ANALYSIS OF RISK FOR THE DESIGN AND THE MEAUSURE OF MITEGATION
APPROACH @ BAPS FOR RISK MITEGATION
In any GMP processes, as per ICH guidance the implementation of QRM is expected at the manufacturing process/products.
Team BAPS believe that the process equipments are the most important part of manufacturing process for any pharma /Bio-Pharma products; hence the process solution/equipment play a key role in achieving the quality of the product directly/indirectly. Success & failure of any process batch is mostly depending on the training/skill set of man power & performance of process equipments/instruments etc.
Team BAPS has a very strong conviction that sooner or later same QRM approach will be made mandatory by regulations at equipment design also. Hence it is an imperative to have an appropriate & proactive integrated approach to meet requirements more efficiently & effectively by incorporating the knowledge & experience into design of all the process solutions.
The risk identified, analyzed & appropriately taken care at process systems design will play a vital role in any QRM.
Anything which has the potential harm to process, process systems, product quality, patients & ultimately the business is “RISK”
Process understanding is the key to identify the potential risks. It is an opportunity to use structured process thinking.
Hence, at BAPS, every single design goes though the Risk assessment so as to get the risk mitigation done at design stage itself to achieve part of QbD- Quality by design at process solutions/equipments.
How it is done at BAPS?
We ask 4 important questions while designing a process system for sterile pharma & Bio-Pharma application.