Quality Assurance

Nogen Pharmed: Quality by Design, Compliance by Commitment

To achieve our stringent quality objectives, a robust and comprehensive Quality Management System (QMS) is essential. This system must be meticulously designed, implemented effectively, and maintained in full compliance with current regulatory requirements. Our QMS adheres to the latest guidelines established by PIC/S, ICH, and WHO.
Quality Assurance (QA) is a comprehensive discipline encompassing all aspects of product quality. We validate our manufacturing processes and implement continuous monitoring to ensure consistent performance and compliance with established parameters. We firmly believe that quality management is not a fortuitous occurrence but rather a collective responsibility shared by all personnel involved in the manufacturing of pharmaceutical products. Our QMS is fully documented, and its effectiveness is continuously monitored and evaluated.
To this end, Nogen Pharmed Caspian Company has established a robust system for process development and monitoring, driven by the active participation of all managers and personnel involved in relevant processes, under the leadership of the organization’s senior management. This system encompasses the organizational structure, methodologies, processes, resources, and activities required to provide assurance and confidence that all products are prepared, manufactured, packaged, and delivered to the end-user in accordance with their intended specifications. These specifications are determined based on prevailing international regulatory requirements.

Lifecycle Quality Management

The unit employs a comprehensive approach to quality assurance that spans the entire product lifecycle, from raw material receipt to end-user consumption.

Equipment Calibration & Maintenance

This unit ensures precise calibration of critical equipment in its dedicated lab, adhering to national and international standards, guaranteeing accurate measurements for consistent product quality.

Comprehensive Documentation and Validation

This unit maintains robust GMP-compliant documentation for all processes and prioritizes equipment qualification (IQ, OQ, PQ) and process validation per GxP guidelines to ensure consistent performance.

Proactive Inspections, Audits, and Corrective Actions

This unit proactively conducts regular inspections and audits based on international guidelines, implementing and monitoring CAPA, QRM, and APQR systems for continuous quality improvement. Foster unity

Quality Assurance

Nogen Pharmed: Continuously Monitoring, Consistently Delivering Quality

Our Quality Assurance activities encompass all stages of the product lifecycle, from the receipt of raw materials through to the end-user’s consumption of the finished product, to ensure the consistent achievement of desired outcomes. We ensure meticulous management of production processes throughout their lifecycle and maintain optimal manufacturing conditions. Calibration, documentation, validation, technical audits and inspections, and the maintenance of quality systems are core components of our responsibilities.

Calibration: Calibration of equipment related to critical parameters such as pressure, temperature, humidity, volume, mass, and dimensions is primarily conducted within the company’s dedicated calibration laboratory. These activities are performed according to documented procedures and in full compliance with relevant national and international standards.

Documentation: Robust documentation practices are fundamental to our Quality Assurance program and are integral to all aspects of Good Manufacturing Practices (GMP). Comprehensive and accurate documentation is maintained for all processes, procedures, and activities.
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