17 04 2023

BIONIAL HEALTHCARE PVT. LTD.
Page 1 of 34
D-97,PHASE-7,INDUSTRIAL AREA,MOHALI,PIN-160055
BATCH MANUFACTURING RECORD
PRODUCT NAME Hydroxyzine Hydrochloride Tablets IP BMR No.:
BATCH No. BATCH SIZE MFG. DATE EXP. DATE REQUIREMENT
EFFECTIVE DATE REVIEW DATE REVISION No. -Nil
1.0 PRODUCT INFORMATION

Product Generic name :
Composition : Each film coated tablet contains:
Hydroxyzine Hydrochloride
IP……………………………….10mg
Excipients………………………………………………
……..q.s
Colour : Approved colour used only
Batch number :
Batch size :
Manufacturing date :
Expiry date :
Shelf Life : 24 Months.
Mfg. Lic. No. : 1994-OSP & 2054 B
Date of commencement :
Date of completion :
AFTER BATCH COMPLETION:

Checked By(Manager - Production) Signature: Date:
Approved By(Manager - QA) Signature: Date:
2.0 CONTENTS OF BMR

S. Particulars Checked by Checked
No. Production by QA
1. General Instruction
2. Granulation
3. Lubrication
4. Sampling of Bulk materials
5. Weight of blended granules
6. Yield calculation
7. Compression
8. Initial Machine Setting
9. In-process Checks ( Production)
10. In-process Checks ( IPQA)
11. Individual Weight Variation (Production)
12. Individual Weight Variation (IPQA)
13. Weight of compressed tablets.
14. Yield Calculation 5
15. Coating 6-9
16. Sampling of finished product 10-11
17. Tablet Inspection 11
Prepared By Checked By Approved By
Name
Designation
Signature
Date
Format No.
BIONIAL HEALTHCARE PVT. LTD. Page 2 of 34
D-97,PHASE-7,INDUSTRIAL AREA,MOHALI,PIN-160055

18. Yield Calculation goods tablets 11

Name
Designation
Signature
Date
Format No.
BIONIAL HEALTHCARE PVT. LTD. Page No.
D-97,PHASE-7,INDUSTRIAL AREA,MOHALI,PIN-160055 3 of 34

3.0 RAW MATERIAL REQUISITION/ISSUE SLIP
Unit Std. Issued
Sr. Weighed Checked. Verified.
Kg / Overa Qty. for Qty. for Analytical Report Exp.
No. Ingredient Claim Assay LOD By By By.
Ltr. ges % 1.0 Lac ……. Lac No. Date.
(%) (%) (Store) (Prod.) (QA)
(in Kg) (in Kg)
Hydroxyzine Kg 1.05
1. 10 mg
Hydrochloride IP
2. Starch (Maize) Kg ---- ---- 3.15 ---- ----
Di Basic Calcium Kg 2.0+
3. ---- ---- ---- ----
Phosphate (DCP) 0.075
Micro crystalline cellulose Kg 4.0
4. ---- ---- ---- ----
(MCC-101)
5. PVP K-30 Kg ---- ---- 0.4 ---- ----
6. Iso Propyl Alcohol Ltr. ---- ---- 8.0 ---- ----
Micro crystalline cellulose Kg 2.0
7. ---- ---- ---- ----
(MCC-102)
8. Talcum Powder Kg ---- ---- 0.4 ---- ----
9. Magnesium Stearate Kg ---- ---- 0.4 ---- ----

Name
Designation
Signature
Date
Format No.

10. Cross carmellose sodium Kg ---- ---- 0.4 ---- ----
Colloidal Silicon Dioxide 0.2
11. ---- ---- ---- ----
(Aerosil)
Polacrillin Potassium 0.4
12. ---- ---- ---- ----
(Kyron-T-314)
Note: 1) As per 1.0 lac batch size qty. of DCP di-hydrate varies as per calculation of active raw material to make the total bulk of material except coating material = 15.0 +
0.075kg( for lub )
* For issued batch as per ___________batch size qty. of DCP di-hydrate varies as per calculation of active raw material to make the total bulk of material except coating
material = ______+
_____________( for lub )
3) Qnty. of active drugs (*)varies as per potency of raw material.
4) Std. quantity required = X x 100 x 100__________________
Assay on anhydrous / dried basis (100 – LOD/ M.C. Water in %)
Here X = claim with overages for total batch size .; M.C. = Moisture Content; LOD = Loss on Drying
5) Total wt. of material except Active ingredients & DCP (for 1.0 lac batch size )= 13.0 kg +0.075kg
* For issued batchTotal wt. of material except Active ingredients & DCP (for_____________batch size )= ____________
Requested by Production Verified by QA Issued by Store Received by Production
(Sign/Date) (Sign/Date) (Sign/Date) (Sign/Date)

Name
Designation
Signature
Date
Format No.
3.1 COATING MATERIAL

Unit Std. Issued
Sr. Weighed Checked. Verified.
Kg / Overa Qty. for Qty. for Analytical Report Exp.
No. Ingredient Claim Assay LOD By By By.
Ltr. ges % 1.0 Lac ……. Lac No. Date.
(%) (%) (Store) (Prod.) (QA)
(in Kg) (in Kg)
Film Coat Kg
1. ---- ---- ---- ----
Isopropyl Alcohol Ltr.

2. ---- ---- ---- ----
Methylene Chloride Kg
3. ---- ---- ---- ----
Kg
4. ---- ---- ---- ----
Requested by Production Verified by QA Issued by Store Received byProduction
(Sign/Date) (Sign/Date) (Sign/Date) (Sign/Date)

Name
Designation
Signature
Date
Format No.
EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil
4.0 CALCULATION SHEET

Material Disulfiram I.P. *If assay as is basis is less than as 100% adjust the qty. as per
following formula. Actual qty.= Std.qty.X100/Assay
AR. No.
Assay THE QUANTITY OF LACTOSEI.P. TO BE TAKEN =
Quantity of Lactose anhydrous will vary based on the Assay of
Factor NA Disulfiram I.P.as is basis to keep the average weight of tablet 760
Overage NA mg.
Qty. required for 500 X 100______
ACTUAL STARCH WT. =[Std. Wt. of Disulfiram I.P.
per tablet (mg) Assay of Disulfiram I.P (………...Kg) + Std. Wt. of Lactose anhydrous (………..Kg)
Qty. required for Qty. per tabs x B. Size
=Total Wt.-(Actual Wt.) = ……………..(Wt. Of Lactose
Batch (Kg) 1000 x 1000 anhydrous)
Actual Quantity
Calculation Done By (Production) Calculation Verified By ( QA ) :
Sign/ Date Sign / Date
5.0 GENERAL INSTRUCTIONS

1. Good manufacturing practices should be followed during the entire process of manufacturing including sampling
and dispensing.
2. All the containers and Equipment’s used for manufacturing shall be properly cleaned as per the relevant SOP.
3. All the Equipment’s and containers should have proper status label with Product name, Batch No., Mfg. Date.,Exp.Date.,
etc.
4. All the equipment’s should be operated as per the relevant SOP’s only.
5. All the measuring equipment’s and containers should be calibrated irrespective of the activity and use within the
date of calibration as per the calibration schedule.
6. Weights of all the Raw materials& Packing Materials should be cross check by production personnel against
dispensing label and dispensing sheet before taken up for manufacturing.
7. Overwriting in BMR shall be strictly avoided.
8. Critical parameters like temperature 20-30ºC, Humidity 35-50%,Differential Pressure (NLT 5 Pascal / NLT 0.5
mm of water) of area and RLAF should be maintained & recorded.
9. In process controls should be carried out throughout manufacturing operations as per relevant BMR and relevant
SOP’s.
10. Ensure that all materials like raw materials, lubricated granules, compressed tablets and coated tablets should
beplaced in respective areas with proper label to avoid mix up.
11. Attach system generated data recording sheets wherever applicable.
12. Line Clearance procedure should be followed.
Name
Designation
Signature
Date
Format No.
5.1GENERAL INSTRUCTIONS FOR PROCESSING

1. Masks and hand gloves should be used during processing.
2. Check for the line clearance, cleanliness of the area and equipment.
3. Appropriate weighing scales should be used while processing.
4. Ensure that all the weighing balances are calibrated.
5. Follow the SOP for processing.
6.0 Dispensing Process: Check for Line Clearance as per SOP No. BH/SOP/031
LINE CLEARANCE FOR DISPENSING
Date: Time:
Previous Product Name: Previous Product Batch No.:
Equipment Name Equipment ID No.
Dispensing Booth BH/WH/DSB/01
Sr. Check points Checked by Verified Remarks

No. (Production) by (Q.A.) (Ok/Not
(✓)or (X) (✓)or (X) Ok)
Check the cleanliness of the respective
1.
material air lock/Pass box/Area.
Ensure the equipments& utensils are clean &
2.
dry.
3. Check the balances are calibrated.
4. Check the calibration tag of RLAF is placed.
Ensure the absence of any materials & BMR
5. of the previous product in the area. Check
authorized BMR is available?
Check the person working in area for proper
6.
uniform i.e. cap, mask & gloves.
Check the temperature & relative humidity of
the area
7.
[I.H. Limit: Temp. = 23-270C, RH= NMT
60%
Check the differential pressure of the area
8. [I.H. Limit: NLT 5 Pascal]
Checked By (Production) Verified By (QA)

Name
Designation
Signature
Date
Format No.
7.0 SPACE FOR WEIGHING TAGS

Check point Checked By Verified By
(Production) (QA) Remarks
(ok/Not ok) (ok/Not ok)
Check the Weighting tags are attached or not.
8.0 Granulation Process: Check for Line Clearance as per SOP No. BH/QA/031
LINE CLEARANCE FOR
WET GRANULATION (SIEVING/ MIXING/ GRANULATION (WET)/ DRYING)
Date: Time:
Sr. Check points Checked by Verified by Remarks

No. (Production) (Q.A.) (Ok/Not Ok)
(✓)or (X) (✓)or (X)
1. Check cleanliness of the area
2. Check the cleanliness of the respective material air
lock/Pass box
3. Ensure the equipments& utensils are clean & dry
4. Ensure the absence of any process slip, materials & BPR of
the previous product in the area
5. Check the temperature & relative humidity of the area
[I.H. Limit: Temp. = 23-27 0C, RH= NMT 60% (wet
granulation)]
6. Check the differential pressure of the area
[I.H. Limit: NLT 5 Pascal]
7. Ensure the status label on the equipment
8. Toolkit and other unwanted things should be removed from
the area
9. Check the person working in area for proper uniform i.e.
cap, mask & gloves.
10. Dustbin should be cleaned

Name
Designation
Signature
Date
Format No.
S. Manufacturing Instructions Date Time Done Checked Verified

No. From To By By by (QA)
(Prod.)
8.1 Granulation Process
Check the weight of all ingredients / raw materials
taken for the batch.
8.2 SCREENING :
a)Record Temp. & Relative Humidity of the area.
Take
Hydroxyzine Starch (Maize) =____kg
Hydrochloride=____kg
Dibasic calcium Microcrystalline
phosphate (Dihydrate) Cellulose=____kg
=____kg
b) Sieve Starch through S.S. sieve # 60 using
mechanical sifter.
c) Sieve MCCP and DCP dihydrate through S.S
Sieve # 60 using mechanical sifter.
d) Sieve Hydroxyzine Hydrochloride through S.S
Sieve # 40 along with sieved starch ,DCP & MCC-
101 using mechanical sifter.
8.3 DRY MIXING : Dry Mixing in: RMG Mass Mixture

(a) Procedure for dry Mixing in Mass Mixture
i) Transfer the sieved material of Step 5.2 (e) in Mass
Mixer and Run the Machine for 30 minutes
(Mixing time of 30 min is for each lot)
ii) After mixing is over proceed for granulation.
(b) Procedure for dry Mixing in RMG
i) Transfer the sieved material of Step 5.2 (e) in RMG.
ii) Allow the RMG to run for 10 min.
(First, run RMG at slow speed at 40 RPM for 1min,
then run at fast speed at 80 RPM for next 9min.)
ii) After mixing is over, proceed for granulation
(Mixing time of 30 min is for each lot)
iv) After mixing is over proceed for granulation.

Name
Designation
Signature
Date
Format No.

(Prod.)
8.4 Binder Preparation
a) Take ___ ltr. Of Isopropyl Alcohol in S.S
Container.
b) To it add ____ PVP K-30 slowly with continuous
stirring till clear solution is formed.
Filter the solution through nylon filter cloth
8.5 Wet granulation
a)Procedure for wet granulation in mass mixture
i)Switch ‘ON’ the mass mixer. Now add the
homogeneous paste of step No. 5.4 into mass mixer
& mix well for 30 minutes till wet mass of dough like
consistency is formed. Intermittent kneading should
be done with the help of S.S flat spatula after 20 min.
Multi mill :Pass the material of step No. 5.5(i)
through multi mill fitted with S.S. mesh size 4mm.
Collect the wet granules in a new polythene bag fitted
into a plastic container.
b) Procedure for wet granulation in mass RMG
Add the binder solution to the dry powder mixture in
RMG ( with slow speed runing) over a time period of
4-5 min
Then mix at slow speed for 4 min & at high speed for
1 min with chopping. Collect the granules in FBD
trolley.
8.6 DRYING,SIEVING & MILLING : Dry Mixing in: RMG Mass Mixture
a)Procedure for drying in Tray Dryer
i)Dry the wet granules in Tray dryer for 15min, at
40C . Rake the granules using S.S.Spatula.
ii) After 15min raise temperature to 60C for 30
minutes with intermittent raking after 10 minutes.
iii)After 30mins. of drying , Pass the dried granules of
step No.5.6(a)(ii) through the mechanical sifter fitted
with S.S. sieve #20. Collect the sieved material in
polythene lined containers.
iv) Coarse material retained on the sieve is passed
through multi mill fitted with S.S. mesh size 1.5mm.
Now pass these granules through 20# mesh .

Name
Designation
Signature
Date
Format No.

(Prod.)
v) Dry these granules of step 5.6(a)(iii) &(a) (iv) Tray
dryer at 70C for_____min till the desired moisture
content not achieved .
vi) Pass the dried granules through mechanical sifter
fitted with S.S. mesh # 25. Collect the sieved material
in polythene lined container.
b)Drying in FBD
i) Dry the wet granules in FBD at 35ºC for15min.
(Note:- During 15min drying, After 5 min &10min.
run ,shake the finger bag for 30 sec then again start
drying till completion of 15 min. Then again shake
the finger bag then rake the granules using S.S.
Spatula)
ii) After 15min raise temperature temp. at 50ºC for
15min.(Note :- During 15 minutes drying Shake
finger bags after 5 ,10 & 15 min for 30 sec each time ,
then again start drying . After completion of 15 min
drying rake the granules using S.S. Spatula.)
iii) Pass the dried granules of step No.5.6(a)(ii)
through the mechanical sifter fitted with S.S. sieve
#20. Collect the sieved material in polythene lined
containers
iv) Coarse material retained on the sieve is passed
through multi mill fitted with S.S. mesh size 1.5mm.
Now pass these granules through 20# mesh
v)Now put all the material again in FBD Bowl for
final drying. Dry the wet granules in FBD at 70ºC for
20min .(Note :- After 5min, shake the finger bag for
30 sec then again start drying till required temp is
attained .Final shaking of bag is to be done for 4
minutes i.e. before taking out material )
vi)Pass the dried granules through mechanical sifter
fitted with S.S. mesh # 25. Collect the sieved material
in polythene lined container.

Name
Designation
Signature
Date
Format No.

(Prod.)
c) Moisture Content
Check the moisture content & note it down. (Moisture
content = 0.6 – 2.4 %)
Moisture Content Observed = ___________%
8.7 Record the weight of dried granules:

Weight of dried granules :
Sr. Gross Wt. Tare Wt. Net Wt.
No. (Kg) (Kg) (Kg)
Total Net weight Dried granules:
Checked By (Production)
Verified By (QA)
8.8 a) Label the containers properly with green colored

‘Process slip’ regarding Product name, Batch no. ,
Batch size, Mfg. Date, Exp. Date, Process stage no. of
containers, date & signature. Send it to Quarantine
store or for lubrication.
b) Record temperature & relative humidity of the area
9.0 Lubrication process : Check for Line Clearance as per SOP No.JP/QA/022
Name
Designation
Signature
Date
Format No.
LINE CLEARANCE FOR LUBRICATION

Date: Time:
Octagonal Blender

No. (Production) (Q.A.) (Ok/Not
(✓)or (X) (✓)or (X) Ok)
2. Check the cleanliness of the respective Pass box
3. Ensure the equipments& utensils are clean & dry
4. Ensure the absence of any process slip, materials & BPR

of the previous product in the area
[I.H. Limit: Temp. = 20- 30 0C, RH= 35-50%]
8. Toolkit and other unwanted things should be removed

from the area
cap, mask & gloves.
10. Dustbin should be cleaned

Name
Designation
Signature
Date
Format No.
By By
No. By
From To (Prod.) (QA)
9.1 LUBRICATION: a) Take:-

MCC-102=______kg Talcum =______kg,
C.C.S = _______kg Magnesium

Stearate =___kg
Kyron-T-314=__kg Aerosil = ______kg
b) Put half of the dried granules in Octagonal

blender.
c) Sieve Mcc-102, C.C.S and Kyron-T-314
through #60.
d) Load material of step no. 10(c ) in octagonal
blender and run for 5 mins.
e) Load remaining dried granules in Octagonal
blender and rum for next 5 minutes.
f) Sieve talc and Magnesium Stearate through S.S
sieve #60 and mix with Aerosil. g) Now sieve this
material through S.S sieve #30 and mix with 05Kg
of material taken from Octagonal blender.
h) Sieve material of step no. 10 (g) through S.S
sieve #16 and load in Octagonal blender.
i) Run Octagonal blender for 3 minutes.
9.2 Unload the lubricated granules into polythene lined container & label it properly with yellow colored ‘Process
slip’ mentioning Product Name, Batch No., Batch size, Mfg. Date, Exp. Date, Process stage, No. of containers &
Signature
9.3 Record the weight of lubricated granules (L.G.).
Weight of lubricated granules :

Sr. No. Gross weight (Kg) Tare weight (Kg) Net weight (Kg)
Total of lubricated granules

Theoretical Wt. Of Lubricated Granules = 128.0 kg YIELD ____________% (I.H. Limit = NLT 99.0%)
Avg. Weight of lubricated granules _________mg
6.4 RECONCILIATION OF LUBRICATED BLEND

Name
Designation
Signature
Date
Format No.
Checked by Verified by
Sr. No. Description Qty. in Kg % Yield
(Production ) (IPQA)
A. Theoretical Wt. Of Lubricated Granules
B. Actual yield for Lubricated granules

C. Sample Quantity (L.O.D/In-Process checks)
D. Sample Quantity (Analysis/Validation/Other
E. Rejects (if any)
F. Total accounted for (B+C+D+E)
G. Unaccountable Loss (A-F)
6.5 a) Transfer the granules to quarantine store & record temperature & Refer To Environment Monitoring
relative humidity of the area. Record
b)Send Testing Requisition Slip to QA asking to withdraw the sample of

lubricated Granules. REFER TO TESTING REQUISITION
SLIP
c) After getting OK report from QC then proceed for compression.
7.0 COMPRESSION: Check for Line Clearance as per SOP No.JP/QA/022
LINE CLEARANCE FOR COMPRESSION
Date: Time:

no. (Production) (Q.A.)
(✓)or (X) (✓)or (X)
2. Check the cleanliness of the respective air lock

3. Ensure the cleanliness of compression machine,
de-dusters, dust extractors & scoops

Name
Designation
Signature
Date
Format No.
4. Ensure the absence of any materials, Batch sheets & BPR

[I.H. Limit: Temp. = 20- 30 0C, RH= 35-50%]
8. Check the calibration status of weighing balance
9. Toolkit and other unwanted things should be removed from

the area
cap, mask & gloves.
11. Ensure that Hopper, turret, feed frame and punches & dies
are properly Cleaned & dried and the dismantled parts are
reassembled.
Checked By (Mfg. Chemist): Verified By (Q.A. Executive):
Signature & Date: Signature & Date:
7.1 Check the Die and Punch for compliance with the specification given below. Punch Set No.
Checks Size Specification Observation(OK or Not OK)
Punch Specification 17.6 mm Oblong, Biconcave
Upper Punch Break line
Lower Punch Plain
Dies Suitable for above
Punch Checked by (Executive Production) Punch Verified by (Executive IPQA)
Time Checked
S. Done By Verified
Manufacturing Instructions Date
No. From To By By (QA)
(Prod.)
7.2 COMPRESSION :
a)after Line Clearance fit the 37 station Rotary

Compression Machine’ with above punch set no.

Name
Designation
Signature
Date
Format No.
details.
Set Penetration at ¼ (20 station )
a)Bring material of Step No. 6.5 to Compression area

& load the material in the hopper of ‘37 station Rotary
Compression Machine’ using S.S. scoop & machine
setting is done to achieve the following parameters :
S.No. Parameter In House Limit Frequency to Check
White coloured,uncoated,round
Description shaped,biconvex tablet with both sides
plain
A Set Weight 150mg
B Weight of 20 tablets _________to __________gm ± _____% INITIAL&EVERY 30 MIN
C Uniformity of weight ± _________% of the Avg. Weight INITIAL&EVERY 60 MIN
E Friability Not more than 1.0% INITIAL&EVERY 60 MIN
F Hardness Not less than ____ kg/ cm2 INITIAL& EVERY 60 MIN
G Length/Diameter _____________ mm + 0.3mm INITIAL&EVERY 60 MIN
H Thickness _____________mm + 0.6mm INITIAL&EVERY 60 MIN
I Disintegration Time NMT ______________Min. INITIAL&EVERY 60 MIN
7.3 Initial Check Parameter by Production:
Thickness Diameter Hardness Disintegrat Friability

ion Time L.H.S R.H.S
L.H R.H L.H R.H L.H R.H L.H. R.H. Inti Fin Per Inti Fin Per
Readin
.S .S .S .S .S .S S S al al c. al al c.
gs
(m (m (m (m (kg/ (kg/ (min (min wt. wt. % wt. wt. %
m) m) m) m) cm2 cm2 .) .) (m (m (m (m
) ) g) g) g) g)
1.
2.
3.
4.
5.
6.
Name
Designation
Signature
Date
Format No.
7.
8.
9.
10.
Averag
e
Min.
Range
Max
Range
Checke
d by
Product
ion
Verifie
d by
IPQA
7.4 WEIGHT VARIATION
A) L.H.S [Wt of one full round Tablets (Individual weights)]:Set wt.: 760 mg Av wt.:
Sr.N Wt Sr.No. Wt Sr.No. Wt Sr.No Wt Sr.No. Wt Sr.No. Wt Sr.No. Wt
1. (mg) 6. (mg) 11. (mg) 16. (mg) 21. (mg) 26. (mg) 31. (mg)
o. .
22
2. 7. 12. 17. 22. 27. 32.
3. 8. 13. 18. 23. 28. 33.
4. 9. 14. 19. 24. 29. 34.
5. 10. 15. 20. 25. 30. 35.
Max.wt. Min.wt. Max. Dev. in % Min. Dev. in %
B) R.H.S [Wt of one full round Tablets (Individual weights)]:Set wt.: 760 mg Av wt.:
Sr.N Wt Sr.No. Wt Sr.No. Wt Sr.No Wt Sr.No. Wt Sr.No. Wt Sr.No. Wt
1. (mg) 6. (mg) 11. (mg) 16. (mg) 21. (mg) 26. (mg) 31. (mg)
o. .
22
2. 7. 12. 17. 22. 27. 32.
3. 8. 13. 18. 23. 28. 33.
4. 9. 14. 19. 24. 29. 34.
5. 10. 15. 20. 25. 30. 35.
Max.wt. Min.wt. Max. Dev. in % Min. Dev. in %

Name
Designation
Signature
Date
Format No.
Time Checked Verifie

S. By
Manufacturing Instructions Date Done By d By
No. From To
(Prod.) (QA)
7.5 a)After achieving above parameters,intimate QA/QC to REFER TO IN PROCESS CONTROL SHEET PAGE
with draw the sample & check for the compliance of
above parameters
b)After getting approval from QA/QC, start the regular

compression .
Machine Speed = 1184-1480 tab/ min. for 37 station

 PLC setting on 37 station compression
machine
Feeder RPM: LHS=16 to 18 , RHS=16 to 18
Turret RPM: LHS= 16 to 18 , RHS=16 to 18
Ratio: LHS= 1, RHS=1
c)Allow the compressed tablets to pass through De-

duster for de-dusting & de-burring and Collect the
tablets in polythene lined containers.
&Collect the tablets in polythene lined containers
7. 6 INPROCESS SHEET OF COMPRESSION
STARTING DATE COMPLETION DATE SET WT. WT. OF 20 TABLETS Limits of wt. of 20 Tablets
________to_______ gm (+……..%)
PARAMETERS DATE TIME READING 1 READING 2 READING 3 READING 4 READING 5
HARDNESS IN kg/cm2

Name
Designation
Signature
Date
Format No.
THICKNESS IN MM
WEIGHT OF 20
FRIABILITY
TAB.
CHECK
L.H.S R.H.S INITIAL FINAL CHECKED
DATE TIME FRIAB D.T ED BY
(mm) (mm) WT. OF WT. OF BY Q.A
ILITY PROD.
TAB. (in TAB.
IN %
gm) (in gm)
7.7 INPROCESS SHEET OF COMPRESSION (UNIFORMITY OF WEIGHT)
DATE
TIME
S. NO. L.H. R.H. L.H.S R.H. L.H.S R.H. L.H.S R.H. L.H.S R.H.
S S (mg) S (mg) S (mg) S (mg) S
(mg) (mg) (mg) (mg) (mg) (mg)
Name
Designation
Signature
Date
Format No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
WT. OF 20
TAB.(in gm)
AVG.WT.
(mg)
MAX.WT.
(mg)
MAX.DEV.
IN %
MIN.WT.
( mg)
MIN. DEV.
IN %
Checked by
Production
Verified by
IPQA

Name
Designation
Signature
Date
Format No.
Note: Additional pages to be issued as per batch size at the time of BMR issuance.
Time Check Verifie

S. ed By
No. From To
(Prod.) (QA)
7.8 a) After completing the compression, pack the

compressed tablets(C.T.) & label the container properly
with yellow colored ‘Process slip’ regarding Product
name, Batch no., Batch size, Mfg. Date, Exp. Date ,
Process stage , no. of containers & signature.
b) Record the weight of compressed tablets (C.T)
7.9
Weight of Compressed tablet :

Total (Net weight of Compressed tablets)

Theoretical Wt. Of Lubricated Granules = 128.0 kg YIELD ____________% (I.H. Limit = 97.0 – 99.8 %)
Checked by (Production ) Verified by (IPQA)
7.10
RECONCILIATION OF COMPRESSED TABLETS
A. Theoretical Wt. Of compressed tablets
B. Actual yield for compressed tablets

Name
Designation
Signature
Date
Format No.
E. Rejects (if any)

7.11 a) Transfer the compressed tablets(C.P.) to quarantine Refer To Environment Monitoring Record
store & record temperature & relative humidity of the
area.
b)Send Testing Requisition Slip to QA/QC asking to

withdraw the sample . REFER TO TESTING REQUISITION SLIP
c) After getting OK report from QC then proceed for
futher process
COATING: Check for Line Clearance as per SOP No.JP/QA/022

8.0
LINE CLEARANCE FOR COATING
Date: Time:

no. (Production) (Q.A.) (Ok/Not Ok)
(✓)or (X) (✓)or (X)

Name
Designation
Signature
Date
Format No.
2. Check the cleanliness of the respective air

lock
3. Ensure the cleanliness of compression
machine,
de-dusters, dust extractors & scoops
4. Ensure the absence of any materials, Batch
sheets & BPR of the previous product in
the area
5. Check the temperature & relative humidity
of the area
[I.H. Limit: Temp. = 20- 30 0C, RH= 35-
50%]
8. Check the calibration status of weighing
balance
9. Toolkit and other unwanted things should
be removed from the area
10. Check the person working in area for
proper uniform i.e. cap, mask & gloves.
11. Ensure that the pan, blower, spray gun and
other parts are properly cleaned dried and
reassembled.

Name
Designation
Signature
Date
Format No.
Time Checked Verifie

S. By
No. From To
(Prod.) (QA)
8.1 Preparation of Film Coat
Film Coat =____Kg IPA= ____Lts
Methylene Chloride= __Lts
a)Take IPA & in it add Film Coat slowly with

continuous stirring so that a vortex is formed. Care
should be taken that no lumps are formed . Then add
color and Stirr it.
b)Now add MDC in it with continuous stirring .
c)Filter the solution through nylon filter cloth.
8.2 Procedure for coating: FOR SET PARAMETERS REFER TO IN PROCESS

a) Load the Compressed tablets in the coating pan. CONTROL SHEETS
b) Start spraying coating solution as prepared in step no.
9.1.Continue spraying till the whole solution is
consumed.
c)Allow the tablets to dry in the pan with blower ON for
5 min.
d)Unload the tablets in polythene lined container & label

the container properly labelled ‘Process slip’ mentioning
Product name, Batch No., Batch size, Mfg. Date, Exp.
Date, Process stage, No. of container & signature.
E)
e) After completion of coating process, note down the

following parameters of coated tablets in ‘In process
Control sheet’.
S. Parameter In House Limit

No.
A Uniformity of ±5.0% of the average weight

Name
Designation
Signature
Date
Format No.
weight (Av. Weight 160.45-170Kg)
B Disintegration NMT 25 min
C Thickness 7.65-8.05mm
D Length 3.47-3.83mm
8.3 INPROCESS SHEET OF COATED TABLETS
PARAMETERS STANDAR OBSERVATION

D LOT I LOT II LOT III LOT IV
PAN SPEED 3-10
(RPM)
BED TEMP. 40OC-45 OC
INLET TEMP. 45OC-55 OC
EXHAUST 34OC-55 OC
TEMP.
ATOMIZATION 2-4 KG
PRESSURE
RPM OF 15-20
PERISTALTIC
PUMP
DIMENSIONS READIN READIN READIN READIN READIN MI MA

G G G G G N. X.
LENGTH/
DIAMETER (IN
MM)
THICKNESS(IN
MM)
DISINTEGRATION TIME:……………………………(LIMIT)
…………………………………………………….

Name
Designation
Signature
Date
Format No.
INPROCESS SHEET OF COATED TABLETS (UNIFORMITY OF WEIGHT)
DATE
TIME
S. NO. LOT I (in mg) LOT II (in mg) LOT III (in LOT IV (in
mg) mg)
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
WT. OF 20 TAB.(in
gm)
AVG. WT.(in mg)
MAX. WT.(in mg)
MAX. DEV. IN %
MIN. WT.(in mg)
MIN. DEV. IN %
CHECKED BY
SIGNATURE BY
SIGNATURE BY

Name
Designation
Signature
Date
Format No.
PRODUCTION CHEMIST
Q.A CHEMIST
8.4 Record the weight of coated tablet. ( C .T
Weight of Coated tablet :


Theoretical Wt. Of Lubricated Granules = 128.0 kg YIELD ____________% (I.H. Limit = 97.0 – 99.8 %)
Average of tablets :
8.5 RECONCILIATION OF COATED TABLETS
Checked by Verified
Sr. Qty. in
Description % Yield (Production by
No. Kg
) (IPQA)
A. Theoretical Wt. Of coated tablets
B. Actual yield for coated tablets

C. Sample Quantity (L.O.D/In-Process
D. Sample
checks) Quantity
E. Rejects (if any)
8.6 a) Transfer the Coated tablets(C.T.) to quarantine store Refer To Environment Monitoring Record
& record temperature & relative humidity of the area.
b)Send Testing Requisition Slip to QA/QC asking to

withdraw the sample .
c) After getting OK report from QC then proceed for REFER TO TESTING REQUISITION SLIP
Visual inspection

Name
Designation
Signature
Date
Format No.
Visula inspection: Check for Line Clearance as per SOP No.JP/QA/022

9.0
LINE CLEARANCE FOR VISULA INSPECTION
Date: Time:

Name
Designation
Signature
Date
Format No.
no. (Production) (Q.A.) (Ok/Not Ok)

(✓)or (X) (✓)or (X)
2. Check the cleanliness of the respective air lock

3. Check and ensure all machine/equipments are clean in
Tablet Inspection area.
4. Ensure the absence of any materials, Batch sheets & BPR
[I.H. Limit: Temp. = 20- 30 0C, RH= 35-50%]
cap, mask & gloves.
Time Check
S. No. Manufacturing Instructions Date Done By ed By
From To
(Prod.)
9.1 Visual Inspection of Tablets:
a) Before start of packing, tablets are visually inspected

as per PROD/SOP-329. After inspection, record the
weight of defective tablets.
(I.H. limit for defective tablets is NMT 0.5% of

Theoretical Wt. of coated tablet i..e.=0.661 Kg)
b) Observed Weight Of Defective

Tab._________________ Kg________________%.

Name
Designation
Signature
Date
Format No.
9.2 Record the weight of Visually inspected Tablets:
Weight of Visually inspected Tablets:


Theoretical Wt. Of Visually inspected Tablets:= 128.0 kg YIELD ____________% (I.H. Limit = 97.0 – 99.8 %)
Average of tablets :
8.5 RECONCILIATION OF Visually inspected Tablets:
A. Theoretical Wt. Of Visually inspected

Tablets:
B. Actual yield for Visually inspected Tablets:

E. Rejects (if any)
8.6 a) Transfer the Visually inspected Tablets to quarantine Refer To Environment Monitoring Record
store & record temperature & relative humidity of the
area.
b)

Name
Designation
Signature
Date
Format No.
1.0 TRANSFER OF RELEASED TABLETS FROM PRODUCTION TO PACKING AREA
Quantity Transferred: ____________ kg  _________________ Tablets.
____________________ ____________________
_______________
Date & Time Sign. (Production) Sign.
(Packing)
If the yield differs from the permissible limit, Quality Assurance & Production should jointly
conduct investigation and the findings aBd decisions should be documented.
2.0 BIFURCATION OF BATCHES FOR PACKING:
BATCH ALLOCATION SHEET
3.0 MOTHER BATCH DETAILS

PRODUCT GENERIC NAME :
MOTHER BATCH NUMBER :
BATCH SIZE :
MANUFACTURING DATE :
EXPIRY DATE :

Name
Designation
Signature
Date
Format No.
NOTE : ONLY SINGLE BRAND WILL BE PACKED IN SAME MOTHER BATCH

NUMBER AND MORE THEN ONE BRANDS WILL BE PACKED IN SERIES OF A & B,….
SERIES.
MOTHER BATCH IS DIVIDED INTO FOLLOWING BRANDS DETAILS ARE

MENTIONED BELOW
ORDER
NO. OF
BATCH NO. QTY (IN PACK PACKING MRP(PER
BRAND NAME BOXES
ALLOTED NO. OF SIZE SPECIFICATION ___ TAB.)
REQUIRED
TAB.)
Remarks : Order quantity may varied after Packing.
SIGNATURE OF
SIGNATURE OF
PRODUCTION MANAGER Q.A

MANAGER/EXECUTIVE

Name
Designation
Signature
Date
Format No.
PACKING
Perform the packing as per Batch Packing Record.

Name
Designation
Signature
Date
Format No.

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BIONIAL HEALTHCARE PVT. LTD.

EFFECTIVE DATE REVIEW DATE REVISION No. -Nil

1.0 PRODUCT INFORMATION

AFTER BATCH COMPLETION:

2.0 CONTENTS OF BMR

EFFECTIVE DATE REVIEW DATE REVISION No. -Nil

Prepared By Checked By Approved By

EFFECTIVE DATE REVIEW DATE REVISION No. -Nil

Prepared By Checked By Approved By

EFFECTIVE DATE REVIEW DATE REVISION No. -Nil

Requested by Production Verified by QA Issued by Store Received by Production

(Sign/Date) (Sign/Date) (Sign/Date) (Sign/Date)

EFFECTIVE DATE REVIEW DATE REVISION No. -Nil

3.1 COATING MATERIAL

Isopropyl Alcohol Ltr.

Requested by Production Verified by QA Issued by Store Received byProduction

(Sign/Date) (Sign/Date) (Sign/Date) (Sign/Date)

Prepared By Checked By Approved By

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

4.0 CALCULATION SHEET

5.0 GENERAL INSTRUCTIONS

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

5.1GENERAL INSTRUCTIONS FOR PROCESSING

Sr. Check points Checked by Verified Remarks

Checked By (Production) Verified By (QA)

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

7.0 SPACE FOR WEIGHING TAGS

Sr. Check points Checked by Verified by Remarks

Checked By (Production) Verified By (QA)

Prepared By Checked By Approved By

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

S. Manufacturing Instructions Date Time Done Checked Verified

8.3 DRY MIXING : Dry Mixing in: RMG Mass Mixture

Prepared By Checked By Approved By

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

S. Manufacturing Instructions Date Time Done Checked Verified

Prepared By Checked By Approved By

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

S. Manufacturing Instructions Date Time Done Checked Verified

Prepared By Checked By Approved By

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

S. Manufacturing Instructions Date Time Done Checked Verified

8.7 Record the weight of dried granules:

Total Net weight Dried granules:

8.8 a) Label the containers properly with green colored

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

LINE CLEARANCE FOR LUBRICATION

Sr. Check points Checked by Verified by Remarks

2. Check the cleanliness of the respective Pass box

3. Ensure the equipments& utensils are clean & dry

4. Ensure the absence of any process slip, materials & BPR

8. Toolkit and other unwanted things should be removed

Checked By (Production) Verified By (QA)

S. Manufacturing Instructions Date Time Done Checked Verified

EFFECTIVE DATE REVIEW DATE 16/12/2024 REVISION No. -Nil

9.1 LUBRICATION: a) Take:-

C.C.S = _______kg Magnesium

b) Put half of the dried granules in Octagonal

Weight of lubricated granules :

B Weight of 20 tablets ___to gm ± _% INITIAL&EVERY 30 MIN

Film Coat =Kg IPA= Lts