LUCENT BIOTECH LTD.

(UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
Product Name:

Label Claim Each Uncoated Chewable Tablet Contains:

Iron (III) Hydroxide Polymaltose Complex
Eq. to Elemental Iron...................100 mg
Folic Acid IP.................................350 mcg
Excipients:......................................q.s.

Mfg. Lic. No. 43/UA/2016

Product Shelf life: …………. Months

BMR Effective Date:
Store in a cool, dry and dark place. a temperature not exceeding
Storage conditions:
30c
Market Domestic
Reference MFR No.: MFR/T/085-00

Standard Batch size 1.0 Lac Assigned Batch size

MFG. Date: Expiry Date:

………………….……… …………………….
Sign/ B.M.R. Received By Sign/
B.M.R. Issued By QA
Date: ………………….. Production Date: ………………

Batch
Batch Completion …………………….
Commencement ………………………….
Date: (Bulk Ready for
Date: (RM Dispensed Date)
Packing)
BMR Reviewed and IPQA Sign/ Date: QA Head Sign/Date:
Final BMR
Batch Release For
Batch Approval
Packing BY IPQA: …………… ……………

Function Prepared By Reviewed By Checked By Approved By

Functional QA officer Executive Production Head-Production Head QA

Sign
Date
Name

Format No.: QA/029/F02-00 1 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

1.0 INDEX:

S. No. Contents Page No.

Products information 1

1.0 Index 2

2.0 Specimen signature & general instructions 3

3.0 Line clearance for dispensing area 4

4.0 Bill of raw material 5-7

5.0 Line clearance for granulation area 8

6.0 Manufacturing process 9-15

7.0 Line clearance for compression 16-27

8.0 Visual inspection & metal detection Line clearance for Visual inspection 28-32

9.0 Batch manufacturing summary 33

10.0 Revision History 33

11.0 Check list of BMR 34

12.0 Verify The Bmr Up To Inspection Stage 34

Format No.: QA/029/F02-00 2 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
2.0 SPECIMEN SIGNATURE:
Specimen signature of person will be made in below table before signing at any place in BMR.
Sr. Signature/
Name of Employee Designation Department Stage
No. Date
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
2.1 GENERAL INSTRUCTIONS:
 Ensure that the area is clean & free from previous batch left-over/traces.
 Clean the equipments as per their respective SOP.
 Ensure that in dispensing area only those materials are stacked / present, which are required
for dispensing of one particular batch.
 After completion of Manufacturing & filling area and the equipments are to be cleaned.
 Follow SOP for personal hygiene.
 Take line clearance for respective stages from QA department before starting production.
 The Batch should dispense according to the BMR.
 All the Ingredients should be issued in a specific area designated for dispensing.
 Ensure that environmental conditions for dispensing are should be NMT 27 OC & Relative
Humidity 55%.
 Ensure that all time in 24 Hrs format & Date DD/MM/YYYY format only.
 Ensure that all measuring devices & balances are calibrated. Equipments require to be
Calibrate/verified daily are done regularly.

Format No.: QA/029/F02-00 3 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
3.0 LINE CLEARANCE FOR DISPENSING AREA: Date:
3.1 Enter the process area as per current version of SOP No.: HR/002
3.2 Check the temperature & relative humidity of the area before commencing, during the
process & at the end, as per the current version of SOP No.: WH/027
3.3 Take line clearance for dispensing as per current version of SOP No.: QA/013
Previous Product: Batch No.:
Status Checked Verified
Sr.
Checks to be Performed Complies/Not By By
No.
Complies (Store) (Q.A)
1. Ensure that status label duly filled at dispensing area.
Ensure that all logbooks duly completed up to previous
2.
activity.
Ensure that absence of any material from previous batch or
3.
product including labels, document etc.
Ensure that the floor, walls, ceilings grills, light fixtures &
4.
doors are clean.
The waste bins should be empty and clean from both inner
5.
and outer side, having clean poly bag inside.
The balance should be verified at the start of daily work &
6.
monthly calibration recorded in the logbook.
7. Ensure the cleanliness of dispensing area.
Check the Cleanliness of Equipment/Accessories:
8. · Surface of RLAF booth
· Utensils/Scoops/ Spoon/ Spatula
Ensure that the reverse laminar air flow is switched on 15
9.
minutes prior to starting the dispensing activity
Ensure the room temperature NMT 27oC & RH NMT 55%
10.
should be within limit & record the same in logbook
11. BMR is available with approved RM requisition slip
Filter (Riser as well as ( RLAF) cleaning records are filled
12.
and accurate.
All personnel are in required apparel viz. gowning, gloves,
13. mask and are without finger-ring and wristwatch and with
clean shaving
Ensure the correctness of materials from AR No., Re-test
14. date, Expiry date of materials to be used for dispensing
against BOM.
If check point complies then tick (√ ) , Dose not complies then tick ( X ) , if Not applicable write ( NA )
After satisfactory verification of all above item, officer/executive IPQA shall provide the line clearance for
further batch/product dispensing and shall record the same in respective batch manufacturing records .

Format No.: QA/029/F02-00 4 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
4.0 BILL OF RAW MATERIAL:

Sr Dispensed Qty. in Kg Dispensing

Name of the Standard
. Quantity (for Overage Quantity
Ingredients & Claim 1.0 Lac) A.R. No. s% Required
Gros Tare Net Done Verifie
N
Specification (Kg) s Wt. Wt. Wt. by/on d by/on
o

Dry Mixing:-
Iron (III)
1. Hydroxide 100 mg 33.500
Polymaltose IP
2. Starch IP -- 15.350

3. Calcium -- 7.800
Carbonate IP
4. Sugar IP -- 31.500
Paste Preparation:-
5. Isopropyl Alcohal -- 35.000
IP
6. P.V.P.K-30 IP -- 1.800
Lubrication:-

7. Talc Purified -- 2.100

IP
Magnesium -- 1.100
8.
Stearate IP
9. Sodium -- 0.425
Saccharin IP
10. Aspartame IP -- 0.082

11. Coca Powder -- 0.550

IH
12. Flavour -- 0.550
Chocolate IH
13. Folic Acid IP 350 mg 0.055

Issued by: Received by: Verified by:

(Prod. Person) (Section In-charge/designee) (QA Person)
Sign/Date: Sign/Date: Sign/Date:

Format No.: QA/029/F02-00 5 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
4.1 ENVIRONMENTAL PARAMETER RECORDING PROCEDURE:
Record the temperature and RH during dispensing of raw material as per current version of
SOP No. WH/027 of dispensing room vs. air lock shall be recorded also. In case of
temperature, RH goes beyond limit any time points of processing period, then stop the activity
& close the material containers. Inform engineering & wait for resume the condition, evaluate
the impact if necessary

Frequency:
A. Initial and every 2 hour ±10 minute interval (for temperature and RH).
B. Environment shall be checked by QA also randomly & recorded in batch record at defined
frequency

Relative Verified By
Temperature Humidity Checked By
Date Time QA
NMT 27oC (NMT 55 %) WH Sign/Date
Sign/Date

4.2 DISPENSING OPERATION DETAILS

Dispensing Dispensing Dispensing done By Supervised By Verified By
Started at Completed Operators WH QA
(Date & Time) (Date & Time) Sign/date Sign/date Sign/date

Format No.: QA/029/F02-00 6 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
5.0 LINE CLEARENCE FOR GRANULATION AREA: Date:
Previous Product: Batch No.:
Status Checked Verified
Sr.
Checks to be Performed Complies/ Not By By
No.
Complies Production Q.A
1. Filled accurate BMR is available till stage
Room temperature NMT 27oC and RH is NMT 55%
2. and recorded
All required materials are available on pellets with
3. approved dispensing slip.
No unwanted/additional material/product available in
4. area
5. Calibration of moisture balance is not due.
6. Cleaned as well as Stage label are available.
Floor and bottom of each machine/ equipment is
7. cleaned.
Waste bin is emptied out and cleaned (free from
8. traces of previous material)
All required utensils/dustbin and area are cleaned
9. (free from traces of previous material and any visual
particulate contamination) and dried.
10. Calibration status of weighing balance is not due.
Approved QC release report for Wash water/swab
11. Sample analysis.
If check point complies then tick (√ ), Dose not complies then tick ( X ) , if Not applicable write ( NA )
5.1 EQUIPMENT CLEANING OF GRANULATION AREA:

Checked Verifie
Cleaning Previous Cleane
Particular Machine ID No.* By d by
SOP No. Product d By
(Prod.) QA
LBL/PD/VS/001
Vibratory Sifter PR/013
LBL/PD/VS/002
Paste Kettle PR/012 LBL/PD/PP/001
LBL/PD/MM/001
Mass Mixer PR/022
LBL/PD/MM/002
LBL/PD/FBD/001
Fluid Bed Dryer PR/016
LBL/PD/FBD/002
LBL/PD/TD/001
Tray Dryer PR/015
LBL/PD/TD/002
LBL/PD/MT/001
Multimill PR/017
LBL/PD/MT/002
LBL/PD/BL/001
Blender PR/018
LBL/PD/BL/002
Electronic
QA/036 LBL/GR/WB/001
Balance
*Select the equipment and tick (√) where is applicable or used

Format No.: QA/029/F02-00 7 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
6.0 MANUFACTURING:
Record the temperature and RH during granulation area of raw material as per current version
of SOP No. WH/027 In case of temperature, RH & goes beyond limit any time points of
processing period, then stop the activity & close the material containers. Inform engineering &
wait for resume the condition, evaluate the impact if necessary
Frequency:
A. Initial and every 2 hour ±10 minute interval (for temperature and RH).
B. Environment shall be checked by QA also randomly & recorded in batch record at defined
frequency
Temp RH Checked By
Date Time Area ID Remark
( NMT 270C) (NMT 55%) (Sign)

6.1 GRANULATION
6.1.1 SIFTING (SIFTER SOP No. : PR/013)
a. Sift all raw materials lot wise including lubricants as per sieve specified below and
record the activity in given table.
b. Check the integrity of each sieve before and after sifting activity.
LOT I Date:
Quanti Sieve Integrity Time Check
Sr. Sieve Done
Material ty Befor After From To ed
No. No. By
In kg e By
Iron (III) Hydroxide
01 40 #
Polymaltose IP
02 Starch IP 40 #
Calcium Carbonate
03 40 #
IP
04 Sugar IP 40 #

05 P.V.P.K-30 IP 40 #

Format No.: QA/029/F02-00 8 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
LOT II Date:
Quanti Sieve Integrity Time Check
Sr. Sieve Done
Material ty Befor After From To ed
No. No. By
In kg e By
Iron (III) Hydroxide
01 40 #
Polymaltose IP
02 Starch IP 40 #
Calcium Carbonate
03 40 #
IP
04 Sugar IP 40 #

05 P.V.P.K-30 IP 40 #

LOT III Date:

Quanti Sieve Integrity Time Check
Sr. Sieve Done
Material ty Befor After From To ed
No. No. By
In kg e By
Iron (III) Hydroxide
01 40 #
Polymaltose IP
02 Starch IP 40 #
Calcium Carbonate
03 40 #
IP
04 Sugar IP 40 #

05 P.V.P.K-30 IP 40 #
LUBRICANTS Date:
Sieve
Quantit Time Done
Sr. Sieve Integrity Checked
Material y By/
No. No. Befor After From To By/on
In kg on
e
01. Talc Purified IP 60#
Magnesium Stearate
02. 60 #
IP
Sodium Saccharin
03. 60 #
IP
04. Aspartame IP 60 #
05. Coca Powder IH 60 #
Flavour Chocolate
06. 60 #
IH
07. Folic Acid IP 60 #

Format No.: QA/029/F02-00 9 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

6.2 PASTE PREPARATION: (PASTE PREPARATION VESSEL SOP No.: PR/012)

a) Disperse IPA IP ______KG in ____ Liter of purified water IP in SS. vessel to form slurry.
b) Measure ______Liters purified Water and add to steam kettle and start heating add to it
P.V.P.K – 30 IP stir to dissolve.
c) Add the slurry of stage a to stage b and stir it well till to form a lumps free translucent paste.
d) Unload the paste in SS container and allow it to cool 50 – 60°C.
e) Prepare the IPA paste lot wise and record the observation in given table.

Time Checke
Quantity Lot Lot Lot Done
Material d
In kg I II III Lot From To by/ On
By/on
I
Isopropyl Alcohal
IP
II
P.VP.K-30 IP
III

6.3 DRY MIXING AND GRANULATION: (MASS MIXER SOP NO.: PR/022)
1. Load the sifted material in Mass Mixture as per sequence given below.

Lot Checke
Quantity Lot Lot
Date Material III d
in Kg. I II
by
Iron (III) Hydroxide
Polymaltose IP
Starch IP
Calcium Carbonate
IP
Sugar IP

2. Dry mix the material for 15 minutes with Mass Mixer at normal speed.
3. Charge the duly prepared paste of Step 6.2 in mass mixer, and start the mixing with Mass
Mixer at Normal speed.
4. Continue the mixing with Mass Mixer. Rack the material then continue the Mixing with the Mass
Mixer till the desired wet mass achieved. If required add Additional purified Water.
5. Repeat the same procedure for each lot.

Format No.: QA/029/F02-00 10 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

Dry mixing
Paste Addition Wet Mixing Checke
In Mixer Wet Milling
Mixer (15 mins) d by/on
Lot No (15 mins)
Fro
From To From To From To To
m
I
II
III

6.4 WET MIXING (MASS MIXER SOP NO.: PR/022)

1. Charge the duly prepared paste in Mass Mixer, and start the mixing with Mass Mixer at
Normal Speed.
2. Continue the mixing with Mass Mixer. Rack the material then continue the mixing with Mass
Mixer till the desired wet mass achieved. If required add additional purified water.
3. Unload the wet mass in FBD bowl.

6.5 DRYING: (FBD SOP NO. :PR/016)

a. Wet mill the mass through 8.0 mm S.S. screen and air dry the wet mass for 10 minutes.
b. Air drying-I the above granules in FBD for 10 min & raking the materials.
c. Drying-I at Inlet air temperature 45 0C - 500C for 20 minutes & the outlet temperature
reaches to 35 to 40 0C raking the materials &
d. Check moisture content LOD should be 2.0 to 3.0 % w/w
Date :
Lot I Lot II Lot III
Activity Time Time Time
From To From To From To
Air Drying
Racking
Drying
Inlet Temp.
Outlet Temp.
LOD
Done by/on
Checked by/on
6.6 SIFTING & MILLING (SIFTER SOP No.PR/013 & MULTIMILL SOP No.PR/017)
1. Sift the dried granules through 20# SS Sieve fitted to the sifter, collect the sifted granules in
cleaned Plastic container lined with polythene bag and affix proper status label.
2. Mill the granules retained on sieve through 1.5 mm SS Screen fitted to the Multimill, collect
the milled granules in cleaned plastic container lined with polythene bag.
3. Record the sifting and milling activity in given table.
4. Check the weight of sifted and milled granules and record in the given table.

Format No.: QA/029/F02-00 11 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

Date:
Milling
Sifting Multimill Checke
Lot Sifter Sieve through Done
through Sieve d
No integrity 1.5 mm by
20# integrity by/prod
screen
From To Before After From To Befor After
e
I
II
III
Theoretical weight of sized granules: …………Kg Balance I.D. No: LBL/GR/WB/001
Container cleaned by:----------------------- Cleanliness checked by:---------------------------
Container Net Wt. Gross Wt. Weight By Checked By
Date Tare Wt. (Kg)
No. (Kg) (Kg) Sign/Date Sign/Date
1
2
3
4
5
6
7
8
9
10
Actual weight of sized granules: ___________ Kg

6.7 LUBRICATION: (BLENDER SOP No. : PR/018)

 Transfer the sifted and milled granules of Sr. No. 6.6 to the blending area.
 Load the sifted and milled granules in blender.
 Mix the fines with lubricants except Magnesium Stearate in geometric proportion in double
poly bags.
 Unload 5 kg mixed granules and mix with Magnesium Stearate in geometric proportion in
double polybag and add in blender and mix for 5 mins.
 Record the observation in the below given table.
 Unload the lubricated granules in containers lined with double polythene bags.
 Check the weight of lubricated granules and record the observation in given

Format No.: QA/029/F02-00 12 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

Quantity
Std. Qty. Required Qty
S. No. Blending Procedure TIME
(In Kg)
in Kg
1.1.1 Load granules containing, Sifted lubricants (6.7) in
Blenders as per sequence given below: From To

Talc Purified 2.100

Sodium Saccharin IP 0.425
Aspartame IP 0.082
Coca Powder 0.550
Flavour Chocolate 0.550
Folic Acid IP 0.055
And then mix for 20 minutes.
1.1.2 Unload 5 kg mixed granules and mix with
Magnesium Stearate IP 1.100
In geometric proportion in double polybag and add in blender and mix for 5 minutes.

EQUIPMENT NAME & ID: Octagonal Blender* LBL/PD/BL/002) DATE:-

Total run Operator Checked Verified by
Start time End time RPM
time Name by (PRD) (QA)

*Select the equipment and tick (√) where is applicable or used

6.8 WEIGHT OF LUBRICATED GRANULES: BALANCE I.D.NO.:LBL/GR/WB/001
Container cleaned by: ----------------------- Cleanliness checked by:----------------------------------
Checked
Container Net Wt. Gross Wt. Weight By
Date Tare Wt. (Kg) By
No. (Kg) (Kg) Sign/Date
Sign/Date
1
2
3
4
5
6
7
8
9
10

Format No.: QA/029/F02-00 13 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
Total

RECONCILIATION OF LUBRICATED GRANULES

Checked by/
Verified
S. No. Details Kg. On
by/On IPQA
Production
1. Standard Batch Size (A)
2. Recovery added (B)
3. (C) Actual Batch Size (A+B):
4. QC Sample for Analysis (D)
5 Other Sample (E) (if any please mention)
6. Wt. of Actual Granules (F)
7. Loss (G)
Batch Yield= D+E+F X 100/ (A) or (C)
8.
Limit: (NLT 99.00 %)
Limits: Standard Yield- NLT 99.00 % (To be established after 10 commercial batches.) if yield
is less or more than the standard record the reason below:
Remarks:_____________________________________________________________________

Checked By /date:________________ Verified By/Date:__________________

Rejection Non recoverable to be record during reconciliation

Non – recoverable rejects destroyed as per SOP NO: PR/058 or dissolve in water and pour them in
Drain & ETP.
Qty of Qty of Checked Verified by
Date Done by Method of Destruction
Rejection Destroyed by (QA)

Format No.: QA/029/F02-00 14 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

6.9 Hold Time Details:

Blend hold time data up to 60 days has been found satisfactory. However it is recommended
that Blend may be stored for not more than 45 days from the date of blending to compression
at a temperature of NMT 27oC & RH NMT 55%

Inward Date of Material Outward Date of Material

Actual Hold Time (Days) Assigned Hold Time (Days)
In-process hold time period: Comply/Does not comply

Remarks (if any)

Checked By (Sign/Date) _______________Verified By (Sign/Date) _______________________

BULK SAMPLE DETAILS

Intimate Q.A. Department to withdraw sample from the bulk for analysis as per the specification.
Take the product for compression only after approval from Q.C. Department.
Test request raised by (Production) Test request received by (IPQA)
Sign : Date : Sign: Date :

Sample taken by: Quantity of sample taken :

Sign: Date : Sign: Date :

If sample is approved then continue for further processing. If it is failed, act as per QA instruction.
Q.C.A.R.N./Date:________________

Format No.: QA/029/F02-00 15 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
7.0 COMPRESSION:
7.1 LINE CLEARANCE FOR COMPRESSION:
7.1.1 Enter the process area as per current version of SOP No.: HR/002
7.1.2 Check the temperature and RH of the area as per current SOP No.: WH/027
7.1.3 Take line clearance for Compression as per current version of SOP No.: QA/013
Previous Product: Batch No.:
Status Checked Verified
Sr.
Checks to be Performed Complies/Not By By
No.
Complies (Prod) (Q.A)
1. Ensure that status label duly filled at compression area.
Ensure that all logbooks/batch records duly completed up to
2. previous activity.
Ensure that absence of any material from previous batch or
3. product including labels, document etc.
Ensure that the floor, walls, ceilings grills, light fixtures & doors
4. are clean.
The waste bins should be empty and clean from both inner and
5. outer side, having clean poly bag inside.
The balance should be verified at the start of daily work &
6. monthly calibration recorded in the logbook.
Ensure the cleanliness of hopper, feed frames, force feeder,
7. chute, turret & lower cam track.
8. Ensure that the cleanliness of metal detector and deduster.
Ensure the absence of residual traces/contaminants from hard
9. to clean areas of the each equipment. Use torch lights where it
is difficult to verify the cleanliness of equipments.
Ensure the room temperature NMT 27oC & RH NMT 55%
10. should be within limit & record the same in logbook
Ensure that the equipments cleaned status label should be with
11. dully filled and signed.
Ensure the blend taken for compression is as per the BMR.
12. Ensure the batch number and quantity as per BMR.
All personnel are in required apparel. gowning, gloves, mask.
13. And are without finger-ring and wristwatch and with clean
shaving
Ensure the QC reports of blend and swab, Rinse samples are
14. available and satisfactory, wherever required.
15. Ensure the passbox is properly cleaned
16. Ensure the tooling of dies & punches installed as per BMR
Calibration status of weighing balance, disintegration and
17. friability apparatus is not due.
If check point complies then tick (√ ) , Dose not complies then tick ( X ) , if Not applicable write ( NA )
After satisfactory verification of all above item, officer/executive IPQA shall provide the line clearance for
further batch/product compression and shall record the same in respective batch manufacturing records.

Format No.: QA/029/F02-00 16 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
7.2 COMPRESSION:(COMPRESSION MACHINE SOP No.: PR/023, PR/024, PR/025 & PR/029)
EQUIPMENT CLEANING OF COMPRESSION:
Checked
Cleaning Previous Cleaned Verified
Particular Machine ID No.* By
SOP No.* Run By by QA
(Prod.)
PR/023 LBL/PD/CM/001
Compression PR/024 LBL/PD/CM/002
machine PR/025 LBL/PD/CM/003
PR/029 LBL/PD/CM/004
LBL/PD/DD/001
LBL/PD/DD/002
Tablet deduster PR/028 LBL/PD/DD/003
LBL/PD/DD/004
LBL/PD/DD/005
LBL/PD/DE/001
Dust Extractor PR/021 LBL/PD/DE/002
LBL/PD/DE/003
*Select the equipment and tick (√) where is applicable or used

7.3 DETAILS OF IN-PROCESS TESTING EQUIPMENTS

List of Equipments/
S. No. I.D. No.* Reference SOP No. Remarks.
Instruments
1. Digital balance LBL/IPQA/AB/001 QC/020
LBL/IPQA/VC/001
2. Vernier Calipers QC/027
LBL/IPQA/VC/002
3. Hardness Tester LBL/IPQA/HT/001 PR/059
4. DT apparatus LBL/IPQA/DT/001 QC/025
5. Friability test apparatus LBL/IPQA/FT/001 QC/026
*Select the equipment and tick (√) where is applicable or used

Instruction:
a) After line clearance bring the all containers of Lubricated granules in the compression area.
b) Check the granules container for proper batch number.
c) Setup and Operate the compression machine as per current version SOP.
d) Check the Upper Punch and Lower Punch and dies before starting the machine for the
correctness and record the observations in Punch set checking record.
e) Load the blended granules into machine hopper and compress the blended granules into
tablets with the parameters given in the table. Start the machine by inching and check for
any noise.
f) Collect first 2 rounds of tablets and destroy them by putting in water.
g) Set the machine to meet the required standard physical parameters as given in the standard
compression parameter and continue the compression of the blended granules.
h) Check the speed of the machine and record the Speed.

Format No.: QA/029/F02-00 17 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
7.4 DIE PUNCH ISSUANCE & VERIFICATION RECORD: (As per SOP PR/004)
Checking all Punches (lower & upper) & Dies shall be verified visually before & after use.
Mark (√) for good, (X) for defective set & NA for not applicable,
ID No: No. of Punch/die
Issue Date:
Shape/Size: Issued:
Die/ Upper Lower Checke Upper Lower
Die Die Checked
punch Punch Punch d by Punch Punch Remarks
By (Name)
No. Pre-inspection (Name) Post-inspection
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17..
18.
19.
20.
21.
22.
23.
24.
25.
26.
27.
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
Format No.: QA/029/F02-00 18 of 34
 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
46
47
48
49
50
51
Lower Punch 12.50 mm Round shape Biconcave
Description Upper Punch 12.50 mm Round shape Biconcave
Dies D tooling
Verified By/Date: (Verified By/Date:
(Pre-Inspection) Post-Inspection)
7.5 Environmental Parameter Recording Procedure for compression: Record the temperature
and RH during compression stage as per current version of SOP No. WH/027. compression
room shall be recorded also. In case of temperature, RH limit any time points of processing
period, then stop the activity & close the material containers. Inform engineering & wait for
resume the condition, evaluate the impact if necessary.
Frequency-
A. Initial and every 2 hour ±10 minute interval (for temperature and RH).
B. Environment shall be checked by QA also randomly & recorded in batch record at defined
frequency
Temp RH Checked
Date Time Area ID By Remark
( NMT 270C) (NMT 55%)
(Sign)

Format No.: QA/029/F02-00 19 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

7.6 MACHINE SETTING & OPERATION:-

Operator will set the machine to achieve optimum results of the output that meets with pre-
defined specifications. The output generated during machine setting shall be disposed off.
Record total time taken in machine setting & operation time in below table.

SETTING TIME OPERATION TIME OPERATE CHECKED

DATE
From To From To D BY BY

7.7 MACHINE SETTING PARAMETERS:

Check & set machine so that output follow the below specifications. These tests to be perform
as per defined frequency & recorded into BMR.
Compression starts up record for production: (Note: One full rotation + 3 tabs. On both sides for
Individual wt & thickness)
Checked
S. Verified
Frequenc Observatio By
No Parameters Standards By QA
y n Prod/Dat
. /Date
e
Description of Brown Colour, Round
Every 2
1. two round biconvex on both side
Hours
tablets plain uncoated tablets
940 mg ± 3 % (Limit:
Average weight Every 1
2. 911.80 mg to 968.20
of tablets Hours
mg)
18.800 gm ± 3 % (Limit:
Weight of 20 Every 1/2
3. 18.236 gm to 19.364
Tablets Hours
gm)
Every 1
4. Thickness 5.80 mm ± 0.3 mm
Hours
Every 1
5. Hardness NLT 3.0 Kgf
Hours
Friability wt of
Every 1
6. 10 tablets NMT 1.0% w/w
Hours
each side
Every 1
7. Disintegration NMT 15 minutes
Hours
Setting
8. Machine Speed 15-20 RPM
time
Setting
9. Diameter 12.50 mm
time

Format No.: QA/029/F02-00 20 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

7.8 INDIVIDUAL TABLETS WEIGHT VARIATION RECORD: (As per SOP QA/017)
Balance ID No.: __________________Date: __________________ Time: _____________________

Machine Operated By:_____________ M/c Start Time:___________M/c Stop Time:________________

LHS RHS
Wt Of 38 / 40 / 54 tablets……… Wt Of 38 / 40 / 54 tablets……..
Avg. Wt. of 38 / 40 / 54 Tabs ……….. Avg. Wt. of 38 / 40 /54 Tabs ……..
1 15 29 43 1 15 29 43
2 16 30 44 2 16 30 44
3 17 31 45 3 17 31 45
4 18 32 46 4 18 32 46
5 19 33 47 5 19 33 47
6 20 34 48 6 20 34 48
7 21 35 49 7 21 35 49
8 22 36 50 8 22 36 50
9 23 37 51 9 23 37 51
10 24 38 52 10 24 38 52
11 25 39 53 11 25 39 53
12 26 40 54 12 26 40 54
13 27 41 13 27 41
14 28 42 14 28 42
Individual Wt. (_____mg±3%) Individual Wt. (_____mg±3%)
Lower = _____ mg Upper = _____ mg Lower = _____ mg Upper = _____ mg
Min___________ max ____________ Min____________ max_____________
Thickness
1 15 29 43 1 15 29 43
2 16 30 44 2 16 30 44
3 17 31 45 3 17 31 45
4 18 32 46 4 18 32 46
5 19 33 47 5 19 33 47
6 20 34 48 6 20 34 48
7 21 35 49 7 21 35 49
8 22 36 50 8 22 36 50
9 23 37 51 9 23 37 51
10 24 38 52 10 24 38 52
11 25 39 53 11 25 39 53
12 26 40 54 12 26 40 54
13 27 41 13 27 41
14 28 42 14 28 42
Thickness (_________ ± 0.3 mm) Lower = _______ mm Upper = _______ mm
Average Thickness:______________mm Min___________mm Max._____mm

Format No.: QA/029/F02-00 21 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

No. 1 2 3 4 5 6 7 8 9 10 Average
Hardness
of 10 tab RHS
(NLT
3 kgf) LHS

No. 1 2 3 4 5 6 7 8 9 10 Average
Diameter
of 10 RHS
tabs
LHS

Initial weight of Final weight of F= i - f x100 (%)

Arms
10 tablets (i) 10 tablets (f) i
Friability
(NMT RHS
1%)
LHS

Disintegration RHS LHS

Time (NMT 15
minutes)
Done By Production (Sign/Date) : __________ Verified by IPQA (Sign/Date) : ________
Note: first 2-3 rounds of tablets from both sides to be destroyed when the m/c is setup for the
product after change over.
Tablets for initial checking treat as non recoverable to be destroyed.
Rejections destroyed as per current version of SOP NO.PR/058

Qty of tablets _________Destroyed By:__________Checked By:________Verified By:_________

Sign/Date : Sign/Date: Sign/Date: Sign/Date:

Format No.: QA/029/F02-00 22 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

7.9 INPROCESS CONTROLS CHART COMPRESSION MACHINE: -

Run machine at a speed of 15 to 20 RPM after successful setting. Record the all test
parameters by QA and Production at defined interval. (Every 1 hours)
Date/ Wt. of 20 Friability Done By
Stage Avg wt. Thickness Hardness
Time tablets NMT 1.0 % w/w (PRD/ QA)
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS
LHS
RHS

Format No.: QA/029/F02-00 23 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
Individual Tablets Weight Variation Record: (Every 1 Hrs) Balance ID No.: LBL/IPQA/AB/001
Production
Date: Time: Date: Time: Date: Time:
Sr. Left Right Left Right Left Right
No. side side Sr. No side side Sr. No side side
(L.H.S.) (R.H.S.) (L.H.S.) (R.H.S.) (L.H.S.) (R.H.S.)
1 1 1
2 2 2
3 3 3
4 4 4
5 5 5
6 6 6
7 7 7
8 8 8
9 9 9
10 10 10
11 11 11
12 12 12
13 13 13
14 14 14
15 15 15
16 16 16
17 17 17
18 18 18
19 19 19
20 20 20
Max. Max. Max.
Min. Min. Min.
Avg. Avg. Avg.
Wt. of Wt. of Wt. of 20
20 Tabs 20 Tabs Tabs
Wt. variation : + % % Wt. variation : + % % Wt. variation : + % %
Wt. variation : - % % Wt. variation : - % % Wt. variation : - % %
D.T.------------------- min D.T.--------------------- min D.T.---------------------- min
Checked By/Date : Checked By/Date : Checked By/Date :
Verified By/Date: Verified By/Date: Verified By/Date:

Individual Tablets Weight Variation Record: (Every 1 Hrs) Balance ID No.: LBL/IPQA/AB/001
Format No.: QA/029/F02-00 24 of 34
 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
QA
Date: Time: Date: Time: Date: Time:
Sr. Left Right Left Right Left Right
No. side side Sr. No side side Sr. No side side
(L.H.S.) (R.H.S.) (L.H.S.) (R.H.S.) (L.H.S.) (R.H.S.)
1 1 1
2 2 2
3 3 3
4 4 4
5 5 5
6 6 6
7 7 7
8 8 8
9 9 9
10 10 10
11 11 11
12 12 12
13 13 13
14 14 14
15 15 15
16 16 16
17 17 17
18 18 18
19 19 19
20 20 20
Max. Max. Max.
Min. Min. Min.
Avg. Avg. Avg.
Wt. of Wt. of Wt. of 20
20 Tabs 20 Tabs Tabs
Wt. variation : + % % Wt. variation : + % % Wt. variation : + % %
Wt. variation : - % % Wt. variation : - % % Wt. variation : - % %
D.T.------------------- min D.T.------------------- min D.T.------------------- min
Checked By/Date : Checked By/Date : Checked By/Date :
Verified By/Date: Verified By/Date : Verified By/Date:

7.10 RECORD OF WEIGHT OF COMPRESSED TABLETS:

Unload & weigh the material, keep in HDPE container lined with double poly bags.

Format No.: QA/029/F02-00 25 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date

Container cleaned by:________Cleanliness checked by:_____ Balance I. D. No.: LBL/PD/TQ/001

Container Gross Wt. Weight By Checked By

Date Tare Wt. (Kg) Net Wt. (Kg)
No. (Kg) Sign/Date Sign/Date
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Total
Reconciliation of Compressed Tablets:
Checked by/
Verified
S. No. Details Kg. On
by/On IPQA
Production
1. Standard Batch Size (A)
2. Qty Received For Compression (B)
3. QC Sample for Analysis (C)
4. Other Sample (D) (if any please mention)
5 Wt. of Compress Tablets (E)
6. Non recovery generated (F)
7. Loss (G)
Batch Yield= C+D +E X 100/ A
8.
Limit: (NLT 98.50 %)
Limits: Standard Yield- NLT 98.50 % (To be established after 10 commercial batches.) if yield is less
or more than the standard record the reason below:
Remarks:_____________________________________________________________________________
Checked By /date:________________ Verified By/Date:____________

Rejection Non recoverable to be record during reconciliation

Rejections destroyed as per current version of SOP No.:PR/058

Format No.: QA/029/F02-00 26 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
Qty of tablets _________Destroyed By:__________Checked By:________Verified By:___________
Sign/Date: Sign/Date: Sign/Date: Sign/Date:
ANALYSIS OF COMPRESSED TABLETS:
Intimate QA Department to withdraw sample from the compressed tablets for analysis as per the
specification. Sample shall be withdrawn from HDPE Drum by QA person after getting sampling
request form production. Take the product for coating only after approval from QC Department.
Sampling Date/Time: _____________Qty of Sample:__________Sample from Drum No.:___________
Taken By:_______________________________QC A.R. No.___________________________________

7.11 HOLD TIME DETAILS OF COMPRESSED TABLETS:

Compressed tablets hold time data up to 60 days has been found satisfactory. However it is
recommended that core tablets may be stored for not more than 45 days from the date of
compression to uncoating at a temperature of NMT 27oC & RH NMT 55%

Inward Date of Material Outward Date of Material

Assigned Hold Time
Actual Hold Time (Days)
(Days)
In-process hold time period: Comply/Does not comply
Remarks (if any)
Checked By (Sign/Date) _______________Verified By (Sign/Date) _______________________

Format No.: QA/029/F02-00 27 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
8.0 VISUAL INSPECTION & METAL DETECTION: (As Per SOP NO. PR/037)
8.0.1 Enter the process area as per current version of SOP No.: HR/002
8.0.2 Check the temperature and RH of the area as per current SOP No.: WH/027
Previous Product: Batch No.:
Status Checked Verified
Sr.
Checks to be Performed Complies/Not By By
No.
Complies (Prod.) (Q.A)

1. Ensure that status label duly filled at inspection area.

Ensure that all logbooks/batch records duly completed up

2.
to previous activity.
Ensure that absence of any material from previous batch
3.
or product including labels, document etc.
The waste bins should be empty and clean from both inner
4.
and outer side, having clean poly bag inside.

5. Ensure the cleanliness of inspection belts.

Ensure the room, temperature NMT 27oC & RH NMT 55%

6.
should be within limit & record the same in logbook
Ensure the Uncoated tablets taken for inspection is as per
7. the BMR. Ensure the batch number and quantity as per
BMR.

8. Ensure the passbox is properly cleaned

Ensure the Metal Detector Challenge Test- before Start

9. the activity, challenge test should be performing for the
metal detector
If check point complies then tick (√ ) , Dose not complies then tick ( X ) , if Not applicable write ( NA )
After satisfactory verification of all above item, officer/executive IPQA shall provide the line
clearance for further batch/product compression and shall record the same in respective batch
manufacturing records

8.1 Environmental Parameter Recording Procedure for Visual Inspection:

Record the temperature and RH during visual inspection stage as per current version of
SOP No. WH/027 inspection room shall be recorded also. In case of temperature, RH & limit
any time points of processing period, then stop the activity & close the material containers.
Inform engineering & wait for resume the condition, evaluate the impact if necessary.

Format No.: QA/029/F02-00 28 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
Frequency-
A. Initial and every 2 hour ±10 minute interval (for temperature and RH).
B. Environment shall be checked by QA also randomly & recorded in batch record at defined
frequency
Checked
Temp RH
Date Time Area ID By Remark
( NMT 270C) (NMT 55%)
(Sign)

8.2 METAL DETECTOR CHALLENGE TEST: (Pre-Inspection) Mention OK/Not OK in

observation.
Metal Detector Challenge Test- before Start the activity, challenge test should be performing
for the metal detector as per SOP No. PR/062 & maintained the record.
If metal pass to the challenge test then use to the metal detector over the activity.

Date-
Check (Pass/Fail)
Remarks
Non Checked Verified
Date Time Ferrous SS Dummy (Test
ferrous by By
Block Block (Block) passes/fail)
Block

8.3 TABLET VISUAL INSPECTION RECORD:

Equipment ID- LBL/PD/TI/001 Date:

Break/ Name Of
Checked by
Date Start time End Time rest Visual Remarks
(PRD)
Period Inspectors

*Rest time should be 10-15 min for the visual inspector at least after every 1.30 to 2.00 hrs.
Rejection (%):Limit: NMT 0.5

Format No.: QA/029/F02-00 29 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
8.4 INSPECTION PROCEDURE

 Operate the Tablet inspection machine as per current SOP No.: PR/037
 Inspection of the Tablets is done visually on visual Inspection machine and passing through
Metal Detector.
 Collect approximate 100 goods tablets during each in-process checking. Check the tablet
defects as per mentioned in the table.
 After completion of in-process checking treat the rejection tablets as non-recoverable and
destroyed as per SOP No.:PR/058
 Collect the inspected Tablets after weighing in duly labeled double lined polythene
containers.
 After completion of visual inspection collect the rejected tablets from rejection pocket of
metal detector and again pass the rejected tablets through metal detector one by one.
 Discard the finally rejected tablets after weighing with other non-recoverable rejected tablets
found during visual inspection.
 Transfer the inspected and release tablets to packing department for packing.
Defects of tablets: Frequency: (Start/ every1 hours/ interval and end)
Dat Types of defects Checked Verified
e& Black Rough By prod. By QA
Shape Chipping Lamination Sticking Cracking
time Spot Surface Sign/date Sign/date

8.5 METAL DETECTOR CHALLENGE TEST: (Post-Inspection) Mention OK/Not OK in

observation.
Metal Detector Challenge Test- before Start the activity, challenge test should be performing
for the metal detector as per SOP No. PR/062 & maintained the record.
If metal pass to the challenge test then use to the metal detector over the activity.

Equipment ID- Date-

Check (Pass/Fail)
Non Remarks
Check Verified
Date Time Ferrous ferrous SS Dummy (Test
ed by By
Block Block Block (Block) passes/fail)

Format No.: QA/029/F02-00 30 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
8.6 Unload and weight record of Inspected tablets Balance ID:___________________

Container cleaned by: _______________ Cleanliness checked by:______________

Container Tare Wt. Net Wt. Gross Weight By Checked By
Date
No. (Kg) (Kg) Wt. (Kg) Sign/Date Sign/Date
1
2
3
4
5
6
7
8
9
10
Total
Comments on type of rejction:____________________________________________________
Rejection sent for Destructin:______________Kg Date:__________________
Rejection (%) : LIMIT:NMT 0.5%
Checked By (Prod.):___________Date:________Verified By (IPQA):_______ Date:_________
8.7 RECONCILIATION OF INSPECTED TABLETS:

Checked Verified
S. No. Details Kg. Nos. by/ On by/On
Production IPQA
1. Standard Batch Size (A)
Wt. of Uncoated tablets received for
2.
Inspection (B)
3. Wt. of Inspected Tablets (C)
4. Recoverable rejects (D)
Non recovery generated (E) = [B -
5
(C+D) ]
Batch Yield= C+D X 100 / A
6
NLT97.80%)
Limits: Standard Yield- NLT 98.00 % (To be established after 10 commercial batches.) if yield is less
or more than the standard record the reason below:

Remarks:_____________________________________________________________________________

Checked By /date:________________ Verified By/Date:____________

Format No.: QA/029/F02-00 31 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
8.8 Hold Time Details of Uncoated tablets:
Uncoated tablets hold time data up to 90 days has been found satisfactory. However it is recommended
that uncoated tablets may be stored for not more than 60 days from the date of uncoated at a
temperature of NMT 27oC & RH NMT 55%. If the date exceeds the specific time, then report to Quality
Assurance for further action.

Inward Date of Material Outward Date of Material

Actual Hold Time (Days) Assigned Hold Time (Days)
In-process hold time period: Comply/Does not comply
Remarks (if any)
Checked By (Sign/Date) __________________Verified By (Sign/Date) ____________________

8.9 RELEASED FOR PACKING

Tablet is released/not released for Packing

A. R. No._____________ (Attach release slip received from Quality Control Department)

Container Tare Wt. Net Wt. Gross Weight By Checked By

Date
No. (Kg) (Kg) Wt. (Kg) Sign/Date Sign/Date
1
2
3
4
5
6
7
8
9
10.
Total

Received By____________________ Checked By:_________________Verified By:_________________

Packing Sign/ Date Prod. Sign/date QA sign/Date

Format No.: QA/029/F02-00 32 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
9.0 BATCH MANUFACTURING SUMMARY

9.1 Comments on Raw Materials:

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

9.2 In-process check & results:

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

9.3 Process Deviation (If any):

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

9.4 Change Control (If any):

______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________

Final BMR Checked By: Final BMR Reviewed By: Final BMR Approved By:

Head Prod. Sign/ Date: QA. Sign/Date: Head QA Sign/Date:

10.0 Revision history

CC Approved
Date Supersedes No. CC No Reason for Change
date
Nil Nil Nil Nil New BMR

Format No.: QA/029/F02-00 33 of 34

 LUCENT BIOTECH LTD. (UNIT-II)
165/3, Nalhera, Anantpur, Puhana, Roorkee, Distt: Haridwar (Uttarakhand)
BATCH MANUFACTURING RECORD
Generic Name Iron (III) Hydroxide Polymaltose Complex And Folic Acid Tablets
Batch Size BMR No. BMR/T/085-00 Revision No. 00
Batch No. Mfg. Date Exp. Date
11.0 CHECK LIST OF BMR
S. Check Point Page Tick Checked
No. No. Mark By QA
1. Products information 1
2. Index 2
3. Specimen Signature 3
4. Dispensing: 4-7
General Instruction, Calculation of API, Line clearance for
Dispensing Area, Bill of Raw Materials. environmental parameter
recording procedure:
5. Manufacturing: 8-15
Equipment Cleaning Record, Swab/Rinse Analysis, Line
Clearance for granulation area, Weight verification of raw
material, Sifting of materials, paste preparation FBD, Sifting &
Milling of materials, blending procedure, bulk intimation & Weight
& Reconciliation .
6 Compression: 16-27
Equipment Cleaning record, Swab/Rinse Analysis Request, Line
Clearance for compression, compression procedure &
Parameter, In process of compressed tablets, weight of
Compressed tablets containers & Reconciliation.die punch
issuance & verification record Environmental Parameter
Recording Procedure For Compression machine setting
parameters analysis of compressed tablets hold time details
7. Tablets Inspection record: Line Clearance for Tablets 28-33
inspection area, Equipment Cleaning record, Swab/Rinse
Analysis Request, Inspection Instruction, weight of Inspected
Tablets containers, Reconciliation of Inspected Tablets. released
for packing batch manufacturing summary Revision history
8. BMR Check List 34
9. Deviation Report if Any
10. Dispensing labels of Raw Material, Semi – finished labels
properly signed to be affixed in BMR.
Note: Put tick mark√ in respective brackets after completion of stage. Put X wherever not applicable.
12.0 VERIFY THE BMR UP TO INSPECTION STAGE:
RELEASE: On the basis of review of manufacturing process, in-process checks & analytical data the
batch is released/not released for Packing.
Checked By Name & Sign/Date ( In- Reviewed By Name & Sign/Date (QA Person)
charge)
Name:- Name:-
Sign/Date: Sign/Date:

Format No.: QA/029/F02-00 34 of 34