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www.biopharminternational.com May 2021 BioPharm International eBook 19 Ly n n (RC A ): C MO s /CDMO s a n d s p o n s o r c o m p a n i e s n e e d t o ensure a highly col laborative rela- tionship. In this it's not just about pl ay i n g n ic e i n t he met aphor ic a l sandbox. It's about focusing on the details to ensure that they have the processes, equipment, qua lit y, and over sight mec ha n isms , a s wel l a s trained and qualif ied staff to work the processes and produce a quality product. They a lso have to ensure that any/a l l bl inders a re removed. Ta k ing of f t he bl inders fa l ls into two different aspects: My Wa y Work s B e s t : W h at I mean is there are a large number of people, departments, and functional u n it s w it h i n t he v a r iou s de p a r t- m e n t s — e a c h w i t h i n t h e i r o w n separate organizations (the CMO/ CDMO and the sponsor). They all have their own ideas, their own pro- cesses, their ow n qua l it y systems, a nd t hei r ow n c u lt u res. T here's a p r o p e n s it y t o b e l i e v e t h a t y o u r tea m ha s a l l t he cor rec t a ns wers. But, is that a lways tr ue? Be open, be inquisitive, and be ready to see if another approach can get you to the same goal—a compliant, f it-for- use system that produces a safe and effective product. S ee t he Forest f rom t he Trees: [ I n t h i s approa c h ,] a ny f i r m , or any person, in any industry, focuses solely what 's in front of their nose and don't look up to see the bigger picture. If a sponsor is work ing to partner with a CMO/CDMO, this phenomenon needs to be ack nowl- edged and acted upon. The people s et t i n g up pro c e s s e s ne e d to s e e that they a re pa r t of a la rger sys- tem. A simple example: the produc- t ion de p a r t ment shou ld con sider how their processes come together and how those processes turns into a product that goes to pack ag ing. Packaging needs to k now how the packaged products go to the ware- house, etc. Then managers and lead- ers, as well as the quality unit, needs to understand how the sum of each individual part becomes the whole. This overall concept has changed du r i n g t he p a nd e m ic b y m a k i n g things a little more complex. First, s o m e of t h e p e r s o n n e l t h a t h a d t y pica l ly been onsite may now be work ing remotely. Instead of face- to-face interactions, they may need t o h a v e i nt e r a c t i o n s o v e r v i d e o. For e x a mple , t he qu a l it y p er son- n e l t h at p r e v io u s l y w ork e d w it h various operational units on inves- t igat ions may be of fsite a nd need to assist remotely. I believe things were much slower at the start of the pandemic, but we as a human race have learned to adapt and speed up over time. The key to managing any CMO/ C D MO r e l a t i o n s h i p i s c o m m u- n i c a t i o n . C o m m u n i c a t i o n s l i n e s between the partners should always be open, which makes it much easier to communicate ef fect ively when- ever a crisis arises. BioPharm: What steps are taken by the CMO/CDMO and sponsor company to prepare a facilit y and / or manufacturing line for regulatory approval? Lynn (RCA): Good question, as I was once told: prior planning pre- cludes poor performance. Planning and prepa ration a re t wo big prin- c ip a l s for t h i s one . F i r s t , i f y ou a re t he sponsor company work ing w it h t he CMO/CDMO you must h av e a col l a b or at iv e p a r t ner sh ip. Without it, the pre-approval of the manufacturing line or new product l i k e ly won't b e a s s uc c e s sf u l h a d t h e s p o n s o r a n d C M O / C D M O worked col laboratively. W hy? The reg u l ator s c a n usu a l ly detec t a ny issues bet ween sponsor and CMO. It comes out during all the various inspectiona l activ ities. T his plan- n i ng a nd prepa r at ion st a r t s f rom day one of your relationship when you sta r t document ing you r qua l- it y agreement and agreeing to how you' ll work together to ensure a f it- for-use product is manufactured or packaged or labeled or tested, etc. Here are some examples: • H o w w i l l t h e s p o n s o r approve the product? • Will you have full access to the batch record and any/all deviations/investigations? • How fast will you be notif ied of issues? • W hat issues will be notif ied a b o ut ? ( H i nt : It s ho u ld n't just be for the critical issues.) • How about change control? • Will you, as the sponsor, be pa r t of t he c h a n g e cont rol process? ( H int: You shou ld or you need to a mend you r quality agreement pronto.) These items are some of the areas that the regulators will investigate. Another area to consider is doing your own mock pre-approval audit to en s u re re a d i ne s s . T h is c a n b e done by the sponsor's auditors or via an independent third-part y (or both at different times). These t y pes of preparator y audits not only help the sponsor and CMO ensure that the pro duc t (s) a re b ei n g pro duc e d i n Partnerships for Outsourcing Quality/Regulations "In selecting a CMO, make certain that you do an onsite audit. Look into the fit-and-finish of the facility." —Steven Lynn, Regulatory Compliance Associates