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Attachment No. H.1

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Raw Materials,
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Intermediates and Product

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Handling

‘, A&&nent No ti.1 - Main Textdoc

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 Attachment H.l Material Handling
Schwarz Pharma Ltd. Revised IPCL Application

CONTENTS

Section Page No

I. MATERIAL STORAGE .................................................................................................... 1

1.1 Raw Materials and Intermediates ............................................................ 1

1.2. Waste storage.. ................................................................................................................. 2

2. MANAGEMENT OF MATERIALS ................................................................................... 2

3. MOVEMENT OF MATERIALS . .. .. . . ... . . .. .. . .. . . .. .. . .. .. .. . . ... . .. . .. .. . .. . .. . .. .. . ...m................s........... 3

4. BUND MANAGEMENT .*.......................................,...........,.......................,.................*.... 3

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Appendix H.l .I Supply Chain Management

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Appendix H.l.2 chemical Storage

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Appendix H.1.3 Bund Integrity Testing

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Appendix H.1.4 Bund Management

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Appendix H.1.5 Bund Locations

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Appendix H.l.6 Material Flow

Appendix H.l.7 Bund upgrade program

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 Attachment H.1 Material Handling
Schwarz Pharma Ltd. Revised IPCL Application

1. MATERIAL STORAGE

The methodology for the storage of materials (separation and segregation) is addressed
in SOP 400.010 Supply Chain Management, which is contained in Appendix H.I.I. A
regular review of the methodology behind the storage procedures of materials is carried
out. This ensures a proper system of storage is implemented.

Materials at Schwarz Pharma Limited are stored in discrete locations depending on the
nature/status of the material. The Health & Safety Officer must be informed of all new
materials as per SOP 610.014, in order that the correct storage location for the material
may be determined based on the chemical properties of the material. Locations of
storage areas within the main facility are contained in Appendix H.1.2 Chemical
Storage, Site Map.

1.1. Raw Material and Intermediate

There are two main bulk chemical storage areas. The Nitration tank farm is located

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immediately to the west of the Plant and is approximately 208m’ in area. It holds 8
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storage tanks for solvents and each ranges in size from 15 to 30m3. The tanks are fully
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bunded and closed so that any accidental spillages or leaks are contained. The
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associated transfer pumps are located within the bunded area. The solvents are hard-
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piped via a modified pipe rack to the Nitration Plant. The over ground pipe is detailed in
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Appendix H.1.6 Material Flow

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An additional storage tank farm is located at the Main Production Building (BPC) which
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holds a further 13 tanks. The nature and quantity of material is detailed in storage areas
within the main facility are contained in Appendix H.1.2 - Chemical Storage. To minimise
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air emissions, treatment/abatement equipment was installed on vessels in the BPC that
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hold substances classified as Class I under the TA Luft 1986 Organics classification
system. This equipment comprises acidic/basic scrubbers for emissions from reactors.

Raw material and packaging for use in pharmaceutical manufacturing, Work in Progress
(WIP) & all finished goods are stored in the Pharma Warehouse. The Chemical
Warehouse is used for the storage of solid raw materials, intermediates & packaging for
use in API manufacture, which require storage indoors.

The Covered drum store, Drum store has two racks and ground level storage. This area
is used for storage of the corrosive Sodium Hydroxide (pearl) & compatibles e.g.
Sodium Chloride. The Open Drum has 6 racks and a number of ground level storage
areas. It is used for storage of drummed solvents/liquid reagents & API work in
progress.

As material is required for manufacturing it is transferred to the Production Supply

Areas (SOP 400.053) where short-term storage occurs while -awaiting usage. All
incoming GMP materials are received to IM Location 902 for short-term staging,
awaiting ‘put away’. Physically the materials may reside in the Pharma Lobby, the floor
area of the Chemical W/H or the roadway.

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 Attachment H.1 Material Handling
Schwarz Pharma Ltd. Revised IPCL Application

Due to the hazardous & water sensitive nature of Lithium Amide, n-Butyl Lithium &
Vilsmeier Reagent, they have a unique storage location in the ‘Lithamide’ store.
Cylinders of Gas used in processing, maintenance & laboratories are stored in a
dedicated area. There is one rail container used as temporary storage area for
recyclable fibreboard drums.

1.2. Waste storage

A dedicated Waste Management Area is in operation at the site. All measures have been
taken to ensure adequate storage space is provided and the area is of suitable
construction to prevent a risk of surface and groundwater pollution. All waste stored is
clearly labelled and marked. A procedure for collection, storage and disposal of waste oils
and scrap metal is employed at the site. Waste Oil control procedures have been put in
place and a dedicated waste oil storage area has been created in the drum storage area.

2. MANAGEMENT OF MATERIALS

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A tool for the procurement of chemicals, inventory management, manufacturing, release
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and shipment of products called Systems, Applications and Products for Data Processing
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(SAP) is employed at Schwarz Pharma Ltd. This indirectly benefits environmental

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management through improved chemical classification for storage and better tracking of
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hazardous waste in storage and for disposal off-site.

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SAP controls storage at two different levels, Inventory Managed (IM) and Warehouse
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Managed CJVM):
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n WM storage allows the storage in discrete ‘bins’ & the exact quantity of material in
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each bin can be seen;

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. IM storage shows the total quantity of material stored in a particular location but
does not display storage to bin level.

The SAP system takes into account the properties & classification of the substance to be
stored, & uses this to dictate the storage location of material. SAP will not allow the
storage of different batches of the same material in a bin nor will it allow the storage of
two different types of material in the same bin. The only exception is the open drum store,
which allow a mixing of different materials due to the availability of bin spaces. The
system will not chose to supply a material to any production process if the material is in

l Quarantine (represented as letter Q on SAP);

l Blocked stock (represented as letter S on SAP).

When QC passes the material on the SAP system it becomes available to be utilised by
production. The SAP system will only supply material to production in the absence of any
letter after the batch number selected.

Attachment
NoH.1-MainTextdoc Page2

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 Attachment H.1 Material Handling
Schwarz Pharma Ltd. Revised IPCL Application

A programme of ongoing Vendor Environmental Appraisal has been in place at Schwarz

Pharma Ltd for a number of years. This involves the evaluation of the top 20 suppliers of
raw materials, from an environmental viewpoint, using key performance indicators. In
addition, the annual vendor appraisal has been extended to incorporate the key indicators
by which all Raw Material suppliers should be assessed. If a supplier is being listed as an
approved supplier they receive a copy of the Schwarz Pharma Ltd. Environmental Survey
prior to commencement of business. The evaluation of suppliers is incorporated into the
standard vendor appraisal procedure.

It is planned to extend the Vendor Environmental Appraisal to a greater number of raw

material suppliers and environmentally significant contractors and consultants such as
waste contractors and suppliers of abatement/measuring equipment.

3. MOVEMENT OF MATERIALS

Solid materials are received at the facility in either steel/fibre drums fitted with tamper
proof closures or bags and are unloaded directly in the warehouse. The materials are

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firstly subject to quarantine and following satisfactory quality control checks, then stored
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in the warehouse, until requisitioned by the production department for processing.
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Movement of solid material externally on-site is by pallet truck or fork truck. Internal
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move-ments of the material is via lifts for floor to floor transfer or charged via stainless
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steel charge chute for transfer to equipment systems,

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Liquid materials are transported on-site in steel drums and plastic containers, similar to
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the movements of solid materials. Within processing buildings, drums are charged from
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dedicated areas. Such areas incorporate closed drains for collection and containment
purposes, which may be accessed to facilitate cleanup of any spillages.
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The movement of materials across the site is shown in Appendix H.1.6 Material Flow. All
physical movements of material and quantity will be reflected immediately on the SAP
system once the transfer orders created for movement of material to required locations
are confirmed. See SOP 400.053 Transfer of Material to Production.

4. BUND MANAGEMENT

All bunds at the Schwarz Pharma Ltd. facility, including Drum stores, Scrubbers, WWTP
and Glycol bunds, are lined. A map indicating the locations of all bund locations is
included in Appendix H.l.5. The Drum storage area has been tested for its resilience to
forklift and truck traffic. Full integrity tests of bunds takes place at a maximum frequency
of 3 years and records relating to the testing are held by the Engineering Department at
Schwarz Pharma. A copy of the most recent bunding report for the Schwarz Pharma Ltd.
facility is included in Attachment H.1.3. This also includes a report on non-compliant
bunds. A summary of the outcome of the testing is included in Appendix H.1.7.

Schwarz Pharma Ltd. has defined a process whereby containment bunds are routinely
inspected and drained of their contents in such a manner as to prevent any possibility of

Affachment
NoH-1-MainText.doc Page3

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 Attachment H.l Material Handling
Schwarz Pharma Ltd. Revised IPCL Application

environmental damage either through spillage, leakage or the improper discharge of

material to surface water drains or groundwater.

Schwarz Pharma Ltd. has implemented a programme for the provision of satisfactory
containment at the facility. The main aims of the programme included the bunding of tank
and drum storage areas. A preliminary risk assessment of material storage at the facility
identified those areas requiring primary action and those storage areas requiring
impervious surfaces to materials stored therein. In total, 29 bunds were identified for the
purposes of this programme (3 bunds located at Bay 130 are now no longer in use and
are therefore not included within the 29 bunds).

All materials drained from bunds are discharged directly to the drainage network, which
brings the effluent to the wastewater treatment plant. The only exception to this rule is the
discharge of nitration bunds. The contents of the nitration plant bunds are normally
discharged to surface water and are only discharged to the wastewater treatment plant if
contaminated. Before discharging liquid from the tank farm bunds, the bunds are checked
for pH to ensure acidity is not a concern. Before discharging from the Mother Liquor
Bunds, the liquid must be checked to ensure it does not contain solids or odour.

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 Attachment H.l Material Handling
URS Schwatz Pharma Ltd. Revised IPCL Application

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Supply Chain Management

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 Page 1 of 7
SUPPLY CHAIN MANAGEMENT PROCEDURE SOP
Effective Date:
Title: STORAGE OF MATERIALS 400.010 Revision No: 20 Date: 10.02.04
Prev Rev No: 19 Dated: 02.10.02

1.0 PURPOSE

To outline the procedure for the storage of all materials (including Packing Materials) to ensure the
proper separation and segregation of chemicals at SCHWARZ PHARMA Limited.

2.0 RESPONSIBILITY

* 2.1 It is the responsibility of the Supply Chain Manager to ensure that the concerned individuals
are familiarised with this SOP in accordance with SOP No. 103.001.
2.2 It is the responsibility of the Materials Technologist & the Warehouse Team Facilitator to

.
ensure that material is stored in a safe and controlled maturer.
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2.3 It is the responsibility of the Materials Technologist in consultation with the Environmental
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and Health Safety Department to provide guidance in the safe storage of materials and that the
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information created on the SAP system is correct.

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3.0 APPROWL
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This SOP and any future changes must be approved by the Supply Chain Manager, the API Manager,
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the Health and Safety Offtcer, Pharma Manager, and the Head of QA and Support Services.
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4.0 SCOPE
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This SOP is in effect in the Supply Chain Management and Manufacturing Departments.

5.0 PROCEDURE

l 5.1 There are several warehouse storage locations & types in SCHWARZ PHARMA Limited and
these are listed in Attachment I and maps showing all the Storage areas
(Attachments III-VI).

5.2 For safety/regulatory purposes, materials at SCHWARZ PHARMA Limited are stored in
discrete locations depending on the nature/status of the material. The Health & Safety Officer
must be informed of all new materials as per SOP 610.014, in order that the correct storage
location for the material may be determined based on the chemical properties of the material.

Written By: Approved By: Approved By: Approved By: Approved By Approved By:

S. O’Donoghue M Dohmam J. O’Halloran D. Mullins Pat Quirke I. Wills

Materials Technologist Supply Chain Mgr. Prod. Manager Health &Safety Phama Mmuf. Mgr. Head of QA &
OfflW Support Services
Date: Date: Date: Date: Date: Date:

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’

Page 2 of 7
SUPPLY CHAIN MANAGEMENT PROCEDURE SOP
Effective Date:
Title: STORAGE OF MATERIALS 400.010 Revision No: 20 Date: 10.02.04
Prev Rev No: 19 Dated: 02.10.02

5.3 Under no circumstances must drums of flammable liquids be stacked more than two pallets
high. The maximum stack height for fibreboard drums is three pallets high

Note: Material locations and contents areprinted once on a weekly basis and the copy is
supplied to the Security Oj?cer every Thursday.

5.4 A computerised system; SAP is used to control the storage and selection of materials
throughout all storage locations at SCHWARZ PHARMA Limited.

5.5 SAP controls storage at two different levels, Inventory Managed (IM) and Warehouse

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Managed (WM) - See Attachment I.
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5.5.1 WM storage allows the storage in discrete ‘bins’ & the exact quantity of material
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in each bin can be seen.

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5.5.2 IM storage shows the total quantity of material stored in a particular location but
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does not display storage to bin level.

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5.6 The SAP system takes into account the properties & classification of the substance to be
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stored, & uses this to dictate the storage location of material (Attachment II).
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5.7 SAP will not allow the storage of different batches of the same material in a bin nor will it
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allow the storage of two different types of material in the same bin. The only exception is
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the open drum store, which allow a mixing of different materials due to the availability of
bin spaces.
5.8 The system will not chose to supply a material to any production process if the material is
in
Quarantine (represented as letter Q on SAP)
Blocked stock (represented as letter S on SAP).

5.9 When QC passes the material on the SAP system it becomes available to be consumed by
production. The SAP system will only supply material to production in the absence of any
letter after the batch number selected.
Note: All physical movements of material and quantity will be reflected immediately on the
SAP system once the transfer orders createdfor movement of material to required
locations are con$rmed See SOP 400.053 Transfer of Material to Production

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 Page 3 of 7
SUPPLY CHAIN MANAGEMENT PROCEDURE SOP
Effective Date:
Title: STORAGE OF MATFRIALS 400.010 Revision No: 20 Date: 10.02.04
Prev Rev No: 19 Dated: 02.10.02

5.10 Storage Locations

5.10.1 TankFarm
5.10.1.1 Bulk solvents/reagents are stored in dedicated tanks in the tank farms.
There are two distinct tank farms at; SCHWARZ PHARMA Limited
Main tank farm (SOP 400.011) & Nitrates Tank farm (SOP 400.052)
both of which are treated as IM storage location 0061 in SAP.
5.10.1.2 Nitric acid for Bay130 is stored in a bulk tank (SOP 400.014) under
IM storage location; 0130.
5.10.1.3 Tank 14 in the main tank farm is used for the storage of bulk waste

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solvent for disposal and is assigned a separate storage in SAP; IM
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location 0014.
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5.10.2 Gas Storage

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,. Cylinders of Gas used in processing, maintenance & laboratories are stored in a

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dedicated area; IM location 0063.

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5.10.3 Pharma Warehouse

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5.10.3.1 Raw materials & packaging for use in Pharmaceutical manufacturing,

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Pharma Work in Progress (WIP) & all finished goods are stored in the
Pharma Warehouse (WM 050).
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5.10.3.2 Capsule Shells, Finished Product Capsules and Tablets are not stored on the
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high levels near the fan heaters.

5.10.3.3 This warehouse consists of high level racking; A to J for the storage
of Class 4.1 & non-hazardous materials.
5.10.3.4 Pure ISDN (class 1) is stored in 4 bins in Rack I at level 1, a
maximum of 600Kgs may be stored at any time (SOP 400.061).
5.10.3.5 WIP material (including Intermediate bulk containers - Matcons) is
stored on racks B & C (WM 055).
5.10.3.6 Packaging material is stored at high levels on the above two racks &
rack E.
5.10.3.7 Equipment may also be stored at high levels on Rack E.
5.10.3.8 There is a designated area in the Pharma Warehouse for the storage of
returned finished product, awaiting disposition, this is located on I
Rack I-OS-01 to I-08-09 (WM904) (SOP 400.058).

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 Page 4 of 7
STJPPLY CHAIN MANAGEMENT PROCEDURE SOP
Effective Date:
Title: STORAGE OF MATERIALS 400.010 Revision No: 20 Date: 10.02.04
Prev Rev No: 19 Dated: 02.10.02

5.10.3.9 The Lobby area of the Pharma Warehouse is designated as an

incoming & outgoing area for the receipt of Raw materials/
Intermediates & for the staging of Finished goods awaiting shipment
(IM 916). If required dividers into Incoming & Outgoing areas will
segregate the area (e.g. a delivery arrives while a shipment is awaiting
collection).

5.10.4 Chemical Warehouse

5.10.4.1 The Chemical Warehouse is managed at WM level & is used for the
storage of Solid Raw Materials, Intermediates & packaging for use in

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API manufacture, which require storage indoors (WM 00 1).
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5.10.4.2 The storage is on racking, A to M, primarily for the storage of Class
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4.1 & non-hazardous materials.

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5.10.4.3 Classes 5,6.1,8 & non-hazardous are stored on Rack H.

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,’ 5.10.4.4 Packaging material & miscellaneous items are stored on Rack M.

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5.10.4.5 Fibreboard drums are stored in the Chemical Warehouse &

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distributed to other locations as required their storage is however

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reflected in SAP IM location W055 (Pharma WIP area).

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5.10.4.6 Plastic drums are stored over the Office in the Chemical Warehouse.
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5.10.4.7 The controlled substance Midazolam (SOP 400.03 1) is stored in the

safe in the Chemical Warehouse ( WM 008).
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5.10.4.8 Rejected Material (SOP 400.059) is stored in a specially designated &

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locked area on J & L Racks (WM 011 Container). RX Material from

Pharma is also stored in this area.

5. IO.5 Lithamide Store (002)

Due to the hazardous & water sensitive nature of Lithium Amide, n-Butyl
Lithium & Vilsmeier Reagent, they have a unique storage location in the
‘Lithamide’ store (WM 002).

5.10.6 Drum Storage Area

5.10.6.1 The Covered drum store, Drum store 1 (WM 004) has two racks
(A&B) & Ground level storage (C). This area is used for storage of
the corrosive Sodium Hydroxide (pearl) & compatibles e.g. Sodium
Chloride.
5.10.6.2 Dimethyl Sulphate is also stored in the covered drum store (SOP
400.045).

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 Page 5 of 7
SUPPLY CHAIN MANAGEMENT PROCEDURE SOP
Effective Date:
Title: STORAGE OF MATERIALS 400.010 Revision No: 20 Date: 10.02.04
Prev Rev No: 19 Dated: 02.10.02

5.10.6.3 The Open Drum store (WM 003) has 6 racks & a number of ground
level storage areas (A to L) & is used for storage of Drummed
solvents/liquid reagents & API work in progress (Rack B).
5.10.6.4 Rejected/ Waste material is stored on Racks A & F in this area in
location WM 005.
5.10.6.5 Oil, Sodium Hypochlorite & Bromine have dedicated bunded storage
areas within this location.
5.10.6.6 An additional waste management area is denoted by location WM
007.

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5.10.7 Production Areas
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Material which is required for manufacturing is transferred to the
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Production Supply Areas (SOP 400.053) where short term storage

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occurs while awaiting usage to planned processes:

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,C BPC Production Supply area (WM 020)

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Nitration PSA (WM 060)

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Pharma Dispensing PSA (WM 051)

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Pharma Palletising PSA (WM 052)

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Material produced by the manufacturing facilities will be confirmed

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5.10.7.2
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on SAP to the appropriate WIP areas, these may be either IM

managed or WM managed:
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BPC WlP areas; WM 021 or IM WO21

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Nitration WIP areas; WM 03 1 or IM W03 1

Pharma WlP areas; WM 055 or IM WO55

This material may either be used in the process immediately or

transferred to a Warehouse location.
Note: The roadway may be usedfor short term staging of material
awaiting transfer to racks.
5.10.7.3 Non-GMP materials used in the WasteWater Treatment Plant
(WWTP) are stored in the Effluent Supply area (WM 051), additional
IBCs may be stored within the Drum store bund.

5.10.8 Goods Receipt area

All incoming GMP materials are received to IM Location 902 for short-term
staging, awaiting ‘put away’. Physically the materials may reside in the Pharma
Lobby, the floor area of the Chemical W/H or the roadway.

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 Page 6 of 7
SUPPLY CHAIN MANAGEMENT PROCEDURE SOP
Effective Date:
Title: STORAGE OF MATERIALS 400.010 Revision No: 20 Date: 10.02.04
Prev Rev No: 19 Dated: 02.10.02

5. IO. 9 Rail Containers

There is one rail container used as temporary storage area for recyclable fibre
board drums :

Container 1: Fibreboard Drums for reuse with Work In Progress material.

5.10.10 Bay 130

5.10.10.1 Due to the fact that Bay 130 is situated off-site, material must be
transferred to & from this facility (SOP 400.056) & storage facilities
are provided on the B 130 site in IM location 0130.

.
5.10.10.2 Storage is provided for both API & Pharmaceutical materials.
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API liquid raw materials are stored in racks in the open store (Racks
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I-l to I-20)
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5.10.10.4 Racks A & B in the B130 warehouse are used as a Pharma production
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supply area & for the short term staging of Pharma finished products
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(maximum staging time 48hr.s).

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5.10.10.5 Racks C & D are used as an API production supply area & for the
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short term staging of API finished products (maximum staging time

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48hrs).
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5.10.10.6 Packaging materials (Liners, fibreboard drums & 200L plastic drums)
are also stored in location 0130.
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5.10.10.7 API work in progress is stored in the production area.

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5.11 Damaged Material/Packaging

In the event of material which has been Passed becoming damaged/contaminated in
any way, or the label becoming detached, the container must be placed to a block
bin on the SAP and then into blocked stock on the SAP SYSTEM, and repackaged
(if necessary) and re-inspected. Once a usage decision is made the material is either
released for consumption or disposal.

5.12 Documentation
Attachment I: List of Warehouse Locations (IM & WM locations)
Attachment II: List of Classification.
Attachment III: Map of the Drum Store areas of the Main Plant.
Attachment IF Map of Pharma Warehouse Locations.
Attachment k Map of Chemical Warehouse Location.
Attachment Y7; Map of Bay 130 Store.
Attachment WI: Site Map.

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 :

Page 7 of 7
SUPPLY CHAIN MANAGEMENT PROCEDURE SOP
Effective Date:
Title: STORAGE OF MATERIALS 400.010 Revision No: 20 Date: 10.02.04
Prev Rev No: 19 Dated: 02.10.02

6.0 FtEWISION

This SOP is reviewed annually according to SOP 100.007. Any necessary changes will be
documented in a new revision of this SOP

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 SUPPLY CHAIN MANAGEMENT PROCEDURE
SOP Page 1 of 1
ATTACHMENT I Effective Date:
4OO-sblO Revision No: 20 Date: 10.02.04
Title: LIST OF WARESHOUSE LOCATIONS (IM & WM LOCATIONS) Prev Rev No: 19 Dated: 02.10.02

r Ma,teri&.Storatie Locations at. sCm= p&&R&&i LIMITED b

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Returns area Pharma Warehouse

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Pharma Warehouse

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050 904

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- Chemical Warehouse Chemical Warehouse safe

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008

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Open Drum store Covered Drum Waste material rack Open Backyard storage
003 store 005 007

BPC Production Supply Area (PSA) Nitration PSA Pharma Dispensing Pharma Effluent Supply
020 060 PSA Pellitising PSA area
051 052 054

BPC Work in Progress Area (WIP) Nitration WIP area Pharma WIP area
021 031 055

Rail Containers
011

EPA Export 25-07-2013:15:03:41

 SOP Page 1 of 1
SUPPLY CHAIN MANAGEMENT PROCEDURE
ATTACHMEXW II 400.010
Effective Date:
Revision No: 20 Date: 10.02.04
Title: LIST OF CLASSIFICATION Prev Rev No: 19 Dated: 02.10.02

Non Hazardous NH Non: Hazardous

1 Explosive Materials
:I LIQ 1 Explosive Materials
:lsoL 1 Explosive Materials
12.1 IFlammable Gas I
12.2 INon-Flammable, non-toxic aas I
12.3 IToxic Gas
C:ZGAS 12 IGases

.
C3LIQ 3 Flammable Liquids

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c4-I SOL 4.1 Flammable Solid ru
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CX-2GAS 4.2 Subs. liable to spontaneous combustion

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IC4-2LK.a 14.2 ISubs. liable to spontaneous combustion

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IC4-2SOL 14.2 ISubs. liable to spontaneous combustion

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IC45GAS 14.3 IFlammable when in contact with water

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IC4-3LlQ 14.3 IFlammable when in contact with water I

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C43SOL 4.3 Flammable when in contact with water

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C4SOL 4 Flammable Solids

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C5-1 GAS 5.1 Oxidizer

c5-1 LIQ 5.1 Oxidizer
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cs-ISOL 5.1 Oxidizer

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C5-2LIQ 5.2 Organic Peroxides

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CSGAS 5 Oxidizing Subs. And Organic Peroxide

1C5LlQ 15 loxidizina Subs. And Oroanic Peroxide I
C5SOL (5 IOxidizing Subs. And Organic Peroxide
C&l GAS 16.1 IToxic Substances I
C6-1 LIQ 6.1 Toxic Substances
C6-I SOL 6.1 Toxic Substances
C6-2GAS 6.2 Infections Substances
C6-2LIQ 6.2 Infections Substances
IL 16.2 llnfections Substances I
SAS 1’5 IToxic and Infectious Substances I
-IQ 16 IToxic and Infectious Substances I
SOL 16 IToxic and Infectious Substances I
:7GAS 17 IRadioactive Substances I
:7LIQ
IC7SOL
k
7
7
Radioactive
Radioactive
Substances
Substances --I
--I
GAS 8 Corrosives
:tlQ 8 Corrosives
CISOL 8 Corrosives
CSGAS 9 Mb rcellaneous Dangerous Goods-
ItsLIQ I9 IMiscellaneous Dangerous Goods I
lC9SOL I9 IMiscellaneous Danaerous Goods I

EPA Export 25-07-2013:15:03:41

 SOP Page 1 of 1
SUPPLY CHAIN MANAGEMENT PROCEDURE
ATIACHMENT lII 400.010
Effective Date:
Revision No: 20 Date: 10.02.04
Title: MAP OF DRUM STORE AREAS OF Prev Rev No: 19 Dated: 02.10.02
THX MAIN PLANT

i A B E C DGJHKILI 003 i

DRUMSTORE 2
AT

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DRUMSTORE 1
B
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”
5

SOP Page 1 of 1
SUPPLY CHAIN MANAGEMENT PROCEDURE
ATTACHMENT IV 400.010
Effective Date:
Revision No: 20 Date: 10.02.04
Title: MAP OF PHARMA WAREHOUSE Prev Rev No: 19 Dated: 02.10.02
LOCATIONS

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--._-_-_------_-- ----
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ixI _-____-._ --..
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WAREHOUSE
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EPA Export 25-07-2013:15:03:41

 .

SOP Page 1 of 1
SUPPLY CHAIN MANAGEMENT PROCEDURE
ATTACHMENT V 400.010
Effective Date:
Revision No: 20 Date: 10.02.04
Title: MAP OF CHEMICAL WAREHOUSE Prev Rev No: 19 Dated: 02.10.02
LOCATIONS

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EPA Export 25-07-2013:15:03:41

 SOP Page 1 of 1
SUPPLY CHAIN MANAGEMENT PROCEDURE
A’ITACHMENT VI 400.016’ Effective Date:
Revision No: 20 Date: 10.02.04
Title: MAP OF BAY 130 STORE Prev Rev No: 19 Dated: 02.10.02

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Last Modified
Drawing No. O%%%+,

(1 pi-k--j
\I
Production storage

EPA Export 25-07-2013:15:03:41

 SOP Page 1 of 1
SUPPLY CHAIN MANAGEMENT PROCEDURE
ATTACHMENT VI 400.010
Effective Date:
Revision No: 20 Date: 10.02.04
Title: SITE MAP Prev Rev No: 19 Dated: 02.10.02

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‘_ EPA Export 25-07-2013:15:03:41

 @@q@@~-fi@

/
/. ./ ^_ . ‘,

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l To include: 5.3.2.3 “Storage of Ametolam and

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. To include new Warehouse locations and new

. To include responsibilities of Safety &

Environmental Department.
n To describe the storage of Returned Material (5.5)
and Capsule Shells (5.10).
. To include the Pharma Manager as a signatory.
. To update 5.10 Pharma Storage

ote after 5.2 stating that Material

Locations and Contents are printed on a daily basis.

EPA Export 25-07-2013:15:03:41

 :. ~“@qq#“~~~
.’ ( ‘y‘i. _*.j i ..
I.. . . :ic. ‘. ,V‘. A * “.
SOP TiTLE: STORAGE OF Mii&IALS ’ SOP NUMB&: 400.010

REVISION REQUESTED REASON FOR REVISION EFFECTIVE

VO. BY: DATE
13 GT l SOP modified to detail locations by 04.09.00
MAC individual Warehouse.
l To update Pharma storage locations in
5.9
l To include Section 5.11
l To update Drawings.
l Change title of ‘Warehouse Team
Leader’ to ‘Warehouse Team
Facilitator’.

.
To include Section 5.13
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To include the maps revised and
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updated on 17.08.00
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To update section 5.8 on Pharmaceutical

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14 GT 17.10.00
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15 GT To specify that Bay 130 is only a staging 09.07.01

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areas for Finished Goods

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16 GT To reflect the revised storage locations in 19.09.01

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the Chemical and Pharma Warehouses and

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to reflect the Nitrates Tank Farm.

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17 S.0.D l To significantly change the storage 26.08.02

en
ns

philosophy & therefore the physical

Co

locations resulting from the

implementation of SAP.
l Including the removal of all
references to Passed & Quarantined
locations.
l To include a listing of hazard
classifications & storage locations &
SAP types (attachments I and II).
l To update Maps (attachments III and
IV).
l Remove reference to the fridge as a
storage location.
l Include a returns area in Pharma
W/H
18 S.O.D. l 510.8 The goods receipt area had 13.12.02
been incorrectly described as 101
instead of 902.

EPA Export 25-07-2013:15:03:42

 ,,;’ j:,

.,:3: . ,.’

REVISION REQUESTED REASONFORREVISION EFFECTIVE

NO. BY: DATE
19 A. C. l To include in 5.10.4.8 that RX Material 12.03.03
from Pharma is also stored in this area.
l To remove references to Rail Containers
2 & 3 as they are no longer in use in
5.10.9.
l To change Department title from
“Materials” to “Supply Chain
Management”.

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l To update list of signatories and
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department changes.
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20 SOD l Update any reference of SIFA LTD

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to SCHWARZ PHRAMA LTD

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Remove any reference to WM

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storage 006
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To remove any reference to Nitric

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Acid in BAY 130

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l To reflect changes to Procedure form

SAP R3 to SAP ENTERPRISE
to

Update signatories
en

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EPA Export 25-07-2013:15:03:42

 SOP RECEIPT COh!FI& hiN ’

SOP TITLE: STORAGE OF MATERIALS

I acknowledge receipt of the above SOP.

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Copvc.
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For All Csni

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I have destroyed (returned in the case of BMI’s) the superceded revision of the SOP.
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Signed: Department:
ht ct

Date:
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EPA Export 25-07-2013:15:03:42

Attachment H.l Material Handling
Schwarz Pharma Ltd. Revised IPCL Application

.
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Appendix H.l.2
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Chemical Storage,
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Site Map
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EPA Export 25-07-2013:15:03:42

 Co
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EPA Export 25-07-2013:15:03:42

 ‘. , .I
--_ .i_~---I’ -’ /
; /
i
‘I
llci
i ----.-.-~ I/i 1 -

-
RAW

WASTE
M,mR!AL IN/OUT

- ,NTERh,EDli\TE / PiiODUCT

L: UQUID WASTE
9: SOLID WSTE

,_._..___-.-- - ---
,’ BOUNDARY
,/”

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a 22/7/04 CC 04/??. Enviro Mods

7 25/5/04 CC 04/189,Monitaring F

6 13/1/04 ,nclude NPD Portocobin

5 26/T/02 Updoted

4 13/5/02 Updated

3 28/8/01 Includes conteen

‘\ i 2 24/g/99 ,ncludes Nitration

\V
1 29/4/99 ,d”&S WWTP oncl
Worehause

R 20/2/97 Phormo Building Include,

EPA Export 25-07-2013:15:03:42