Research and Development areas were in the past traditionally excluded from the “regulatory envelop”, since it strictly applied to the production environment with regard to GMP compliance.
However, an increasing requirement for the application of GXP (GMP,GLP,GCP) principles to the complete Product Life Cycle has been driven by FDA’s ‘risk-based-approach’ initiative, and especially by the more recent guidances subsequently developed from it: ICH Q8, Q9, Q10 and Q11.
Concepts such as Quality by Design (QbD) apply from the early development stages. Sound scientific criteria applied to evaluate results and data contribute to the product and process knowledge, which is the key to providing, and proving, the necessary control of the process and the consistent quality of the product.
Before going to the production plant, the manufacturing process should be understood in depth, including its Critical Process Parameters (CPP). This knowledge gives the ability to drive improvements within what is considered the Design Space without potentially affecting the quality of the product. This, in turn, leads to the optimization of the process without the need for revalidation or regulatory prior approval.
TDV provides experience in R&D projects for:
- Solid, semi-solid and liquid dosage forms
- Active Pharmaceutical Ingredients (API’s)
- Sterile and aseptic manufacturing
GxP related services to research and development:Technology:
- ICH Q8 development models
- Preparation of GXP (GLP, GMP, GCP) regulatory inspections
- Process Analytical Technology (PAT)
- GMP in Pharmaceutical Development
- Clinical Trial Supplies management
- Development Reports
- Expert Reports
For further information about GxP in R&D and Technology Transfer, please contact: