Medicell Laboratory Incorporation

Documentation no: 0001 Title subject: Date issued: 03/25/19

MASTER MANUFACTURING
FORMULA
Date Effective: 04/02/19
Page no. 1 of 10

Name of the product: Carbocisteine Syrup

Dose of formulation: 125 mg / 5 mL

Description: Carbocisteine syrup is a mucolytic agent for the adjunctive therapy of

respiratory tract disorders characterised by excessive, viscous mucus,
including chronic obstructive airways disease. The active ingredient is
carbocisteine. It is a smooth and colorless in appearance and show a
syrupy liquid.

Starting materials:  Carbocisteine  Citric Acid  Menthol

Crystal

 Sodium  Methyl  Flavor

Hydroxide Paraben
 Sucrose  Propyl  Propylene
PAraben Glycol

 FD & C #40

Volume per bottle: 60 mL

Volume of all ingredients: 180 mL

Statement: We produced 3 bottles of Carbocisteine Syrup

 Medicell Laboratory Incorporation

Documentation no: 0001 Title subject: Date issued: 03/25/19

MASTER MANUFACTURING
FORMULA
Date Effective: 04/02/19
Page no. 2 of 10

Code No. Ingredients QUANTITY 60 ml

60 ml

RM001 Carbocisteine 3.6 g 3.6 g

RM002 Sodium 1.44 g 1.44 g

Hydroxide

RM003 Sucrose 72 g 72 g

RM004 Citric Acid 1.728 g 1.728 g

RM005 Methyl Paraben 0.162 g 0.162 g

RM006 Propyl PAraben 0.036 g 0.036 g

RM007 Menthol Crystal 0.018 g 0.018 g

RM008 Flavor 0.005 ml 0.005 ml

RM009 Propylene Glycol 0.040 ml 0.040 ml

RM010 FD & C #40

Prepared by/ Date: Checked by/Date: Approved by/ Date:

Marielle Ambrosio/ Jermielene Nimer/ Mylene Mendoza/

03/25/19 04/02/19 04/02/19
 Medicell Laboratory Incorporation

Documentation no: 0002 Title subject: Date issued: 03/25/19

MASTER MANUFACTURING
ORDER
Date Effective: 04/02/19
Page no. 3 of 10

Product: Carbocisteine Syrup CPR No. LM-JHK 329 Product Code No. 65256

Department: Liquid Supersedes MF No. JK-OO-59 Shelf life: 2 Years

MF No. GR-026-9 Date: 05/11 /17 Reference MF No. JK-009-2

Effectivity date: 04/02/19 And CPR dated: 03/28/19
Mfg. Date: 03/25/19 Packaging Started
Exp. Date: 03/12/21 Date03/28/19Time4:00PM

Code No. Ingredients QUANTITY 60 ml

60 ml (for 3 bottles)

RM001 Carbocisteine 3.6 g 10.8g

RM002 Sodium 1.44 g 4.32g

Hydroxide
RM003 Sucrose 72 g 216g

RM004 Citric Acid 1.728 g 5.184g

RM005 Methyl Paraben 0.162 g 0.486 g

RM006 Propyl PAraben 0.036 g 0.036 g

RM007 Menthol Crystal 0.018 g 0.108 g

RM008 Flavor 0.005 ml 0.015 ml

RM009 Propylene Glycol 0.040 ml 0.12 ml

RM010 FD & C #40

PREPARED BY CHECKED BY: APPROVED:

NAME: NAME: NAME:
 Medicell Laboratory Incorporation

Mylene Mendoza Jermielene Nimer Marielle Ambrosio

Date: 03/25/19 Date: 04/02/19 Date: 04/02/19

Documentation no: 0003 Title subject: Date issued: 03/25/19

MASTER MANUFACTURING
PROCEDURE
Date Effective: 04/02/19
Page no. 4 0f 10

Code No. FUNCTION Ingredients QUANTITY 60 ml

60 ml (for 3 bottles)

RM001 Mucolytic Carbocisteine 3.6 g 10.8g

agent
RM002 Oxidizing Sodium 1.44 g 4.32g
Agent Hydroxide
RM003 Preservative Sucrose 72 g 216g

RM004 Chelating Citric Acid 1.728 g 5.184g

Agent
RM005 Antimicrobial Methyl 0.162 g 0.486 g
Agent Paraben
RM006 Antimicrobial Propyl 0.036 g 0.036 g
agent PAraben
RM007 Antifoaming Menthol 0.018 g 0.108 g
agent Crystal
RM008 Flavoring Flavor 0.005 ml 0.015 ml
agent
RM009 Emulsifying Propylene 0.040 ml 0.12 ml
agent Glycol
RM010 Additives FD & C #40
 Medicell Laboratory Incorporation

Documentation no: 0001 Title subject: Date issued: 03/25/19

MASTER MANUFACTURING
PROCEDURE
Date Effective: 04/02/19
Page no. 5 0f 10

Product: Carbocisteine Syrup CPR No. LM-JHK 329 Product Code No. 65256

Department: Liquid Supersedes MF No. JK- Shelf life: 2 Years

OO-59
MF No. GR-026-9 Date: 05/11 /17 Reference MF No. JK-009-2

Effectivity date: 03/18/19 And CPR dated: 03/28/19

Mfg. Date: 03/25/19 Packaging Started
Exp. Date: 03/12/21 Date03/28/19Time4:00PM
EQUIPMENT
EQUIPMENT Certified Clean Checked

By/ Date By/ Date

SS DOUBLE JACKETED TANK

Marielle Ambrosio Jermielene Nimer
03/24/19 03/25/19
MILLING MACHINE
Marielle Ambrosio Jermielene Nimer
03/24/19 03/25/19
MIXER MACHINE
Marielle Ambrosio Jermielene Nimer
03/24/19 03/25/19
SYRUP TRANSFER PUMP
Marielle Ambrosio Jermielene Nimer
03/24/19 03/25/19
LIQUID SYRUP
MANUFACTURING TANK Marielle Ambrosio Jermielene Nimer
03/24/19 03/25/19
 Medicell Laboratory Incorporation

Documentation no: 0001 Title subject: Date issued: 03/25/19

MASTER MANUFACTURING
PROCEDURE
Date Effective: 04/02/19
Page no. 6 0f 10

SIGNATURE SHEET
Supervisor/ Checker Operator

Name(IN CAPITAL Signature Name(IN CAPITAL Signature

LETTERS) LETTERS)
 Medicell Laboratory Incorporation

Documentation no: 0001 Title subject: Date issued: 03/25/19

MASTER MANUFACTURING
PROCEDURE
Date Effective: 04/02/19
Page no. 7 0f 10

PROCEDURE

QUANTITY DONE BY/ DATE CHECKED BY/DATE

1.) Weigh the Carbocisteine 10.8 g Jermielene Nimer Marielle Ambrosio

03/25/19 03/25/19

2.) Weigh the Sodium 4.32 g Jermielene Nimer Marielle Ambrosio

hydroxide 03/25/19 03/25/19

3.) Weigh sucrose and add 72 g Jermielene Nimer Marielle Ambrosio

distilled water, boiled to 03/25/19 03/25/19
dissolve, filtered, and allow to
cool. Set Aside.
4.) Dissolve Sodium 4.32g Jermielene Nimer Marielle Ambrosio
Hydroxide in water. 03/25/19 03/25/19
10ml
H20-

5.) Dissolve the drug Jermielene Nimer Marielle Ambrosio

carbocisteine in Sodium 03/25/19 03/25/19
hydroxide and filter.
6.) Dissolve methyl Jermielene Nimer Marielle Ambrosio
paraben and propyl paraben in 03/25/19 03/25/19
propylene glycol.
 Medicell Laboratory Incorporation

7.) Add the citric acid and Jermielene Nimer Marielle Ambrosio
dissolved in distilled water to 03/25/19 03/25/19
the mixture.

8.) Add the mixture in the Jermielene Nimer Marielle Ambrosio

sucrose. 03/25/19 03/25/19

9.) Mix the the filtered Jermielene Nimer Marielle Ambrosio

carbocisteine in the mixture 03/25/19 03/25/19
and add the water based
flavor.

pH: 3.8
10.) Determine yield and ask Jermielene Nimer Marielle Ambrosio
QC to get samples. 03/25/19 03/25/19
Theoretical yield:180 ml
Actual yield:180ml
% yield:100%
Limit: 98-100%
11.) Seal the container and Jermielene Nimer Marielle Ambrosio
fill upon release by Quality 03/25/19 03/25/19
Control

IPQC TEST

Appearance:

Color: Clear, colorless

Odor: Lemon scent

Taste: Sweet

Clarity Clear

pH 3.8
 Medicell Laboratory Incorporation

PREPARED BY CHECKED BY: APPROVED:

NAME: NAME: NAME:
Mylene Mendoza Marielle Ambrosio Jermielene Nimer

Date: 03/25/19 Date: 04/02/19 Date: 04/02/19

Documentation no: 0004 Title subject: Date issued: 03/25/19

MASTER PACKAGING
INSTRUCTIONS

Date Effective: 04/02/19

Page no. 8 of 10

Product: CPR No. LM-JHK 329 Shelf Life: 2 Years Packing Size: 60ml
Carbocisteine
Syrup

Department: Product Code: 65256 Packing Code: 55894 Bar Code:

Liquid

MF No. GR- Supersedes MF No. Batch Size: 180ml Lot No. JHK564

026-9 JK-OO-57

Effectivity Packaging Started Packaging Target Fill: 60ml

Date: 04/02/19 Finished

Mfg. Date: Issued by/Date

03/25/19 MARIELLE AMBROSIO/
03/29/19
Exp. Date: Date03/28/19 Date03/29/19 Approved for packing
03/12/21 Time4:00PM Time4:00PM by/Date:

ALICE SILVERIO/
04/01/19
Product Description: Carbocisteine Syrup 125mg/5 ml is clear syrup with Lemon odor and sweet lemon taste.
 Medicell Laboratory Incorporation

Documentation no: 0001 Title subject: Date issued: 03/25/19

MASTER PACKAGING
INSTRUCTIONS

Date Effective: 04/02/19

Page no. 9 of 10

BATCH ACCOUNTABILTY
Theoretical yield 180ml

Actual yield 180ml

Equipment

Equipment Cleaned by/Date Checked by/ Date

1. Filling Machine
MARIELLE AMBROSIO JERMIELENE NIMER
03/25/19 03/24/19
2. Capping Machine

MARIELLE AMBROSIO JERMIELENE NIMER

03/25/19 03/24/19
3. Labelling machine

MARIELLE AMBROSIO JERMIELENE NIMER

03/25/19 03/24/19
4. Cartoning machine
MARIELLE AMBROSIO JERMIELENE NIMER
03/25/19 03/24/19
 Medicell Laboratory Incorporation

PREPARED BY CHECKED BY: APPROVED:

NAME: NAME: NAME:
Mylene Mendoza Marielle Ambrosio Alice Silverio

Date: 03/25/19 Date: 04/02/19 Date: 04/02/19