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Quality Assurance

Since inception, Julphar is committed to ensuring good health for the community at large. The company has seen a phenomenal growth in terms of manufacturing facilities, and adherence to cGMP, GLP and other international benchmarking standards, including those laid down by MOH - UAE, WHO, UNICEF, ISO 9000 and ISO 14000, and adaptation of EMEA and ICH guidelines for bio-similar approval process. Julphar is engaged in the manufacture of diversified range of finished sterile and non-sterile pharmaceuticals and bio-similar drug substances like recombinant erythropoietin, while production of recombinant human Insulin and several vaccines are in the pipeline. Julphar’s products help keep millions healthy. Quality assurance at Julphar, therefore, is a wide ranging concept covering all matters that individually and collectively influence the quality of a product. It serves as an umbrella for business expansion plans, new products development, new projects & tech-transfers, regulatory affairs, quality control, validation, production, maintenance, inspection and distribution. Investment in Manpower, Machines, Methods and Materials have been the keys to Julphar’s continuous success over the last 30 years. Special emphasis is laid on human resource development by providing training in managerial and technical skills both internally and externally as applicable. The manufacturing facilities are designed to comply with cGMP requirements with clean rooms classifications in accordance with FDA and NASA
standards. The environmental compliance is achieved through continuous monitoring and control of temperature, humidity, air swabs, personnel swabs for viable count and non-viable count in critical areas. The potency, efficacy and safety of products being manufactured at Julphar is achieved through implementation of validation master plans, execution of installation, operation and performance qualifications and frequent calibration of critical variable to assure accuracy & precision. Particular emphasis is made on vendor approval plans and vendor rating and audits to assure the quality is built into the products.

 Julphar successfully qualifies several GMP and GLP audits every year by international regulatory bodies from the countries where Julphar’s products are being marketed. Moreover, the annual internal audits are also being conducted to assure continuous improvement. Julphar strongly believes in corrective actions and preventive measures approach as an integral part of its quality system design. More recently, Julphar’s efforts over the last 30 years were recognized in terms of human resource development fulfilling, corporate social responsibility and establishing corporate governance when the company won the Sheikh Mohammed Bin Rashid Al - Maktoum Business Award instituted by Dubai Chamber of Commerce. The in-process control and quality control laboratories are equipped with state of the art analytical instruments and auto check masters to minimize the human error. The specifications are derived from International Pharmacopoeia. The in-process control sampling is based on statistical sampling plans as per Military Standards 105E. The compliance to documentation is achieved through intranet documentations website, where more than 15,000 documents are archived to achieve consistency, accuracy and precision.

Over 2000 standard operating procedures describe responsibilities and define personnel flow, materials flow and documentation trail with full traceability. Validation is a component of quality assurance associated with a particular all products, systems or processes and is considered essential to GMP to assure that the finished products meet all quality and design protocols and end product consistently meet their specifications.

 Quality assurance of pharmaceutical drug products and drug substances at Julphar is a major public health challenge, particularly in light of growing cross-border health issues and the international dimensions of health trade. The manufacturing procedures are validated to prove that a procedure, process, activity, material equipment involved or systems actually achieve its expected results. The bioequivalence studies conducted in accordance with GCP, further postulate the therapeutic equivalence to be considered interchangeable with a competitor’s product. Besides, the stability studies of products are conducted in accordance with WHO guidelines to assure product shelf life, efficacy and safety for end users.

Leadership

The highest decision-making body in Julphar is the Board of Directors, which approves decisions recommended by the top management team (TMT), headed by the Chief Executive Officer. The implementation is delegated to Directors and Managers. The impact of leadership is evaluated on yearly basis through sales achievement against annual sales target, new products developed, increase in profitability. The performance is reviewed internally on a monthly basis and reported to external stakeholders, auditors and Board of Directors on a quarterly basis.

Workforce & Talent Management

 Julphar believes in aligning its workforce strategy to its business strategy to maintain and increase competitive advantage. Julphar workforce is comprised of nationals and non-nationals. Workforce engaged in Julphar technical and non-technical operations is fully supported in terms of healthy workplace and surroundings. Growth in the workforce numbers and their enhanced technical competence are the key to Julphar’s success. In Julphar, training and skill development of the employees is an on-going process.

Workforce Alignment

The recruitment of workforce is closely overseen by the human resource department and concerned departmental directors, keeping in view the organizational needs and evolving technologies. The vision, mission & strategic objectives of the organizationon are kept in view at the 􀆟 me of recruitment and, subsequently, during the progress of the employee.

Workforce Management

The existing system has evolved over the years. All employees work in accordance with the UAE labour laws. All employees are part of group accident insurance policy. The workplace environment is suitable for employees of different color, language, race and religion. The human resource department continuously adopts best practices based on prevailing and emerging market trends.

Corporate Governance

Julphar’s Board of Directors (BoD) consists of nine directors. There are also committees to manage various aspects of governance, viz., Internal Monitoring Committee, Audit Committee and Remuneration Committee. The Audit and Remuneration Committees consist of Board members. These committees are independent and report directly to the Chairman of the Board of Directors. The internal and external auditors report directly to the Board of Directors. The Board of Directors of Julphar is the ultimate decision-making authority in Julphar. The size and composition of the Board is in accordance with the Emirates Securities & Commodities Authorities stipulations, prevailing commercial laws and the Articles of Association of Julphar. The nomination, selection, appointment and re-appointment of directors are done by Annual General Meeting; the directors are appointed for a three-year term. The organization acquires necessary capabilities and competencies by nominating / appointing industrial experts. The potential conflicts of interest are avoided, in general. All related transactions are brought to the knowledge of BoD & disclosures made as per IFRS in the company’s audited financial statements.

Corporate Social Responsibility

Julphar exercises its corporate social responsibility (CSR) by generating employment avenues and continuous development of human resources. The company provides housing and healthcare for its employees. The company housing complex also includes community club, mosque, children’s nursery and supermarket. Julphar is committed to the government’s Emiratisation policy. The company provides educational support; conducts academic training for
school, college and university students; and provides on-job training opportunities. Julphar also sponsors professional
seminars and conferences at national and international level, and site visits of its facilities. Among other community
initiatives are blood donation drive every year in coordination with UAE Health Authority and comprehensive firefighting and evacuation drill in collaboration with civil defense authorities from Ras Al Khaimah and Abu Dhabi. The CSR initiatives of the company are communicated to stakeholders through media and company website.
 

Commitment to Environment & Safety

Successful environmental management provides opportunities for cost savings; the most common benefits derive from a review of resource/ energy utilization and its efficiency, forcing full consideration of alternative energy sources and their cost effectiveness. The other primary element is minimization of waste and effective waste management. The responsible environmental attitude has dramatically improved the image of the company, fostering better relations with its stakeholders. The scope and severity of environmental legislation is ever increasing. An ISO 14001:2004 EMS environmental management system ensures recognition of the requirements and compliance ensures safe and healthily work environment. For environmental performance achievement, Julphar has adopted a structured approach with a commitment for continual improvement. An in-house solid waste incinerator plant has recently been erected to comply with local and federal requirements for managing safe disposal of solid waste generated by our operations. We encourage our subcontractors to follow environmental compliance. We support continuous education of our employees. We organize public awareness programs for safe disposal of medicines to ensure protection of natural flora and fauna. We strongly believe in reduction of waste, re-use of resources and recycling of materials. Our e􀄫 orts have resulted in our achievement of ISO 14001 Certiffication.