Batch Manufacturing Record(BMR)

Batch Manufacturing Record(BMR)

Document NoEffective DateRevision NoSupersedes Doc No
BMRNovember
Product NameAtorvastatin  calcium equivalent to Atorvastatin 10 mgpage 1 to….
Batch NoBatch Size2000000 tablets

 

Product Code
CompositionEach film coated tablet contain

Atorvastatin  calcium equivalent to Atorvastatin 10 mg

MFG DATE
EXP DATE
SHELF LIFE
BATCH MFG .COMMENCED ON
BATCH MFG. COMPLETED ON
QUANTITY PACKED
% YIELD :       LIMITS:90.0-100%
BMR PREPARED/COMPILED BY
BMR REVIWED BY
QTY RELEASED FOR DISPATCH

BATCH RELEASE 

REMARKS: All content of the batch record have  been checked ,reviewed & found complying/not compiling with the proper requirements .as per in-process check records & analytical  data submitted  by quality control the product complies/does not comply  with specifications. Hence the batch can/cannot be released for further manufacturing stage.

 QA Head

Authorized byDesignationSignatureDate

 

Prepared byChecked byApproved by
Designation
 Signature
Date

 

Tables of contents

2.0 Checklist of BMR

Sr.NoCheck PointsPage NoProductionQA
1Batch release and composition
2Check list of BMR
3General instruction
4Line clearance check for  dispensing
5Dispensing sheet of Raw Material
6Dispensing sheet of Coating Material
7Calculation of Material
8General instruction for manufacturing
9Equipment required for manufacturing

Manufacturing  Process

10Line clearance of granulation
11Affix dispensing label
12Manufacturing process
13Line clearance check for blending
14Blending
15Weight and reconciliation record of blend
16Analysis requisition sheet for blend analysis

Compression Process

17Compression general  instruction
18Line clearance  for compression
19Initial checks  for compression parameters & metal detector  performance record
20Start-up checks
21In process checks(RH.S)
22In process checks(L.H.S.)
23Uniformity of  weight
24Weight record of compressed tablets. Reconciliation
25Analysis requisition sheet

Coating process

26Line clearance for coating process
27Affix coating material dispensing label
28Coating process & parameter record
29Weighing record of coated tablet. Reconciliation of coated tablet
30Analysis  Requisition sheet
31Tablet inspection
32Reconciliation of inspected tablet

Documentation reconciliation

General Instructions

Dispensing of Raw material

  1.  Use nose mask and hands gloves during operation.
  2. Check for line clearance , cleanliness of the area  equipment and record the observations
  3. Check the temperature %RH  & differential pressure  of  dispensing area (20-25°c , 50±20%  NLT 1.2 mm of water)
  4. Check for qc approved label   and necessary details (material name, item code, manufacture’s name , B.no, MFG, EXP, A.R No, retest date etc.) on raw material container before weighing.
  5. Check and transfer the raw material required for batch near dispensing booth.
  6. Operate dispensing booth as per current SOP. Dispense the excipients first , remove  them from the dispensing area prior  to active ingredient dispensing.
  7. Make necessary entries in the manufacturing work order and the  store ledgers
  8. Attach dully filled dispensed material label to the dispense raw material and transfer the dispense material to dispensed material quarantine area.

Line clearance check for Dispensing of Raw Materials 

Name of previous  productBatch No.
EquipmentDispensing cabinetEquipment No.

Dispensing area:

Sr. No.ActivityStatus
Is the temperature 20-25°c? Actual Temp
Is the Humidity 50±20%RH?
Is the pressure differential NLT actual 1.2
Is the room is clean where the material to be dispensed is kept?
Is LAF table cleaned and switched on at least 15 minutes before staring dispensing ?
Are all the materials of previous batch/ product been completely removed including dust bins?
Is the balance is clean and calibrated?
Does all the materials to be dispensed have approved status?
Are all the dispensing device are clean & ready for use?
Are polybags of various sizes required for dispensing materials available?
Is the copy of said BMR relevant to dispensing available?

Note: Put √ where complies and put × where does not complies

Done by(Warehouse)Checked by (Production)verified by (Quality Assurance)
sign:

date

sign:

date

sign:

date

Start TimeStop Time
Done byDone by

Line clearance give at:

Raw Material Issue Note:

Sr.NoIngredientsSpec.Std.qtyActual QtyA.R NoGross wt.Tare wt.Net wtWt.byChecked byVerified by
StoreProductionQA
1Atorvastatin  calcium MicronizedIH2.17
2Microcrystalline Cellulose(Avicel PH 101)USP10.93
3Lactose Monohydrate(Pharmatose 200M)USP10.90
4Calcium carbonate (PPL)(Calopake extra light)EP/BP1.000

Water contents  shall be compensated  on the basis of actual %of water in API.  If the assay of the API is  more than 100%  the standard quantity of Atorvastatin  calcium shall be taken

Atorvastatin  calcium should be micronized& the particle size of Atorvastatin  calcium should be d90 below 50 micron.

Theoretically  10.85 mg Atorvastatin  calcium is equivalent to 10 mg Atorvastatin .

Quantity of Microcrystalline Cellulose to be adjust based on  actual assay & % w/w  water content of Atorvastatin  calcium

Sr.NoIngredientsSpec.Std. qtyActual QtyA.R NoGross wt.Tare wt.Net wtWt.by
Store
Checked byVerified by
ProductionQA
Blinder solution
Polyvinyl Pyrrolidone  K 30(Kollidon K 30)EP/BP1.000
Isopropyl AlcoholEP/BP8.00
Lubricant 
Colloidal Anhydrous  Silica (Aerosol 200)USP1.000
Croscarmellose sodium (Ac-di-SD-711)USP1.400
Magnesium StearateEP/BP0.600

 

Absent in final tablets

Requisitioned  by (Production)                                   Date

Coating material issue note:

Sr.NoIngredientsSpec.Std.qtyActual QtyA.R NoGross wt.Tare wt.Net wtWt.by
Store
Checked byVerified by
ProductionQA
Coating material
Opadry pinkIH1.000
purified waterEP/BP5.00

Requisitioned  by (Production)                                   Date

Calculation of material required for a single A.R no for the standard batch size

Calculation of Atorvastatin  calcium(For Single A.R.No)

A.R.No of Atorvastatin  calcium

Assay on Dried Basis (ODB)——-%w/w

LOD——–%w/w

Standard quantity of Atorvastatin  calcium for batch on 100% Basis(Q)in Kgs i.e. 2.17 Kgs for 200000 tablets batch size as per BMR.

Actual Quantity to be issued  Std Qty (Q) *100*100

against of Atorvastatin  calcium (Q1)in Kgs  =  Assay on (ODB)*(100-LOD)

 

Note: if quantity of Atorvastatin  calcium  insufficient for batch then proceed with under mentioned  calculation.

Calculation of material required if material available is not sufficient  from one Batch or Lot, then calculation of next  Lot/Batch shall be performed as under.

From first A.R No. quantity of batch  available (Q1) which insufficient for the batch & in this case remaining quantity shall be taken from another batch A.R No along with Q1 for 100% assay basis by the following expression.

A.R No of  Atorvastatin  calcium

Assay on Dried basis (ODB) ——%w/w

LOD——-% w/w

Quantity available Atorvastatin  calcium =  Kg

Available Quantity on

100% basis  of Atorvastatin   =  Quantity available * Assay (ODB)*(100-LOD)

calcium in Kgs(Q1)                           ————————————— = Kgs

100*100

Further use the following  expression to calculate the quantity of additional Atorvastatin  calcium quantity required from next batch or Lot 

A.R No. of Atorvastatin  calcium ————–

Assay on Dried basis (ODB) ——%w/w

LOD——-% w/w

Quantity  required of Atorvastatin  calcium another lot or batch at 100% basis in Kgs (Y)=Std. Quantity reqd. for the batch – Quantity for 1st  lot/batch. = ———-Kgs.

Available Quantity to be

issued against of Atorvastatin   = Std. quantity (Y)*100*100

calcium (Y1)in Kgs                           ————————————— = Kgs

Assay on (ODB)*(100-LOD)

Total Quantity issued in Kgs

Note: if more than two batches required than calculation follow these steps.

Adjustment or statement batch size in Kgs. 

Actual quantity of Atorvastatin  calcium to be calculated on the basis of assay and water of drug and the quantity to be compensated with microcrystalline cellulose (Avicel PH101).

Actual quantity of Atorvastatin  calcium – Standard quantity of Atorvastatin  calcium = Kgs

Standard  qty. of microcrystalline cellulose -quantity =Kgs

Calculation done by Production                                          Date

  • General instruction for Manufacturing 

During the operation all personnel of manufacturing area should wear clean uniform, cap, nose mask , hand gloves.

Check the relative humidity , temperature and pressure difference and record were ever necessary & should be Temp 20-25ºc  & RH 50±20%,PD -NLT 1.2 mm water.

Check the line clearance , cleanliness  of area and equipment.

Cross  check the weight of the material before taking up to manufacturing against dispensing label and status label.

In case of any deviations in the process ,intimate to the QA and take approval from the QA  for the same .

Whenever there is a machine break down during processing , rectify the machine and take again line clearance from QA before staring the operation.

Holding time

Dispensed materials : 15 days from the date of dispensing .

Blend : Compression to be completed with in 15 days from the date of quality control approval.

Compressed tablets : To be coated within 30 days from the date of compressed tablets

approval; by QC.

Coated tablets : Packing to be completed with in 45 days from the date of approval by QC.

Note : if hold period is expired, send the sample for Re-test to QC for approval before taking to next stage of operation.

Equipment NameEquipment Number
S.S Scoops & Inprocess plastic containers
Balance 300 gm/150 Kgs
Dispensing cabinet
Vibratory sifter
Fluid bed processor
Conta blender
Balance 1000 Kgs
Tablet compression machine 37 STN 45 STN
Balance 150 Kgs /600 gm
Deduster
Metal Detector
Dust collector
Lifting & positioning device
Balance(150 Kgs)|
Friability Apparatus
Digital hardness tester
Disintegration test apparatus
Vernier  caliper
Balance 220 gms
Auto coater machine
Solution preparation tank
Colloidal mill
Tablet inspection machine
Balance 150 Kgs

Manufacturing Process

Line Clearance for Granulation

Name of previous productBatch No
Equipment
  1. Vibro  sifter
  2. Fluid bed processor
Equipment NO

Granulation area

Sr.NoActivityStatus (√ or ×)
1is the temperature 20-25°c? Actual Temp
2is the Humidity 50±20%RH actual
3is the pressure differential NLT 1.2 Actual
4is the room clean , where the material to be processed is kept & where the processing is to be done?
5Do all the equipment have cleaned status labels & is the cleaning in the validity periods?
6Are all the material of previous product/batch been removed including the dust bin
7Are all the documents /papers  for the previous product / batch been removed
8Is the BMR for same product & required batch available?
9Are all  the material issued  are of the required batch & product only?

Note: Put √ where complies and put × where does not complies

Done by(production)Checked by (Production)Verified by(QA)
sign:

date:

sign:

date:

sign:

date:

Affix dispensing label

Atorvastatin Calcium MicronizedMicrocrystalline cellulose (Avicel PH 101)
Lactose MonohydrateCalcium Carbonate (PPT)(Calopake extra light)
Polyvinyl Pyrrolidone K 30(Kollidon K 30)Isopropyl Alcohol
Colloidal Anhydrous SilicaCroscarmellose  sodium
Magnesium Stearate

Manufacturing Process

ActivitiesOperator Checked byDate
Record the Environmental Conditions

Room Temperature ——–(Limit 20-25°c)

Relative Humidity———-(Limit 50±20%)

Pressure Difference ———(limit NLT)

Sifting

Sleve integrity checked (Before sifting)

Set sifter with 40 sleve and sift & mix

Atorvastatin Calcium Micronized

Standard Quantity 2.17 kg

Calcium Carbonate (PPT)(Calopake extra light)

Standard Quantity 1.000 kg

Set sifter  with 40 #sleve & mix with

Microcrystalline Cellulose (Avicel PH 101)

Standard Quantity 10.93kg

Lactose Monohydrate (Pharmatose 200M)

Standard Quantity 10.93kg

Collect sifted material in polyline container

Check the sleve integrity # 40 after sifting

Start Time  

Stop Time

Preparation of binding solution

Collect in a SS vessel

Isopropyl

Standard Quantity 8.00kg

ActivitiesOperator Checked byDate

Add slowly into isopropyl alcohol following material under stirring

Polyvinyl Pyrrolidone K 30(Kollidon K 30)    Kgs

Standard Quantity 1.000kg

Stir the solution until the Polyvinyl Pyrrolidone K 30(Kollidon K 30) is compleltely dissolved

Granulation

Set FBP & load in top spray product container ,sifted materials from 10 min at 20 rpm

Mixing starting at

Mixing over at

Blower speed

Set the parameters as given in following table

ParametersSetObserved
Inlet temperature30°-65°c
Bed temp.20°-35°c
Blower speed20-40Hz
Peristaltic pump speed20-80 rpm
Operator
Checked by
Date

Granulate material by spraying with binder and with   continuous drying. Dry the granules till the LOD of the granules is NMT 3.0% by halogen moisture balance

Granulation Time

From
To
LOD(NMT 3.0%)
Upload the dried granules in polyline containers

 

ActivitiesOperator Checked byDate

Sifting & Size reduction

Sleve integrity checked(before sifting)

Pass the dried granules through mesh 20 fitted on a vibro sifter

Start Time:

Stop Time:

Sleve integrity checked (after sifting)

Record of dried granules weight

Theoretical weight of granules            26.00Kgs

Actual weight of granules         Kgs

Loss                                               Kgs

Limit of loss 1.5%Actual Loss     %

Line clearance for Blending

Name of previous productBatch No
EquipmentConta Blender(Bin 150 lts)Equipment NO

Blending area

Sr.NoActivityStatus (√ or ×)
1is the temperature 20-25°c? Actual Temp
2is the Humidity 50±20%RH actual
3is the pressure differential NLT 1.2 Actual
4is the room clean , where the material to be processed is kept & where the processing is to be done?
5Do all the equipment have cleaned status labels & is the cleaning in the validity periods?
6Are all the material of previous product/batch been removed including the dust bin
7Are all the documents /papers  for the previous product / batch been removed
8Is the BMR for same product & required batch available?
9Are all  the material issued  are of the required batch & product only?

Note: Put √ where complies and put × where does not complies

Done by(production)Checked by (Production)Verified by(QA)
sign:

date:

sign:

date:

sign:

date:

Blending

ActivitiesOperator Checked byDate
 Sifting of lubricants

Set sifter with 40# sleve for lubricant ans sift

Colloidal Anhydrous Silica      Kgs

Standard Quantity 1.000 kg

Croscarmellose  sodium          Kgs

Standard Quantity 1.40kg

Set sifter with 60# sleve and sift

Magnesium Stearate            Kgs

Collect sifted material in polyline container

Check the sleve integrity # 40 after sifting

Start Time  

Stop Time

Blending

Fit IPC container to Conta Blender.

Load dried granules & lubricants in conta blender. Mix it for 15 min. on 9 RPM speed.

RPM of Blender9 RPMActual
Started atStopped at

Total Blending time(Std time 15 min.)

Weigh the material . Affix the label on the IPC. Transfer it to blend hold room

Weight Record of blend 

Date—-

Container NoContainer CleanlinessGross wt (Kgs)Tare wt (Kgs)Net wt(Kgs)Weighed byChecked by
Total

Lubricant Granules Reconciliation 

  1. Theoretical weight of the lubricated granules
  2. Actual weight of granules
  3. QC samples
  4. In-process check loss
  5. Process loss
  6. Actual percentage yield B*100/A  =   —–  =    ——  Kgs
  7. Reconciliation yield (B+C+D)*100/A  = —– = —— %

Checked by (Prod)

Counter Checked by (QA)

Send dully filled analysis requisition to QC Department to collect the sample  for analysis

Requisition analysis sheet  sent bySampled by
DateDate

Analysis Requisition sheet

Blend analysis

Mfg Date :                                                         Exp date:

Batch size :

Test required :

Signature:                                 Date:

Sampling Details

Sampled by:                       Sample qty:                    Sample date:

Test Report

A.R No

TestStandard SpecificationObservation
DescriptionWhite colour granule powder
AssayAtorvastatin  calcium 95-105% of LC
ReportThe sample complies/does not complies with the specification number

 

Analyzed by/DateChecked by /DateApproved by/Date
Chemist QC Executive QAQC Head
Sign:Sign:Sign:
Date:Date:Date:

Compression

  1. Bring approve blend into the Compression area
  2. Attach meatal detector unit after de-duster of compression M/C at both the side (LHS & RHS).Check the performance of metal detector at every start of the operation & every 4 hour during compression using 0.2 mm ferrous & 0.4 mm Non ferrous block  & record the observation .
  3. Compress the blend using upper punches 7.0 mm round  , standard , concave embossed with «10» & lower punches 7.0 mm round  , standard , concave plain .Set the parameters of compressed tablets as per the parameter mentioned below

Destroy the compressed tablets of initial two rotations

Carry out the initial checks before starting the operations as specified in the specification given.

Check and enter the individual weight of 37/45 tablets from RHS & LHS separately   in the formats provided

Check the record the Thickness  & Hardness ,DT, Friability , group wt of 20 tablets .

Check and enter the uniformity weight of 20 tablets from LHS  as well as  RHS in the prescribed format.

Collects the tablets in double polythene cover lined, tightly closed , container. weigh each container & record the weight in the given format

 The tablets used for the in process check should be destroyed as per current SOP

Line Clearance Checks for Compression Process                  Date

Name of previous productBatch No
Equipment
  1. Tablet compression Machine(37/45 stn)
  2. Metal  Detector
  3. DE duster unit
  4. Dust collector
  5. lifting and positioning device
Equipment NO

Compression  area

Sr.NoActivityStatus (√ or ×)
1is the temperature 20-25°c? Actual Temp
2is the Humidity 50±20%RH actual
3is the pressure differential NLT 1.2 Actual
4is the room clean , where the material to be processed is kept & where the processing is to be done?
5Do all the equipment have cleaned status labels & is the cleaning in the validity periods?
6Are all the material of previous product/batch been removed including the dust bin
7Are all the documents /papers  for the previous product / batch been removed
8Is the BMR for same product & required batch available?
9Are the bags fixed to dust collectors are dedicated ones
10Do the bins containing granules for the compression are of the relevant product/batch number and bins have released status ?
11Are the metal detector challenged?
12Is the startup test as per BMR?

Note: Put √ where complies and put × where does not complies

Done by(production)Checked by (Production)Verified by(QA)
sign:

date:

sign:

date:

sign:

date:

Line clearance given at———-on———-

Initial Checks

ToolDescriptionObservationChecked by
Upper punch7.0 mm round  , standard , concave embossed with «10»
Lower punch7.0 mm round  , standard , concave plain

 

DescriptionWhite to off white , round shaped coated tablets embossed with «10» on one side and plain on another side.
Weight of 20 tablets2.90gm /±3.0%
Average weight145.00mg ±3.0%
Thickness3.60mm±0.2mm
Diameters7.10 mm
HardnessNLT 20Kgs
Disintegration timeNMT 15 min
FriabilityNMT 1%

Performance Checks for Metal Detector 

Frequency: at every start of the operation & every 4 hour during compression

Size of Metal Block : 0.2 mm (ferrous) & 0.4 mm (Non ferrous)

DateTimeLHS EQP No.RHS EQP No.Checked by
FerrousNon FerrousFerrousNon Ferrous

Initial Checks

Weight of 20 tabletsAverage weightDiametersHardnessThicknessDisintegration timeFriabilityAppearanceApproved by
Sign(Prod)Sign(QA)
2.90gm /±3.0%145.00mg ±3.0%7.10 mmNLT 20Kgs3.60mm±0.2mmNMT 15 minNMT 1%White to off white , round shaped coated tablets embossed with «10» on one side and plain on another side.

Compression started  at —— on——-by——–checked by——

Compression completed at ——–on——–by——-checked by——

Compression m/c speed (RPM/60)

for compression machine——(20 -30 RPM)      by——-checked by——–

for  compression machine ——(30-50 RPM) by ——-checked by——-

Start up checks

Weight variation -LHSWeight variation -RHS
Weight of 37/45 tabletsWeight of 37/45 tablets
Average wtAverage wt
No.WeightNo.WeightNo.WeightNo.WeightNo.WeightNo.Weight

Weight no of equivalent to no of punches used (Limit for weight variation :±7.5%)

Actual variation LHS :       %  to    %

Actual variation RHS :       %  to    %

Done by                       Date                   Checked by               Date

In-process Check records (RHS)

Limit2.90gm±3.0%(2.813-2.97)3.60±0.2mm(3.40-3.80mm)NLT 2.0 Kgs (4.48kp)NMT 1%NMT 15 mininitials
Frequency½hourlyhourly2hourly2 hourly2 hourly
DateTimeWeight of 20 TabsThicknessHardnessFriabilityD.toper.checked by

In-process Check records (LHS)

Limit2.90gm±3.0%(2.813-2.97)3.60±0.2mm(3.40-3.80mm)NLT 2.0 Kgs (4.48kp)NMT 1%NMT 15 mininitials
Frequency½hourlyhourly2hourly2 hourly2 hourly
DateTimeWeight of 20 TabsThicknessHardnessFriabilityD.toper.checked by

Uniformity of Weights 

Limit of variation from the average weight ± 7.5%
Individual WeightTo be checked after 2 hour

RHS

Total weight of 20 tablets          gm       Av. wt of a tablet                   mg

Sign                               Time                         Actual deviation                %

LHS

Total weight of 20 tablets          gm       Av. wt of a tablet                   mg

Sign                               Time                         Actual deviation                %

RHS

Total weight of 20 tablets          gm       Av. wt of a tablet                   mg

Sign                               Time                         Actual deviation                %

LHS

Total weight of 20 tablets          gm       Av. wt of a tablet                   mg

Sign                               Time                         Actual deviation                %

RHS

Total weight of 20 tablets          gm       Av. wt of a tablet                   mg

Sign                               Time                         Actual deviation                %

LHS

Total weight of 20 tablets          gm       Av. wt of a tablet                   mg

Sign                               Time                         Actual deviation                %

Weight Record of Compressed Tablet

Cont. NoGross wt.Tare wt.Net wt.Weighed byChecked by
Total weight

Reconciliation of compressed Tablet

StageKgsNumber
Theoretical
Weight of granules received for compression
Weight of compressed tablet
Tablets send to Quality Control
In process sample
Loss during compression%%
Actual percentage yield%%
Reconciliation percentage yield%%
Reconciled by (Prodution)

date

Send dully filled analysis requisition to Q.C Department to collect the sample for analysis
Requisition analysis sheet sent bysampled by

Analysis Requisition Sheet

Stage : Compressed Tablet
Mfd date :                                     Exp. date:

Batch Size :

Test Required:

Sign :                        Date:

Sampling Details
Sample by                                              Date
Sample Qty
Test Report
A.R. No
Report          the sample complies/does not comply with the specification no
Analyzed byChecked byApproved by
Chemist QCExecutive QCHead QC
Sign:Sign:Sign:
Date:Date:Date:

Coating  Process

Name of previous productBatch No
Equipment
  1. Solution preparation tank
  2. Colloidal mill
  3. Auto coater machine
Equipment NO

Coating room

Sr.NoActivityStatus (√ or ×)
1is the temperature 20-25°c? Actual Temp
2is the Humidity 50±20%RH actual
3is the pressure differential NLT 1.2 Actual
4is the room clean , where the material to be processed is kept & where the processing is to be done?
5Do all the equipment have cleaned status labels & is the cleaning in the validity periods?
6Are all the material of previous product/batch been removed including the dust bin
7Are all the documents /papers  for the previous product / batch been removed
8Is the BMR for same product & required batch available?
9Ensure that container containing tablets for coating have released status
10Is the startup test as per BMR?

Note: Put √ where complies and put × where does not complies

Done by(production)Checked by (Production)Verified by(QA)
sign:

date:

sign:

date:

sign:

date:

Line clearance given at———–on———

Affix coating material dispensing label                Date

Opadry pink

Coating Process

ParametersLimitsObservations
Room Temperature20-25°c
Pressure DifferentialNLT 1.2
Relative Humidity50±20%
Checked by:

Date:

Preparation of Solution

In solution preparation tank add and prepare solution of the following materials

Opadry Pink

Std. Qty. 1.000 Kgs

Purified water

Std. Qty. 5.00 Kgs

Stir the solution for 1 hour

Solution preparation

Stirring Duration              from

To

Solution prepared by

Checked by

date

Coating

Load the tablets in coating pan. Start hot water blower , set supply air temperature at 65 -80°c. Start exhaust fan, warm the tablet  bed to 45°c.

When exhaust temp reaches 45°c, adjust spray gun , start the peristaltic pump with coating solution. Spray  the solution on rolling tablet bed; simultaneously keep on drying  the tablets . continue coating till the solution get exhausted.

Continue coating as per the following parameters

S.noParametersSpecificationObservation
1Pan speed3-6 rpm
2Peristaltic pump6-15 min
3inlet temperature65°c-80°c
4Exhausted temperature45°c-55°c
Coating time
To
Coating done by
Checked by            Date

Upload the tablet in polyline container and weight it. Check  & record the above parameters of coated tablets

ParametersSpecificationObservation
DescriptionPink, circular, biconvex film coated tablets with«10»embossed on one side and plain on other side.
Weight of 20 tablets3.00±3.0%(2.91-3.09 gms)
Average tablet150 mg± 3.0%
Thickness3.70±2.0mm
D.TNMT 30 min
Checked by

Weight Record of Coated Tablet

Cont. NoGross wt.Tare wt.Net wt.Weighed byChecked by
Total weight

Reconciliation of  Coated Tablet

StageKgsNumber
Theoretical200000 tablets
Tablet received for coating
QC sample
In process check loss
Loss during coating%%
Actual percentage yield%%
Reconciliation percentage yield%%
Reconciled by (Prodution)

date

Send dully filled analysis requisition to Q.C Department to collect the sample for analysis
Requisition analysis sheet sent bysampled by

Analysis Requisition Sheet

Stage : Bulk Coated Tablet
Mfgdate :                                     Exp. date:

Batch Size :

Test Required:

Sign :                        Date:

Sampling Details
Sample by                                              Date
Sample Qty
Test Report
A.R. No
Report          the sample complies/does not comply with the specification no
Analyzed byChecked byApproved by
Chemist QCExecutive QCHead QC
Sign:Sign:Sign:
Date:Date:Date:

Tablet Inspection

  1. Use nose mask and hand gloves during operation.
  2. Check for line clearance , cleanliness of the area  equipment and record the observations
  3. Transfer the coated tablet into the tablet inspection area.
  4. Transfer required qty. of tablets into the hopper of tablet inspection machine
  5. Inspect each tablets for any defects and segregate the good and rejected one
  6. Keep the inspected tablets in double polyethylene bag lined drum, weigh and record

Line clearance (Tablet Inspection)           Date

Time

Sr.NoActivityStatus (√ or ×)
1is the temperature 20-25°c? Actual Temp
2is the Humidity 50±20%RH actual
3is the pressure differential NLT 1.2 Actual
4is the room clean , where the material to be processed is kept & where the processing is to be done?
5Do all the equipment have cleaned status labels & is the cleaning in the validity periods?
6Are all the material of previous product/batch been removed including the dust bin
7Are all the documents /papers  for the previous product / batch been removed
8Are the remainants of previous batch/product removed?
9Is the area is clean & dity?
10Are relevant status labels affixed?
11Equipment clean (check visually or wash water reports)?

Checked by Production                  Counter Checked by QA

Tablet Inspection Record

Cont. NoWeight of tabletsWt. of tablets after inspectionRejected tabletsDateTimeInspected byChecked by
FromTo

Reconciliation of inspected tablets

NoStageKgsNumber
1Theoretical
2Tablet received for inspection
3Inspected tablets
4Rejection Tablets
5Actual percentage yield
Checked by

Document  Reconciliation

S.NoDescriptionQtyProduction(Sign)QA(Sign)
1No. of BMR pages
2No. of additional pages
3No. dispensing labels

Reviewed By Production                                                 Approved By QA

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