SAFFRON PHARMACEUTICALS (PVT.

)
LTD.
PRODUCTION DEPARTMENT
Title: Batch Manufacturing Order Document #
PR/GN/FM/001
Issue date: 20-08-2007
Product: Cetrix syrup 5mg/5ml B. No: B. Size: 2000 L
Requisite Date Issue Date Date Mfg. Started: Date Mfg.
Completed:

Prepared By Checked By Approved By Authorized By

In-charge Production Manager Quality Director

Pharmacist Manager Operations Operations
S.# GR
Material Qty Uni Multiplyi Qty Unit W.T Check Received
N ng
No. Theoretic t Actu By ed By By
al Factor Q.A. Prod.
al
1 Cetirizine 2HCl 2.0 kg
2 Sugar 600.00 kg
Methyl paraben
2.00 kg
3 sodium
Propyl paraben
0.50 kg
4 sodium
5 Citric acid 2.00 kg
6 Sodium citrate 4.00 kg
7 Sodium Benzoate 2.00 kg
Amaranth red
0.08 kg
8 Color
9 Menthol 0.10 kg
10 Propylene glycol 6.00 kg
11 Strawberry No.1 2.0 L
12 Polysucralose 8.60 kg
13 Sorbitol 300.00 kg
14 Liquid glucose 600.00 kg
15 2000.0
D.I. Water Q.S to L
0

Theoretical Total Actual Total

Theoretical Yield: ____________________ Practical Yield: _________________ Yield (%):

__________________

Remarks
 ___________________________Scale up batch as per T-
10_________________________________________
________________________________________________________________________________________
________________________________________________________________________________________

SAFFRON PHARMACEUTICALS (PVT.)

LTD.
PRODUCTION DEPARTMENT
Title: Batch Manufacturing Formula Document
#:PR/GN/FM/001
Issue Date/#: 25-09-
2009/01
Product: Cetrix syrup 5mg/5ml B. No: B. Size: 2000.00
Liters

Requisite date Issue date Date Mfg. started Date Mfg.

completed

Prepared by/on Checked by/on Approved by/on Authorized by/on

In-charge Production Manager Quality Director

Pharmacist Manager Operations Operations
Revision history (Brief description of changes): To add Item Code, Scale mg/mL
and Specs.

S. Item GRN Ingredients Spe Scale Quantit Actual Weigh Checked

# Code No. cs mg/mL y Quantit ed By
per y By QAI Pro
batch (Kg) d.
(Kg)
1 AM- BP 1.00*
Cetirizine 2HCl 2.00*
006
2 IM- BP 300.00
Sugar 600.00
0099
3 IM- Methyl paraben BP 1.00
2.00
0060 sodium
4 IM- Propyl paraben BP 0.25
0.50
0077 sodium
5 IM- BP 1.00
Citric acid 2.00
0027
6 IM- BP 2.00
Sodium citrate 4.00
0085
7 IM- BP 1.00
Sodium benzoate 2.00
0083
8 IM- Amaranth red MS 0.04
0.08
0006 Color
9 IM- BP 0.05
Menthol 0.10
0056
10 IM- Propylene glycol BP 3.00 6.00
 0078
11 IM- MS 0.001
Strawberry No.1 2.00 L
0098 mL
12 IM- MS 4.30
Polysucralose 8.60
0072
13 IM- BP 150.00
Sorbitol 300.00
0093
14 IM- BP 300.00
Liquid glucose 600.00
0051
15 Purified Water q.s. to BP 1.00 2000.00
make L
mL
Theoretical Total 2000.00 Liters
POTENCY ADJUSTMENT OF CETIRIZINE 2HCl
Formula = Quantity per batch (Kg) multiplying factor given by QC for this GRN
Quantity of Cetirizine 2HCl to be weighed = 2.000 =
Kg
* Quantity of Cetirizine 2HCl is subjected to potency adjustment to 100 % by multiplying
the adjustment factor given by QC to this quantity.
Manufacturers Specifications
NOTE: 1. Dispensing tags of each ingredient should be attached herewith on the back
of this sheet.
2. Take into account the filling weight, if applicable for the purpose of yield
calculation.
Yield:
Bulk Syrup: _________________Filled Bottles: _________________ Packed Bottles:
_____________________
Theoretical Yield: ____________ Practical Yield: _______________ Total Loss
(Mfg/filling.): ______________
Scale up route: ____________ Scale up Batch as per T-
10______________________________
___________________________________________________________________________________________
___________________________________________________________________________________________

SAFFRON PHARMACEUTICALS (PVT.)

LTD.
PRODUCTION DEPARTMENT
Title: Batch Manufacturing Formula Document #:
PR/GN/FM/001
Issue Date/#: 03-01-
2011/02
Product: Cetrix syrup 5mg/5ml B. No: B. Size: 2000.00
Liters

Requisite date Issue date Date Mfg. started Date Mfg.

completed
Prepared By/on Checked By/on Approved By/on Authorized By/on

In-charge Production Quality Assurance Deputy Plant

Pharmacist Manager Manager Manager
Revision history (Brief description of changes): To change documentation
signatory.

S. Item GRN Ingredients Specs Scale Quantit Actual Weigh Checked

# Code No. . mg/mL y Quantit ed By
per y By QAI Prod
batch (Kg) .
(Kg)
1 AM- BP 1.00*
Cetirizine 2HCl 2.00*
006
2 IM- BP 300.00
Sugar 600.00
0099
3 IM- Methyl paraben BP 1.00
2.00
0060 sodium
4 IM- Propyl paraben BP 0.25
0.50
0077 sodium
5 IM- BP 1.00
Citric acid 2.00
0027
6 IM- BP 2.00
Sodium citrate 4.00
0085
7 IM- BP 1.00
Sodium benzoate 2.00
0083
8 IM- MS 0.04
Amaranth red Color 0.08
0006
9 IM- BP 0.05
Menthol 0.10
0056
10 IM- BP 3.00
Propylene glycol 6.00
0078
11 IM- MS 0.001
Strawberry No.1 2.00 L
0098 mL
12 IM- MS 4.30
Polysucralose 8.60
0072
13 IM- BP 150.00
Sorbitol 300.00
0093
14 IM- BP 300.00
Liquid glucose 600.00
0051
15 Purified Water q.s. BP 1.00 2000.00
to make L
mL
Theoretical Total 2000.00 Liters
POTENCY ADJUSTMENT OF CETIRIZINE 2HCl
Formula = Quantity per batch (Kg) multiplying factor given by QC for this GRN
Quantity of Cetirizine 2HCl to be weighed = 2.000 =
Kg
* Quantity of Cetirizine 2HCl is subjected to potency adjustment to 100 % by multiplying
the adjustment factor given by QC to this quantity.
Manufacturers Specifications
NOTE: 1. Dispensing tags of each ingredient should be attached herewith on the back
of this sheet.
2. Take into account the filling weight, if applicable for the purpose of yield
calculation.
Yield:
Bulk Syrup: _________________Filled Bottles: _________________ Packed Bottles:
_____________________
Theoretical Yield: ____________ Practical Yield: _______________ Total Loss
(Mfg./filling): _____________
Scale up route: ____________ Scale up Batch as per T-
10________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________

SAFFRON PHARMACEUTICALS (PVT.)

LTD.
PRODUCTION DEPARTMENT
Title: Batch Manufacturing Formula Document #:
PR/GN/FM/001
Issue Date/#: 03-01-
2011/02
Product: Cetrix syrup 5mg/5ml B. No: B. Size: 2000.00
Liters

Requisite date Issue date Date Mfg. started Date Mfg.

completed

Prepared By/on Checked By/on Approved By/on Authorized By/on

In-charge Production Quality Assurance Deputy Plant

Pharmacist Manager Manager Manager
Revision history (Brief description of changes): To replace citric acid with citric
acid anhydrous.

S. Item GRN Ingredients Specs Scale Quantit Actual Weigh Checked

# Code No. . mg/mL y Quantit ed By
per y By QAI Prod
batch (Kg) .
(Kg)
1 AM- BP 1.00*
Cetirizine 2HCl 2.00*
006
2 IM- BP 300.00
Sugar 600.00
0099
3 IM- Methyl paraben BP 1.00
2.00
0060 sodium
4 IM- Propyl paraben BP 0.25
0.50
0077 sodium
5 IM- Citric acid BP 1.00 2.00
 0027 anhydrous
6 IM- BP 2.00
Sodium citrate 4.00
0085
7 IM- BP 1.00
Sodium benzoate 2.00
0083
8 IM- MS 0.04
Amaranth red Color 0.08
0006
9 IM- BP 0.05
Menthol 0.10
0056
10 IM- BP 3.00
Propylene glycol 6.00
0078
11 IM- MS 0.001
Strawberry No.1 2.00 L
0098 mL
12 IM- MS 4.30
Polysucralose 8.60
0072
13 IM- BP 150.00
Sorbitol 300.00
0093
14 IM- BP 300.00
Liquid glucose 600.00
0051
15 Purified Water q.s. BP 1.00 2000.00
to make L
mL
Theoretical Total 2000.00 Liters
POTENCY ADJUSTMENT OF CETIRIZINE 2HCl
Formula = Quantity per batch (Kg) multiplying factor given by QC for this GRN
Quantity of Cetirizine 2HCl to be weighed = 2.000 =
Kg
* Quantity of Cetirizine 2HCl is subjected to potency adjustment to 100 % by multiplying
the adjustment factor given by QC to this quantity.
Manufacturers Specifications
NOTE: 1. Dispensing tags of each ingredient should be attached herewith on the back
of this sheet.
2. Take into account the filling weight, if applicable for the purpose of yield
calculation.
Yield:
Bulk Syrup: _________________Filled Bottles: _________________ Packed Bottles:
_____________________
Theoretical Yield: ____________ Practical Yield: _______________ Total Loss
(Mfg./filling): _____________
Scale up route: ____________ Scale up Batch as per T-
10________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________