MANUFACTURING WORKS ORDER

Product :- Paracetamol Solution Quad Theoretical Yield 1000 L

Product Code PSI Actual Yield (total nett
mass)
Batch Number Transferred to Stock
( Total Number of
VIALS )
Production Manager Date Commenced
Authorised
Quality Assurance Date Completed
Manager Authorised

Special Instructions :- This page is used to show how much material was dispensed for
inclusion into the product .

Code Material Batch No. Standard Actual Percentage Comments

Quantity
Quantity Variance

PA1 Paracetamol 10.00 kg

MAN-1 Mannitol 38.50 kg

CH Cysteine 0.25 kg
hydrochloride
monohydrate
DSPD Dibasic sodium 0.104 kg
phosphate
WFI Water for Injection Qs to 1000
L
SH Sodium Hydroxide* qs

DHCl Diluted Hydrochloric qs

acid**
N Nitrogen qs

* If required for pH adjustment, weigh 100g Sodium Hydroxide pellets and dissolve in 1000ml of water
for injection to obtain 10% solution.
**If required for pH adjustment use Diluted Hydrochloric acid NF

Written by : Checked by: Approved by:

Issue Date : April Supercedes : new Page 1 of 5 Specification

2013 Number: PSI-1

MASTER MASTER
Dispensary Weighing Schedule

Product :- Paracetamol Solution Quad Batch Size 1000 L

Product Code PSI Date Commenced
Batch Number Date Completed
Time Commenced
Time Completed

Special Instructions: - This page is used to show how much material was dispensed for inclusion into
the product.
Code Material : Paracetamol Standard Quantity : 10.00 kg
Quantity Lot ID Expiry Weighed Checked Comments
By By

Code Material : Mannitol Standard Quantity : 38.50 kg

Quantity Lot ID Expiry Weighed Checked Comments
By By

Code Material : Cysteine hydrochloride Standard Quantity :0.25 kg

Quantity Lot ID Expiry Weighed Checked Comments
By By

Code Material : Dibasic sodium phosphate Standard Quantity :0.104 kg

Quantity Lot ID Expiry Weighed Checked Comments
By By

Written by : Checked by: Approved by:

Issue Date :April Supercedes : New Page 2 of 5 Specification

2013 Number: PSI-1

MASTER MASTER
Operating Procedures Schedule

Product :- Paracetamol Solution Quad Batch Size 1000 L

Product Code PSI Date Commenced

Batch Number Date Completed

Standard Process :- Mixing

Equipment Code Previous Product Batch No.

1000 Lt Steel jacketed vessel

Stirrer

Scoop

Thermometer

Dipstick
N.B.

1. Ensure all G.M.P. checks are carried out

2. All calculations where necessary , to be done on the reverse side of these pages
3. Read all procedures carefully before commencing

Stage Kg g Procedure Oper. Ph

1. Ensure that the Nitrogen cylinders have QA released
labels on them.

1.1 Ensure that the equipment sterilisation tags are positive

2. To the steel jacketed vessel add ± 500 litres of water for

injection.
2.1
Chill the water to 40 C , and begin stirring

When the temperature has stabilised to 40 C record the

2.2
temperature.

2.3 Temperature = C

Written by : Checked by: Approved by:

Issue Date :April Supercedes : New Page 3of 5 Specification

2013 Number: PSI-1

MASTER MASTER
Operating Procedures Schedule

Product :- Paracetamol Solution Quad Batch Number

Stage Kg g Procedure Oper Ph

3. Sparge the water with Nitrogen for at least 30 minutes

Time commenced

Time completed

3.1 10 00 Add while stirring Paracetamol

Stir for 10 minutes , while continuing sparging

Time commenced

Time completed
3.2 Cool to 30 °C

When the temperature has stabilised to 30 C

3.3
record the temperature.

Temperature = C

4 38 50 Add while stirring Mannitol

4.1 Stir for 5 minutes

Time commenced

Time completed

5 25 Add while stirring Cysteine hydrochloride

5.1 Stir for 5 minutes

Time commenced

Time completed

6 104 Add while stirring Disodium phosphate dehydrate

6.1 Stir for 5 minutes

Time commenced

Time completed

Written by : Checked by: Approved by:

Issue Date :April Supersedes : New Page 4 of 5 Specification

2013 Number: PSI-1

MASTER MASTER
Operating Procedures Schedule

Product :- Paracetamol Solution Quad Batch Number

Stage Kg g Procedure Oper Ph

7. Continue sparging and make up to volume with water for
injection .

7.1 Stir for 5 minutes

Time commenced

Time completed

7.2 Record the volume in the tank

Volume = L
7.3
(Range = 1000 L ± 1.0 L)
8 Filter the solution through a 5 micron filter into a sterile
steel holding vessel

8.1 Submit a sample to QA , and complete all the

documentation
8.2 In-process checks
Clarity: clear and colourless
pH: 5.5 (5 – 6) (adjust with Dilute Sodium
Hydroxide 10% USP or Dilute
hydrochloric acid 10% USP)
Assay: 10 mg/ml (9.5 – 10.5) paracetamol
Colony count: less than 10 cfu per 100 ml

Written by : Checked by: Approved by:

Issue Date :April Supersedes : New Page 5 of 5 Specification

2013 Number: PSI-1

MASTER MASTER
In-process Specification and report Form

Product Name :- Paracetamol Solution Quad Batch Number

Strength: 1 g/ 100 ml
Analytical procedures: SOP: PSI-001 Quad
Code: PSI Quantity:

Test Specification Result

Appearance Clear practically colourless solution
Clarity: clear and colourless
pH: 5.5 (5 – 6)
Assay: 10 mg/ml (9.5 – 10.5) paracetamol
Colony count: less than 10 cfu per 100 ml

Analysis performed by Checked by Product disposition

Specification compiled by 15 03 2013

Specification checked by 15 03 2013

Specification approved by 15 03 2013

Page 1 of 1
Issue Date :April 2013 Supercedes : New

MASTER MASTER
 Packing Works Order

Product:- Paracetamol Solution Quad Theoretical Yield 10 000 units

Container: 100 ml Vial

Product code Actual Yield

Batch Number Transferred to stock

Production Manager Date Commenced

Authorised

Quality Assurance Date Completed

Manager Authorised

Special instructions :- This page is used to show how much material was dispensed . It should include
all wastage and lost material , with comments in the appropriate pages .

Code Material Standard Actual Percentage Comments

Quantity Quantity Variance
Bulk Paracetamol solution 1 000 L
GVP 100 ml Type II clear Glass vials 10 000
VSG 20 mm rubber stoppers 10 000
AVS 20 mm aluminium seals 10 000
PIPS Paracetamol Solution Quad PI 10 000
PILPS Paracetamol Solution Quad PIL 10 000
CPS Paracetamol Solution Quad 10 000
carton
LPS Paracetamol Solution Quad label 10 000
T-4 Trays 1 000
Shrinkwrap 10.2 kg

Written By : Checked by : Approved by:

Issue Date :20130805 Supersedes : New Page 1 of 9 Specification No. PSI-2

MASTER MASTER
 Packing Works Order: Filling

Product :- Paracetamol Solution Quad Theoretical Yield 10 000 Vials

Container: 100 ml Vial

Product Code Actual Yield (total nett

mass)

Batch Number Transferred to Stock

( Total Number of
Tablets )

Production Manager Date Commenced

Authorised

Quality Assurance Date Completed

Manager Authorised

Special Instructions :- This page is used to show how much material was dispensed for inclusion into
the product .

Batch Material Standard Actual Percentage Comments

No. Quantity Quantity Variance

Paracetamol Solution Quad 1 000 L

100 ml Type II Glass Vials 10 000

20 mm rubber stoppers 10 000

20 mm aluminium seals 10 000

Written by : Checked by: Approved by:

Issue Date :20130805 Supersedes : New Page 2 of 9 Specification Number: PSI 2

MASTER MASTER
Operating Procedures Schedule

Product :- Paracetamol Solution Quad Batch Size 100 000 Vials

Product Code Date Commenced

Batch Number Date Completed

Standard Process :- Filling

Equipment Code Previous Product Batch No.

Filler

Filter 5 µm

Autoclave

N.B.

1. Ensure all G.M.P. checks are carried out

2. All calculations where necessary , to be done on the reverse side of these pages
3. Read all procedures carefully before commencing

Line Layout

Vial Autoclaving
fill /seal

Stage Kg g Procedure Oper Ph

1.

1.1 Ensure that the filter has had a positive bubble test and
has been passed by QA

Ensure that the equipment sterilisation tags are positive

Approved by:
Written by : Checked by:

Issue Date :20130805 Supersedes : New Page 3 of 9 Specification Number: PSI 2

MASTER MASTER
 Operating Procedures Schedule

Product :- Paracetamol Solution Quad Batch Number

Stage Kg g Procedure Oper Ph

2. FILL Vials

2.1 Stopper and crimp seal

2.2 Ensure that all filled Vials are passed through the leak
test.

2.3 All Vials must be electronically tested for particulate

matter.

2.4 Ensure that the autoclave has a recent validation and

calibration certificate and only use program 2
PUT VIALS INTO AUTOCLAVE
Limits
Sample every hour and submit to QC for the
following
Volume NLT 100 ml NMT 102 ml
Particulate matter NMT 3000 > 10 µm
NMT 300 > 25 µm

Written by : Checked by: Approved by:

Issue Date :20130805 Supersedes : New Page 4 of 9 Specification Number: PSI 2

MASTER MASTER
 Packing Works Order:

Product :- Product:- Paracetamol Registration No.

Solution Quad
Container: 100 ml Vial

Batch No.:- Schedule :- S4

Shelf Life :- 2 years Date Commenced

Expiry Date :- Date Finished

P/Product
Equipment Plant No. Previous Product
Batch No.
Labeller
Shrink Tunnel

N.B.
1. Ensure that QC are called to carry out swabs, where necessary, on all equipment prior to use.
2. Ensure that all G.M.P. checks are carried out.
3. All calculations to be carried out on the reverse of these documents.
4. Read operating instructions carefully before commencing.
5. All examples of printed packaging material attached to this document are to be countersigned by the
pharmacist and packing hall supervisor.
6.
Line Layout

Labelling Cartoning Shrinkwrap

PI

Labeller:
1. Pass all Vials through the labeler
Cartoning
2. Insert 1 Vials in each carton
3. Insert the Package insert and PIL
4. Put ten cartons into a tray and shrinkwrap

Batch Number and Expiry on Labels and Carton

Q.A. Sign Pharmacist sign

Batch number

Expiry date

Written By : Checked by : Approved by:

Issue Date :20130805 Supersedes : New Page 5 of 9 Specification No. PSI

2

MASTER MASTER
 Packing Works Order

Product:- Paracetamol Solution Quad Batch Number

Container: 100 ml Vial
Special Instructions: - A sample of the leaflet , carton and the label must be attached to the reverse of this page
and signed by both the line leader and the pharmacist opening the line .
Line opening clearance check Operator Pharm.

Line

Line leader

Previous product packed

Previous product batch number

No similar product in packing area

Area clean and free of previous product

Equipment check

Line set up as per layout

Bulk Dopamine Injection Oper. Phar Oper Phar
Product Approved date
Code Expiry date
Batch number No. of containers
Carton Oper. Phar PI Oper Phar
Product Product
Code Code
Batch number Batch number
PIL Oper. Phar Label Oper Phar
Product Batch
Code Code

Vial Oper. Phar

Product
Code

Packing Line opened by Signature Date

Packing Hall Supervisor
Packing Hall Pharmacist

Written By : Checked by : Approved by:

Issue Date :20130805 Supersedes : New Page 6 of 9 Specification No. PSI

2

MASTER MASTER
 Line Check Sheet

Product :- Product:- Paracetamol Solution Quad Batch Number :-

Container: 100 ml Vial

Shelf Life 2 years Packing Date Expiry Date

Special Instructions

7. The first line check at the start of every day must be carried out by the packing hall pharmacist
8. Checks by the line leader must be carried out every 60 minutes , or after every breakdown
9. A minimum of 4 checks per day must be carried out by the packing hall pharmacist

Time
Checked By
Bulk Batch
Number
Label
Batch Number
Expiry
Particlulate
matter: NMT
3000 > 10 µm,
NMT 300 > 25
µm (QC test)
Volume in
container (NLT
102 ml)
PI Identity
Code
PIL Identity
Code
Carton
Batch Number
Expiry Date
Code
Tray
Quantity per tray
10

Written By : Checked by : Approved by:

Issue Date :20130805 Supersedes : New Page 7 of 9 Specification No. PSI 2

MASTER MASTER
 Line Closing

Product :- Product:- Paracetamol Solution Batch Number

Quad
Container: 100 ml Vial

Units transferred to stock reconciliation

No. of Pallets Cases per Pallet Units per Case Total Units per Pallet

Total number of Units transferred to stock

Line Check Supervisor

Units transferred checked
Unused, re-usable packing components returned to
stores

Line Leader
All Bulk material removed from area
Unused packing material counted , destroyed and
removed
Rejects counted , removed and destroyed
All equipment cleaned and checked
Stock neatly packed and quarantine labels afixed

Written By : Checked by : Approved by:

Issue Date :20130805 Supersedes : New Page 8 of 9 Specification No.PSI 2

MASTER MASTER
 Packing Reconciliation Sheet

Product:- Paracetamol Solution Quad Batch Number

Container: 100 ml Vial

Bulk Reconciliation
Nett Bulk Issued to Packing

Actual Nett Bulk received a

Variance

Packing Reconciliation
Average unit SG b

Theoretical packing hall issue a/b c

Pack size d 100

Theoretical pack yield c/d e

Mass of rejects f

Mass of overage g

Total f+g h

Accounted loss in units h/bd

Actual packed yield i

QA samples j

Other samples taken (specify) k

Transferred yield i-( j + k ) l

Rejects as a % of bulk f/a x 100

Percentage Yield i/e x 100

Yield variances greater than 1 % to be reported to packing hall pharmacist and QA

Reconciled by Signature

Line leader

Checked by

Packing Hall supervisor

Sectional head ( pharmacist )

Written By : Checked by : Approved by:

Issue Date :20130805 Supersedes : New Page 9 of 9 Specification No. PSI

2

MASTER MASTER
Final Product Release Specification and report Form

Product Name :- Paracetamol Solution Quad Batch Number

Solution for infusion
Strength: 1 g/ 100 ml
Analytical procedures: SOP: PSI-001 Quad
Code: PSI Quantity:

Test Specification Result

Test title Limits
Appearance A clear practically colourless solution.
Identification A: The retention time of the major peak of
(Method oral the Sample solution corresponds to that of
solution) the Standard solution, as obtained in the
Assay.
B: TLC- The RF value of the principal spot
obtained from the test solution corresponds
to that obtained from the Standard solution.
Assay 95 – 105 %
4-aminophenol NMT 0.005 %
method
USP<227>
Total impurities NMT 1 %
Cysteine 23.75 – 26.25 mg
Hydrochloride
Particulate matter <300 ≥ 25 µm
USP <788> < 3000 ≥ 10 µm
method 2
Bacterial It contains not more than 0.2 USP
endotoxins Endotoxin Units per mg of paracetamol
Sterility No growth is observed.
Osmolality 290 (280 – 300) mOsm/kg
pH 5.5 (5.0 – 6.0)
Volume in vial NLT 102 ml and NMT 104 ml

Analysis performed by Checked by Product disposition

Specification compiled by 15 03 2013

Specification checked by 15 03 2013

Specification approved by 15 03 2013

Issue Date :April 2013 Supercedes : New Page 1 of 1

MASTER MASTER
Finished Goods Inspection and Report Form

Product Name :- Paracetamol Solution Quad Batch Number

Solution for infusion
Strength: 1 g/ 100 ml
Container: Vial

Code: PSI Quantity

Test Specification
Result
Appearance Clear practically colourless solution

Outer Pack Carton containing 1 x 100 ml vial

Outer Pack Batch As per QA signed data

No.
Outer pack Expiry As per QA signed data
date
Inner Pack Clear glass vial containing clear practically
colourless liquid
Inner label Batch No. As per QA signed data

Inner label Expiry As per QA signed data

Date
Storage Conditions At or below 25 °C

Package Insert code Correct

PIPSI
Patient Information Correct
Leaflet code PILPSI
CoA Results within limits
Batch Documents No Deviations

Analysis performed by Checked by Product disposition

Specification written by Specification Checked by Specification Approved by

Specification Number: Supercedes issue no. New Page 1 of 1

FPSI

MASTER MASTER
Raw Material Specification Form
Material Name Paracetamol (Acetaminophen USP) Batch No.
Method of Testing USP
Approved Manufacturer Confucius Chemicals Code. Pa1
Shelf life 12 months
Storage conditions Preserve in tight, light-resistant Expiry
containers, and store at room
temperature. Protect from moisture
and heat.
Certificate of Analysis correct
Number of containers received Sampling protocol
Number of containers
Sampled
Test Specification Result
Description White, odourless, crystalline
powder
Identification A. Infrared Absorption
<197K>
B. The retention time of the
major peak of the Sample
solution corresponds to that
of the Standard solution, as
obtained in the Assay.
Assay 98.0%–102.0% on the dried
basis
Residue on Ignition <281>: NMT 0.1%
Limit of Free 4-Aminophenol NMT 0.005%
Organic Impurities
N-(4-Hydroxyphenyl) propanamide. NMT 0.05 %
N-(2-Hydroxyphenyl) acetamide. NMT 0.05 %
N-Phenylacetamide. NMT 0.05 %
N-(4-Chlorophenyl) acetamide NMT 0.001 %
Unspecified impurity NMT 0.05 %
Total Impurities NMT 0.1 %
Loss on Drying <731> NMT 0.5%

Material Tested by : Signed Date

Report Checked by : Signed Date
Material Disposition : Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.08.05 Page 1 of 1

MASTER MASTER
Raw Material Specification Form
Material Name Cysteine Hydrochloride USP Batch No.
Method of Testing USP
Approved Manufacturer Fine Chemicals Code. CH
Shelf life 12 months
Storage conditions Preserve in well-closed containers. Expiry
Certificate of Analysis correct
Number of containers received Sampling protocol
Number of containers
Sampled
Test Specification Result
Description White crystals or crystalline
powder.
Identification A. Infrared Absorption 197K
Assay 98.5%–101.5% on the dried
basis
Residue on Ignition NMT 0.4%
<281>
Chloride and Sulfate, NMT 0.03%.
Sulfate <221>
Iron <241>: NMT 30 ppm
Related Compounds
Individual impurities: NMT 0.5%
Total impurities: NMT 2.0%
Optical Rotation, +5.7° to +6.8°
Specific Rotation
<781S>
Loss on Drying <731>: It loses 8.0%–12.0% of its
weight.

Material Tested by : Signed Date

Report Checked by : Signed Date
Material Disposition : Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.08.05 Page 1 of 1

MASTER MASTER
Raw Material Specification Form
Material Name Dibasic Sodium Phosphate (Dihydrate) Batch No.
USP
Method of Testing USP Code. DSPD
Approved Manufacturer Protea Chemicals
Shelf life 12 months Expiry
Storage conditions Preserve in tight containers.
Certificate of Analysis correct
Number of containers Sampling protocol
received Number of containers
Sampled
Test Specification Result
Description Colourless or white, granular or
caked salt.
A. Identification Tests The solution meets the
General, Sodium<191> requirements for sodium.

B. Identification Tests The solution meets the

General, Phosphate requirements for Phosphate
<191>
ASSAY 98.0%–100.5% on the dried
basis
Insoluble Substances NMT 20 mg (NMT 0.4%)
Chloride and Sulphate, Chloride 221- NMT 0.06%
Sulphate 221 NMT 0.2%
Arsenic, Method I <211> NMT 16 ppm
Loss on Drying <731>: Dihydrate 18.5%–21.5%

Material Tested by : Signed Date

Report Checked by : Signed Date
Material Disposition : Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.08.05 Page 1 of 1

MASTER MASTER
Raw Material Specification Form
Material Name Diluted Hydrochloric Acid USP-NF Batch No.
Method of Testing NF
Approved Manufacturer Protea Chemicals Code. DHCl
Shelf life 12 months
Storage conditions Preserve in tight containers Expiry
Certificate of Analysis correct
Number of containers Sampling protocol
received Number of containers
Sampled
Test Specification Result
Description Colourless, odourless liquid.
Identification Tests— It responds to the tests for
General, Chloride <191> Chloride
ASSAY 9.5–10.5 g of HCl in each 100
mL
Residue on Ignition NMT 2 mg
<281>
Free Bromine or The chloroform remains free
Chlorine from any violet coloration for at
least 1 min.
Sulphate Neither turbidity nor precipitate
appears within 1 h.
Sulphite Neither turbidity nor
decolourisation of the iodine
occurs.

Material Tested by : Signed Date

Report Checked by : Signed Date
Material Disposition : Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.08.05 Page 1 of 1

MASTER MASTER
Raw Material Specification Form
Material Name Mannitol USP Batch No.
Method of Testing USP
Approved Manufacturer Fine Chemicals Code. Man-1
Shelf life 12 months
Storage conditions Preserve in well-closed containers Expiry
Certificate of Analysis correct
Number of containers received Sampling protocol
Number of
containers Sampled
Test Specification Result
Description White, crystalline powder or free-flowing
granules.
Identification A. Infrared Absorption <197K>

Assay 97.0%–102.0% on the dried basis

Related Substances
Isomalt (1st peak) NMT 0.05%; NMT the area of the
principal peak obtained with Standard
solution C
Sum of isomalt and NMT 2.0%; NMT the area of the principal
maltitol: peak obtained with Standard solution B
Unspecified NMT 0.10% for each impurity; NMT twice
impurities: the area of the principal peak obtained
with Standard solution C
Sorbitol NMT 2.0%; NMT the area of the principal
peak obtained with Standard solution B
Total impurities: 2.0%; NMT the area of the principal peak
obtained with Standard solution B
Reducing Sugars NMT 0.1%, expressed as glucose;
Nickel NMT 1 µg/g
Melting Range or Class I <741>: 165–170 °C
Temperature,
Appearance of The Sample solution is clear and
Solution colourless

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.08.05 Page 1 of 2

MASTER MASTER
Raw Material Specification Form
Material Name Mannitol USP Batch No.
Method of Testing USP
Approved Manufacturer Fine Chemicals Code. Man-1
Shelf life 12 months
Storage conditions Preserve in well-closed containers Expiry

Test Specification Result

Loss on Drying NMT 0.5 %
<731>
Conductivity NMT 20 µS/cm at 25
Microbial The total aerobic microbial count (TAMC)
Enumeration Tests is NMT 102 cfu/g,
<61> The total combined molds and yeasts
count is NMT 102
Tests for Specified Escherichia coli absent
Microorganisms <62>
Bacterial Endotoxins less than 2.5 IU/g
Test <85>

Material Tested by : Signed Date

Report Checked by : Signed Date
Material Disposition : Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.08.05 Page 2 of 2

MASTER MASTER
Raw Material Specification Form
Material Name Nitrogen USP-NF Batch No.
Method of Testing NF
Approved Manufacturer Afrox Code. N
Shelf life
Storage conditions Preserve in cylinders. Expiry
Certificate of Analysis correct
Number of containers Sampling protocol
received Number of containers
Sampled
Test Specification Result
Description Colourless, odourless, tasteless
gas.
Identification The flame of a burning wood
splinter is extinguished when
inserted into a test tube filled with
Nitrogen.
Assay NLT 99.0%, by volume, of N2.
Carbon Monoxide NMT 10 ppm
Limit of Oxygen NMT 1.0%
Odour No appreciable odour is
discernible.

Material Tested by : Signed Date

Report Checked by : Signed Date
Material Disposition : Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.08.05 Page 1 of 1

MASTER MASTER
Raw Material Specification Form
Material Name Sodium Hydroxide USP-NF Batch No.
Method of Testing NF
Approved Manufacturer DOW Chemical Code. SH
Shelf life 12 months
Storage conditions Preserve in tight containers Expiry
Certificate of Analysis correct
Number of containers Sampling protocol
received Number of containers
Sampled
Test Specification Result
Description White, or practically white, fused
masses, in small pellets, in flakes,
or sticks, and in other forms.
Identification A solution (1 in 25) responds to the
General, Sodium <191> tests for Sodium
Assay 95.0%–100.5% of total alkali; NMT
3.0% of sodium carbonate (Na2CO3)
NLT 54.0% and NMT 59.8% of
sodium.
Potassium NMT 0.5%
Insoluble substances and A solution (1 in 20) is complete,
organic matter clear, and colourless to slightly
coloured

Material Tested by : Signed Date

Report Checked by : Signed Date
Material Disposition : Signed Date

Specification compiled by 20180430

Specification checked by 20180430

Specification approved by 20180430

Date of last amendment 2013.11.15 Page 1 of 1

MASTER MASTER
Raw Material Specification Form
Material Name Water for injection WFI

Method of Testing USP

Approved Manufacturer In-House
Sampling Protocol
Points sampled

Test Specification Result

Description Water purified by distillation,
with no added substance
Bacterial endotoxins contains less than 0.25 USP
Endotoxin Unit per mL
Total Organic Carbon Meets the requirements
Water Conductivity Meets the requirements
Bacteriological Purity Less than 10 colony forming
units per 100ml

Material Tested by: Signed Date

Report Checked by: Signed Date
Material Disposition: Signed Date

Specification compiled by
09/2007
Specification checked by
09/2007
Specification approved by
09/2007

Date of last amendment 2006/09/03 Page 1 of 1

MASTER MASTER
 Packaging Material Specification

Material Name Aluminium vial seal Supplier Batch

Number
Code AVS Number of Containers
Batch Number Quantity Received
Supplier Caps n Seals Sampling Protocol
Industries

Tests Specification Result

Description Silver aluminium vial seal

Dimensions External Diameter of Vial Neck 7.4 ± 0.2

Internal Diameter of Seal 20.40 ± 0.1
Diameter of Perforation on Seal 10.11 ± 0.2
Height of Seal 7.60 ± 0.2

Material Aluminium

Visible defects No major defects

Cleanliness Caps are clean and free of dust or particles.

Material tested by Report checked by Material Disposition

Signed Date Signed Date Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 1 of 2

MASTER MASTER
Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 2 of 2

MASTER MASTER
 Packaging Material Specification

Material Name Carton for Supplier Batch

Paracetamol solution Number
Quad

Code CPS Number of Containers

Batch Number Quantity Received

Supplier DAVBAR Sampling Protocol

Tests Specification Result

Description Carton for Paracetamol solution

Dimensions 100mm Height ,width 60 mm, depth 60 mm

Material White, glazed coated board 400 microns

Construction Reverse tuck-end carton with slit lock flaps , and

glued side seam

Colour Black Pantone Process

Yellow Pantone Process
Green Pantone Process

Grain direction At right angles to the glue joint

Surface treatment Water based varnish

Fastness to light Does not fade on exposure to light , does not

yellow

Resistance to scuff Is resistant to scuffing

Material tested by Report checked by Material Disposition

Signed Date Signed Date Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 1 of 1

MASTER MASTER
 Packaging Material Specification

Material Name Glass Vial 100 ml Supplier Batch

Number
Code GVP Number of Containers
Batch Number Quantity Received
Supplier Schott Sampling Protocol

Tests Specification Result

Description Glass Vial 100 ml
Dimensions •Diameter OD 51.6 mm
•Height 94.5 mm
•Closure ISO 20
•Neck finish Crimp neck ISO 20 mm
•Weight 89 g
Material Clear USP type II glass
Volume of container •Nominal volume 100 ml
•Brimful volume 119 ml
Glass Grains Test Maximum Volume of 0.02 M HCl per g of Test
USP Glass (mL) = 0.85
Surface Glass Test Maximum Volume of 0.01 M HCl per 100 mL of
USP Test Solution (mL) = 0.5
Visible defects No major defects
Cleanliness Clean and free of dust or particles of broken
glass

Material tested by Report checked by Material Disposition

Signed Date Signed Date Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 1 of 2

MASTER MASTER
 100 ML Clear Glass Vial

DESCRIPTION

Component Number: 1500

Composition: 100 ml injection vial made of type II clear glass with crimp neck
ISO 20 mm.

DIMENSIONS Schott Drawing No. 12012-51000

Schott Drawing No. 12012-51000

d2-20 mm
d3 17.5 mm (neck)
d4 12.6 mm
h1 94.5 mm

h3 20 mm
h2 74.5 mm

51.6 mm

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 2 of 2

MASTER MASTER
 Packaging Material Specification

Material Name Vial Label Supplier Batch

Paracetamol Solution Number
Quad

Code LPS Number of Containers

Batch Number Quantity Received

Supplier DAVBAR Sampling Protocol

Tests Specification Result

Description Label for Paracetamol Solution Vials

Dimensions 50mm x 80mm

Material Fassons high gloss white

Reel Details Core diameter 50mm

Reel diameter 50 mm min ; 200 mm max
Winding Label on outside ;right edge
leading

Colour Green Pantone Process

Yellow Pantone Process
Black Pantone Process

Fatness Fastness to artificial light

Scuffing Resistant to rubbing and scuffing

Material tested by Report checked by Material Disposition

Signed Date Signed Date Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 1 of 1

MASTER MASTER
 Packaging Material Specification

Material Name Package Insert Supplier Batch

Paracetamol Solution Number
Quad

Code PIPS Number of Containers

Batch Number Quantity Received

Supplier DAVBAR Sampling Protocol

Tests Specification Result

Description Package insert for Quad Dopamine Injection

Dimensions 290 mm x 210 mm

Material Oyster opaque 60 gsm

Folding Folded along long axis twice and three times

along short axis with uniform spacing between
the folds

Colour Black Pantone Process

Print quality Printing is legible and unsmudged

Print Accuracy Printing corresponds to approved master

Material tested by Report checked by Material Disposition

Signed Date Signed Date Signed Date

Specification compiled by 20180831

Specification checked by 20180831

Specification approved by 20180831

Date of last amendment 2013.11.15 Page 1 of 1

MASTER MASTER
 Packaging Material Specification

Material Name Package Information Supplier Batch

Leaflet Paracetamol Number
Solution Quad

Code PILPS Number of Containers

Batch Number Quantity Received

Supplier DAVBAR Sampling Protocol

Tests Specification Result

Description Patient Information Leaflet for Paracetamol

Solution

Dimensions 290 mm x 210 mm

Material Oyster opaque 60 gsm

Folding Folded along long axis twice and three times

along short axis with uniform spacing between
the folds

Colour Black Pantone Process

Print quality Printing is legible and unsmudged

Print Accuracy Printing corresponds to approved master

Material tested by Report checked by Material Disposition

Signed Date Signed Date Signed Date

Specification compiled by 20180831

Specification checked by 20180831

Specification approved by 20180831

Date of last amendment 2013.11.15 Page 1 of 1

MASTER MASTER
 Packaging Material Specification

Material Name Vial stopper 20 mm Supplier Batch

Number
Code Number of Containers
Batch Number Quantity Received
Supplier Vial-bottle Sampling Protocol
Company

Tests Specification Result

Description 20mm gray butyl rubber stopper type I medical
rubber
Dimensions size: 20mm
1)OD of Flange :19.12 mm ± 0.2 mm
2)ID of Neck : 12.9 mm ± 0.2 mm
3)Height of Flange :2.62 mm ± 0.1 mm
4)Total height :8.02 mm. ± 0.3 mm
Material butyl rubber
Visible defects No major defects
Cleanliness Clean and free of dust or particles

Material tested by Report checked by Material Disposition

Signed Date Signed Date Signed Date

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 1 of 2

MASTER MASTER
 DESCRIPTION

Component Number: ISO 20

Composition: Butyl rubber stoppers 20mm in gray color to seal vials

Mould Number: hvrs027

DIMENSIONS

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 2 of 2

MASTER MASTER
 Conformance Specification

Tests Specification
Description 20mm gray butyl rubber stopper type I medical rubber
Biological Reactivity Meets the requirements
Tests, In Vitro <87> .
Appearance of Solution S is not more opalescent than Reference Suspension B for
solution Type I closures
The turbidity of Solution S is not greater than that for Reference
Suspension B (6 NTU FTU) for Type I closures
Solution S is not more intensely coloured than the Colour Standard
Acidity or Alkalinity Not more than 0.3 mL of 0.01 N sodium hydroxide produces a blue
colour, or not more than 0.8 mL of 0.01 N hydrochloric acid produces a
yellow colour, or no titration is required.
Absorbance The absorbances at these wavelengths do not exceed 0.2 for Type I
closures or 4.0
Reducing Substances The difference between the titration volumes is not greater than 3.0 mL
for Type I closures
Heavy Metals Solution S contains not more than 2 ppm of heavy metals as lead
Extractable Zinc Solution S contains not more than 5 ppm of extractable zinc.
Ammonium no more than 2 ppm of NH4 in Solution S
Volatile Sulfides Any black stain on the paper produced by the test solution is not more
intense than that produced by the control substance
Penetrability The force for piercing is no greater than 10 N (1 kgf) for each closure,
determined with an accuracy of ±0.25 N (25 gf).
Fragmentation There are no more than five fragments visible.
Self-Sealing Capacity None of the vials contain any trace of blue solution.

Specification compiled by 2013.11.5

Specification checked by 2013.11.8

Specification approved by 2013.11.15

Date of last amendment 2013.04.03 Page 2 of 2

MASTER MASTER