Middle East for Vaccines (MEVAC) is the first private vaccine facility in Egypt for Research and Development, manufacturing, packing, and distribution of live and inactivated vaccines for MEVAC, and Toll for others.

MEVAC management is committed to implementing all system requirements for:

1. Quality Management System (QMS) ISO 9001: 2015,

which supports the achievement of the desired results of MEVAC objectives to monitor and review information on these external and internal issues.

       2. Environmental Management System (EMS) ISO14001: 2015,

to provide a framework for the protection of the environment to respond to environmental changes and balance the situation with social and economic needs.

      3. Occupational Health & Safety Management System (OH&S) ISO 45001:2018,

to provide a framework for managing the prevention of death, work-related injury, and ill health, to prevent work-related injury and ill health to workers, and to improve and provide a safe and healthy workplace for its workers and other persons under its control.

       4. Good manufacturing rules and practices in accordance with Egyptian requirements and laws and European GMP Guidelines and relevant legal acts and regulations. The top management will install and ensure compliance with EU-GMP guidelines. It ensures the effectiveness of the QMS, by carrying out regular management reviews as required by EU-GMP.

       5. Energy Management System (EnMS) ISO 50001:2018, to continually improve energy performance, including energy efficiency, energy use, and energy consumption, Searching for clean renewable energy, maintaining energy resources, and reduction of carbon emissions.

At MEVAC we are confident that the implementation of these QHSE Integrated systems, Energy management system, and EU-GMP will have a positive impact on all manufacturing processes, individuals, and the work environment within MEVAC as well as the external environment.

We are committed at MEVAC to establishing & developing various procedures to determine the external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of these QHSE Integrated systems, Energy System, and Eu-GMP.

We are committed at MEVAC to recording & assessed all issues including positive and negative factors or conditions for consideration, which affect our goals.

We are seeking at MEVAC to understand the external context to be facilitated by considering issues arising from the legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local, which will affect our goals.

We are seeking MEVAC to understand the internal context to be facilitated by considering issues related to values, culture, knowledge, and performance of the MEVAC Facility, which support achieving the desired result of MEVAC's goals.

MEVAC is committed to determining:

The interested parties that are relevant to the QHSE Integrated system, EnMS, and Eu-GMP.

b. The requirements of these interested parties that are relevant to the QHSE Integrated systems, EnMS,

c. Requirements for achieving and implementing EU GMP in accordance with Egyptian requirements and laws and European directives.

we are committed at MEVAC to monitoring and reviewing information about these interested parties and their relevant requirements.

MEVAC’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

We are committed at MEVAC to determining the processes needed for the QHSE Integrated systems, EnMS, and EU GMP, and their application throughout our facility, to be considered:

1. Determine the inputs required and the outputs expected from these processes;
2. Determine the sequence and interaction of these processes; Determine and apply the criteria and methods (including monitoring, measurements, and related performance indicators) needed to ensure the effective operation and control of these processes;
3. Determine the resources needed for these processes and ensure their availability;
4. Assign the responsibilities and authorities for these processes; Address the risks and opportunities as determined following the requirements of actions to address risks and opportunities,
5. Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
6. Improve the processes and the QHSE Integrated systems, EnMS, and EU GMP.

MEVAC QHSE Integrated systems and EnMS were activated in all company sites to meet all the requirements of an international standard:

ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, and ISO 50001:2018 to ensure and maximize the effectiveness and efficiency of controls to prevent all types of risk as well as risk controls negative has been factored in that commitment cycle "Plan-Do-Check-Act"

­MEVAC’s Top management approach to the QHSE Integrated systems and EnMS supports building success over the long term and creates options for contributing to sustainable development by:

1. Protecting the environment (Infrastructure & work Environment) by preventing or mitigating adverse impacts
2. Mitigating the potential adverse effect of the QHSE Integrated systems and EnMS on the MEVAC facility.
3. Assisting MEVAC in the fulfillment of compliance obligations.
4. Continually improve the QHSE Integrated systems EnMS to enhance quality performance.
5. Achievement of the QHSE Integrated Systems and EnMS Objectives.
6. Developing our employee’s skills by increasing acknowledgment awareness, training, and measurable evaluation and reviewing of the QHSE Integrated systems and EnMS Objectives is our priority.
7. Preventive maintenance of all equipment and machines within the facility to maintain the working environment and workers.
8. Provide a suitable working environment.
9. Provide medical insurance for all employees.
10. Safe disposal of solid and liquid wastes after treatment to protect the external environment from pollution.
11. Protect the human element from the risk of injuries in the work environment and prevent exposure to accidents, injuries, and occupational diseases.
12. Preserving elements of the physical element of the facilities and what they contain equipment from damage and loss as a result of accidents.
13. Providing and implementing all the requirements of the occupational health and safety branch of knowledge that you install security and tranquility in the hearts of workers while performing their duties.
14. Participation and consultation for all employees in the OH&S management system, through:

1. MEVAC top management is committed to encouraging the participation of workers, and where they exist, workers’ representatives, in the development, implementation, and maintenance of the OH&S management system
2. In addition, this includes the receipt of suggestions for the improvement of the OH&S management system, which can lead to improvements in MEVAC’s OH&S performance.
3. The provision of mechanisms to promote and enable effective cooperation between managers and non-managers, e.g. workers’ safety delegates, workers’ health, and safety committees, or joint health and safety committees, as well as provision for the selection of representatives (through worker union organizations) under applicable legal requirements and other requirements;
4. Protecting from dismissal or reprisals, including disciplinary or other adverse measures, for reporting, or removing themselves from situations of danger or imminent harm.
5. Removing barriers to participation or reducing them to a minimum when removal is not possible, is essential if the OH&S management system is to be effective.
6. Feedback in the OH&S management system is dependent upon worker participation. MEVAC are ensure workers at all levels are encouraged to report hazardous situations so that preventive measures can be put in place and corrective action is taken.

We are committed at MEVAC & continually strive to achieve all requirements of the QHSE Integrated systems and EnSM and be fulfilled without exclusion.

• MEVAC ensures that:

a- The products are consistently produced and controlled in compliance with quality standards and appropriate for their intended use.

b- Ensuring the best quality products and services to the customers.

c- MEVAC is accountable to ensure procedures are in place that adequately defines the expectations for work that supports or directly affects, product quality, product registration, and/or data that support product quality and animal or human safety