1.

PURPOSE

Continual assurance that the process of Vitamin B Complex Tablet remains in a state of control
(the validated state) during commercial manufacturing.

2. PREREQUISTE

2.1. Process Validation Report

PV Report No. Date Remarks

Revalidation

2.2. Control Strategy

Specifications Process & Material

Control Strategy
Method Parameters Controls Attribute
API
Compounding
- Dissolved
active
solution
(vitamin B12)

2.3. RISK ASSESSMENT

To assess what process stage

PROCESS SEVERITY OCCURANCE RISK

Compounding High Medium High
Compression High Medium High
Blistering Medium Low Low
Packaging Low Low Low

  OCCURANCE
MEDIU
  HIGH M LOW
SEVERITY

MEDIU
HIGH HIGH HIGH M
MEDIU MEDIU
M HIGH M LOW
MEDIU
LOW M LOW LOW

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3. RESPONSIBLE

3.1. Production
- Participate in CPV meetings
- Participate in deviation investigation

3.2. Validation
- Prepare CPV Protocol
- Prepare CPV Meetings
- Collect data from BPR
- Evaluate data
- Coordinate any correction or follow-up actions
- Prepare CPV Report

3.3. Quality Assurance

- Participate CPV in meetings
- Review and approve CPV Protocol
- Review and approve CPV Report

4. DATA EVALUATION

5. METHODOLOGY

5.1. Identify process parameters and attributes that need to be monitored

Furosemide 20 mg Tablet is an orally administered medication. Furosemide is a potent diuretic

with a rapid action. It is also used for the treatment of edema associated with heart failure,

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 including pulmonary edema and with renal and hepatic disorders and maybe effective in patients
unresponsive to thiazide diuretics.It is also used in the treatment of hypertension, either alone or
with other antihypertensives.

Processing of the product involves the following steps: Wet mixing, Drying, Comminuting, Final
Mixing, Lubrication, Compression, Blistering and Packaging.

6. OBJECTIVES

This Process Validation Protocol aims to:

6.1. Provide a systematic approach to identify measure and document the critical steps in the
manufacturing process of Furosemide 20 mg Tablet that require control to ensure a
reproducible final product.
6.2. Establish acceptable operating ranges that guarantee product conformance to all quality
specifications.
6.3. Confirm the reproducibility of the established process parameters in at least three Process
Validation batches.
6.4. Generate sufficient data to establish documentary evidence that Am-Europharma Corp. can
routinely manufacture Furosemide 20 mg Tablet consistently and meets the high quality
standards and applicable regulatory bodies.

7. SCOPE

This protocol shall apply to three (3) process validation batches of Furosemide 20 mg Tablet with
batch size of 30.22 Kg equivalent to 200,000 Tablets, manufactured at Tablet Area of Am-
Europharma Corp. Plant in Calamba, Laguna.

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8. METHODOLOGY

8.1. A prospective validation approach will be used for this validation study
8.2. All validation batches will be manufactured following the same manufacturing process as
detailed in the manufacturing instructions. The validation batches should meet all
requirements specified in the protocol
8.3. All critical process variables in the manufacturing process will be monitored.
8.4. Verify desirable attributes of the product and its components and confirm limitations and
constraints for these attributes.
8.5. Confirm controls or testing parameters that will be measured.
8.6. Verify that all relevant SOPs are current and are being followed.
8.7. Verify that equipment qualifications and calibrations have been completed for all
equipment to be used in the manufacturing process

9. PRODUCT FORMULATION

Active Ingredient Approved Manufacturer of API

Furosemide Polydrug Laboratories PVT. LTD. - India

LABEL PER PER BATCH

RAW MATERIAL FUNCTION CLAIM PER DOSAGE 200,000
TABLET UNIT TABLETS
Active Ingredient
Active
**Furosemide Pharmaceutica 20.000 mg 21.00 mg 4.200 Kg
l Ingredient
Inactive Ingredient
Lactose Monohydrate Diluent 64.44 mg 12.800 Kg
Cornstarch A Diluent 45.55 mg 9.100 Kg
Cornstarch B Binder 13.00 mg 2.600 Kg
FDC Yellow # 5 Colorant 0.20 mg 40.00 g
Talc Lubricant 3.00 mg 600.00 g
Magnesium Stearate Lubricant 4.00 mg 800.00 mg
*Purified Water Wetting Agent (5.00 mL) 10.00 L
Weight per Tablet 151.10 mg 30.220 Kg
Remarks:
* Used only as processing aid and is completely driven off from the final
product.
** With 5% Excess to compensate production loss.

10. PROCESS DESCRIPTION

Weighing of Raw Materials

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10.1. PROCESS FLOWCHART
Furosemide
Mixing – Preparation of Active
Cornstarch A Sigma Blender EQT -006
Mesh screen #20
Time – 20 minutes
Lactose

A
FD&C Yellow #5
Binder Preparation with Color
Purified Water SS Stock Pot

Cornstarch B

Purified Water

A Wet Mixing
Sigma Mixer EQT -006

Wet Comminution
Mesh # 4
C Manual sieving

Drying
Fluid Bed Dryer EQT - 002
Temperature- 60˚C Test parameters:
Time –NMT 1 hour (or until MC is
D Description
NLT 0.5% & NMT 1.0%) Moisture Content

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 Dry Comminuting
E Mesh # 16
Cizer Mill EQT - 028

Dried comminuted granules

Dried comminuted granules Final Mixing

Sigma Blender EQT-006
Talc Time – 5 minutes

Lubrication
Magnesium stearate Sigma Blender EQT-006
Time – 3 minutes

Test Parameters:
Bulk Granules Description
Moisture Content
Assay

Compression
CadmachTabletting Machine Test Parameters:
EQT-012 Description
Tablet weight
Hardness
Time Friability
Bulk Tablets Thickness
Disintegration Test
Dissolution Test
Assay
Primary Packaging
Blister filling Machine
EQT-001 /010 Test Parameters
Leaker’s Test

FilledTime
blister flaps

Manual Packaging

Furosemide 20 mg Tablet blister

packed by 20’s box of 100’s

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10.2. PROCESS CHARACTERIZATION

Critical Process Critical Quality

Process Step Equipment, Machine
Parameters Attributes
1. Mixing –
Sigma Blender  Load
preparation of
EQT-006,  Mixing time  Homogeneity
active
ingredient
Mesh screen #20  Speed
 Temperature of
2. Binder
Stainless steel stockpot, purified water
Preparation +  Homogeneity
Stirrer  Volume of Purified
Colorant
water
 Load size
3. Wet Sigma Blender
 Speed  Homogeneity
Granulation EQT-006
 Mixing Time
 Mesh Size
4. Wet Screening Mesh screen #4  Mesh Integrity  Homogeneity
 Mesh condition
 Temperature
Grovers Fluid Bed Dryer
5. Drying Distribution  Moisture Content
EQT-002
 Drying Time
 Mesh Size
Cadmach Cizer Mill
 Mesh Integrity
6. Comminuting EQT-028  Particle size
 Blade setting
Mesh Screen # 16
 Speed
 Mesh size
Sigma Blender
 Mesh Integrity  Particle size
7. Final Mixing EQT-006
 Mixing Time  Homogeneity
Mesh screen #30
 Load size
 Mesh size
Sigma Blender  Mesh integrity  Moisture Content
8. Lubrication EQT-006  Mixing Time  Assay
Mesh screen # 30  Speed  Homogeneity
 Load size
 Weight
 Thickness
 Machine speed
Cadmach CMB4-27  Hardness
9. Compression  Compression pressure
EQT-012  Disintegration
 RH/Temp
 Dissolution
 Friability
 Sealing temperature
 Air pressure
Blistering Machine  Appearance
 Cooling temperature
10. Blistering Hoong A  Complete sealing –
EQT-001/EQT-010  Speed
no leak
 Yeild

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 10.3. SAMPLING PLAN

PROCESSING SAMPLING TESTS TO BE PURPOSE METHOD ACCEPTANCE

STAGE PLAN DONE CRITERIA
Raw Materials  Per QC Per QC To ensure that As per QC Acceptance
Sampling Plan Acceptance test all raw materials Tabulation of QC Criteria
for RM are cleared for lot number of raw
Acceptance use materials used
 100 % ID Test
Binder Solution Visual inspection To evaluate
physical
Organoleptic Uniform yellow
Appearance characteristic of
examination translucent paste
the binder
solution
Wet Mix One random To evaluate the
Slightly wet, yellow
sample from Completeness of physical Organoleptic
colored almost spherical
Sigma Blender wet mixing characteristic of examination
granules
the wet mix
Dried Granules One random To determine
Sartorius
sample from FBD Moisture the moisture
Moisture 0.5 – 1.0%
content content of the
analyzer, 100°C
dried granules
One random To evaluate the
sample from the physical
collecting characteristics Organoleptic Yellow colored
Appearance
container of the of the dried examination granules
comminuting comminuted
machine granules
Final Mix Take composite Moisture Physical  Sartorius  1.00 %- 3.00%
samples (5 x 20g) Content characterization, Moisture
from top, middle and uniformity Analyzer,
and bottom of distribution 100°C
portion of the of active
blender after Appearance ingredient of Visual inspection  Yellow granules
lubrication the final blend
(see illustration,
for reference on
sampling points) Validated HPLC  NLT 90.0% - NMT
Assay Method 110.0% of the
labeled amount of
Furosemide

SAMPLING POINT ILLUSTRATION (Sigma blender)

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 SAMPLING
LOCATION
POINT NO.
1 Upper Left Corner
2 Upper Right Corner
3 Lower Left Corner
4 Lower Right Corner
5 Middle Part

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 PROCESSING SAMPLING TESTS TO BE ACCEPTANCE
PURPOSE METHOD
STAGE PLAN PERFORMED CRITERIA
Compression 1. Take 10 Pre-control test To adjust the
tablets from Purpose: For machine to
the front and machine produce tablets Weigh 10
back ejection adjustment with weights as tablets
after machine purposes prior to close as possible individually
RSD: NMT 2%
set-up. run to the nominal and compute
weight and for the RSD
minimize
variation within
the samples
2. Take 60  Visual To evaluate  Visual  Size 6 in
tablets from Inspection physical Inspection diameter,
front and back characteristics of yellow, round,
ejection after tablets prior to flat beveled
passing the actual run edge tablet
pre-control test and plain on
the other side

 Individual  Manual  151.10 mg ±

Weight Weighing 5%
(143.545 mg –
158.55 mg)

 Thickness  Mitutuyo  3.00mm -

Thickness 5.00 mm
Tester

 Hardness  Hardness  4.0 Kp- 6.0

Tester Kp

 Disintegratio  TaijinGuomi  NMT 30

n ng minutes
Disintegratio
n Tester

 Friability  TaijinGuomi  NMT 1.0%

ngFriabilator

Compression 3. Take 5 tablets Weight, For statistical SPC Mean weight and
(continuation) from front and thickness and process control range per
back ejection hardness (to measure & subgroup are in-
every 9 analyze process control.
minutes during variation)
the entire
compression
run. (to obtain
20 SPC sub

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 groups given 3
hours
compression
run)

4. Take 100 Description Visual Yellow, round,

tablets samples inspection flat beveled edge
from front and tablet and plain
back ejection on the other side
during the
Start, Middle,
and End of the
compression run
Weight Manual 151.10 mg ± 5%
weighing (143.545 mg –
158.55 mg)
Diameter Mitutuyo 6.00 mm
Digimatic
Caliper
Thickness Mitutuyo 3.00mm - 5.00
Digimatic mm
Caliper
Hardness Hardness tester 4.0 Kp- 6.0 Kp
Disintegration Taijin Guoming NMT 30
Test Disintegration minuutes
Tester
Dissolution Test Validated NLT 80% (Q) of
Analytical the labeled
method amount of
Furosemide
(C12H11ClN2O5S) is
dissolved in 60
minutes
Uniformity of Validated Meets USP
Dosage Units by Analytical Requirements
Content method Maximum
Uniformity Allowable
acceptance value
is ≤15 .

Identification Validated The ultraviolet

Test Analytical absorption
method spectra obtained
exhibit maxima
and minima at
the same
wavelengths
Assay To evaluate Validated NLT 90.0% - NMT
assay of Analytical 110.0% of the
compressed method labeled amount of
tablets Furosemide
Primary Take 5 blister Appearance To check seal Visual Yellow round flat
Packaging flaps x 20’s integrity inspection beveled edge

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 every 30 Leakers Test tablets blister
minutes from packed by 20’s ;
start to end of clear PVC/
blister filling. printed Alu foil
Leakers Test

No Leak
Take 5 blister Total Aerobic Estimation of USP Does not exceed
flaps by 20’s microbial count the number of 1000 CFU per
from start, viable aerobic gram
middle and end Total combined micro-organisms Does not exceed
of blister filling yeasts and present and for 100 CFU per
operation molds freedom from gram
Escherichia coli designated absent
microbial
species in the
finished product

7. EVALUATION

The results obtained from the process validation batches will be compared with the product
specifications and processing parameters from the registered in order to establish acceptable
operating ranges, where applicable and validate specifications.

8. CONCLUSION

9. VALIDATION REVIEW AND APPROVAL

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Reviewed by: Reviewed by: Approved by:
Date: Date: Date:

Irma M. Rodenas Celerina V. Samonte Olivia Y. Licuanan

QC Manager Production Manager QA Compliance Manager

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10. ATTACHMENTS

10.1. Raw Materials Monitoring Form

RAW MATERIAL BATCH NUMBER

QUANTITY
NAME BATCH NO. 1 BATCH NO. 2 BATCH NO. 3
**Furosemide 4,200 Kg QC Number Quantity QC Number Quantity QC Number Quantity
Lactose
12.800 Kg
Monohydrate
Cornstarch A 9.100 Kg
Cornstarch B 2.600 Kg
Magnesium
40.00 g
Stearate
Talc 600.00 g
FDC Yellow # 5 800.00 mg
*Purified Water 10.00 L
 10.2. Process Parameter Monitoring Forms
10.2.1. Compounding
Equipment/Quantity/
PROCESS/ OPERATION Parameters/ Acceptance PVB-01 PVB-02 PVB-03
Criteria
1. Preparation of Active Sigma Blender EQT-006,
Mesh screen #20
 Furosemide 4.200 Kg
 Lactose 12.800 Kg
 Cornstarch A 9.100Kg
Time Time Time
Start
Mixing 20 minutes
End
Net
Operator N/A
SS Stock pot,
2. Granulation Binder
Preparation + Colorant
 FD&C #5 40.00 g
700.00 mL
 Boiling purified water
Temp: 90-100°C
SS Stock pot

 Cornstarch B 2.600 Kg

 Purified water 3.00 L

6.00 L
 Boiling purified water
Temp: 90-100°C
Operator N/A
Sigma Blender EQT-006, Time Time Time

3. Wet Granulation
Time: TBE Start
End
Net
Operator N/A

4. Wet Comminuting Mesh screen#4

Operator N/A

5. Drying FBD EQT-002

 Air Inlet 60ºC

 Outer damper opening 40ºC

 Shaking Interval TBE

 Shaking Frequency TBE

 Drying Time 30 – 45 minutes Time Time Time
 Start
End
Net
Operator N/A
Cadmach cizer mill
EQT-028
Sieve: Mesh # 16
6. Comminuting
Blade setting: Knives
forward
Speed: 2250 rpm
Operator N/A
Sigma Blender EQT-006,
7. Mixing and Lubrication Mesh screen #30

 Talc 600.00 g

Time Time Time

Start
Mixing 5 minutes
End
Net

 Magnesium stearate 800.00 g Time Time Time

Start

Mixing 3 minutes End

Net
Operator N/A
BATCH ACCOUNTABILITY OF FINAL MIX
Theoretical Yield:
Total Output
30.220 kg
Percentage Yield 98.00% - 100.50%

10.2.2. Compression

Settings/ Operating BATCH NUMBER

Process/Operation
Ranges PVB-01 PVB-02 PVB-03
Machine: Cadmach CMB4-27 (27 Stations) EQT-012
A. Equipment Number
B. Toolings Used
6.0 mm, UP, round,
Upper Punch (UP): flat beveled edge,
plain
6.0 mm, LP, round,
Lower Punch (LP): flat beveled edge,
plain,
Dies: 6.0 mm, round
 C. Machine Speed TBE
D. RH (%) 40% - 60%
E. Room Temperature (°C) 20°C - 25°C
Start : ______ Start : ______ Start : ______
Total Processing Time TBE End: _______ End: _______ End: _______
Net: _______ Net: _______ Net: _______
Theoretical Yield:
Total Output
200, 000 tablets
NLT 95.0%
Percentage Yield
NMT 100.0%
Date Done

Machine Operator

10.2.3. Packaging
Setting / Operating BATCH NUMBER
Process/Operation
Ranges PVB-01 PVB-02 PVB-03
Machine: Hoong-A Ministar V
A. Equipment Number
99 flaps – 114 flaps /
B. Machine Speed
minute
C. Sealing Temperature
120 ° C - 190° C
(oC)
D. Air Pressure 195 psi
E. Cooling Temperature 10.0° C
Total Output 10,000 blisters

Percentage Yield 97.50% - 101.50%

Machine Operator
10.3. In-Process/Product Attributes Monitoring Form
BATCH NUMBER
Parameters Specifications
Batch no. 1 Batch no. 2 Batch no. 3
Binder Solution
Uniform yellow
1. Description
translucent paste
Wet Mix
Slightly wet, yellow
1. Description colored almost
spherical granules
Dried Granules
Yellow colored
1. Description
granules
2. Moisture content 0.5% - 1.0%
Final Mix
1. Description yellow granules
2. Moisture Content 1.0% - 3.0%
NLT 90.0% - NMT T T T
3. Assay 110.0% of the M M M
Furosemide labeled amount of
Furosemide Tablet B B B
 BATCH NUMBER
Parameters Specifications
Batch no. 1 Batch no. 2 Batch no. 3
Compressed Tablet
Yellow, flat, beveled edge
1. Description size 8 mm diameter tablet,
plain on both sides
151.10 mg ± 5%
2. Individual Weight (143.545mg – 158.655
mg)

3. Thickness 3.00 mm -5.00 mm

4. Hardness 4.0 kp – 6.0 kp)

5. Disintegration NMT 30 minutes
NMT 1.00%, with no
6. Friability capped, cracked, cleaved
or broken tablets
NLT 90.0% - NMT
7. Assay 110.0% of the labeled
amount of Furosemide
8. Uniformity of Dosage
Units AV: L1≤ 15
(Content Uniformity)

The ultraviolet absorption

9. Identification spectra obtained exhibit
maxima and minima at the
same wavelength
NLT 80% (Q) of the
labeled amount of
10. Dissolution
(C12H11ClN2O5S) is
dissolved in 60 minutes
 BATCH NUMBER
Specifications
Parameters Batch no. 1 Batch no. 2 Batch no. 3
PACKAGING
Pack Sizes SS x 100s
SS x 20 ;
Blister Strip Cut
20 tablets per blister strip
Packaging Check 1.Blister strips should have
smoothly cut edges
2.Each pocket should contain
one tablet
3. Blister Strips should be free
from pinholes in the sealing
area.
4.Blister Strips should be
properly locked/sealed
5. Each strip/pocket should be
coded with the correct batch # &
expiry date
6.Inserts should be properly
folded / placed in each
individual box
7. Individual boxes should be
properly closed and sealed
8.Individual boxes should be
properly packed in the
corrugated box
9. Corrugated boxes should be
properly sealed with polytape
(side to side and end to end) –
top and bottom
Leakers Test No Leak

Microbial Test

Total Aerobic
NMT 1000 CFU per gram
microbial count
Combined yeasts and
NMT 100 CFU per gram
molds

Escherichia coli Absent

10.4 Process Capability Data

BATCH NUMBER
Batch no. 1 Batch no. 2 Batch no. 3
PROCESS CONTROL CHART
  Grand Mean
 Mean Range
 UCLR
 LCLR
 UCLX
 LCLX

PROCESS CAPABILITY ANALYSIS

 Cr (<0.75)
 Cp (>1.33)

 Cpk (>1.00)

Process Mean

Target weight (mean)

% Deviation from Specification Mean

% Above USL
% Below LSL

% Samples Outside Specifications

95% Confidence Interval

Remarks:
10.5 Qualification / Documentation Pre-requisites

10.5.1 Room Qualification

Specification Limit : RH- 40 % - 60 %
Room temperature - 20˚C - 25˚C

*TMPC
No
Name of Room Relative Humidity Temperature **AP ***Y Checked by/ Date:
.
C M

Batch No.:
1 Dispensing Room
2 Compounding Room (Wet Granulation)
3 Compounding Room (Drying Area)
4 Compounding Room (Comminution)
5 Compounding Room (Dry Mixing)
6 Compression Room
7 Blister Packing Room
10.5.2 Equipment Qualification

Viable
No. Name of Equipment Equipment No. Calibrated
Microbes

Batch No.:
1 Mettler Toledo Balance MMD – BAL - 021
2 Sartorius ED 2244
3 Moisture Analyzer MMD-MOB-001
4 Sigma blender EQT-006
5 Grovers Fluid Bed Dryer EQT-002
CadmachCizer Mill Machine
Upper part
Cover/ hopper
6 EQT – 028
Scoop
Mesh/ screen
Blades
7 Sigma Blender EQT-006
8 Cadmach CM-27B EQT-012
Hoong-A Ministar V3 Blister
9 Packaging Machine EQB-010
Feeding Table
Green Trust 7E-A Leakers Tester MMD-VAI-001
10.5.3Documentation

BATCH NUMBER
No. Name of Document
Yes No Yes No Yes No
1 Personnel training documentation in place
2 Equipment qualification (IQ/OQ) documentation in place
3 Test method validation documentation in place
4 SOP’s available for:
4.1 Machine Operation
4.2 Manufacturing Process
10.6 FINISHED PRODUCT TECHNICAL SPECIFICATION

PARAMETER SPECIFICATION PROCEDURE

1.0 APPEARANCE Yellow, round flat beveled edge tablet Visual Examination
and plain on both sides.

2.0 DIAMETER 6.0 mm ( 5.88 mm- 6.12 mm ) ± 2% In-house

3.0 THICKNESS 3.00 mm – 5.00 mm In-house

4.0 HARDNESS 4.0Kp- 6.0Kp In-house

5.0 DISINTEGRATION NMT 30.0 minutes In-house

TIME

6.0 WEIGHT PER 151.10 mg ( 143.545 mg – 158.655 mg) In-house

TABLET ± 5%

7.0 IDENTIFICATION The ultraviolet absorption spectra

obtained exhibit maxima and minima at USP 39
the same wavelengths.

8.0 UNIFORMITY OF AV: L1≤ 15

DOSAGE UNITS by USP 39
CONTENT
UNIFORMITY

9.0LIMIT of NMT 0.8% of Furosemide Related

FUROSEMIDE Compound B USP 39
RELATED COMPOUND
B

10.0 DISSOLUTION Not less than 90.0 % and not more than
TEST 110.0% of the labeled amount of USP 39
 Apparatus 2/50 C12H11ClN2O5S is dissolved in 60
rpm/ Phoshate minutes.
buffer pH 5.8, 900
mL

11.0 ASSAY Not less than 90.0% and mot more than
110.0% of the labeled amount of USP 39
C12H11ClN2O5S
10.7 FINISHED PRODUCT CERTIFICATE OF ANALYSIS