GXP in Research and Development
The areas of Research and Development were in the past excluded from the “compliance infrastructure” traditionally applied to the GMP-compliant manufacturing and control operations.
However, the FDA’s ‘risk-based-approach’ initiative and, later, the guidelines that emerged from that initiative: ICH Q8, Q9, Q10, Process Analytical Technology (PAT)… brought the requirement for the application of GxP principles (GLP, GMP, GCP) to the entire Lifecycle of a pharmaceutical product in a much higher level.
Concepts such as Quality by Design (QbD) are applied since the initial stages of development. The application of solid scientific criteria for the evaluation of results and data or the design of experiments, contribute to the knowledge and understanding of the product and the process, which is the key for obtaining and demonstrating the necessary control on the process and its design and the consistent quality of the product.
The manufacturing process, before its transfer to the production plant, it must be thoroughly understood, including the Critical Process Parameters (CPP). This knowledge provides the ability to make improvements within what is considered the Design Space without potentially affecting product quality. Consequently, an optimization of the process is achieved without the need for revalidation or regulatory approval.
Improving both product and process understanding, in combination with quality risk management, it will support the establishment of an appropriate control strategy for consistent product quality and improved process performance.
During the development phases of drugs, products used in clinical trials must be manufactured with quality standards equivalent to those applied in commercial drugs, adapting some requirements to the development phases. The labelling and secondary packaging of clinical trial medication is an essential part of the process to ensure that volunteers or designated patients take assigned medication.
For topics related to Good Clinical Practice (GCP) and Pharmacovigilance (GPvP) see the related section.
TDV offers an extensive experience in R&D projects of:
and the following GxP-related services associated with research and development:
- Risk analysis during development, scaling and process validation
- ICH Q8 development models
- Preparation of GXP regulatory inspections (GLP, GMP, GCP)
- Process Analytical Technology (PAT)
- Development reports
- Expert reports
- GMP in Pharmaceutical Development
- Support in labeling and distribution of medication for Clinical Trials
- Internal audits in the Pharmaceutical Development areas
- Review of Drug dossiers for Registration (DMF, CTD)
For more information about GxP in Research and Development, contact: