Manufacturing Controls for Thosoe InterestedFDA wants to know how pure your plasma is?
We manufacture it in sterile environment, No dummy, have you tested how pure it is? ... Uhh
Well how are you gonna test it?
Wait you're telling me theres no analytical method (aka test) to tell you because you have a new drug and you get interference from the other things in the product like salt, proteins and other stuff found in plasma?
Sh*t, now what?
Research and Development. The lab now has to develop a way to test. Great The scientists spent 6 months finding new way to do it. Thats it right?
No, now you gotta take the test and validate it using positive controls, negative controls blah blah blah. So you need to write up a protocol. Takes 3 months cause you gotta approve it with management and review it and make sure its right and budget the money and order the new industrial testing equipment and find a place to install it with qualification controls.
Protocol done? Now what? Now to do more science on the new method. Oh, the protcol states you gotta run a hundred tests over different different days with X different scientsits and X different peices of equipment to make sure it runs consistently each time no matter who does the test and what kind of environment you do it in?
Can it differienciate between the new drug and a peice of turd? Yes? Great! now lets write up a report! Wait, the report needs 3 months to write it? and its 100 pages and you need a biostatistian to do the math to see if the numbers are right?
Ok, great finally the report is done. give it to the FDA. Wait what do you mean you cant send them a 100 page report? Oh you need regulatory to put it in a way that easier to read for the FDA?
Ok fine, now lets hand it over to regulatory... what do you mean you need 2 months to prepare a submission... why? Regulatory need to read it, understand it, answer the questions posted by FDA, summarize all 100 pages and put it into a way FDA likes to read it and send it to the FDA. What? manufacturing didnt tell you about the new equipment they installed in the new building? Did you write a report for the new equpment? How it was installed? Oh you did, why didnt you give it to us in the first place? Oh you didnt think we needed that?
Whats that? 1.5 years from the date FDA asked you a question you hasn't thought about or you thought was enough to prove the way you manufactured it was consistent and safe? Yes that's drug development for you folks.