Skip links

Quality & Compliance

Where precision meets responsibility

At Gentech Pharmaceuticals, quality is not a department — it’s a mindset embedded into every step of our manufacturing process. From sourcing raw materials to final product release, we operate with a deep commitment to compliance, consistency, and patient safety.

01 Where Precision Meets Responsibility

Therapeutic Areas We Serve

GMP Certified (Good Manufacturing Practice)

Our facility operates under internationally recognized GMP standards, ensuring every batch is safe, effective, and consistent.

EDA Licensed

Authorized by Egypt’s Drug Authority, our operations adhere to strict regulatory frameworks.

Ongoing Regulatory Alignment

We continuously update our practices in line with evolving local and international guidelines (e.g., WHO, EMA, FDA-equivalent standards where applicable).

02 Our Quality Approach

Our quality approach

  • Raw material testing and supplier qualification
  • In-process controls during manufacturing
  • Finished product evaluation and batch release

Equipped with advanced instrumentation for:

  • Stability testing
  • Dissolution profiling
  • Microbial and particulate analysis
  • Validation and calibration protocols

We are committed to investing in the professional development and growth of our employees.

  • Internal audits & CAPA systems
  • Cross-functional training and SOP reviews
  • Tech transfer and documentation control systems

Traceability. Accountability. Integrity.

Every product that leaves our facility carries the full traceability of its production lifecycle — a testament to our belief that quality is built, not inspected.

03 Traceability Accountability Integrity

Looking ahead

Our team is actively working to expand our capabilities into other dosage forms in the near future — further strengthening our position as a complete solution partner in generic pharmaceuticals.