Avicenna Chemotherapy Inc. is a subsidiary of Ajand Pharma Holding Inc. It is science-based organization which manufactures HiPo (High Potency) oral (tablet and capsule) and injectable (infusion and lyophilized vials) drug products with extremely low OELs. Regulatory Affairs, Sales, Marketing and other administrative functions are conducted through our head office in Tehran. Manufacturing and QA/QC Departments are located in Kaveh Industrial Park, 90 km south of Tehran.
All production equipment are closed systems with CIP (Clean in Place) capability, preventing any possibility of environmental contamination or exposure of the personnel to the chemicals used or produced during the production process o HiPo drug products. OELs are constantly measured as per generally accepted protocols (SOPs) internally as well as by external auditors and documented.
Various formulation protocols are optimized and validated by our subsidiary Andisheh Pharma R&D Inc. prior to production at Avicenna Chemotherapy Inc. Utter care is taken in assuring adherence to environmental and workplace safety regulations. Closed system production ensures no contact between the chemicals and the environment from compounding to blistering (oral drug products) and from dissolution to capping with rubber stoppers of lyophilized and infusion vials (injectable drug products). All exhaust air from production equipment is fully scrubbed with appropriate neutralizing agent ensuring our commitment to the environment.
The manufacturing facility 700 m2 and is composed of two separate sections for the production of oral and injectable drug products. HVAC systems provide Class A and Class D areas in the manufacturing facility. Closed system compounding, tableting, coating and blistering systems are used for oral products and closed system dissolution, microfiltration vial filling, lyophilization and capping is utilized throughout the production processes of HiPo drug products. Butterfly valve technology is used for closed system transfer of solids (hopper to press). Utility rooms (boilers, chillers, compressed air, deionized water, distilled water, water for injection, tank farms, water treatment facility, raw material and API warehouses are located on a 20,000 m2 facility. Extensive effluent water treatment facility ensures neutralization of HiPo compounds followed by treatment of the effluent resulting in consistently lower levels of BOD and COD of effluent water than those required by the Environmental Protection Organization. Engineering support is provided by Engineering Department which includes chemical, mechanical and electrical engineers and their supporting technical staff.
Technical staff teams are comprised of a core of Ph.D. and M.Sc. chemists or Pharm.Ds. with supporting technical staff. Quality Control Laboratories include state-of-the-art equipment such as HPLCs, GCs, UV, IR Atomic Absorption, etc. Because of our close association with major academic institutions in Tehran (see Andisheh Pharma R&D Inc. at www.andishehphRD.com), we have access to high-end analytical instruments such as solid state NMR, powder X-ray, laser particle size distribution analyzer, etc. .
As a part of quality assurance, continuing in-house and off-site training of personnel on quality-related issues is documented to ensure highest quality for our products. Strict adherence to cGMP guidelines as set by FDA and ICH is company philosophy. Over 1500 comprehensive Standard Operating Procedures (SOPs) are in place and all staff members undergo continuing in-house and off-site training of personnel on cGMP issues
Manufacturing summary includes receiving, quarantine, sampling and testing of raw material followed by actual production with in-process sampling in critical steps, in Class D and Class A facilities. All production steps from the start of production to blistering (oral drug products) or rubber stopper capping (injectable drug products) are carried out in closed system equipment with CIP capabilities. Final products are shipped to customers after QA/QC approval.
Plant Master File (Type I) and Drug Mater File (Type II) are available on all products. The open portion of DMFs in CTD format is submitted to clients for Regulatory Affairs.