BATCH MANUFACTURING RECORD (BMR)

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

  • AppearanceEvery 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)

 

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