No. Anorganisation cannot act as a contract batch certification site only. Thesponsors of a clinical trial may wish to keep the final QP certification stepof IMP manufacture in house as they carry ultimate responsibility for thetrial. Otherwise, any contract organisation such as yours must be inv...
5、ngoing / follow up stability (no stress tests) -Previous released batch used as reference sample in an OOS investigation showing OOS or suspect results. -Batches for clinical trials. All solutions and reagents must be retained until all data has been second person verified as being within ...