BMR Cephracap 500 Cap Checked 1

Batch Manufacturing Record (BMR) Page No.
: 1 of 16
BETASEF-500 CAPSULE Cefuroxime 125 mg &
Batch No:
Clavulanic Acid 31.25 mg/5 ml
Doc. No.: BMR-A-002 Product Code: PFS-A-002 Pack Size (PS): Wt: 70.500 Kg
Issue Date:03 MAR 2017 DAR No: 272-277-023 PS-1(Commercial Pack) : 1 x 70 ml Standard Unit: 1,500 Phials
Issue No: 01
Shelf Life: 1.5 Years PS-2(Physician sample) : 1 x 70 ml Batch PS-1: 1,500 Phials
Effective Date: 20 Mar 2017
Revision No: 00. Date: N/A White to light yellowish free flowing powder for suspension Size PS-2: 1,500 Phials
Written by: Checked by: Checked by: Approved by: Authorized by:
Md. Armin Minhaz Md. Shafiul Azam Md. Abu Salim Md. Eunus Ali Md. Enamul Hoque
Executive, PD Asst. Manager, PD Asst. Manager, Production QA Manager Plant Manager
Date: Date: Date: Date: Date:
REVISION HISTORY
Rev. No. Date Initiated by Description of Change Done by
First Version, Rev: 00 00 Md.Kamrul Hasan New N/A
CONTENT OF BATCH MANUFACTURING RECORD (BMR)

Sl. Description Sl. Description
1.0. EQUIPMENTS/ACCESSORIES LIST 3.6. Manufacturing Instructions
2.0. DISPENSING 3.7. Start-up Check
2.1. Receiving of Starting Materials 3.8. In-process specifications
2.2. Product Changeover Clearance 3.9. In-process Monitoring Record
2.3. Instructions for Dispensing 3.10. Traceability of Cap manufacturing Personnel
2.4. Dispensing Order Sheet (DOS) 3.11. Duration & Quantity of Cap manufacturing
2.5. Calculation 3.12. Yield Analysis
2.6. Traceability of Dispensing Personnel 3.13. Productivity Analysis
3.0. CAPSULE MANUFACTURING 4.0. Affix all CLEANED Labels
3.1. Product Changeover Clearance 5.0. Affix all DISPENSING TAGs
3.2. General Instructions 6.0. ENCLOSURE
3.3. Counter Weight checking of Dispensing Materials 7.0. GLOSSARY
3.4. Machine set-up 8.0. DEVIATION REPORT
3.5. Material Receiving 9.0. BMR CHECK & REVIEW
1.0. EQUIPMENTS / ACCESSORIES LIST

Process Equipment/ Capacity Equipme Operating SOP Cleaning SOP
Batch Manufacturing Record (BMR) Page No.: 2 of 16
Batch No:
Issue No: 01
Accessories list nt ID No.

Dispensing Booth (Vertical
Model:2254-
Laminar Reverse Flow Work PL/MP/105 PRD/SOP/OPCL/028.01 PRD/SOP/OPCL/028.01
RF-SS-SP-2
Station)
Balance 300 kg PL/MP/ PRD/SOP/OPCL/029.01 PRD/SOP/OPCL/029.01
Balance 5100 gm PL/MP/ PRD/SOP/OPCL/030.01 PRD/SOP/OPCL/030.01
Dispensing Balance 610 gm PL/MP/ PL/PRD/SOP/OPCL/031.01 PL/PRD/SOP/OPCL/031.01
Hygrometer ---- --- ---

1kg, 500, 250
SS Scoop gm
--- --- ---
SS Spoon 50, 25 gm --- --- ---
20, 10, 2, 1 &
Poly bags 0.5 kg
--- --- ---
Trolley ~ 300 Kg PL/MP/069 --- ---
Balance PL/MP/ PRD/SOP/OPCL/029.01 PRD/SOP/OPCL/029.01
Double Cone Blender 50-60 Kg PL/MP/095 PRD/SOP/OPCL/006.01 PRD/SOP/OPCL/006.01
SS Screen (20 mesh) 20 mesh --- --- ---

Blending
SS Screen (30 mesh) 30 mesh --- --- ---
Poly Bags 60 kg --- --- ---
HDPE Containers 70-80 Kg --- --- ---
SS Scoop 2, 1 kg --- --- ---

Trolley ~ 300 Kg PL/MP/069 --- ---
Hygrometer --- PL/MP/074 --- ---
Automatic Capsule Loading 27000
PL/MP/085 PRD/SOP/OPCL/001.01 PRD/SOP/OPCL/001.01
Machine Cap/Hour
Without AL-30
Encapsulation Manual Capsule Filling upto 72000 PL/MP/ PRD/SOP/OPCL/002.01 PRD/SOP/OPCL/002.01
Machine cap/Hour
Without AL-30
Manual Capsule Filling upto 72000 PL/MP/ PRD/SOP/OPCL/002.01 PRD/SOP/OPCL/002.01
Machine cap/Hour
Output: 100000
Capsule polishing machine Cap/hr
Capsule Inspection & Sorting Upto 60000

Machine Cap/Hour
2.0. DISPENSING
2.1. Receiving of Starting Materials in Dispensing Area of Cephalosporin
Batch No:
Issue No: 01
Check the followings in the air lock of ‘Material Entry’ according to SOP No. PRD/SOP/GN/008.01.
□ Incoming drums/ containers/ bags/ boxes are clean.
□ No breakage/leakage in the container.
□ No materials except relevant to this batch of the product are present.
□ Correct materials of sufficient amount as per DOS.
□ All materials affixed with proper approval labels (PASSED labels) of QA/QC.
Received by (DA):…………………………… Checked by (PO):…………………………….
Date:…………………. Date:…………………….
2.2. Product Changeover Clearance
Previous Product: Code: Batch No:
Check the followings in the Dispensing area according to SOP No.: QA/SOP/GN/025.00
□ All materials of previous batch are removed from this area.
□ All extraneous materials & equipments/accessories except relevant to this batch are removed.
□ All labels, documents, loose/waste papers of previous batch are removed.
□ The whole area is properly cleaned & recorded.
Area Code Cleaned by Date Log Book Ref
1. Dispensing Area WR 127
□ All equipments are properly cleaned & recorded.
Equipments Code Cleaned by Date Log Book Ref
1. Dispensing Booth PL/MP/105
2. Balance PL/MP/
3. Balance PL/MP/
□ All utensils/ accessories are properly cleaned & recorded.
Utensils/ Accessories Code Cleaned by Date Log Book Ref
□ All balances used are calibrated and recorded. Daily performance is checked & recorded.
□ Dispensing booth & exhaust system is working properly.
□ All materials/ equipments are labeled properly.
□ Temperature:………………… (Range: 18-270C)
□ Relative Humidity:…………… (Range: 30-65%)
□ All protective clothing of dispensing personnel i.e. hand gloves, nose mask, dress, shoes, caps are properly
cleaned.
Checked by (WH):……………………… Checked by (Prod):…………………… Checked by:(QA):………………………
Date:…………………….. Date:……………………. Date:……………………..
□ Ready for Dispensing

2.3. Instructions for Dispensing
2.3.1. Issue the DISPENSING TAG of all starting materials.
2.3.2.The working personnel wear protective dress, caps, hand gloves, nose mask, eye protector; working shoe during
dispensing to protect the working personnel against raw materials that might be coming into contact with the skin
and inhaled into lungs.
2.3.3.The working personnel must have a good state of health and should show qualities of neatness and orderliness.
2.3.4. Never dispense more than one batch at a time.
2.3.5. At the material air lock, ensure that only one batch of a product passes through the air lock at a time and single
batch stays at single pellet.
Comment
Checked
by QA
s:
Batch No:
Issue No: 01
2.4. Dispensing Order Sheet (DOS)
Checked by
Production
ConNo Bal. No Weighed by
QC Ref.
No
100,000 pcs
kg
Actual Qty./
Batch
Potency
pcs
512.50 mg 51.250 kg
Std. Qty.
/Batch
1,00,000
1.000 pc
/Capsule
Std. Qty.
Ph. Gr.
SP
BP
Batch No:
Issue No: 01
Material Name
Cephradine Monohydrate (Compacted)*
EHG capsule shell Size # 0 (Cap : Green Opaque, Body: White Opaque)
………………………………
Time
(API)according to potency ( as it is basis) , including overage. For

* Adjust the Quantity of Active Pharmaceutical Ingredients
………………………………
Time Started:
calculation see page # 06

…………………………………...
…………………………..
Total Man Date Dispensed:
Total Time Required:
Ended:
Batch No:
Issue No: 01
Total Man Hours:
of material entry of manufacturing area and ask manufacturing to collect.

Material Received by (Prod.)
Total Time Required:
Material Checked by (QA)

Time Ended:
processing
RAC-007
REE-001
Code
air lock
thebefore
Material Checked by (Prod.)
area
Time Started:
dispensed
send allmaterials in starting materials to
the manufacturing
Material Issued by (Ware house)
Date Dispensed:
check
After
Cross the dispensed
dispensing
2.0. DISPENSING (Continued)

2.5. Calculation
Batch No:
Issue No: 01
2.5.1. CALCULATION FOR SINGLE LOT:
Total quantity of Cephradine to be dispensed per batch -------------------------------------------------------------- (W):
500.00 x 102.5 x 100000
Theoretical Quantity = KG = 51.250 KG
100 x 1000 x 1000
51.250 x 100
Actual Quantity = KG = KG --------------------------------------------------W1
Potency
CALCULATION FOR MULTI LOT (If required):

2.5.2.
{W1 – Quantity of Cephradine from 1st batch (a)} X Potency of 1st batch
KG = KG-------------W2
Potency of 2nd batch
Quantity of 1st batch, W1 = KG

Quantity of 2nd batch, W2 = KG
So, Total quantity of Cephradine, W= (W1+W2) = KG
Remarks:
Done by (WH): Checked by (Prod.): Checked by (QA):
2.6. Traceability of Dispensing personnel

Sl. Name ID No. Signature Sl. Name ID No. Signature
01 04
02 05
03 06
3.0. ENCAPSULATION / CAPSULE MANUFACTURING

Batch No:
Issue No: 01
3.1. Product Changeover Clearance

Previous Product: Code: Batch No:
Check the followings in the capsule manufacturing area according to SOP No.: QA/SOP/GN/025.00
□ All materials of previous batch are removed from this area.
□ All extraneous materials & equipments/accessories except relevant to this batch are removed.
□ All labels, documents, loose/waste papers of previous batch are removed.
□ The whole area is properly cleaned & recorded.
Area ID No. Cleaned by Date Log Book Ref
1. Encapsulation Area CM 111
□ All equipments are properly cleaned & recorded.
Equipments ID No. Cleaned by Date Log Book Ref
1. Automatic Capsule Loading Machine PL/MP/085
2. Manual Capsule Filling Machine PL/MP/086
3. Capsule De-dusting & Polishing Machine PL/MP/087
4. Air Displacement Unit PL/MP/
5. Capsule Inspection & Sorting Machine PL/MP/089
6. Balance PL/MP/
7. Hygrometer PL/MP/
□ All utensils/ accessories are properly cleaned & recorded.
Utensils/ Accessories ID No. Cleaned by Date Log Book Ref
□ All balances used are calibrated and recorded. Daily performance is checked & recorder.
□ Exhaust system is working properly.
□ All materials/ equipments are labeled properly.
□ Temperature:………………… (Range: 18-270C)
□ Relative Humidity:…………… (Range: 35-50%)
□ All protective clothing of involved personnel i.e. hand gloves, nose mask, dress, shoes, caps are properly cleaned.
Checked by (Prod):…………………… Checked by (QA):………………………

Date:………………….. Date:……………………..
□ Ready for Capsule Manufacturing
3.2. General Instructions
3.2.1. Protective clothing, shoes, masks, gloves of General Production Area should not be used in Cephalosporin area.
3.2.2. Operators must wear protective cloth covering whole body except eyes and gloves during manufacturing of the produc t.
3.2.3. Follow the manufacturing sequence strictly as directed in the procedure.
3.2.4. Mention the machine run hour in all different steps.
3.2.5. Label all concerning equipments with product name & batch number.
3.2.6. Attach all Cleaned & Under Operation labels of the area/equipments and DISPENSING TAGs to the BMR.
3.2.7. Wash hands and exposed areas of the body immediately after completion of work
3.3. Counter weight checking of dispensed materials
Check all the ingredients listed in the manufacturing ie. material name, material batch no., quantity , etc.
Checked by
Code Name of Materials Specifica Dispensed Checked QC Ref.
tion Qty. (KG) Qty. (KG) No. Operator PO
RAC-007 Cephradine Monohydrate (Compacted) BP
EGH capsule shell,
REE-001 Size # 0 (Cap : Green Opaque, Body: White Ph.
Opaque) Grade
Recovery (if any)
3.0. ENCAPSULATION / CAPSULE MANUFACTURING (Continued)

Batch No:
Issue No: 01
3.4. Machine set-up

1. Set the capsule hand filling machine and capsule shell loader to meet the specified parameters
as per specification.
2. Set the change parts for shell size # 0 of capsule hand filling machine and capsule shell loader according to
specified SOP.
3. Operate the capsule loader empty condition two turns to ensure correct set-up.
Operator: Production Officer:

Name:………………………………… Name:…………………………………
Sign:……………..….Date:…………. Sign:……………..….Date:………….
3.5. Material Receiving

Receive properly labeled and correct materials from blending section in accordance with BMR.
Cont 1 Cont 2 Cont 3 Total

Product: Cephracap 500 Capsule
Gross
Batch No:………… Tare
Net
Fill wt/Cap: mg No. of capsules (Theoretical):
Delivered by: Date: Received by: Date:
Affix PASSED label (Released for Encapsulation) here

Batch No:
Issue No: 01
3.6. Manufacturing Instructions MC Man Done by Checked

Hour Hour by
3.6.1. Encapsulation
1. Specification of Empty Hard Gelatin Capsule Shell:
Shell size : #0
Color :
Cap : Green Opaque
Body : White Opaque
ID Mark :
Cap : “EURO” in Black ink
Body : “EURO” in Black ink
2. Load the Empty Hard Gelatin Capsule Shell in the hopper of the
Automatic Capsule loading Machine and load the shell trays with empty
shell.
3. Operate the shell loader in accordance with specific SOP.
4. Weigh the quantity of Blended Cephradine required for each plate filling
i.e. for filling 300 capsules, calculated as per following:
Quantity required for 1(one) capsule: 535.00 mg, Actual…………….
Quantity required for 300 capsules: 160.500 gm, Actual…………..
5. Encapsulate the weighed quantity of Blended Cephradine by Manual
Capsule Filling Machine in accordance with specific SOP.
6. Encapsulate a minimum amount of capsules (one plate) according to
specifications (mentioned in start-up check) by following above
mentioned manufacturing instructions and request QA to take samples
for start-up check.
7. Getting Start-up Release start Encapsulation. If 2 (two) machines are in
operation, separate start-up checks should be done.
3.6.2. Polishing
1. Polish the filled capsules with Capsule De-dusting & Polishing Machine.
During Polishing ensure that the polished capsules must be shining in
appearance and free from dust.
2. Operate the Capsule De-dusting & Polishing Machine in accordance
with specific SOP.
3.6.3. Inspection & Sorting
1. Visually check the polished capsules with Capsule Inspection & Sorting
Machine. Properly check, Sort out and reject Capsules for following
defects.
a. Visual leakage / Pinhole.
b. Chipped / Dented edge.
c. Loose Cap / body.
d. Print defects.
e. Dust / Powder.
f. Empty shell.
g. Long body / short cap.
h. Short body / long cap.
2. Operate the Capsule Inspection & sorting Machine in accordance with
specific SOP.
3.6.4. Inspection of sorted products
Production Officer: QA Officer:

Name:………………………………… Name:…………………………………
Batch No:
Issue No: 01
MC Man Hour Done by Checked

3.6. Manufacturing Instructions (Continued) Hour by
3.6.5. Collect the polished, checked & sorted capsules into cleaned tarred HDPE
containers lined with double polythene bags. Label them with the
PRODUCT NAME, BATCH NO & DATE.
3.6.6. Request QA to draw sample for analysis by issuing a TR.
3.6.7. After getting approval from QA, transfer the Capsules for packaging.
3.7.Start-up Check
Sl. No. Parameter Specification Observation QA

01 Appearance Size # 0 capsule, Green Opaque cap and
White Opaque body, filled with white or pale
yellow powder.
ID Mark Cap: “EURO” in Black ink
Body: “EURO” in Black ink
02 Locking C/NC
03 Fill Wt. of 300 caps gm
04 Average mass (gm)
10 units from each MC
Av. Shell wt(mg): 98.00 mg
………………… MC1
Av. Wt of content (mg):
535.00 mg…………….
Av. Filled-cap wt(mg):
633.00 mg……………
10 units: 6.33 gm
Limit: 6.33gm ± 2% (10 units)
( 6.203 – 6.456) gm
Individual mass (gm)
20 units from each MC MC2
(18/20 within ±5.0%
2/20 within ±10.0%)
05 Disintegration Time Not More Than 15 Minutes

Remarks:
□ Ready to start-up Capsule Manufacturing

QA Officer: Production Officer:
3.8. In process specification

Tablets
Sl. Respon
Parameter Specification (IPC Limit) Frequency Req.
No. /Side sibility
01 Appearance Size # 0 capsule, Green Opaque cap Start of run & every 30 QA/PO
and White Opaque body, filled with white minutes
or pale yellow powder.
02 Weight 10 Capsules from each gm ± 2% (10 units) Start of run & every 15 10 QA/PO
of filled MC, 6.33 gm………….. ( – ) gm minute
capsules Individual 20 units 18/20 within ±5.0%, 2/20 within Start of run & every 1 hour 20 QA
from each MC ±10.0%
03 Disintegration Time Not More Than 15 Minutes Start of run & every 2 hour 06 QA
During in-process control, if any data over IPC limit, please stop further action and contact with the supervisor immediately.
Batch No:
Issue No: 01

3.9. In-process Monitoring Record of Encapsulation, Polishing, Inspection & Sorting
After getting start-up release begin to encapsulate, polish & check the batch. Check & record the IPC parameters as
specified in the following table.
Observation Result
Observation Frequency: 15 minutes or as specified
Parameters Date
Time
0
Room Temp C
Relative Humidity %
Pressure Difference Pa
Free from dust & powder Y/N
Properly Locked Y/N
No defective capsules Y/N
No empty shell Y/N
No print defect Y/N
Fill Wt. of 300 caps gm
Average mass (gm) Av. Shell wt(mg): 98.00 mg………………. Av. Wt of content (mg): 535.00 mg………………..
10 units from each MC Av. filled-cap wt(mg): 633.00 mg………………. 10 units:6.33 gm……………………..
Acceptance Limit:
6.33gm ± 2% (10 units) MC A
( 6.203 – 6.456) gm
MC B
Mean of Side A & B
Remarks
Operator
Checked by (PO)
Observation Result
Observation Frequency: 15 minutes or as specified
Parameters
Date
Time
0
Room Temp C
Relative Humidity %
Pressure Difference Pa
Free from dust & powder Y/N
Properly Locked Y/N
No defective capsules Y/N
No empty shell Y/N
No print defect Y/N
Fill Wt. of 300 caps gm
Average mass(gm) Av. Shell wt(mg): 98.00 mg………………. Av. Wt of content (mg): 535.00 mg………………..
10 units from each MC Av. filled-cap wt(mg): 633.00 mg………………. 10 units:6.33 gm……………………..
Acceptance Limit: MC A
6.33gm ± 2% (10 units)
MC B
( 6.203 – 6.456) gm
Mean of Side A & B
Remarks
Operator
Checked by (PO)
Note: Other IPC parameters such as Individual mass, Disintegration Time etc should be recorded periodically in separate IPC Sheet by QA.
Batch No:
Issue No: 01
3.10. Traceability of Encapsulation/ Capsule Manufacturing Personnel

Sl. Name ID No. Sign MH Sl. Name ID No. Sign M
H
Encapsulation
01 04
02 05
03 06
Polishing
01 04
02 05
03 06
Inspection & Sorting
01 04
02 05
03 06
3.11. Duration & Quantity of Capsule Manufacturing

Encapsulation
Date: Date: Date: Date: Date: Date:
From To From To From To From To From To From To
Quantity:
Polishing
Quantity:
Inspection & Sorting

Quantity:
Theoretical Quantity Sample Quantity(Capsule) Defective/ Rejected Waste During Encapsulation

Received Quantity of Shell (Blend)

Batch No:
Issue No: 01
3.12. Yield Analysis

3.12.1. After completion of manufacturing of capsules, calculate the yield.
3.12.2. Weigh the containers and record the Net Weight of filled Capsules produced (EA)
below.
Cont. 1 Cont. 2 Cont. 3 Total (Kg) Net Weight of

(Kg) (Kg) (Kg) filled Capsules
(EA) (Kg)
Gross Wt. (Kg)
Tare Wt. (Kg)
Net Wt. (Kg)
Done by
(Sign with Date)
3.12.3. Actual Weight of Blend (EB) ………………Kg
3.12.4. Total weight of empty capsule shell (EC) ………………Kg
3.12.5. Calculated weight (Theoretical) of filled capsules (ED=EB+EC) ………………Kg
3.12.6. QA/QC Sample (EE) ………………Kg

3.12.7. Reject/Problematic (EF) ………………Kg
3.12.8.Total Account EG (EA+EE+EF) ………………Kg
3.12.9. Total % Accounted EH [(EG/ED)X100] ………………%
3.12.10. % Actual Encapsulation Yield EI (EE=EA÷EDx100) ………………%
3.12.11. Average Wt. of Capsule as per IPC Check sheet EJ ………………mg Checked by PO
(Sign with Date)
3.12.12. No of Caps for further processing EK (EA/EJ x X 1,000,000) ……………...nos
3.12.13. Variance:………………………..
Acceptable Range: 98% - 102% of the theoretical weight of capsules must be
accounted for EI. Any deviation from this must be reported on the
reverse side of this page with explanation.
Reworks (for next Batch):
Sl. Step Quantity
01 Blending
02 Encapsulation
03 Polishing
04 Checking & Sorting Reviewed by
Total Quantity Head, Production
(Sign with Date)
3.13. Productivity Analysis

Machine set up time (a) Hours Average machine output/ Hour %
Preparation time (b) Hours Total Man Involved Person
Actual Manufacturing time (c) Hours Total Man Hours Hours
Machine disassembly time (d) Hours Average output/ Man Hour
Machine cleaning time (e) Hours Date started
Total Machine Hours Hours Date completed
(a+b+c+d+e)
Operator’s signature Production Officer’s signature
4.0. Affix all CLEANED TAG’s

Batch No:
Issue No: 01
Sl. Put (√) mark

Name of Cleaned TAG’s ID No.
No. (If available)
1. Cleaned TAG of Dispensing Area WR 127
2. Cleaned TAG of Dispensing Booth PL/MP/105
3. Cleaned TAG of Dispensing Balance PL/MP/114
4. Cleaned TAG of Dispensing Balance PL/MP/079
5. Cleaned TAG of Encapsulation Area CM124
6. Cleaned TAG of Capsule Shell Loading Machine PL/MP/085
7. Cleaned TAG of Encapsulation Machine PL/MP/
8. Cleaned TAG of Encapsulation Machine PL/MP/
9. Cleaned TAG of Encapsulation area Balance PL/MP/
10. Cleaned TAG of Polishing Machine PL/MP/003
11. Cleaned TAG of Sorting Machine PL/MP/089
Affix all CLEANED TAG’s
5.0. Affix all DISPENSING TAG’s
Put (√) mark

Sl. No. Name of Dispensing TAG’s Code No.
(If available)
1. Dispensing TAG of Cephradine (Compacted) RAC-007
Dispensing TAG of EGH Capsule shell # 0 of
2. REE-001
Cephracap 500 Capsule.
Affix all DISPENSING TAG’s
7.0. ENCLOSURE
Batch No:
Issue No: 01
8.0. GLOSSARY
Sl Abbreviation Elaboration Sl Abbreviation Elaboration Sl Abbreviation Elaboration
01 DA Dispensing Assistant 12 QC Quality Control 23 Cont. Container
02 Product Development 13
PDV Sign Signature 24 Wt. Weight
& Validation
03 Active Pharmaceutical 14
API ID Identification 25 Kg Kilogram
Ingredient
04 PM Plant Manager 15 RH Relative Humidity 26 gm Gram
05 Quality Assurance 16 Standard Operating
QAM SOP 27 mg Miligram
Manager Procedure
06 Deputy Production 17
DPM Ref Reference 28 ml Mililitre
Manager
07 DO Dispensing Officer 18 IPC In-process control 29 Qty/Qnty Quantity
08 PO Production Officer 19 MH Man Hour 30 MC Machine
09 QA Quality Assurance 20 LOD Loss On Drying 31 Temp. Temperature
10 Prod. Production 21 RMG Rapid Mixer Granulator 32 No Number
11 WH Warehouse 22 Sl Serial Number 33 TR Test Request
9.0. DEVIATION REPORT (If any) Deviation Ref. No. Date:

Sl Process Parameter Deviated Possible Reason Action Taken
The batch has been manufactured following this BMR with above/without any deviation.
………………………
Officer/Head, Production
10.0. BMR CHECK & REVIEW
All necessary documents related to BMR are reviewed & compiled properly.
Production Quality Assurance
Officer/ Sr. Officer, Production Officer/ Sr. Officer, Quality Assurance
Head, Production Head, Quality Assurance

BMR Cephracap 500 Cap Checked 1

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Batch Manufacturing Record (BMR) Page No.

CONTENT OF BATCH MANUFACTURING RECORD (BMR)

1.0. EQUIPMENTS / ACCESSORIES LIST

Accessories list nt ID No.

Balance 5100 gm PL/MP/ PRD/SOP/OPCL/030.01 PRD/SOP/OPCL/030.01

Dispensing Balance 610 gm PL/MP/ PL/PRD/SOP/OPCL/031.01 PL/PRD/SOP/OPCL/031.01

Hygrometer ---- --- ---

Balance PL/MP/ PRD/SOP/OPCL/030.01 PRD/SOP/OPCL/030.01

Double Cone Blender 50-60 Kg PL/MP/095 PRD/SOP/OPCL/006.01 PRD/SOP/OPCL/006.01

SS Screen (20 mesh) 20 mesh --- --- ---

Poly Bags 60 kg --- --- ---

HDPE Containers 70-80 Kg --- --- ---

SS Scoop 2, 1 kg --- --- ---

Balance PL/MP/ PRD/SOP/OPCL/029.01 PRD/SOP/OPCL/029.01

Capsule Inspection & Sorting Upto 60000

□ Ready for Dispensing

Cephradine Monohydrate (Compacted)*

(API)according to potency ( as it is basis) , including overage. For

calculation see page # 06

of material entry of manufacturing area and ask manufacturing to collect.

Material Checked by (QA)

2.0. DISPENSING (Continued)

CALCULATION FOR MULTI LOT (If required):

Quantity of 1st batch, W1 = KG

Done by (WH): Checked by (Prod.): Checked by (QA):

2.6. Traceability of Dispensing personnel

3.0. ENCAPSULATION / CAPSULE MANUFACTURING

3.1. Product Changeover Clearance

Checked by (Prod):…………………… Checked by (QA):………………………

3.0. ENCAPSULATION / CAPSULE MANUFACTURING (Continued)

3.4. Machine set-up

Operator: Production Officer:

3.5. Material Receiving

Cont 1 Cont 2 Cont 3 Total

Affix PASSED label (Released for Encapsulation) here

3.0. ENCAPSULATION / CAPSULE MANUFACTURING (Continued)

3.6. Manufacturing Instructions MC Man Done by Checked

Production Officer: QA Officer:

MC Man Hour Done by Checked

Sl. No. Parameter Specification Observation QA

05 Disintegration Time Not More Than 15 Minutes

□ Ready to start-up Capsule Manufacturing

3.8. In process specification

3.0. ENCAPSULATION / CAPSULE MANUFACTURING (Continued)

3.10. Traceability of Encapsulation/ Capsule Manufacturing Personnel

3.11. Duration & Quantity of Capsule Manufacturing

Inspection & Sorting

Theoretical Quantity Sample Quantity(Capsule) Defective/ Rejected Waste During Encapsulation

3.0. ENCAPSULATION / CAPSULE MANUFACTURING (Continued)

3.12. Yield Analysis

Cont. 1 Cont. 2 Cont. 3 Total (Kg) Net Weight of

3.12.6. QA/QC Sample (EE) ………………Kg

3.13. Productivity Analysis

4.0. Affix all CLEANED TAG’s

Sl. Put (√) mark

Affix all CLEANED TAG’s

5.0. Affix all DISPENSING TAG’s

Put (√) mark

Affix all DISPENSING TAG’s

9.0. DEVIATION REPORT (If any) Deviation Ref. No. Date:

Officer/ Sr. Officer, Production Officer/ Sr. Officer, Quality Assurance

Head, Production Head, Quality Assurance

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