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BATCH PRODUCTION RECORD

Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 1 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

A. BATCH COMPLETION DETAILS

Manufacturing Date

Printed by (Date and Time): «PRTBY» «PRTDT» «PRTTM» «PRTBY_ID»

This document is electronically generated and can be used for Batch Manufacturing.

B. BPR ISSUANCE VERIFICATION DETAILS:

Checklist Yes / No* Verified by QA (Sign & date)

All pages of current approved version of BPR are available

All pages printed are legible, accurate and matching with master BPR.

Watermark is correctly printed on all pages of BPR (If applicable)

*(In case of No, return the document by cancelling it for destruction and reissue the document with appropriate documentation)
C. MASTER BPR APPROVAL SIGNATURES

DESCRIPTION SIGNATURE DATE & TIME

Prepared By «PER»(«PERID») «DATE1» - «TIME1»

Reviewed By «REV»(«REVID») «DATE2» - «TIME2»

Approved By «APP»(«APPID») «DATE3» - «TIME3»

Document classification: «DOCC»

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 2 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

D. CRITICAL PROCESS PARAMETERS AT A GLANCE:

S. No. Operation No. Critical Process Parameter Range / Limit for the operation Justification for criticality Equipment No.
NA NA NA NA NA NA

E. ABBREVIATIONS

S. No. Serial Number Op. No. Operation Number

Temp. Temperature I.H.B.No: In-House Batch Number
Qty. Quantity NA Not applicable
W.E.ID.No. Weighing Equipment Identification Number M.E.ID.No. Measuring Equipment Identification Number
F. PPE SYMBOLS

Air Line Nomex or acid Nomex or acid

Face shield Goggles Wrist strap Gloves - Nitrile Nose Mask
Respirator alkali proof suit alkali proof hood

G. WET HOLDING INFORMATION:

Name of Material Operation Number Storage conditions Wet holding period (Days)

Not applicable Not applicable Not applicable Not applicable

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 3 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

H. BATCH SUMMARY SHEET

Deviation in Material / in-process checks/ Process deviation if any: (Include deviation statement and reference Incident Report Number)

Deviation in Critical process parameters, if any: (Include deviation statement and reference Incident Report Number)

Batch review Remarks ( Production):

Batch Reviewed by (Production) Name

(Prod. Manager/ Shift In-charge) Sign /Date
Batch review Remarks (QA):

Reviewed by QA (Sign & Date) :

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 4 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

I. INPUTS

Operation Allowable Range

Raw material Name / Code Name SAP Code Unit Standard Quantity Remarks
Number Minimum Maximum
7. APL-5 WM (Apremilast) 200030586 Kg Q NA* NA*

Note: 1. Ensure the input material in approved state before use.

2. * Required quantity from APL-5 WM (Apremilast) bulk batch material shall be taken as input.
PACKING MATERIAL:

S. Standard Quantity In-house Performed by

Packing Material Name / Code Name SAP Code Unit Remarks
No. Quantity used Batch No. Sign. & Date

1. HDPE Drums 50 Lts Capacity 150000386 No. 4

2. Anti-Static Bag 660 x 914 (25 Kg Cap)(W) 150006343 No. 8
3. Triple Laminated Polybags 30" X 40" 150001941 No. 4
4. Silica Gel Bags, 1 gm Packing 150002365 No 100*
5. Silica Gel Bags, 50 gm Packing 150003832 No 50*

Note: 1. Packing material quantities may vary are based on requirement.

2. Ensure all packing material are in approved stage before usage.
3. * Silica gel quantity will be consume based upon desiccant calculation (mentioned below).

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 5 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 6 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

Calculated Checked
Desiccant calculation (Silica gel)
by by
1. Initial moisture content in (%) X1= 0.1%
2. Lower moisture content X2 = _______% (X2 value before unloading material)
3. Lowest among X1 and X2 (X)=_______%
4. Moisture absorption while handling (Y) = 0.42%
5. Total moisture pick up (Z) = Y-X =_______-_______=________%
6. Water content in g (A) = Output API quantity in gm x Z /100= ___________x Z/100=__________g
7. Area of triple laminated bag in m2 (B) =
2 X ((Length of triple laminated bag in inches x 0.0254) x (Breadth of triple laminated bag in inches x 0.0254)) = 2 x ( (____) x
(_____))=_______m2 where L,B are length and breadth of TLB in inches and L being the smaller one
8. WVTR of TLB = 0.0242 g/m2/day
9. Permeation through TLB in g (C) = (Shelf life in days x B x WVTR of TLB) = 730 x ________x 0.0242= _________g
10. Bag volume in Liters =(LXLXB/3.14) *0.0614=(_______X_________X______/3.14) *0.0614==__________
11. Volume of product in Liters =API quantity in Kg/bulk density in g/ml=_______/0.29=
12. Total head space in Liters (M)=Bag volume in Liters -volume of product in Liters=_______-_________=
13. Head space available with post product filling(N)= 0.1(10% of available Head space)
14. Head space available in Liters (P) =MXN=_______X_________=________
15. Head space volume in m3(Q) =PX0.001=_______X0.001 =_________
16. Head space moisture in grams in 1m3 air at 30° C(R)=30.4
17. Available head space moisture in grams(S)=QXR= _______X30.4=________
18. Total free moisture available in grams (T)=A+C+S==_______+_________+_______=
19. Adsorption capacity of desiccant=200mg/gram of absorbent
20. Desiccant calculation in grams=T/(adsorption capacity of desiccant/1000) =_______/( _________/1000)=

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 7 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

J. SAFETY INFORMATION

Raw material /
Chemical Information / Hazard Precautions
Packing material / Utility

 Ensure earthing and Bonding to the micronize and Sifter.

 Avoid contact with the material by any means.
 Powder Safety Data (MIE value = <4 mJ;
 Ensure 15-20 minutes relaxation time to the material prior to the operation.
APL-5 WM (Apremilast) Dust Explosion class = St2H)
 Ensure usage of earth-rod and anti-static polybags.
 Irritant
 PPE Usage: Nomex suit with griddle hood and nitrile gloves.
 Ensure DCP Fire Extinguisher availability in near-by place.

 Closed handling and safe venting.

 O2 monitoring in clean rooms.
Nitrogen Gas  Asphyxiation  Spot O2 checks, if used in the open, in intermediate areas, to establish safe
levels.
 Ensure the working condition of Oxygen analyzer.

 Full / partial (to reach below MOC) inertization.

Air  Promotes combustion.
 Ionize, to overcome static atmosphere

 Low humidity hinders static decay and can  Humidity control.

HVAC
lead to fire / explosion.  Ionization.

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 8 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

K. BATCH MANUFACTURING OPERATIONS (Encircle the equipment to be used if more than one option is available)

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 9 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Equipment Time Performed by:
Op.
Description Name & Date Remarks
No. From To Sign & Date
Number

Collect the APL-5 WM (Apremilast) input material

sample and send it sample to QC for Particle Size
Distribution (D90) analysis as sample No.
APL5WM(M)-03. Particle Size Distribution (D90):
HDPE
1. Note: 1. Without waiting for APL5WM(M)-03 sample _______ µm
Drum
result proceed for next operation. (Limit: For Information)
2. Ensure usage of earth-rod, kept inside the anti-static
polybag and relaxation time to the material.
3. PPE Usage: Nitrile gloves, dust mask and Face-shield.

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 10 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Visual
Check the cleanliness and dryness of the Air Jet mill and OK/ Not OK
accessories visually and also check the cleaning status
cleanliness:
validity in the equipment log book. Cleaning
OK / Not OK
Note: 1. If validity is within the stipulated time proceed for Validity:
further operations. Cleaning Solvent:
2. If required based on the product requirement or if Cleaning
validity of the Air Jet mill is not within the stipulated time Cleaning Qty.: _______Kg
clean the Air Jet mill with 30.00 Kg of Methyl Iso butyl W.E.ID.No.:
ketone (MIBK) as per the current version of SOP No. SOP-
CTO15-10-0098 and record the cleaning details. Air Jet I.H.B.No:
3. Ensure that double body earthing and bonding are mill Visual
provided to the Air Jet mill. 2500664 OK/ Not OK
cleanliness:
2. 4. Ensure complete dryness of the Air Jet mill. Scoop___ Checked by:
5. Ensure Air Jet mill is free from extraneous matter, if Sampler__ Dryness: OK / Not OK
particles are found clean the Air Jet mill as per the current Earth Air filters
version of SOP No.SOP-CTO15-10-0021. rod____ OK / Not OK
Integrity
6. Ensure the air filters integrity which are connected to the If air filter integrity is not ok:
Air Jet mill. New Filter: Used / Not used / NA
7. During Cleaning of Air jet mill and its accessories ensure
PTW to be followed with the usage of justrite can. Number of particles:
8. Wear Nomex suit with nitrile gloves and multi-vapour Observed: ____ / Not observed
cartridge mask.
9. Check the water droplets in air / nitrogen filter during pre-
cleaning. If water droplets are observed unload the water and Water droplets observed: Yes / No
dry the line.

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 11 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Cleaning Solvent:

Run the system for NLT 30 minutes by applying Cleaning Qty. ____Kg
air/Nitrogen pressure with Feed pressure 0.25 - 3.0
Kg/cm2 and Mill pressure 0.25 - 3.0 Kg/cm2, check the W.E.ID.No.:
foreign particles on the filter cloth, there should not be
any black particles on the filter cloth, if particles are I.H.B.No:
observed clean the lines with 30.00 Kg of Methyl Iso
butyl ketone (MIBK), change the cartridges (if required), Cleaning Solvent:
dry the lines with air before fixing and continue the Air Jet
operation till no particles are observed on the filter cloth. mill Cleaning Qty. ____Kg
3. Checked by:
Note: 1. After completion of operation, remove the filter 2500664
cloth which is placed after the terminal filter (filter
W.E.ID.No.:
nearest to the equipment).
2. Dry the Air Jet mill and accessories by using lint free
I.H.B.No:
cloth / air and check the cleanliness and dryness visually.
3. Wear Nomex suit with griddle hood, nitrile gloves, Observed /
Particles:
multi-vapour cartridge mask and wrist band Not Observed
4. Adjust the main pressure in the pressure switch before Visual
OK/ Not OK
proceed for micronization operation cleanliness:
Main pressure adjusted in the
pressure switch: Yes / No

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 12 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Apply air (or) nitrogen pressure to the system through
0.2 µ filters. Feed Pressure: ____Kg/cm2
Air Jet
Note: 1. Feed Pressure: 0.25 - 3.0 Kg/cm2
4. mill
2. Mill Pressure: 0.25 - 3.0 Kg/cm2
2500664
3. Ensure that O2 analyzer is in working condition and Mill Pressure: ____Kg/cm2
AHU is in once through mode if nitrogen is using

Run the system for 10 - 15 minutes with Feed Pressure: Feed Pressure: ____Kg/cm2
0.25 - 3.0 Kg/cm2 and Mill pressure: 0.25 - 3.0 Kg/cm2 to
Air Jet
identify any leaks and stabilize both mill pressure and
5. mill
feed pressure.
2500664
Note: Ensure that O2 analyzer is in working condition
and AHU is in once through mode if nitrogen is using. Mill Pressure: ____Kg/cm2

Place the collection bowl under the delivery point of Air Air Jet
6. Jet mill. mill
Note: Ensure Earthing to the collection bowl. 2500664

7. Micronize the APL-5 WM material slowly in lot wise by Air Jet mill Micronized material Lot-1:
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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 13 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
applying air (or) nitrogen with feed pressure 0.25 - 3.0
Kg/cm2 and mill pressure 0.25 - 3.0 Kg/cm2 by charging the
material into hopper through screw feeder RPM 20 ± 10
and continuously collect the product in collection bowl. Particle size Distribution (D90):
Note: 1. Wear Nomex suit with griddle hood, nitrile gloves _____ µm
and wrist band. (Limit: 20 - 30 µm)
2.Ensure scoop earthing while charging the material.
3. Ensure that 15-20 minutes relaxation time is given
Micronized material Lot-2:
before charging the material.
4. Ensure multiple earthing are provided to the material. Particle size Distribution (D90):
5. Ensure that anti-static poly bag is used. _____ µm
6. Don’t shake the poly bag while charging the material. (Limit: 20 - 30 µm)
7. Ensure that Mesh guard is provided for feeding
chamber. 2500664
Micronized material Lot-3:
8. Ensure that O2 analyzer is in working condition and
AHU is in once through mode if nitrogen using. Particle size Distribution (D90):
9. Ensure the usage of earth-rod while charging the _____ µm
material. (Limit: 20 - 30 µm)
10. Ensure that earthing and bonding are provided in
HDPE drum to discharge the static electricity.
Micronized material Lot-4:
11. After charging of material in the hopper, cover the top
of hopper with SS Lid. Run the system for ~5 minutes and Particle size Distribution (D90):
wait for 10-15 minutes. _____ µm
12. Restrict the limited manpower while Micronization (Limit: 20 - 30 µm)
13. Filter bag pulsation with nitrogen shall be performed
for every ~5 minutes.
14. After completion of lot-1 micronization, flush the

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 14 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Micronizer by applying feed pressure 0.25 - 3.0 Kg/cm2 for
NLT 60 minutes and then collect the sample and send it to
QC for Particle Size Distribution (D90) as sample No.
APL5WM(M)-01 and wait for the result.
15. If the Particle Size Distribution (D90) result is more
than 30 μm repeat micronization operations till PSD
meeting the specification. If the Particle Size Distribution
(D90) result is less than 20 μm, keep the material aside.
16. Based on the obtained Particle Size Distribution (D90)
sample result, proceed for further lots (Lot-2, Lot-3, and
Lot-4) of micronization with similar parameters (Or)
different micronization parameters within the specified
range followed by sample submission to QC for Particle
Size Distribution (D90) as sample No. APL5WM(M)-01.
17. To avoid static discharge any personal handling during
this material must be grounded by means of conductive
footwear, gloves and wristbands.
18. If the nitrogen is using for micronization, ensure the
room AHU is in once through mode.
19. Ensure second line person availability for supervision.
20. After completion of micronization continue the feed
pressure 0.25 - 3.0 Kg/cm2 without mill pressure for 1 - 3
hours and collect the holdup material from inside air jet
mill into the collection bowl.

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 15 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number

Combine all micronized lots which complies to

APL5WM(M)-01 (Limit: D (90) 20-30 μm). Finally
keep it in HDPE Drum.
Note: 1. Enter the weighing details in the table
given below.
Total Combined Lots Quantity:
2. Wear Nomex suit with griddle hood, nitrile gloves and
HDPE __________Kg
8. wrist band.
Drum
3.Ensure that 15-20 minutes relaxation time is given to Balance ID:___________
the material.
4.Ensure Usage of Earth-rod while handling the
material.
5.Ensure that anti-static poly bag is used.
6.Don’t shake the poly bag while charging the material.

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 16 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Visual cleanliness: OK / Not OK
Check the cleanliness, dryness of the Sifter, accessories Cleaning Validity OK / Not OK
& Magnetic separator visually and also check the Cleaning Solvent:
cleaning status validity in the equipment log book.
Cleaning Quantity: ________Kg
Note: 1. If validity is within the stipulated time, proceed for
further operations. W.E.ID.No.:
2. If pre cleaning is required based on the product requirement I.H.B.No:
or If Cleaning validity of the sifter, accessories & Magnetic Integrity Check: OK / Not OK
separator is not within the stipulated time clean the sifter,
accessories & Magnetic separator with 25.00 Kg of Methyl Mesh Size:
iso butyl ketone (MIBK) as per the current version of SOP Sifter Extraneous Observed/
No. SOP-CTO15-10-0094 and record the cleaning details. 2500762 matter(sifter) Not observed
3. Ensure CEMS is in working condition before start up. Scoop
9. Checked by:
4. Ensure multiple earthing to Sifter and its accessories ______ No. of particles (sifter): ______
5. Use 20/30/40 No. size mesh, check the integrity of mesh. Earth rod
6. Ensure that Magnetic separator is fixed to the Sifter and ________ Extraneous
Observed/
ensure that Magnetic separator free from extraneous matter. matter(Magnetic
Not observed
7. Ensure Sifter is free from extraneous matter, if particles are separator)
found clean the Sifter as per the current version of SOP No.
SOP-CTO15-10-0021. No. of particles on Magnetic separator:
8. During cleaning of Sifter and its accessories ensure PTW to ________
be followed with the usage of justrite can.
8. Wear Nomex suit with nitrile gloves and multi-vapour
cartridge mask. Visual
OK / Not OK
9. Dry the sifter and accessories by using lint free cloth. cleanliness:

10. Sieve the material through magnetic separator on sifter Sifter Bulk density: __________ g/ml Checked by:
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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 17 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
by using 20/30/40 No. mesh and collect sieved material
into the clear polyethylene bag, which is previously
purged with nitrogen and tie it properly with plastic strip
by twisting after removing the air as far as possible.
Keep the above bag in a triple laminated bag, keep the
silica gel (As per calculation) and seal (No. of seals-4) it
with multiline seal (VNS without vacuum and nitrogen
only heat seal it properly). Finally keep the packed
material in HDPE drum. Finally weigh material and
label it.
Note: 1. Stop the vibro-sifter only after no collection
observed from discharge.
2. Collect retained material into clean HDPE drum (Limit: Report the result)
2500762
containing clear polyethylene bag, tie it with plastic
strip, weigh and label it.
3. Ensure earthing and bonding to the Sifter while
sieving.
4. During sieving Static energy value shall be checked.
5. To avoid static discharge any personal handling
during this material must be grounded by means of
conductive footwear, gloves, and wristbands.
6. Collect the sieved material composite material sample
and send it to QC for Bulk density as sample No.
APL5WM(M)-02.
7. Take tare weight of the packing material before
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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 18 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
sieving the material.
8. Ensure no gaps were left while sealing and proper
care is taken during packing.
9. Material should be preserve in tight containers at
control room temperature (25°C). [Excursions are
allowed between 15°C to 30°C].
10. Ensure 10-15 minutes relaxation time to the material
after collection and ensure the usage of Earth-rod while
sieving.
11. Wear Nomex suit with griddle good and nitrile
gloves, and wrist band.
Retained material: _____ Kg
Keep the Retainers separately and send for disposal as Loss: ________ Kg
HDPE
11. per the SOP. Check the integrity of the Sifter mesh after Checked by:
Drum W.E.ID.No. ________
sieving.
Mesh integrity: OK / Not OK

Weighment Details
Bag strip No. Performed Checked
S. Gross Wt. Drum Seal Tare Wt. Net Wt.
Balance ID Lot No. Cont. No. by sign & by sign &
No. Clear (Kg) No (Kg) (Kg)
date date

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 19 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number

Total Quantity in Kg

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 20 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number

Send ATR Sheet to QC for Complete Analysis as

Sample No. APL-5WM (M)
Note: 1. Ensure usage of Earth-rod, kept inside the anti-
static polybag while sample collection.
HDPE
12. 2. To avoid static discharge any personal handling Sampling Quantity: _____Kg Checked by:
Drum
during this material must be grounded by means of
conductive footwear.
3. Wear Nitrile hand gloves, Face-shield, goggles & dust
mask, wrist band.

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 21 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Cleaning Solvent:
Clean the Sifter, magnetic separator with a mixture of
30.02 Kg of Methanol and 2.2 Kg of DMSO and Dry the Cleaning Qty.: _______Kg
sifter with nitrogen and check the cleanliness & dryness
W.E.ID.NO.:
visually.
Note: 1. Wear Nomex suit with nitrile gloves and multi- I.H.B.No:
vapour cartridge mask. Cleaning Solvent:
2. Clean the accessories with required quantity of
Purified Water / WFI Water. After completion of Cleaning Qty.: _______Kg
Sifter
cleaning wipe, the accessories with lint free cloth for W.E.ID.NO.:
2500762
dryness.
Scoop I.H.B.No:
13. 3. Ensure that the Magnetic separator free from Checked by:
______
extraneous matter. Integrity of mesh: OK / Not OK
Earth rod
4. Ensure sifter is free from extraneous matter, if any Extraneous Observed/
________
particles are found it shall be routed through an incident. matter(Sifter) Not Observed
5. Check the integrity of Sifter mesh. If any mesh No of particles _______
damage is observed, raise an incident & replace it with
new one and record the details in the Log book. Extraneous
Observed/
matter(magnetic
5. During cleaning of Sifter and its accessories ensure Not Observed
separator)
PTW to be followed with the usage of justrite can.
6. Ensure earthing to sifter and it’s accessories and No of particles _______
personnel earthing to be ensured. Visual
OK/ Not OK
cleanliness:

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 22 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Cleaning
Solvent:

Cleaning Qty.: _______Kg

Clean the Air Jet mill and accessories with a mixture of W.E.ID.NO.:
30.02 Kg of Methanol and 2.20 Kg of DMSO and check
the cleanliness and dry the Air Jet mill and accessories I.H.B.No:
by using lint free cloth / air and check the cleanliness
and dryness visually. Cleaning
Air Jet Solvent:
Note: 1. During cleaning of Air jet mill and its
14. mill Checked by:
accessories ensure PTW to be followed with the usage of
2500664 Cleaning Qty.: _______Kg
justrite can.
2. PPE Usage: Nomex suit with nitrile gloves and multi-
vapour cartridge mask. W.E.ID.NO.:
3. Ensure earthing to Air jet mill and it’s accessories
and personnel earthing to be ensured. I.H.B.No:

Visual
OK/Not OK
cleanliness:

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 23 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
After sampling, tie the clear polyethylene bag properly
with plastic strip by twisting after removing the air as far
as possible and keep the above bag in a triple laminated
bag, keep silica gel (As per calculation) and seal (No. of
seals-4) it with Multiline seal (VNS without vacuum and
nitrogen only heat seal it properly). Keep the packed
material in HDPE drum. Finally weigh material and
label it.
Note: 1. Wear nitrile hand gloves, goggles, nose mask
Face-shield.
2. Take the tare weight of the packing material before HDPE
15. Checked by:
packing. Drum
3. Ensure usage of earth rod in anti-static poly bag,
earthing to sampler/scoop.
4. ~ 15 minutes of relaxation time shall be given while
unloading the material.
5. Material should be preserve in tight containers at
control room temperature (25°C). [Excursions are
allowed between 15°C to 30°C].
6. Use new triple laminated poly bag during repacking of
material.

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 24 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

OPERATION SHEET
Op. Equipment Time Performed by:
Description Name & Date Remarks
No. From To Sign & Date
Number
Weighment Details
Bag strip No. Performed Checked
S. Gross Wt. Drum Seal Tare Wt. Net Wt.
Balance ID Lot No. Cont. No. by sign & by sign &
No. Clear (Kg) No (Kg) (Kg)
date date

Total Qty in Kg

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 25 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

L. YIELD SUMMARY

Yield

Theoretical Expected Actual

Product & Yield (Kg) = % Performed by Checked by Sign.
Stage Output Mol. Wt. X input % Actual(Kg)X100 Sign. & Date & Date
(Qty.) Kg (Kg)
Expd*. Yield (Kg)X 100 Theoretical yield
Input Mol. Wt. Theoretical Yield

Q Kg of APL-5WM (M)
Apremilast &
for Q Kg of APL-5 WM Report the yield
APL-5WM (M)
as input

Note: 1. Report the actual yield details of sieved material

2. Q = Input quantity (APL-5 WM)

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 26 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

M. IN-PROCESS/ VALIDATION SAMPLING DETAILS:

Sent by (Sign &

Operation Sample Test Recorded by
S. No. Sample No.(S) Date) (Time-As Test Result AR No.
No.(S) Name requested (Sign & Date)
applicable)

Input bulk Particle size Particle Size Distribution (D90):

1. 1 APL5WM(M)-03
material (D90) (Limit: For Information)

Particle Size Distribution (D90):

Micronized Particle size _____ µm
APL5WM(M)-01
material lot-1 (D90)
(Limit: 20 - 30 µm)
Particle Size Distribution (D90):
Micronized Particle size _____ µm
APL5WM(M)-01
material lot-2 (D90)
(Limit: 20 - 30 µm)
2. 7.
Particle Size Distribution (D90):
Micronized Particle size _____ µm
APL5WM(M)-01
material lot-3 (D90)
(Limit: 20 - 30 µm)
Particle Size Distribution (D90):
Micronized Particle size _____ µm
APL5WM(M)-01
material lot-4 (D90)
(Limit: 20 - 30 µm)

Sieved Bulk density: _______g/ml

3. 10. APL5WM(M)-02 Bulk density
material (Limit: Report the result)

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 27 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

PARAMETER RECORD SHEET

Operation No. 7.: Micronize the APL-5 WM material slowly in lot wise by applying air (or) nitrogen with feed pressure 0.25 - 3.0 Kg/cm2 and mill
pressure 0.25 - 3.0 Kg/cm2 by charging the material into hopper through screw feeder RPM 20 ± 10 and continuously collect the product in collection
bowl.

Record the Feed pressure, Mill pressure and Screw feeder frequency (RPM) for every 10±5 minutes.

Feed pressure Mill pressure Frequency of Performed by

Lot No. Date Time Remarks
(Kg /cm²) (Kg /cm²) Screw Feeder (RPM) sign. & Date

(Op.No. = Operation Number)

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 28 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

PARAMETER RECORD SHEET

Operation No. 7.: Micronize the APL-5 WM material slowly in lot wise by applying air (or) nitrogen with feed pressure 0.25 - 3.0 Kg/cm2 and mill
pressure 0.25 - 3.0 Kg/cm2 by charging the material into hopper through screw feeder RPM 20 ± 10 and continuously collect the product in collection
bowl.

Record the Feed pressure, Mill pressure and Screw feeder frequency (RPM) for every 10±5 minutes.

Feed pressure Mill pressure Frequency of Performed by

Lot No. Date Time Remarks
(Kg /cm²) (Kg /cm²) Screw Feeder (RPM) sign. & Date

(Op.No. = Operation Number)

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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 29 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

PARAMETER RECORD SHEET

Operation No. 7.: Micronize the APL-5 WM material slowly in lot wise by applying air (or) nitrogen with feed pressure 0.25 - 3.0 Kg/cm2 and mill
pressure 0.25 - 3.0 Kg/cm2 by charging the material into hopper through screw feeder RPM 20 ± 10 and continuously collect the product in collection
bowl.

Record the Feed pressure, Mill pressure and Screw feeder frequency (RPM) for every 10±5 minutes.

Feed pressure Mill pressure Frequency of Performed by

Lot No. Date Time Remarks
(Kg /cm²) (Kg /cm²) Screw Feeder (RPM) sign. & Date

(Op.No. = Operation Number)

N. LIST OF ATTACHMENTS
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BATCH PRODUCTION RECORD
Product & Stage Apremilast & APL-5WM (M) SAP Code 200032020 Page No : 30 of 30
Batch Size & _______ Kg of APL-5 WM as Batch No. «BATCHNO»
Mfg. Location CTO-SEZ-PU-01
Facility input & Production Block-1 Process Order No. «AUFNR»
Document No. Trial BPR-CC1000102327 Effective Date «DATE4»

S. No. Name of the product Number of copies (Including labels)

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

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