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 Premises

Zahravi is located in Tabriz, Iran over a site that is 120,000 sq meters land with 28,000 sq meters are allocated to the plant itself.

All products for both domestic and export markets are manufactured within this plant.

The areas of the facilities within the plant are as below.

No.

Name

Area

1

Sterile facility

768.74 m2

2

Hard capsules facility

497.15 m2

3

Soft-gel capsules facility

1173.89 m2

4

Dedicated Soft-gel capsules facility

526.55 m2

5

Tablets facility

546.79 m2

6

Dedicated Oral Solid Dosage facility

457.84 m2

Layouts for these facilities are attached in Appendix 6.

There are separate warehouses available for raw materials, packaging materials and finished products .Quality Control and microbiological laboratories are segregated from the manufacturing areas and is within the factory site.

Work timetable/shifts

The working hours in Zahravi is 7:00 to 16:30.

Drawing of the production areas

The drawing of the production areas is provided in Annex 6.

Circulation diagrams for personnel and materials in the plant

The circulation of diagrams of the plant of Zahraviare provided in Annex 6.

Brief description of heating, ventilation and air conditioning (HVAC) systems.

All production units have independent provision of various utilities on mezzanine floor made of concrete floorings. All HVAC systems, Purified water, WFI (where required), Dust extraction system, Compressed air and Nitrogen supply are supplied at the manufacturing / processing / filling stations through stainless steel piping.

The Hazard facility has also been provided with dedicated utilities & HVAC systems on the service floor.

Air Handling—Air handling systems have been designed to prevent cross -contamination between areas and zones of every production line. For dedicated areas processing the same product, it is permissible to recycle a portion of the exhaust air back into the same area.

In multipurpose production areas where several products are completely confined in closed vessels piping systems, the extent of filtration of the air supply (combined fresh make-up air and recycled air) is acceptable if the conditions are consistent with other existing regulations (e.g., environmental , safety). However, there are data to demonstrate adequacy of the air handling system for every unit through monitoring system.

Heating, ventilation and air conditioning (HVAC) systems have been designed to provide pre required environmental condition in the manufacturing area.

A dedicated independent Air Handling Unit system have been provided to prevent cross contamination in processing and primary packing areas in each production.

There is independent dust extraction system. Systems provided to ensure continuous dust extraction during the operations to keep the environment cleanliness in the processing area.

Entire HVAC system has been designed to provide over or under pressure in, each production rooms toward adjustment room. System provides standard air changes per hour in the rooms.

In the processing area, return air ducts have been provided at a lower level in the wall and the supply grills are located in the ceiling. Return air from the area passes through filters followed by chilled or hot water system.

All classifications containing, air change rate, supply & exhausted air (cfm), pressure differentials, temperature, humidity and Particle Counting are controlled and monitored according their GMP compatible design.

In supply and return or exhaust air HEPA filters are used in critical rooms according to zonification.

The HVAC systems and site performance are controlled with P.M (preventative maintenance) programs and relevant SOPs.

Brief description of Zahravi water system

Water which is used in production of all drugs meets the required pharmacopoeia standards. Data from periodic testing are available to show compliance with chemical and microbiological standards, including immunity from pathogenic organisms for Water for Injection (WFI). Appropriate specifications for chemical and microbial quality have been established and periodic testing conducted. Such specifications will vary depending on the process and the point in the process when the water is used. The water quality standards reflect the intended use of the product. The frequency of microbial and chemical testing of Purified Water (PW) is dependent upon a variety of factors, including the test results and the point in the process (e.g., final wash in equipment) at which such water is used . Similar principles to those discussed above for PW apply to WFI used in sterile and pyrogen-free processing. The WFI system is monitored for microorganisms, and reports of monitoring are reviewed as is required for finished dosage forms .

The capacity of water system is 12m3/h.

The new central water treatment system(RO), which is under validation studies, includes PW, WFI, pure steam, generation and distribution.

The schematic diagram of the water system (1/2) and new water system (2/2) are attached in Appendix 7.

Brief description of other relevant utilities.

Zahravi uses clean and process steam, compressed air and nitrogen during the manufacture of its products and for operations of some of its equipment. Where these utilities have direct product contact or are GMP impacting, point of use filters of 0.22micron are used to provide assurance of quality.