Good day all. I need some guidance and direction. we are starting up a pharmaceutical manufacturing facility from scratch. so need to design the rooms and get all the equipment and paperwork in place. very daunting challenge ahead but definitely will be so rewarding if accomplished. our client is willing to sign a contract of 1 product for now-an injectable vial. any tips, advice and links that you can share will be highly appreciated
See the PDA for facility requirements.
Are you designing the rooms and facility, utilities, systems in-house? Or will you employ a professional contractor/engineering firm? This is a very daunting task and aseptic manufacturing is more critical to have the facility correct. Have you thought about reaching out for engineering/contractor consulting?
This is something my firm can help you with, having designed Aseptic Facilities from the ground up, including eventual validation, quality systems (like document management).
Hi Jared
can i please have your email address so we can communicate further.
yes i am currently looking for a consultant so if you can email me on luthfiyah@t2n.co.za then we can set up a meeting