How SeerPharma Supports Complex GMP Facility Projects

SeerPharma has a long-standing reputation for helping pharmaceutical and medical device companies establish new or upgrade existing GMP manufacturing facilities. The team is currently engaged in multiple facility projects across the APAC region, working on complex facility projects involving the manufacture of:

• Radiopharmaceuticals
• Advanced Therapy Medicinal Products (ATMPs), including:
  • Cell and Gene Therapies
  • mRNA Diagnostics and Therapies
• Hospital Compounding Pharmacy Operations
• Medical Devices

From facility design to workforce training, our holistic approach addresses the critical challenges businesses face throughout these complex projects.

Here’s how we deliver value across the entire lifecycle of GMP facility development.

Facility Design, Construction, and Qualification Support

Designing and constructing a GMP-compliant manufacturing facility is a multifaceted endeavour. Organisations must navigate stringent regulatory requirements, manage numerous stakeholders, and ensure extensive documentation is in place.

Our Solution

SeerPharma provides comprehensive support throughout the design, construction, and qualification phases, including:

• Design Phase: Assisting with layouts and workflows to achieve GMP compliance for your specific process and product needs.
• Documentation Deliverables: Preparing essential qualification documentation for design and construction to facilitate approvals and audits.
• Construction Oversight: Providing QA oversight for subcontractors and builders to ensure adherence to compliance specifications.
• Commissioning and Qualification: Guiding and documenting validation processes to ensure the facility is operationally qualified.
• Requirements Traceability Matrix (RTM): Providing a comprehensive traceability matrix that documents the entire validation effort by linking the Qualification Test Protocols to the User Requirements and Specifications, to ensure that all critical requirements defined for the facility and systems have been tested.

Process Validation Documentation

Robust process validation is essential for regulatory compliance, manufacturing consistency, and product quality. However, preparing effective validation documentation often requires specialised expertise.

Our Solution

We develop comprehensive process validation documentation to meet regulatory standards, ensuring that manufacturing processes consistently produce high-quality products.

Computer System Validation (CSV)

In GMP environments, computerised systems such as ERP, LIMS, EMS, and eQMS must meet strict validation requirements to ensure data integrity, system reliability, and regulatory compliance.

Our Solution

SeerPharma conducts thorough Computer System Validation (CSV) to ensure that GMP IT systems comply with regulatory standards such as 21 CFR Part 11 and Annex 11, while performing effectively in their intended environments.

QA Oversight for Sub-Contractors and Vendors

Maintaining GMP compliance across subcontractors, builders, and suppliers is critical to ensuring the quality and safety of final products.

Our Solution

We provide comprehensive QA oversight to monitor and assist the performance of external partners, ensuring they meet GMP requirements throughout the lifecycle of your project.

Pharmaceutical Quality System (PQS) Development

Establishing an effective Pharmaceutical Quality System (PQS) (also referred to as Quality Management System (QMS)) is vital for compliance and operational success. However, many organisations struggle to design and document systems tailored to their needs.

Our Solution

SeerPharma supports clients by:

• Designing and implementing PQS frameworks aligned with operational goals.
• Preparing key documents, including Quality Manuals, policies, procedures, records, and templates.
• Assisting with the creation of batch records to streamline production and documentation.

GMP and QMS Training

Employee training is critical to ensuring compliance and operational excellence, yet many companies lack structured programs to address these needs.

Our Solution

We deliver targeted training programs, including:

• GMP Training: Customised sessions to instil a thorough understanding of GMP requirements.
• PQS Training: In-depth training on specific PQS elements to support system implementation and maintenance.

Mock Regulatory GMP Audits

Regulatory inspections are pivotal moments for organisations, and preparation is key to a successful outcome.

Our Solution

SeerPharma conducts mock regulatory GMP audits to help businesses identify compliance gaps, prepare for inspections, and enhance their readiness. These audits replicate real-world scenarios and provide actionable recommendations to strengthen compliance systems.

Partnering for Compliance and Growth

SeerPharma addresses the complex challenges pharmaceutical and medical device companies face when building new or upgrading existing GMP operations. From initial facility design to preparing for regulatory audits, our services enhance compliance, drive operational efficiency, and set the stage for long-term success.

Contact SeerPharma today to learn how we can support your GMP facility project and help set you up for success.