The development, scaling up and final manufacturing of processes are required to meet with cGMP regulations wherever products are marketed whilst remaining in compliance with all other local governing codes, laws, guidelines and regulations.
With a high focus on process understanding No deviation Pte. Ltd. can assist you to implement a cost effective solution and practice under the currently much discussed concepts, e.g. quality risk management or quality by design as outlined in respective ICH and ISPE documents.
In No deviation Pte Ltd, we understand your goal while recognising that there is no universal solution to the challenge of process development and manufacturing. We develop, with a great sense of empathy, appropriate support solution by observing and communicating with you. We will define with your team the identified support needs and implement it while assessing continuously the efficiency of planned action based on your immediate and long terms needs.
Our objective is to provide a ‘how to’ guidance when implementing technical activities using a science and risk-based approach throughout the project lifecycle. This approach includes the need of competent engineering input throughout, especially for design and control of pilot and commercial scale manufacturing processes, equipment and facilities.
Regardless of the project phase support required (e.g. development, design, implementation, etc.) No deviation Pte. Ltd. remains in line with the Quality Target Product Profile, defining the Critical Quality Attributes and prioritizing actions and resources on the risk ranking using harm and/ or severity to the patients.
We have today successfully applied those principles supporting large MNC’s as well as small local companies with limited resources, proving the scalability of our approach and our understanding of the client and patient safety priorities.