Will anyone provide me with basic SOP , process flow to be followed by people of R&D / FR&D, so that we can follow those procedures in our firm.
Please refer following ICH Guideleines,
- PHARMACEUTICAL DEVELOPMENT -Q8(R2)
- QUALITY RISK MANAGEMENT - Q9
- PHARMACEUTICAL QUALITY SYSTEM- Q10
- DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES
(CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11
The overall approcah, strategies of the ptoduct development (F R & D) activities and the documentation should be based on combination of the above referred guidleines (Quality By Design-QbD concept).
Quality by Design (QbD):
QbD IS a 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.
Quality by Design approaches of pharmaceutical development (R & D) are highlighted below,
Systematic, relating mechanistic understanding of material attributes and
process parameters to drug product CQAs
Multivariate experiments to understand
product and process
Establishment of design space
Design space- It is a 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).
PAT tools utilised (PAT- Process Analytical Technology)
The concepts outlined in the above ICH Quality Guidelines (ICH Q8(R2), Q9, Q10 and Q11)
provide opportunities for science- and risk-based approaches for use in drug development and regulatory decisions.
Thank you for your valuable reply…
You are always welcome.