ABM GROUP SITE MASTER FILE

ABM GROUP SITE MASTER FILE

IRAN- Mashhad- street Daneshjoo

phone. 09155014415

Brief History of revision:

Prepared by Review by Approved byelecteronic Manager Machinery manager Director ManagerEng.Mohamad khirati Eng. aligholizadeh Eng.Abbas Ali Ashoury

1393.09.23 1394.02.21 1394.03.03

1-Contents

1- GENERAL INFORMATION:..................................................................................................................................6

1-1- Site Address and Contact Details..............................................................................................................6

1-1-1-Identification number of the site:..............................................................................................6

1-2- Authorised Designer manufacturing activities of the site:........................................................................6

1-2-1-TYPE OF PRODUCTS MANUFACTURED:......................................................................................7

1-2-2-Other Manufacturing activities:.................................................................................................7

ABM Company Research and Development Department activities:.......................................................8

In the following table we listed our R&D activities as you see from the beginning of 1995 to 2013:..............8

1-2-4-Manufacturing Licenses:...........................................................................................................9

2- Quality Management System:...........................................................................................................................9

2-1- Quality Policy............................................................................................................................................9

2-1-1-Accrediation Bodies:................................................................................................................9

2-2- Release procedure of finished product:..................................................................................................10

2-3- Management of suppliers and contractors.............................................................................................10

2-3-1-Assessment of Suppliers:........................................................................................................10

2-3-2-Assessment of Critical Supplies...............................................................................................10

2-3-3-Release for Sale Procedure:....................................................................................................11

2-4- Quality Risk Management:.....................................................................................................................11

3- Personnel:.......................................................................................................................................................11

3-1- Key personnel:........................................................................................................................................11

3-2- Number of Employees:...........................................................................................................................11

3-3- Training Program for Personnel:.............................................................................................................12

3-4- Health Requirements for Personnel Engaged in Production:..................................................................12

3-5- Personnel Hygiene Requirements, Including HSE:..................................................................................12

3-6- Organization Chart:................................................................................................................................13

4- PREMISES AND EQUIPMENT............................................................................................................................13

4-1- Premises:................................................................................................................................................13

4-2- Equipment:.............................................................................................................................................15

4-2-1-Calibration and qualification of instruments:............................................................................16

5- Documentation:..............................................................................................................................................16

5-1- Quality System Documents:....................................................................................................................16

5-2- Preparation, Revision and Distribution of Quality System Documents:..................................................17

5-3- Documents Preparation, Distribution and Control:................................................................................17

6- Production:......................................................................................................................................................17

6-1- Type of products:....................................................................................................................................17

6-2- Process Validation:.................................................................................................................................18

6-3- Responsible Authorities for Validation:..................................................................................................18

6-4- Rework and Reprocess:..........................................................................................................................18

7- Material Management and Warehousing:......................................................................................................20

7-1- Procedures for handling raw materials, steel,alominum.beress. polieteilen. finished product quarantine release and storage:......................................................................................................................................20

7-2- Handling rejected Material and products:..............................................................................................20

8- Quality Control:...............................................................................................................................................20

8-1- Quality Control system for manufacturing and product release:............................................................20

9- Distribution, Complaints and Product Recall:..................................................................................................21

9-1- Recording system for distribution..........................................................................................................21

9-2- Arrangements for Handling Complaints and Product Recalls:................................................................22

10- Self Inspection...............................................................................................................................................23

10-1- Self Inspection System..........................................................................................................................23

APPENDICES:

APPENDIX1: Product List

APPENDIX 2: CompanyQuality Control Laboratory Equipment List

APPENDIX 3: GMP Certificate

APPENDIX 4:Organizational chart

APPENDIX 2Floor layout

1- GENERAL INFORMATION:

1-1- Site Address and Contact Details

Company Name: ABM GROUP CompanyPostal Address: PO Box 9188958487 Mashhad-KhorasanRazavi-IranStreet Address: Daneshjoo- Mashhad-KhorasanRazavi-Iran24 hours contact telephone number::+98-09155014415Fax: +98-51-Website:www.abmgroup.irEmail:abmashoury@yahoo.comOffice Address: 4th floor, No 39 Highway, Tehran, IranPhone:+98-21-Fax: +98-21-

1-1-1-Identification number of the site:LATITUDE 33.42539, LONGITUDE 53.24241Latitude 34 degrees, 21.54 minutes northLongitude 53 degrees, 21.53 minutes east

1-2- Authorised filling.pacpackaging. labelling. manufacturing activities of the site:

ABM GROUP co. has been established in 1995, in Mashhad(Iran) to produceand design small machine injection and large volume solution injection and irrigation Dosage. abm Company is a joint venture of Ashoury machinery and the state pensioner fund on a land of 2 acres having a 7000 square meter construction. The unique installation of ABM due to parenteral industry has met

aseptic areas and other international standards, which has been nominated as the superior industrial unit in KhorasanRazavi province of Iran. The factory complex is including different buildings and departments such as power-plant. Water treatment, distillation, solution preparation, filling area, sterilization, packaging, also raw material, and R&D..

1-2-1-TYPE OF PRODUCTS MANUFACTURED:Products which produced in this site are sterile FILLING Machine- packaging- laminar flow sys. and so on. Authorized product are given in Appendix 1.

1-2-3-ABM Company Research and Development Department activities:

In the following table we listed our R&D activities as you see from the beginning of 1995 to 2013:

No Project Name Date

1 Design scrap (deflashing bottle sys.)for BFS machine Ended 1997

2 Start working on packaging machine Abmpack0094 1000ml- 100 ml bag 2014 up to 2015

3 Working on for laminar sys. on bag filling machine 12 series. 1999 up to 2001

4 Developing new product labelling machine. 2000 up to 2001

5 Scrap removal machine Design. 2000 up to 2002

6 2002

7 2001 up to 2002

8 2001 up to 2005

9 2002 up to 2003

10 2003 up to 2008

11 2006 up to 2007

12 2006 up to 2008

13 2007 up to 2009

14 2009 up to 2011

15 2011 up to 2013

Ref. 05

2- . Personnel:

3-1- Key personnel:

Name Designation Relevant Industrial Experience Education

Abbas Ali Ashoury Kakhki

Director Manager 19 yrs Pharm D

3-2- Number of Employees:

DepartmentQuality

Assurance Site Laboratory WarehouseRegulatory

OfficeStaff Numbers 3 17 3 1 2Percentage of

education degree 100% 9% 65% 30% 100%

3-1- Training Program for Personnel:

Arrangement and performing the training program is under supervision of abm manager department.

Eng. group trained in italy- switzerland- azarbayjan- for design machinery.

Appendix3:GMP Certificate

3- PREMISES AND EQUIPMENT

4-1- Premises:

4-1-1- Characteristics of buildings and departments:ABM Company is consist of several departments including MACHINE DESIGN production area, laboratories, utility and power plant section, offices and warehouse.All the plans of floors and manufacturing areas and identification scale are attached in Appendix5.

Size type of the buildingsCode Description Area (m2) Area (HTR)0001 Office 150 0. 01500002 Laboratory 40 0. 0400003 Production Dept 1700 0. 17000004 Utility 750 0.07500005 Store Dept 1200 0.12000006 Green Area 2000 0.2000

Total Area: 5840 (m2) Total Area: 0.5840 (HTR)

Appendix

APPENDIX 1ABM GROUP Company

Product List

Product ID Name of product(abm name) Abm code volume dimension

Appendix 2ABM GROUP Company

Design Laboratory Equipment List

Mechanic Lab. Equipment

NO NAME OF EQUIPMENT

BRAND NAME NO NAME OF EQUIPMENT

BRAND NAME

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

Appendix4:Organizational Chart

4- Material Management and Warehousing:

7-1- Procedures for handling raw materials, bulk drug substances, finished product quarantine release and storage:

Starting materials are purchased from approved suppliers in accordance with SAMEN's Quality Assurance procedure. SAMEN's approved supplier list is reviewed by the Quality Manager on a biannual basis.Upon receipt raw materials intended for production are placed in the "quarantined production material" area located within the quarantine store. The QC department is informed of the arrival and the goods inspection procedure is initiated.Arrival and numbering of such goods, documentation in the quarantine area logbook, controlled labeling and goodsinspection are procedures.All handled according to QA procedure.All items,located in the quarantined production material area are inspected by the Quality department against the published Raw Material Specifications. Items successfully passing the inspection procedure are labeled accordingly to sign out before removal.Formulation material (excipients) undergo further analysis (chemical analysis) and remain in quarantine until the result have been received and acceptance criteria have been satisfied.Reference document controls and method of sampling (and weighing) analytical and retention samples.SAMEN is authorized by the MOR to release finished product for supply. The procedure for quarantining product prior to release testing, storage and dispatch is controlled as outlined in reference documents.Products are identified and processed according to a color based labeling system. All movement of product is well documented.

7-2- Handling rejected Material and products:

Rejected incoming materials remain in quarantine and are either returned to the supplier or disposed of by an authorized contractor.Non-conforming and expired or returned product is disposed of in a controlled manner according to the relevant SOP. Non-conforming product and quarantine and segregated from the product according to the instructions and labelling methods outlined in the relevant SOP. The certificate of Destruction is filed in the Non-conforming product folder in the Quality department.

5- Quality Control:

8-1- Quality Control system for manufacturing and product release:

SAMEN adopts specifications and test methods as described in the US Pharmaceutical (USP) wherever possible. European Pharmacopoeia (EP) methods and specifications are also take into consideration when developing a new product. Where there is no pharmacopoeias monograph, the product is manufactured to specification accepted by the other relevant regulatory authority.The Quality Control system includes documented procedures for sampling, performing tests and recording results including chemical and microbiological testing of the following:

Intermediates and finished product

In-process samples

Stability trials

Air and surface environmental samples

Process water(WFI and PW) samples

Cleaning verification and validation samples

The system provides for checking and review of test results, investigation of out of specification results, data trending, and preparation of certificates of Analysis.QC SOP's are in place that cover the operation, maintenance and calibration of analytical equipment.Systems are in place for the retention of raw material, packaging,in-process finished and stability samples in secure and controlled environments.

Managing Director

Commercial

DeputyIntl Commer

cial Manager

Domestic

Commercial

Manager

Project, Plannin

g & Training Deputy

Deputy to

ProductionMainten

ance Manager

Production

Manager

Technical

Maintenance

DeputyFinancial Manager

Administrative

Manager

Financial &

Administrative Deputy

Biotechnology deputy

Laboratories & Quality Control DeputyI.P.Q.C

ManagerQ.C

ManagerR&D

Manager

Biotechnology

Manager

Responsible Pharmacist Officer