Name of Company: SKN_Laboratories____ 1 of ___

Product: Phoria Analgesic ointment Batch Number: _______________

Issued by (QA): Kate Evangelista______ Production Manager: Nikkae Angob

SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CHECKLIST OF BATCH RECORD

Document Availability checked by

No Description QA / Quality
Production Date Date
Coordination Office
I Formulation
Manufacturing
II
specifications
People/Manpower
Parts/Materials
Production/Method
Process/Equipment
Tests
III Label Sample
SOP to Batch
IV
Processing
Clean Room and
V
Equipment Check
VI Line Clearance Details
Manufacturing
VII
Procedure
VIII Batch sampling
IX Batch Reconciliation
X BMR Certification
 Name of Company: SKN_Laboratories____ 2 of ___
Product: Phoria Analgesic ointment Batch Number: _______________
Issued by (QA): Kate Evangelista______ Production Manager: Nikkae Angob

SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

MANUFACTURING ORDER

Product: Phoria Analgesic ointment Manufacturing

Batch Size: 100g (2 50g container jar) Date Started: ____________________
Proposed size of the container: __50g__ Date Finished: ___________________
Batch Number: ______________________
Expiry Date: _______________________

I. FORMULATION:

Control Item code Ingredients Amount Working Checked

number number (Original amount by
Formula)
Indicate sp.gr

II. MANUFACTURING SPECIFICATIONS:

1. People / Manpower – qualifications, protective garments

Personnel should wear protected garments (laboratory gown, mask, hairnet, clean
pair of gloves) appropriate to the operations to be carried out. Any unhygienic
practice within the manufacturing areas or in any other area where the product
might be adversely affected is forbidden.

Deviations, if any
 Name of Company: SKN_Laboratories____ 3 of ___
Product: Phoria Analgesic ointment Batch Number: _______________
Issued by (QA): Kate Evangelista______ Production Manager: Nikkae Angob

2. Parts / Materials – raw material, label, container, precautions for line clearance

Assayed
Inspected Sampled
Materials Specific Use Purpose Specifications by/
by by
Reference
Methyl
Counterirritant Adjuvant
salicylate
Camphor Counterirritant Adjuvant
Odor Flavoring
Menthol
enhancer agent
Odor Flavoring
Eucalyptol
enhancer agent
Imparts
Coloring
Color distinctive See
agent
appearance attachment
Oleaginous
Mineral oil As emollient
vehicle
Stiffening
White wax To stabilize
agent
As ointment
Petrolatum Basis
base
Wrapping
For wrapping Packaging
paper

Deviations, if any:

3. Production / Method – critical steps in the procedure, documentation

a. Triturate and powder camphor and menthol in a mortar and pestle, separately.
b. Add methyl salicylate and eucalyptol into 10 ml of mineral oil.
c. Add to the liquid mixture the powdered menthol and camphor.
d. Add additional amounts of mineral oil until the volume reaches 50 ml.
e. Melt white wax and petrolatum in an evaporating dish.
f. Add the liquid mixture into the melted base.
g. Pour label amount into the container and allow to solidify.

Deviations, if any:
 Name of Company: SKN_Laboratories____ 4 of ___
Product: Phoria Analgesic ointment Batch Number: _______________
Issued by (QA): Kate Evangelista______ Production Manager: Nikkae Angob

4. Process / Machine – environment, equipment, instrument for QC tests

Mortar and pestle

Evaporating dish
Beaker heater
Stirring rod

Deviations, if any:

5. Tests – QC, IPQC

Note: See attachment

Deviations, if any:

III. PRODUCT SPECIFICATIONS:

Note: See attachment

Prepared by: __________________ Approved by: __________ (Teacher)

Date: _____________ Date: _______________
 SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

IV. LABEL SAMPLE:

 SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

BATCH MANUFACTURING RECORD

Product: Phoria Analgesic ointment Manufacturing

Batch Size: 100g (2 50g container jar) Date Started: ____________________
Proposed size of the container: 50g___ Date Finished: ___________________
Batch Number: ___________________
Expiry Date: _____________________

V. SOP PRIOR TO BATCH PROCESSING:

a. All ingredients must be checked and approved by QC prior to use

b. All ingredients must be labeled properly. Weights and volumes must agree with
the approved MO.
c. All equipment and accessories must be cleaned. SOP # (Ex #) _______
d. Processing room must be cleaned. SOP # (Ex #) _______
e. Wear necessary protective garments.

VI. CLEAN ROOM AND EQUIPMENT CHECK:

Cleaned by Checked by
(student in-charge of (student in-charge of
processing) packaging)
Drug-Solid Manufacturing
room _____________________ _____________________

Required Equipments: _____________________ _____________________

Mortar and pestle

Evaporating dish
Beaker heater
Stirring rod

Deviations if any:

VII. LINE CLEARANCE DETAILS:

Line Previous/Simulta Present Previous Checked Line Date/

Name neous Products Product product
/No. material
clearance
cleared
Batch Pack Batch Pack by given by Time
off from
No Size No Size QA
the area
Yes /No
DSM
NA NA NA
R–1

VIII. MANUFACTURING PROCEDURE:

SOP # (Exercise #): _______________

a. Triturate and powder camphor and menthol in a mortar and pestle,

separately.
By: ______________________________ Checked by: _______________________
student in-charge of processing student in-charge of packaging

b. Add methyl salicylate and eucalyptol into 10 ml of mineral oil.

By: ______________________________ Checked by: _______________________
student in-charge of processing student in-charge of packaging

c. Add to the liquid mixture the powdered menthol and camphor.

By: ______________________________ Checked by: _______________________
student in-charge of processing student in-charge of packaging

d. Add additional amounts of mineral oil until the volume reaches 50 ml.
By: ______________________________ Checked by: _______________________
student in-charge of processing student in-charge of packaging

e. Melt white wax and petrolatum in an evaporating dish.

By: ______________________________ Checked by: _______________________
student in-charge of processing student in-charge of packaging

f. Add the liquid mixture into the melted base.

By: ______________________________ Checked by: _______________________
student in-charge of processing student in-charge of packaging

Pour label amount into the container and allow to solidify.

By: ______________________________ Checked by: _______________________
student in-charge of processing student in-charge of packaging

IX. BATCH SAMPLING:

BULK FINISHED
Sample Use Military Sampling Plan [Single, Use Military Sampling Plan [Single,
size Tightened] on batch size Tightened]
Sampled student in-charge of processing student in-charge of processing
by
Tim    
e
Dat    
e
Result Met specifications [for all products] Met specifications [for all products]
Verified by student in-charge of packaging student in-charge of packaging
Disposition Accepted [for all products] Accepted [for all products]

X. BATCH RECONCILIATION FOR BULK PRODUCT: (Show computations)

ACTUAL/GROSS ________________________ (______________ % to TY)

YIELD (Bulk Size)
Sample (S) ________________________ (______________% to AY)
Net Yield (AY–S) ________________________ (______________% to AY)

THEORETICAL YIELD ________________________

(computed based on
WF)
LOSS/OVERAGE (TY- ________________________ (_______________% to TY)
AY)

XI. BMR CERTIFICATION

MANUFACTURING DEPARTMENT:
 The contents of this document have been checked and verified by me. The
information contained herein is complete and true to the best of my knowledge.
Deviations, if any, are reported.

Hence submitted to Quality Assurance Department.

Signature of Production Officer (processing): ________________________________

Date of Completion: ________________ Date of Submission: __________________

QUALITY ASSURANCE DEPARTMENT:

I hereby certify that this batch record is reviewed by me to ensure that the above-
mentioned batch process has been carried out according to the Authorized Master
Formula and processing instructions.

All operational steps have been scrutinized & approved according to the checklist
(attached) and have been found to be complete.

Signature of Quality Assurance Review Officer (packaging): ____________________

Date of Receipt: ____________________ Date of Approval: ___________________

Actual/gross yield (bulk product) = as weighed (solids/semisolids) or measured (volume

for liquids)

Theoretical yield = batch size (with qs as total amount of preparation) or the total weight
or volume as computed
Gross yield (% to Theoretical yield) = Actual/Gross yield x 100
Theoretical yield
Sample % to AY = sample size x100
Actual/Gross yield

Net Yield = Actual/Gross yield - sample size

Net Yield % to AY = Net yield x 100

Actual/Gross yield

Loss/overage = TY – AY X 100
TY

Loss = + waste
- overage

Student who will:

Document Part Personnel
Weigh Process Label
MO Header QA x    
  Production Manager   x  
Part I Formulation Checked by     x
Part II Manufacturing Inspected/Sampled x    
specifications 2. by
   Assayed by     x
MO Prepared by x    
Part V Clean Room Cleaned by   x  
  Checked by     x
Part VI Line Clearance Checked by     x

Line
clearance
given by
BMR
  QA x    
Part VII. Procedure by   x  
  Checked by     x
Part VIII. Sampling Sampled by x    
  Verified by     x
Part X BMR Certification Production Officer   x  
  QA Review Officer x    

SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CERTIFICATE OF ANALYSIS

Raw Material: Methyl salicylate

Item code: RMM38
Reference: www.parchem.com/Methyl-Salicylate-getpdf-001531.aspx

PARAMETERS SPECIFICATION RESULT

1. Color colorless to pink clear liquid

-8.00 to -7.00 °C. @ 760.00

2. Melting Point
mm Hg
222.00 to 224.00 °C. @
3. Boiling Point
760.00 mm Hg
1.18000 to 1.18500 @
4. Specific Gravity
25.00 °C

5. Vapor Density 5.26

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________

SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CERTIFICATE OF ANALYSIS

Raw Material: Camphor

Item code: RMC14
Reference: www.parchem.com/Camphor-Oil-getpdf-002901.aspx
 PARAMETERS SPECIFICATION RESULT

colorless to yellow-brown
1. Color
liquid
fresh, herbaceous,
2. Odor
camphor

3. Flash Point 45°C +/- 2 CC

4. Specific Gravity 0.875 - 0.900

0.87 kgl (white), 0.97 kgl

5. Density
(yel.), 1.07 kgl (brown)

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________

SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CERTIFICATE OF ANALYSIS

Raw Material: Eucalyptol

Item code: RME23
Reference: www.parchem.com/Eucalyptol-getpdf-016815.aspx
 PARAMETERS SPECIFICATION RESULT

1. Melting Point 1.5 ºC

camphor-like odor, spicy

2. Odor
cooling taste

3. Appearance Colorless transparent liquid

4. Specific Gravity 0.921 - 0.924

5. Aroma Having the camphor tang

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________
 SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376
CERTIFICATE OF ANALYSIS

Raw Material: Mineral oil

Item code: RMM38
Reference: Handbook of Pharmaceutical Excipients 6 th edition

PARAMETERS SPECIFICATION RESULT

1. Specific gravity 0.845–0.905

2. Color Transparent, colorless

Odorless when cold and
3. Odor has a faint odor of
petroleum when heated
4. Taste Tasteless

5. Viscosity ≥ 37mm2/s

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________
 SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CERTIFICATE OF ANALYSIS

Raw Material: White wax

Item code: RMW67
Reference: Handbook of Pharmaceutical Excipients 6 th edition
PARAMETERS SPECIFICATION RESULT

1. Density 0.95 – 0.96 g/cm3

2. Melting point 61 - 65°C

Soluble in chloroform,
ether, fixed oils, volatile
oils, and warm carbon
3. Solubility
disulfide; sparingly soluble
in ethanol (95%); practically
insoluble in water.
4. Unsaponified matter 52 – 55%

5. Acid value 17 – 24

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________
 SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CERTIFICATE OF ANALYSIS

Raw Material: Petrolatum

Item code:
Reference: Handbook of Pharmaceutical Excipients 6 th edition
PARAMETERS SPECIFICATION RESULT

Practically insoluble in
acetone, ethanol, hot or
cold ethanol (95%),
glycerin, and water; soluble
1. Solubility
in benzene, carbon
disulfide, chloroform, ether,
hexane, and most fixed and
volatile oils.
2. Melting range 38 - 60°C

Pale yellow to yellow –

3. Color
colored, translucent

4. Odor & Taste Odorless and tasteless

5. Specific gravity at 60°C 0.815 – 0.880

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________

SKN Laboratories
 Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CERTIFICATE OF ANALYSIS

Raw Material: Menthol

Item code: RMM36
Reference: Handbook of Pharmaceutical Excipients 6 th edition
PARAMETERS SPECIFICATION RESULT

1. Congealing range 27–28°C

2. Melting point 34°C

Very soluble in ethanol
(95%), chloroform, ether,
fatty oils and liquid paraffin;
freely soluble in glacial
3. Solubility acetic acid; soluble in
acetone and benzene; very
slightly soluble in glycerin;
practically insoluble in
water.
4. Specific gravity 0.904 at 15°C
Free-flowing or
agglomerated crystalline
powder, or colorless,
5. Form
prismatic, or acicular shiny
crystals, or hexagonal or
fused masses

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________

SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376
 CERTIFICATE OF ANALYSIS

PARAMETERS SPECIFICATION RESULT

PARAMETERS FOR ANALGESIC OINTMENT (IPQCT)
Reference:

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________

SKN Laboratories
Nasipit, Talamban, Cebu City, Philippines
Contact us: 0949 402 7325/ 0917 700 3585/ 0943 808 2376

CERTIFICATE OF ANALYSIS
FINISHED PRODUCT
Reference:

PARAMETERS SPECIFICATION RESULT

Assayed by: ________________________ Date: _______________

Reviewed by: _______________________ Date: _______________