Manufacturing

At Alrai Pharmaceutical Industry Co. (L.L.C), we have an advanced microbiology testing facility to ensure that our products consistently meet the highest quality and safety standards.

Alrai Pharma Quality Assurance Unit ensure the product provided by the organization is fit for purpose and meet both external and internal requirements, including legal compliance and customer expectations through establishing a comprehensive Quality System. A Quality Assurance unit manage all the activity related to defining the source of defects and prevents their effects on the product quality, the activities are:

Documentations: we have an experienced team responsible for all documents and record related to specific products for release purposes and keep the records for the same. And responsible for annual product review withreference to the latest Good Manufacturing Practices (GMP) rules, the team also, preform all documentation activities mentioned in the internal documentation system and as required by latest versions of GMP

Auditing: Our Auditing team is implementing the auditing system and procedure activities, in addition, the auditing team is responsible for follow up the action suggested by Quality Assurance department.

Internal Compliance Inspection: it’s ensures implementation of the required daily activities of compliance section duties that assure the compliance with internal quality system is addition to Good Manufacturing Practices (GMP) regulation and rules.

Training: we have a qualified team that perform and coordinate with company departments and other external training centers all training activities mentioned in the training system including the latest requirements of GMP

The Validations and Calibration team at Alrai Pharmaceutical Industry Co. (L.L.C) is a well-equipped and competent unit that ensures all company tools, systems, and processes are properly validated and aligned with internal policies, while strictly complying with pharmaceutical regulations.

The Guarantors of Regulatory Compliance 

The Regulatory Affairs department is responsible for ensuring that a medicinal product remains compliant with regulatory standards throughout its entire life cycle. Before a product can be placed on the market, it must receive a Marketing Authorization (MA) granted by national or supranational competent authorities. Once authorized, the product remains under continuous regulatory oversight.

Regulatory Affairs teams are essential in the development of new medicines. They work in close collaboration with R&D and industrial teams, supporting the preparation and submission of registration dossiers. They are also the preferred point of contact for health authorities, particularly when arranging scientific advice meetings with local regulatory agencies.

Regular And Global Control 
Regulatory Affairs also play a critical role in reviewing and validating promotional materials to ensure that all marketing activities comply with applicable national and international regulations. Furthermore, they ensure adherence to responsibilities defined by the Chief Pharmacist, in accordance with pharmaceutical laws and practices.