Good Manufacturing Practice (GMP) Facility

Sidra Medicine’s Good Manufacturing Practice (GMP) Facility is a specialized, controlled environment designed to support the safe and compliant preparation of clinical-grade products for patient care and translational activities. The facility operates under robust quality management systems to ensure consistency, traceability, and patient safety across all manufacturing processes.

Sidra Medicine is home to the first GMP Facility in Qatar and it is certified ISO 9001 and accredited ISO 17025, marking a national milestone in quality-driven operations, clinical manufacturing and testing. GMP Facility reinforcing Sidra’s role as a leader in advanced healthcare and translational innovation.

Quality, Accreditation & International Standards

The GMP Facility ISO9001:2015 certified by the British Standard Institution to prove it consistently provides high quality flowless products/services time after time, consistently meets patient/customer/regulatory needs with a strong focus on operations, patient/customer satisfaction, performance improvement, and demonstrate commitment to Quality along with an environmental consideration to climate change

The GMP Facility is ISO 17025:2017 accredited by US-PJLAB, demonstrating technical competence, validated methodologies, and rigorous manufacturing product quality controls testing results. Operations are aligned with internationally recognized Good Manufacturing Practice (GMP) principles and relevant regulatory guidelines referenced by the World Health Organization (WHO), US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

These foundations define the requirements to ensure that manufactured products are consistently produced and tested are controlled under the highest quality standards appropriate for their intended use. At Sidra Medicine, adherence to these principles ensures that all manufactured products meet defined standards of quality, safety, purity, and effectiveness.

Controlled Manufacturing Environment

Sidra Medicine’s GMP Facility includes dedicated cleanroom environments designed to support the controlled preparation of clinical-grade products in accordance with Good Manufacturing Practice (GMP) principles. The cleanrooms are engineered to minimize microbiological and particle contamination risks and maintain product integrity through controlled air quality, pressure differentials, and environmental conditions.

Cleanroom environments are designed and monitored in accordance with ISO 14644 standards, with continuous monitoring of particulate levels, temperature, and humidity. Access is strictly controlled, and all activities are performed by trained personnel following approved gowning procedures and standard operating protocols.

Environmental monitoring, routine qualification, and documented cleaning and disinfection programs are implemented to ensure ongoing compliance and reproducibility. These measures ensure that all manufacturing activities are carried out in an environment that supports the preparation of products that are traceable, pure, safe, and effective, in line with Sidra Medicine’s quality and patient safety commitments.

All manufacturing activities are conducted under approved standard operating procedures, with documented oversight and full traceability across materials, processes, and outputs.

A Quality System Built on the 5 P’s of GMP

GMP operations at Sidra Medicine are structured around the core principles of People, Processes, Procedures, Premises, and Products, ensuring a comprehensive and integrated approach to quality and compliance.

  • People: Trained and qualified personnel operating within clearly defined roles and responsibilities
  • Processes: Controlled, validated manufacturing workflows designed to ensure consistency and reliability
  • Procedures: Documented and controlled standard operating procedures governing all activities
  • Premises: Dedicated cleanroom and controlled environments designed to minimize contamination risk
  • Products: Clinical-grade outputs prepared under strict quality and traceability requirements

The 5 P’s ensures that quality is embedded at every stage of the manufacturing lifecycle.

Governance, Oversight & Traceability

Quality systems encompass:

  • Documented and controlled procedures
  • Personnel training and competency assessment
  • Equipment qualification and process validation
  • Environmental monitoring and risk control
  • End-to-end traceability across the manufacturing lifecycle

These systems ensure that products are prepared in a manner that is traceable, pure, safe, and effective, in alignment with Sidra Medicine’s institutional governance frameworks and patient safety commitments.

Clinical & Translational Impact

The GMP Facility plays a critical role by enabling specialized therapies and clinically adjacent services at Sidra Medicine. By providing a controlled, quality-driven environment for clinical-grade manufacturing, the facility supports the responsible translation of advanced therapies from concept to patient application.

Through strong governance, internationally aligned quality standards, and a commitment to excellence, the GMP Facility reinforces Sidra Medicine’s mission to deliver innovative, patient-centered care grounded in scientific rigor and safety.

Massimino Jan Miele

Manager, GMP Facility

The GMP Facility at Sidra Medicine is managed by Massimino Jan Miele. Mr. Miele is a senior laboratory and quality professional with more than 20 years of international experience in cell and gene therapy manufacturing, hematopoietic stem cell transplantation (HSCT) processing, transfusion medicine, GMP facility operations, and quality management systems. He joined Sidra Medicine in 2015 and has been leading the design, development, and commissioning of the GMP Facility and Cellular Therapy Unit for the delivery of clinical-grade cellular products for tissue, cell and gene therapy. His work includes the establishment and operationalization of cleanroom environments, GMP manufacturing of CAR-T cells and mesenchymal stromal cells, cord blood banking, production of autologous serum eye drops, and the implementation of quality systems in compliance with ISO, FACT-JACIE, Joint Commission International (JCI), and Ministry of Public Health (MoPH) requirements.

Services

Sidra Medicine supports the collection, processing, and long-term storage of umbilical cord blood to preserve the quality and integrity of hematopoietic stem cells for potential future use. The service is delivered through approved clinical protocols and informed parental consent, with strict requirements for quality, traceability, and governance applied throughout the process.

Cord blood banking activities are conducted within controlled environments and supported by GMP-aligned workflows and quality systems, ensuring that collection, processing, and storage meet defined standards for safety, consistency, and long-term viability, in accordance with applicable regulatory and ethical frameworks.

Storage & Service Details

  • Cord blood units are cryopreserved and stored under controlled conditions for long-term storage of up to 25 years
  • Collection is performed at birth by trained clinical staff, followed by controlled processing and quality checks prior to storage
  • Each stored unit is fully traceable and managed under approved quality and governance frameworks.
  • Storage duration and service options are defined at enrollment and documented through informed consent.

Pricing

Cord blood banking packages are available starting from QAR 17,000, depending on the selected storage plan and service options.

Sidra Medicine prepares Autologous Serum Eye Drops (ASEDs) within its GMP Facility to support patients with severe and refractory ocular surface disease. ASEDs are derived from a patient’s own blood and are rich in naturally occurring growth factors that support epithelial healing and ocular surface restoration.

This therapy is indicated for selected patients with conditions such as Stevens–Johnson syndrome, Sjögren’s syndrome, post-LASIK dry eye, neurotrophic keratopathy, and dry eye disease associated with diabetes mellitus, based on clinical assessment and prescription.

Sidra Medicine is the first healthcare institution in Qatar to introduce Autologous Serum Eye Drops, representing a significant advancement in personalized, patient-centered ophthalmic care.

GMP Preparation & Quality

ASEDs are prepared within a controlled GMP environment using GMP-aligned workflows, with strict quality controls and full traceability from blood collection through preparation and dispensing. Preparation and release are performed under institutional governance and quality oversight to ensure safety, consistency, and suitability for clinical use.

Patient Journey

The ASED service follows a clearly defined clinical pathway:

  • Physician prescription and eligibility assessment
  • Blood collection at Sidra Medicine
  • Laboratory processing and serum preparation in the GMP Facility
  • Dispensing of ready-to-use eye drops (typically supplied for a defined treatment period)
  • Follow-up and re-supply, if clinically indicated
  • ASEDs are prepared for individual patient use only and must not be shared, to mitigate infection risk and ensure patient safety

Why Autologous Serum Eye Drops

  • Made from the patient’s own blood
  • Rich in growth factors that support natural healing
  • Suitable for severe and refractory dry eye conditions
  • Prepared under the highest safety and quality standards
  • Delivered within Qatar’s first clinically introduced ASED program

Sidra Medicine’s GMP Facility supports the controlled manufacturing of Mesenchymal Stromal Cells (MSCs) for approved clinical and translational applications. MSC manufacturing activities are conducted under GMP-aligned workflows with defined quality controls to ensure cell identity, purity, safety, and consistency.

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