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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frequently asked questions
Frequently Asked Questions
QA (Quality Assurance) and QC (Quality Control) are both essential parts of a company's quality system, but they have different functions:
- QA (Process-Oriented): Focuses on the systems and processes used to ensure quality is built into how a product is developed and manufactured. Responsibilities include maintaining the Pharmaceutical Quality System (PQS), approving procedures, reviewing batch documentation, managing deviations and corrective and preventive actions (CAPA), qualifying suppliers, overseeing change control, conducting audits, and monitoring compliance with Good Manufacturing Practice (GMP).
- QC (Product-Oriented): Focuses on evaluating materials and products against predefined quality requirements. Responsibilities include sampling and testing raw materials, in-process samples, drug substance, and drug product, maintaining analytical methods and specifications, stability testing, and investigating atypical or out-of-specification (OOS) results. QC data supports decisions on whether materials are suitable for release.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) apply broadly similar scientific standards to biologics. Both require evidence that a product is consistently manufactured and adequately controlled, and that its quality, safety, and efficacy support its intended use. Both apply International Council for Harmonisation (ICH) guidelines and use the Common Technical Document (CTD) structure for submissions.
However, approval in one market does not automatically satisfy the requirements of the other:
| Feature | UK (MHRA) Requirement | US (FDA) Requirement |
| Clinical Trial Entry | Clinical Trial Authorisation (CTA) supported by an IMPD | Investigational New Drug (IND) application |
| Marketing Application | Marketing Authorisation Application (MAA) | Biologics License Application (BLA) |
| Batch Certification | Requires a Qualified Person (QP) to certify manufactured batches | Operates under US legislation; does not use the QP system |
| Specialist Oversight | Independent NIBSC batch release for certain vaccines/blood products | Establishment registration, inspections, and FDA product-release |
For companies operating across both markets, the practical work is less about reconciling fundamentally different science and more about managing two parallel regulatory relationships, submission formats, jurisdiction-specific requirements, and inspection regimes efficiently.