"What SOP bro...?"
Requires the PV approval of LJR for bulk processes
What is SOP-GE2243
From Buffer Mixing...For execution 3, the end of transfer sample for lot 1426700005 had a pH of 5.89, which was below the lower control limit of 5.8932 (refer to Figure 3). As the HMI readability of the Mettler Toledo S220 pH meter used in execution 3 is 0.01, the difference between the sample pH and the lower control limit was determined to be not practically significant. Additionally, the end of transfer sample pH of 5.89 met the acceptance criteria of 5.55 - 6.04 pH units as specified in Table 2. As all samples during solution mixing and transfer met the acceptance criteria outlined in Table 2 and all samples including end of transfer were within the statistical control limits
What is a Protocol Exception
MFG inputs which require an event in the quality system if not met
What is a Process Condition
Uses the term Biologics License Application
Who is the FDA
For a high impact deviation, VA1004 requires what additional information to be included in Section 1 of Form-VA3519
What is RTO language
Requires the approval of MFG, QA Ops and PV for REQ doc types
What is SOP-GE5093
From C3 PPQ...In Section 4.3 of PV-PTCL-049487 (1.0) and PV-PTCL-049489 (1.0) it was stated that trend rule violations for FDS release specification results according to SOP-GE2219 would be evaluated for impact on process performance qualification. However, insufficient historical data was available at IOPS Rensselaer to generate statistical control limits and warning limits established based on the width of each release specification limit were used per SOP-GE2219. Therefore, to further evaluate process consistency with regards to REGN668 C3P1 150 mg/mL FDS release specification testing, statistical control limits established based on PA11 historical experience as described in DT-RL-LR-03995 (5.0) and DT-RL-LR-06108 (1.0) were also utilized. As warning limits established per SOP-GE2219 were used to evaluate FDS release specification testing for PA7 PPQ lots, in addition to statistical control limits, there is no impact to validation
What is a PGE
Serve as measures of process consistency and possess low risk, if any, to SISPQ. Includes an additional control of a pre-determined value that is needed to ensure process consistency is maintained within a range defined by historical process capability, characterization or platform knowledge
What is an IPM w/ Limit
Ministry of Food and Drug Safety (MFDS)
Who is South Korea
What are the 5 types of validation activities that require formal stability or at least an assessment of formal stability per PV-Plan-0023?
What are: PPQ, at-scale HT, WCB qual, refiltration, and LIVCA
Governs PTCLs to assess a system, method or process by collecting data that demonstrate performance abilities or instruct/document an action but NOT deviate from effective batch records or SOPs with instructions that impact manufacturing process
What is SOP-GE4985
From VEGF HC PPQ...During the manufacture of FDS lot 8337600052, there was a 1 CFU/10 mL bioburden recovery at the filtered FDS pool (refer to Section 8.2.3.1). While pending the outcome of the investigation, an additional two lots were added to the process performance qualification campaign as a conservative approach to ensure three successful consecutive PPQ executions. This decision was documented in TD-PS-14658 (1.0), VEGF Trap (Aflibercept) IVT High Concentration, 114.3 mg/mL, Formulated Drug Substance PPQ Continuation in PA12, IOPS Raheen. As EOE23-0650 determined the microorganism was most likely introduced during sample handling or testing and is not process related, there is no impact to validation due to this bioburden recovery and all 5 lots discussed herein were successful PPQ executions.
What is a Protocol Exception
An output measuring a detectable point in the MFG process which may be indicative of a unit ops performance to a CPP or a CQA w/o an established link to a CPP or CQA not measured prior to release
What is a Non-CQA
Federal Commision for the Protection against Sanitary Risk (COFEPRIS)
Who is Mexico
When are the impact assessments, per SOP-GE5093, required to be completed?
What is prior to implementing the change, at min a pre-implementation task
QA Director level approval is required for all Validation Master Plans, Validation Plans and associated appendices
What is SOP-VA3283
From VEGF HC PPQ...During the manufacture of SEC lot 8337500052, it was identified that the post-sampling SEC pool net weight was less than expected. This was due to recording the net weight in a previous step, instead of the gross weight as required. Actions were taken to obtain the correct pool weight and use that value in the subsequent total protein and yield calculations as discussed in NOE23-13103. As the total protein content and yield values were able to be obtained accurately, there was no impact to subsequent processing and all performance parameters met the predefined limits, indicating no impact to process validation.
What is a Deviation
Has the potential to pose safety/efficacy risks impacting product SISPQ or ensures final product is free from microbial contamination AND can be de-risked with control
What is criticality can't be de-risked with control
Uses bracketing strategy to determine post-approval change strategy
Who is Japan
The REGN7075 ProA PAR study confirmed that high elution buffer pH is a CPP due to impact on bispecific purity. If the CPP range is 5.80, what pH goes into the MR per SOP-GE5545 and why?
What is 5.80 b/c downstream detection