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The Definitions Of Management And Quality Assurances

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On occasion it is necessary to remove from use certain raw materials, packaging materials, or finished products due to processing problems or other reasons. Until the disposition is determined of the material is discarded, Quality Assurances places material on hold/blocked stock in SAP and /or attaches a “hold Tag” to prevent material use and notifies those affected by the hold.

Once the material /batch are placed on hold per SOP H740, the area Group Leader or designee transfers the material/batch to the Quarantine Room 28-176 for segregation. Batch/materials are logged into the quarantine room storage log (see blank attached Form I602). At the end of each month, the owner of the quarantine storage room or designee generates and sends a …show more content…

However, an Material Disposal Order (MDO) could not be issued for those batches / materials because they were not found in SAP, as they were not received in SAP. Per SOP A713 (Merchandise Disposal Orders (MDO) for All Types, Including Controlled Substances and Listed Chemicals), a physical “MDO” is generated by placement of inventory into “Blocked“ and “D” status. This prompts the system to activate the MDO process. According to the aforementioned SOP, GMP Services, Records and PMQA are able to generate the physical MDO for the disposal of obsolete and unusable materials, including DEA - Regulated Materials. This is done by placing the materials/batch in "Blocked" and "D" status in SAP.

During interviews with SMEs and review of related SOPS (I602 and A713), it was suggested that although SOP I602 was generated to assure better management of the Quarantine Room, this observation is most likely due to lack of communication and/or understanding of the responsibilities of different parties due to lack of standardization of the process. In addition to batch/materials on "QA Hold" not found in SAP or staged outside of the Quarantine Room, the storage log (Form I602) was found to be not up-to-date or not reflecting the current inventory inside the Manufacturing Quarantine Storage Room

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