My know-how in medicinal chemistry served us comprehend the molecular interactions improved, which performed a crucial function in creating a powerful drug.
Expiry date: The date place over the container / labels of the API specified some time all through which the API is predicted to remain in set up shelf existence technical specs if stored below outlined problems and and then it should not be utilised.
In addition, it contains the small print from the activity performed by whom, checked by whom, at what time activity was performed, at what date action was carried out and signature of the staff involved in the batch or exercise.
“In one project, we aimed to style and design a more powerful antiviral drug. Working with organic chemistry principles, we modified the structure of an present molecule to reinforce its binding affinity.
Rinse sampling: Significant areas or areas of equipments which couldn't be swabbed must be rinse sampled or right extracted by solvent. Tubes, nozzles, pipes or containers with floor Those people are certainly not fairly obtainable for direct surface sampling need to be rinsed with solvent.
Soon after quite a few rounds of testing and tweaking, we effectively scaled up the method inside our pilot plant. This resulted in a rise in Total generate by 30% and drastically decreased waste generation.
And in the event you favor a picture of most of the questions, Here's an image of 350 fantastic questions to request.
“In one task, I was tasked to scale up the synthesis of a new drug compound. The lab-scale system was effective although not suited to massive-scale production resulting from protection concerns and value inefficiencies.
Goal: To style a approach that will continuously supply a business merchandise Conference high quality more info characteristics.
On top of that, inaccessible spots of equipment that can not be routinely disassembled is usually evaluated.
It's a certified written doc which describes the comprehensive instructions specifications for accomplishing operations or any action and non-particular to any product, approach or material.
The documented verification the devices, instrument, facility and method as put in or modified, perform as intended through the mounted functioning assortment.
QAS20 849 Points to contemplate on the various techniques –which include HBEL – to ascertain carryover boundaries in cleaning validation for identification of contamination pitfalls when production in shared facilities
A dialogue forum is a superb medium to share with college students Whatever you’ve realized from your own studies and ordeals. It's also possible to make use of a discussion forum to emphasize vital concepts protected in a selected module or to elaborate on a topic that the training course lecture or readings didn’t check here include in depth.