Aiding GMP control for product development and regulatory approval.
Quality Assurance (QA), Auditing, and Regulatory Affairs are critical functions in the pharmaceutical and biotechnology industries, ensuring that products are safe, effective, and compliant with regulatory standards. GRA provides support to organisations with experienced Qualified Persons (QPs)and QA experts.
Our methods and approaches compliment advancement and acceleration of AI based development approaches in this area where across and within massively complex assay, process and clinical data is required.
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National Regulatory Agencies, i.e. FDA, EMA, MHRA, PMDA
Working with national regulatory agencies involves understanding their expectations for compliance, data integrity and quality management systems (QMS). While similar, each agency has nuanced requirements and by staying aligned with their frameworks, this ensures that development, manufacturing and distribution activities meeting their expectations, are in control and audit ready.
ICH Guidelines & Other Supporting Data for Characterisation and Comparability
ICH guidelines provide internationally harmonised technical guidance across regions. They set out agency expectations in areas such as quality risk management, product development, validation, stability, etc. These frameworks enable consistent interpretation and application of regulatory expectations across different territories for biopharmaceutical development and operations.
Facility Compliance
Facility compliance involves routine inspection readiness, documentation practices & system validation. It ensures that manufacturing environments meet applicable regulatory Quality Management System (QMS) promotes continuous improvement and keeps operations aligned with evolving expectations and audit findings.
Material Standards
Raw materials must meet defined standards, including pharmacopeial compliance, consistent quality and validated supply chains. Robust material control underpins product reliability and traceability. For cellular therapies, where input variability is inherent, strict standards are especially vital to ensure safety and efficacy and are especially critical for cellular therapies.
Pre-Approval Inspection (PAI)
A PAI evaluates production facility readiness of commercial distribution. It includes assessments of quality systems, data integrity management and validation status. Proactive auditing and consistent documentation are essential for demonstrating control to regulatory agencies and is a critical stage prior to commercial production.
Pharmacopoeia Requirements
Pharmacopoeia vary by country, i.e. US, British, Japanese pharmacopoeia, etc. However, all define quality expectation and standards for raw materials excipients and finished products. Meeting these requirements ensures consistency, traceability and compliance across the supply chain. Adherence is essential for demonstrating product integrity and supports audit readiness and regulatory approval in both clinical and commercial settings.
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