The sponsor has presented plans to address these impacts to ensure that the proposed project will upon implementation of the specific agreed measures, comply with the environmental and social requirements - the host country laws and regulations and the World Bank/IFC environment and social policies and the environmental, health and safety guidelines. The information about how these potential impacts will be addressed by the sponsor/project is summarized in the paragraphs that follow. Further information is provided in the attached documentation.
Hikma Pharmaceuticals Operations in Jordan: Established originally in the late 1970s the current operation occupies a 0.6 hectare site situated in light industrial manufacturing area in Amman. In general the following types of products are manufactured at this facility: solid, semi-solid, and liquid dosage forms of pharmaceuticals. Common utilities are provided for the main plant, the penicillin plant and the sterile operation in which parenteral compounds are manufactured. The penicillin manufacturing facility is segregated from other operations, as is the sterile area.
Quality and sustainability of water supply for manufacturing: The Jordanian facility uses water from the municipality of Amman and also from local ground water wells. Hikma has evaluated the supply aquifer and determined that aquifer recharge and draw down are well balanced so that the raw water supply is sustainable for the foreseeable future. Well and municipal water are hard and have relatively high total dissolved solids content and thus are not acceptable for manufacturing without supplemental treatment. Reverse osmosis is used to produce high quality dematerialized water for manufacturing processes, equipment cleaning and other activities requiring high purity water. Sample collection and analyses are carried out routinely to ensure continuing high quality of water for all purposes.
Purchase, storage, use and recovery of hazardous materials: A significant number of chemical compounds are used in different operations. Hikma will audit all of its operations to ensure that transport, storage, containment and marking systems are consistent with IFC guideline requirements for Hazardous Materials Management.
Air emissions: The company has committed to make air emissions compliant with IFC Guideline requirements. Solvents used in reactors will be collected in a solvent recovery system and to the extent feasible reused in plant operations. Ventilation systems for the manufacturing operations are designed to prevent cross contamination among the manufacturing areas. Air streams are purified with wet scrubbers and Eurovent fabric filters affording 99% efficiency of particulate removal. Wastewater from wet scrubbers is sent to the wastewater treatment plant on site. Solids collected in the system are shipped off site for thermal destruction.
Treatment of liquid effluents: Facility wastewater is treated in an on-site activated sludge wastewater treatment plant. Treated effluent complies with Jordanian regulatory requirements but significantly exceeds IFC’s guideline requirements for BOD5, COD, and suspended solids. Wastewater treatment will be expanded as needed in compliance with the attached corrective action plan to produce a final effluent consistent with IFC requirements.
Solid and hazardous waste management: Domestic and hazardous waste generated by facility operations are segregated according to inherent characteristics and collected by the municipality of Amman for destruction and disposal.
Corporate quality, manufacturing, and environmental management capacity: Hikma has in place a Total Quality Management System that is designed to ensure that each item is produced to a predefined and consistent level of quality that meets applicable design specifications and customers’ expectations. Hikma’s quality management manual provides standard operating procedures to implement required activities at all levels to achieve the stated quality goals. Hikma has the following manufacturing and quality certifications: FDA approval (since 1995); UK Medicines Control Agency (MCA) approval (since 2000); ISO 9000 (since 1997); and ISO 9001 (since March 2003). These certifications along with associated, frequent audits by certifying agencies ensure that potential shortcomings in the implementation of management designed and approved activities are quickly identified and rectified.
Occupational health and safety: An important part of Hikma’s occupational health and safety program is an extensive system for employee training and development. New employee training, on the job training, job rotation, coaching and mentoring are all part of the system developed to operate cooperatively with quality management. Hikma will further its program by implementing the requirements and achieving international certification for the occupational health and safety management system in compliance with the attached corrective action plan.
Hikma Pharmaceuticals Operations in Portugal: Hickma Farmacêutica, established in 1992, is a wholly owned subsidiary of Hikma Investment. The role of the Portuguese operation is to produce injectables for Hikma’s worldwide marketing network. Its sophisticated fully automated 4,800 square meter facility near Lisbon was designed in accordance with the Portuguese, European Union, and the US FDA requirements. The facility operates in strict compliance with the Current Good Manufacturing Practice (CGMP). Hickma Farmacêutica plants have been inspected and approved by the FDA. The facility contains two separate plants: a filling plant for injectable cephalosporine in small and large vials and the other one for non-betalactam liquid injectables in ampoules and vials of different sizes. A central service area containing laboratories, storage facilities and administrative offices supports both plants. Currently Hickma Farmacêutica is building a new storage facility and reorganizing the plants in order to make each totally separate from the other to guarantee septic independence.
Water supply for manufacturing: Hikma’s facility in Portugal uses water from the municipality of Sintra. The water goes through three stages of purification to produce high quality dematerialized water for manufacturing processes, equipment cleaning and other activities requiring high purity water. Sample collection and analyses are carried out routinely to ensure continuing high quality of water for all purposes.
Hazardous materials management: Hickma Farmacêutica uses a significant number of chemicals but mostly in small quantities. Management of hazardous materials is currently consistent with international good practice. The company will ensure that transport, storage, containment and marking systems are consistent with IFC guideline requirements for Hazardous Materials Management. Domestic and hazardous waste generated by facility operations are segregated according to inherent characteristics and collected by an authorized firm for destruction and disposal.
Air emissions: The company has committed to make air emissions compliant with IFC Guideline requirements. Solvents used are collected in a solvent recovery system and destroyed as very little of the recovered material is suitable for reuse. Ventilation systems for the manufacturing operations are designed to prevent cross contamination among the manufacturing areas. Air streams are purified to 99% efficiency of particulate removal. Wastewater from wet scrubbers is sent to the wastewater treatment plant on site. Solids collected in the system are shipped off site for thermal destruction.
Treatment of liquid effluents: Facility wastewater is treated in an on-site wastewater treatment plant. Treated effluent complies with Portuguese regulatory requirements and IFC guidelines. Wastewater treatment will be expanded as needed for Hikma’s expansion.
Occupational health and safety: Hikma’s occupational health and safety standards are consistent with international good practice and statistics show low accident frequency and severity. There is strong emphasis in employee training and development. New employee training, on the job training, job rotation, coaching and mentoring are all part of the system developed to operate cooperatively with quality management. Life and fire safety systems are regularly inspected and kept in compliance with Portuguese and EU requirements.
Commitment to social development activities in corporate operations: Hikma makes contributions to social development activities and these include the production of oral rehydration salts in collaboration with the Ministry of Health and WHO in Jordan, manufacturing of multivitamins (Ordovit) for Jordanian school children, and sponsoring of employees to undertake higher education, both locally and elsewhere in Europe and the USA. Additional contributions to social development activities for employees and the larger community are being planned.
Manufacturing operations in other countries: Hikma will bring other new and acquired operations in which the company has controlling interest into compliance with IFC/WBG policies and guidelines and host country regulatory requirements. The schedule for completion of these objectives will be negotiated to ensure that it is acceptable to IFC.
