:. attachment no. h.1 raw materials, intermediates and

. .

Attachment No. H.1 :.

Raw Materials, Intermediates and Product 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

Appendix H.l .I Supply Chain Management

Appendix H.l.2 chemical Storage

Appendix H.1.3 Bund Integrity Testing

Appendix H.1.4 Bund Management

Appendix H.1.5 Bund Locations

Appendix H.l.6 Material Flow

Appendix H.l.7 Bund upgrade program

Attachment No H.1 - Main Text.doc Page i

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

An additional storage tank farm is located at the Main Production Building (BPC) which 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 air emissions, treatment/abatement equipment was installed on vessels in the BPC that 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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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

A tool for the procurement of chemicals, inventory management, manufacturing, release and shipment of products called Systems, Applications and Products for Data Processing (SAP) is employed at Schwarz Pharma Ltd. This indirectly benefits environmental management through improved chemical classification for storage and better tracking of hazardous waste in storage and for disposal off-site.

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

n WM storage allows the storage in discrete ‘bins’ & the exact quantity of material in each bin can be seen;

. 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.

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

Liquid materials are transported on-site in steel drums and plastic containers, similar to the movements of solid materials. Within processing buildings, drums are charged from dedicated areas. Such areas incorporate closed drains for collection and containment purposes, which may be accessed to facilitate cleanup of any spillages.

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

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

Supply Chain Management

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SUPPLY CHAIN MANAGEMENT PROCEDURE SOP

Title: STORAGE OF MATERIALS 400.010

Page 1 of 7

Effective Date: 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.

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

3.0 APPROWL

This SOP and any future changes must be approved by the Supply Chain Manager, the API Manager, the Health and Safety Offtcer, Pharma Manager, and the Head of QA and Support Services.

4.0 SCOPE

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:

S. O’Donoghue Materials Technologist

Date:

Approved By:

M Dohmam Supply Chain Mgr.

Date:

Approved By:

J. O’Halloran Prod. Manager

Date:

Approved By:

D. Mullins Health &Safety OfflW

Date:

Approved By

Pat Quirke Phama Mmuf. Mgr.

Date:

Approved By:

I. Wills Head of QA &

Support Services

Date:

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Page 2 of 7


5.3

5.4

5.5

5.6

5.7

5.8

5.9

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.

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

SAP controls storage at two different levels, Inventory Managed (IM) and Warehouse Managed (WM) - See Attachment I.

5.5.1 WM storage allows the storage in discrete ‘bins’ & the exact quantity of material in each bin can be seen.

5.5.2 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 (Attachment II).

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

Quarantine (represented as letter Q on SAP) Blocked stock (represented as letter S on SAP).

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

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

dedicated area; IM location 0063.

5.10.3 Pharma Warehouse 5.10.3.1 Raw materials & packaging for use in Pharmaceutical manufacturing,

Pharma Work in Progress (WIP) & all finished goods are stored in the Pharma Warehouse (WM 050).

5.10.3.2 Capsule Shells, Finished Product Capsules and Tablets are not stored on the 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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STJPPLY CHAIN MANAGEMENT PROCEDURE SOP


Page 4 of 7


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 API manufacture, which require storage indoors (WM 00 1).

5.10.4.2 The storage is on racking, A to M, primarily for the storage of Class 4.1 & non-hazardous materials.

5.10.4.3 Classes 5,6.1,8 & non-hazardous are stored on Rack H. ,’ 5.10.4.4 Packaging material & miscellaneous items are stored on Rack M.

5.10.4.5 Fibreboard drums are stored in the Chemical Warehouse & distributed to other locations as required their storage is however reflected in SAP IM location W055 (Pharma WIP area).

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

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

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


5.10.6.3

5.10.6.4

5.10.6.5

5.10.6.6

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). Rejected/ Waste material is stored on Racks A & F in this area in location WM 005. Oil, Sodium Hypochlorite & Bromine have dedicated bunded storage areas within this location. An additional waste management area is denoted by location WM 007.

5.10.7 Production Areas 5.10.7.1 Material which is required for manufacturing is transferred to the

Production Supply Areas (SOP 400.053) where short term storage occurs while awaiting usage to planned processes:

,C BPC Production Supply area (WM 020) Nitration PSA (WM 060)

5.10.7.2

Pharma Dispensing PSA (WM 051) Pharma Palletising PSA (WM 052)

Material produced by the manufacturing facilities will be confirmed on SAP to the appropriate WIP areas, these may be either IM managed or WM managed:

BPC WlP areas; WM 021 or IM WO21 Nitration WIP areas; WM 03 1 or IM W03 1 Pharma WlP areas; WM 055 or IM WO55

5.10.7.3

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. 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


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

5.10.10.2 5.10.10.3

5.10.10.4

5.10.10.5

5.10.10.6

5.10.10.7

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. Storage is provided for both API & Pharmaceutical materials. API liquid raw materials are stored in racks in the open store (Racks I-l to I-20) Racks A & B in the B130 warehouse are used as a Pharma production supply area & for the short term staging of Pharma finished products (maximum staging time 48hr.s). Racks C & D are used as an API production supply area & for the short term staging of API finished products (maximum staging time 48hrs). Packaging materials (Liners, fibreboard drums & 200L plastic drums) are also stored in location 0130. API work in progress is stored in the production area.

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: Attachment II: Attachment III: Attachment IF Attachment k Attachment Y7; Attachment WI:

List of Warehouse Locations (IM & WM locations) List of Classification. Map of the Drum Store areas of the Main Plant. Map of Pharma Warehouse Locations. Map of Chemical Warehouse Location. Map of Bay 130 Store. Site Map.

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:

SUPPLY CHAIN MANAGEMENT PROCEDURE

Title: STORAGE OF MATERIALS

SOP

400.010

Page 7 of 7


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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Title:

SUPPLY CHAIN MANAGEMENT PROCEDURE ATTACHMENT I

LIST OF WARESHOUSE LOCATIONS (IM & WM LOCATIONS)

SOP

4OO-sblO Effective Date: Revision No: Prev Rev No:

20 19

Page 1 of 1

Date: 10.02.04 Dated: 02.10.02

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

Pharma Warehouse 050

- Chemical Warehouse

Returns area Pharma Warehouse 904

Chemical Warehouse safe 008

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

BPC Production Supply Area (PSA) Nitration PSA 020 060

Pharma Dispensing Pharma Effluent Supply 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

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SUPPLY CHAIN MANAGEMENT PROCEDURE ATTACHMEXW II

Title: LIST OF CLASSIFICATION

SOP

400.010

Page 1 of 1


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

:ZGAS C

C3LIQ

c4-I SOL

CX-2GAS

12.3

12

3

4.1 4.2

IToxic Gas IGases

Flammable Liquids

Flammable Solid

Subs. liable to spontaneous combustion IC4-2LK.a 14.2 ISubs. liable to spontaneous combustion I IC4-2SOL 14.2 ISubs. liable to spontaneous combustion I IC45GAS 14.3 IFlammable when in contact with water I IC4-3LlQ 14.3 IFlammable when in contact with water I

C43SOL 4.3 Flammable when in contact with water

C4SOL 4 Flammable Solids C5-1 GAS 5.1 Oxidizer

c5-1 LIQ 5.1 Oxidizer

cs-ISOL 5.1 Oxidizer C5-2LIQ 5.2 Organic Peroxides

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

-IQ SOL

1’5 IToxic and Infectious Substances I 16 IToxic and Infectious Substances I 16 IToxic and Infectious Substances I

:7GAS 17 IRadioactive Substances I :7LIQ

IC7SOL

GAS k :tlQ

CISOL

CSGAS

7 Radioactive Substances 7 Radioactive Substances

8 Corrosives 8 Corrosives 8 Corrosives

9 Mb I9

rcellaneous Dangerous Goods-

IMiscellaneous Dangerous Goods I

--I --I

Its LIQ lC9SOL I9 IMiscellaneous Danaerous Goods I

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SUPPLY CHAIN MANAGEMENT PROCEDURE ATIACHMENT lII

Title: MAP OF DRUM STORE AREAS OF THX MAIN PLANT

SOP

400.010

Page 1 of 1


i A B E C DGJHKILI 003 i

DRUMSTORE 2 AT

B DRUMSTORE 1

A

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” 5

:

SUPPLY CHAIN MANAGEMENT PROCEDURE ATTACHMENT IV

Title: MAP OF PHARMA WAREHOUSE LOCATIONS

SOP

400.010

Page 1 of 1


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--._-_-_------_-- ---- -_ ixI _-____-._ --.. WAREHOUSE

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

SUPPLY CHAIN MANAGEMENT PROCEDURE ATTACHMENT V

Title: MAP OF CHEMICAL WAREHOUSE LOCATIONS

SOP

400.010

Page 1 of 1


.

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

Title:

SUPPLY CHAIN MANAGEMENT PROCEDURE A’ITACHMENT VI

MAP OF BAY 130 STORE

SOP

400.016’ Effective Date: Revision No: 20 Prev Rev No: 19

Page 1 of 1

Date: 10.02.04 Dated: 02.10.02

Last Modified Drawing No. O%%%+,

(1 \I

pi-k--j Production storage

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

SUPPLY CHAIN MANAGEMENT PROCEDURE ATTACHMENT VI

Title: SITE MAP

SOP

400.010

Page 1 of 1


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

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l To include: 5.3.2.3 “Storage of Ametolam and

. 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.

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

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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’.

l To include Section 5.13 l To include the maps revised and

updated on 17.08.00 14 GT To update section 5.8 on Pharmaceutical 17.10.00

r* Warehouse. 15 GT To specify that Bay 130 is only a staging 09.07.01

areas for Finished Goods 16 GT To reflect the revised storage locations in 19.09.01

the Chemical and Pharma Warehouses and to reflect the Nitrates Tank Farm.

17 S.0.D l To significantly change the storage 26.08.02 philosophy & therefore the physical 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.

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

REVISION REQUESTED NO. BY: 19 A. C.

REASONFORREVISION EFFECTIVE DATE

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.

20 SOD

l To change Department title from “Materials” to “Supply Chain Management”.

l To update list of signatories and department changes.

l Update any reference of SIFA LTD to SCHWARZ PHRAMA LTD

l Remove any reference to WM storage 006

l To remove any reference to Nitric Acid in BAY 130

l To reflect changes to Procedure form SAP R3 to SAP ENTERPRISE

l Update signatories

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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.

. For All Csni Copvc

I have destroyed (returned in the case of BMI’s) the superceded revision of the SOP.

Signed: Department: Date:

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


Appendix H.l.2

Chemical Storage,

Site Map

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

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

‘. , .i I’ -’ .I ;

--_ _~--- ‘I

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llci i i ----.-.-~ I/i 1 - RAW M,mR!AL IN/OUT

- WASTE

- ,NTERh,EDli\TE / PiiODUCT

L: UQUID WASTE

9: SOLID WSTE

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,_._..___ -.-- - ---

,/” ,’ BOUNDARY

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

2 24/g/99 ,ncludes Nitration

1 29/4/99 ,d”&S WWTP oncl Worehause

20/2/97 Phormo Building Include, R

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

:. attachment no. h.1 raw materials, intermediates and

Documents