Verta Life Science’s Consultants have experience developing pharmaceutical products, for all therapeutic classes.
Our development expertise includes
- Drug substance chemical development and synthesis,
- Drug product formulation in all dosage forms,
- Analytical method development.
Where appropriate we apply Design for Manufacture principles consistent with following ICH Objectives
Demonstrate an enhanced knowledge of product performance over a range of material attributes, manufacturing process options and process parameters. This understanding is typically gained by application of, for example, formal experimental designs (DOEs), process analytical technology (PAT)*, and/or prior knowledge. Quality risk management principles are helpful in prioritizing the additional pharmaceutical development studies to collect such knowledge.
QUALITY BY DESIGN (QbD):
Systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
Critical Process Parameter (CPP):
A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.
Critical Quality Attribute (CQA):
A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval (ICH Q8)
Quality Target Product Profile (QTPP):
A prospective summary of the quality characteristics of a drug product that ideally will be achieved to ensure the desired quality, taking into account safety and efficacy of the drug product.
Real Time Release Testing (RTRT):
The ability to evaluate and ensure the quality of in-process and/or final product based on process data, which typically include a valid combination of measured material attributes and process controls