I need some help with the case study and the associated questions:
COUNTERMEASURES INC. (CMI) is a virtual manufacturing company that has a contract to supply a million doses of recombinant anthrax vaccine to the US Government for stockpiling. Some of this material will be used to conduct a phase I clinical trial involving military and civilian volunteers. The US Government (Department of Defense [DOD]) will be the Sponsor and holder of the IND under which the trial will be conducted). Since it has no manufacturing facility of its own, CMI subcontracted with MEGATECH Inc. (MTI), a contract manufacturing Organization (CMO) that owns a current Good Manufacturing Practice (CGMP) – compliant Manufacturing facility, to manufacture the vaccine. DOD also contracted with the Trials-R-US (TRU) clinic to conduct the phase I trial at their facility 75 miles away from the MTI manufacturing site. The DOD/CMI contract requires that CMI deliver the required number of vaccine vials for the trial to the TRU Repository through its subcontractor (MTI). As the staff at TRU was receiving the vaccines that came in three packages, they observed that one corner of one of the packages showed evidence of physical damage and as they unwrapped the outside coverings, they discovered that a number of the vials had been crushed and their contents spilled. A quick inspection of the remaining vials that appeared to be intact revealed that colored particulates were present in several of the vials The two intact packages were moved into a temperature- controlled holding area while the third (damaged) was transferred to a separate temperature controlled area. The vaccine excipient included a rich medium with a broad buffering capacity requiring a storage temperature of 2-4oC. Four days later, the Quality control manager at TRU who had been away on a trip went into the room where the damaged package was being held to complete the paper work he would need to prepare his report to CMI and MTI. He immediately noted that it was quite warm in the “Walk-in” cold room, being obviously warmer than 10oC.
Consider yourself as Director, Regulatory Affairs, MGI
1. Identify the risks (if any) this incident poses to the end user of your product and to your manufacturing facility
2. Outline the actions you would take to minimize the impact of these incidents on the integrity of your GMP operations. Develop a regulatory response.