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INCEPTA PHARMACEUTICALS LTD.

 

R & D Facilities

 
Production Facilities

The production site comprises of six different multi-storied buildings, which provide areas for the production of pharmaceutical products.

Cephalosporin and general products are manufactured in those buildings, Cephalosporin facility is physically separated from other areas.

The following product forms are manufactured on site:

GENERAL PRODUCTS
LIQUID STERILE (Terminally sterilized and aseptically filled ampoule)
SOLID DOSAGE (Capsules, Tablets, Powder)
ORAL LIQUIDS
TOPICAL CREAMS AND OINTMENT
NASAL SPRAY
   
CEPHALOSPORIN
STERILE POWDER (Aseptically filled vials)
SOLID DOSAGE (Capsules, Tablets, Powder )
   
 
 

Production Facilities

Manufacturing and packaging operations are carried out according to the validated methods through systematically qualified machines with full documentation at all stages of operations.

The production sites follow the cGMP guidelines for environmental requirements of the manufac- turing and packaging area, as well as comply with the EHS requirements.

Highly sophisticated HVAC systems are used to condition, monitor and supply clean air to the working zone according to the manufacturing zone concept, capture and control any dust, vapour, gas or fume generated, as well as treatment of recirculated and/or exhausted air. Temperature and moisture level are maintained at the desired level through this system.

Design of the room and air-conditioning systems ensure:

 
Prevention of contamination of the product.
 
Protection of the environment.
 
Protection of people.
 
Prevention of the ingress of vermin, insects, birds etc.

There are different environmental zones maintained within the manufacturing area.

Planned, organized, ongoing training programs take place based on a written plan and are documented. Personnel at all levels undergo general cGMP and Technical Training appropriate to perform their job satisfactorily.

Purified Water and Water for Injection plant and distribution Systems are designed to maintain the water Quality according to the relevant Requirements and state-of-the-art engineering design which includes e.g. 24 hours run circulation loops, smooth interior surfaces, adequate Materials, minimum flow rates.