stage.
- Ensure that the equipment Logbook is filled up to the previous stage.
- Batch documents are completed up to this stage.
Challenge Test for Metal Detector
- Ferrous
- Non-Ferrous
- SS Block
- Dummy Block
Tablet Inspection Record
- Container.Number
- Wt.of Tablets (Kg)
- Wt. of Tablet After Inspection
- Rejected Tablet
- Inspected By
RECONCILIATION OF INSPECTED TABLET
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:
- No. of BMR pages
- No. of Additional pages
- No. of Dispensing Labels
BMR REVIEW:
- Reviewed By Manager-Production and Manager-Quality Assurance
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 records & 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)