KHORRAMAN QUALITY ASSURANCE

Herbal medicines, aligned with global quality standards

At Khorraman Pharmaceutical Co., Quality Assurance is more than a department – it is a culture. From research and development to the product reaching the patient, every process is monitored using a risk-based approach, rigorous documentation and full compliance with GMP and international quality management standards.

Integrated Management System (IMS) Focus on Safety, Environment & Quality Continuous performance monitoring
30+ years of continuous herbal medicine production Compliance with National Food & Drug Organization requirements Commitment to continuous process improvement
Internationally accredited certificates
ISO 9001:2015 Certificate - Quality Management System
ISO 9001:2015 – Quality
ISO 14001:2015 Certificate - Environmental Management System
ISO 14001:2015 – Environment
ISO 45001:2018 Certificate - Occupational Health and Safety Management System
ISO 45001:2018 – HSE
IMS / QLA Integrated Management Certificate
IMS / QLA Certificate
CORE QUALITY PRINCIPLES

A systematic, evidence-based and people-centered approach

Khorraman’s Quality Assurance system combines regulatory requirements, pharmaceutical industry best practices and a forward-looking view of public health. Quality policies focus not only on the final output, but on the design, control and continuous optimization of all processes.

Q
Quality is designed, not only tested
Quality by Design (QbD)
In the development of herbal products, quality is built in from formulation and selection of raw materials. Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) are identified, documented and monitored throughout the development cycle.
Aligned with modern QbD approaches from FDA and EMA
R
Quality Risk Management
ICH Q9 – Risk Based
Risks related to quality are identified, evaluated and controlled at every stage of the product life cycle – from sourcing medicinal plants to packaging. Risk assessments drive preventive controls and the prioritization of resources.
Using FMEA, HACCP and risk matrix methodologies
D
Transparent, traceable documentation
Data Integrity & Traceability
From production records to analytical reports, all documents are structured, traceable and securely archived. ALCOA+ principles (Attributable, Legible, Contemporaneous, Original and Accurate) are applied to data recording and verified during internal and external audits.
Audit-ready documentation at any point in time
G
Full compliance with GMP
Good Manufacturing Practice
Facility layout, material and personnel flow, equipment qualification, calibration, environmental control and preventive maintenance are all designed and documented in line with GMP requirements. Periodic audits ensure ongoing compliance.
Special focus on herbal and botanical preparations
L
Continuous training and competency
Competency & Culture
Quality is the result of both systems and people. Competency matrices are defined for all critical roles, and tailored training programs (GMP, safety, environment, handling of herbal materials and more) are delivered regularly and assessed for effectiveness.
Encouraging a no-blame, speak-up culture around errors
C
Continuous improvement & market feedback
Continuous Improvement
Complaints, suggestions and feedback from physicians and patients are valuable inputs for system improvement. Key Performance Indicators (KPIs) are monitored and analyzed regularly and used in relevant committees to define corrective and preventive actions.
PDCA cycles embedded across all organizational levels
CERTIFICATES & STANDARDS

Integrated Management System (IMS) at Khorraman Pharmaceutical Co.

In line with our mission to promote public health and sustainable development, Khorraman has established and maintains an Integrated Management System covering quality, environment, and occupational health & safety. These certificates reflect our practical commitment to international standards and regulatory requirements.

ISO 14001:2015 – Environmental Management System
ISO 14001:2015 – Environmental Management System
Protecting the environment alongside medicine production View full certificate
ISO 45001:2018 – Occupational Health and Safety Management System
ISO 45001:2018 – Occupational Health & Safety Management System
A safe working environment for our people View full certificate
QA PROCESS AT KHORRAMAN

From herbal active ingredient to finished product on the pharmacy shelf

Every product at Khorraman follows a clearly defined path of control and approval. This includes incoming material control, in-process controls, intermediate testing, final product testing, batch record review and Quality release of each batch.

Critical Control Points (CCPs)

For each production batch, a set of Critical Control Points is defined where non-compliance could impact the efficacy, safety or stability of the product. These points are selected based on risk, the nature of the herbal material and regulatory expectations.

  • 1
    Identification and control of herbal raw materials (pharmacopoeial standards, microbiological tests, pesticides and heavy metals control).
  • 2
    Monitoring of extraction, concentration, mixing and filling conditions using statistical process control (SPC) tools.
  • 3
    Chemical, physical and microbiological testing of finished products using validated analytical methods (e.g. GC, GC-MS, HPLC).
All activities are performed according to approved SOPs. Any deviation is recorded, investigated and, when necessary, leads to corrective and preventive actions (CAPA).
1. Supplier qualification & incoming control
Evaluation and approval of suppliers, definition of technical specifications for raw materials and packaging components, and confirmatory testing before acceptance of each material lot.
2. In-process monitoring & production oversight
Quality Assurance presence on the shop floor to supervise SOP execution, environmental conditions, line clearance and in-process controls (IPQC) during production.
3. Quality control testing & batch release
Comprehensive testing of each batch using validated methods, review of analytical results, production and packaging records, and final authorization for batch release by QA.
4. Post-marketing surveillance & feedback
Follow-up of complaints, batch traceability, evaluation of any adverse event reports and close collaboration with the medical community to continuously improve product quality and performance.
Need additional documentation or technical details?
Khorraman’s Quality Assurance team is available to answer your technical questions regarding standards, test methods and quality control procedures.
Response time: During business days and office hours