制药验证文件-洁净压缩空气GMP评估(英文版)

GMP and Functional Risk Assessment for Compressed AirGMP and Functional Risk Assessment for Compressed Air Page 1 of 15DOCUMENT HISTORYThis risk assessment serves as GMP and Functional Risk Assessment for Systems, as well as traceability matrix between requirement,potential risk, and measure to control risk (e.g. specific test specification, additional requirement to mitigate risk, SOP).Risk Assessment ProcedureStep 0 – Approval Cover Page and Document History▪The section “Risk Assessment Work Session Attendance” will be used to record work session number, list of attendees, and the work session date.▪After completion of the Risk Assessment (before executing the specific measures) the Risk Assessment will be initially approved (section “Assessment”).▪In case that the approved Risk Assessment will be revised, the initial approval of the Risk Assessment is obsolete and the revised Risk Assessment requires a new approval. The Revision Number must be adapted accordingly.▪If - all defined measures and tests are completed and- in all rows the cell “Measures completed” is assessed “Yes”then the Risk Assessment is finally approved in the section “Final Assessment Approval”.Step 1 – Description of the current process / work flowGMP and Functional Risk Assessment for Compressed Air Page 2 of 15Fill out columns “Source Document”, “Function” and “Reverse Function”▪Source Documents typically encompass the System URS, block diagram, and/or functional description, but related documents must also be considered. For example, if the 21 CFR Part 11 assessment demonstrates that the system must comply with Part 11, a row must be added in thecorresponding GMP/FRA to ensure traceability to this GMP critical requirement. Other System level “umbrella” documents, egg AutomationURS and/or Electrical URS that contain Critical GMP requirements that apply to many systems, must either have their own GMP/FRAassessments, or the GMP critical requirements traced in each System level GMP/FRA.Step 2 –Risk Assessment [column “Risk Assessment”]Probability Ratingo Low (L): Due to the design failures may not occur. The design is well known and often used.o High (H): The design is new and not well known. There is a high probability that failures occur.Impact Rating▪Which impact has the described failure, independently of the probability rating?o Low (L): No impact to the product quality.o High (H): Impact to productProbability of Detection▪Which probability of failure detection is given? Is it possible to detect the failure immediately or latest during Quality Control/batch release?o High (H): The failure will be detected immediately.o Low (L): The failure can not be detected immediately. The failure may not be detected during Quality Control tests.GMP criticality▪Assess the risk in regard to product quality and patient safety. Note: GMP criticality is not the same as GMP-relevance. GMP relevance will not be changed by application of specific measures and control. GMP criticality is reduced by proper design and control of the process. Forexample, sterilization process failures (e.g. temperature not reached during sterilization) have high GMP criticality, but proper design of thesterilizer and control of the process with sensors reduces GMP criticality. However, although GMP criticality has been reduced, the GMPrelevance of a compliant sterilization cycle remains unchanged.o High (H): There is an impact on product quality and/or patient safety and/or the impact is not under control / not acceptable.o Low (L): There is insignificant impact on product quality and/or patient safety and/or the impact is under control / acceptable.▪Record the unique URS ID number in the Reference Document column for all GMP crit ical requirements (marked “H”).▪For each GMP critical requirement, insert the specific URS requirement in the Function column.GMP and Functional Risk Assessment for Compressed Air Page 3 of 15Step 3 – Definition of specific measures to mitigate risks (columns Measures, Action)The main measures are, but not limited to:▪Definition of additional design requirements (e.g. in URS, FS) to mitigate risk▪Definition and execution of additional, specific IQ, OQ and PQ tests▪Generation of specific Standard Operating Procedures (SOPs)▪Specific operational procedures▪Additional sensors for process monitoring and control▪Calibration of quality relevant/critical sensors▪Cleaning validation▪Safety measures and arrangementsDefine and document the responsible person and the due date for the specific measure.Step 4 – Risk Assessme nt [column “Risk Assessment considering defined measures”]Assessment in view of the successful execution of all defined measures to mitigate risks.Apply the same rating as in Step2:Probability RatingThe probability of occurrence if all defined measures are implementedImpact RatingThe impact of an event usually remains the same independently of the defined measures.Probability of DetectionThe probability of detection of an event if all defined measures are implementedGMP-criticalityThe GMP-criticality must be low, otherwise additional measures must be defined.Step 5 – Execution of specific measuresGMP and Functional Risk Assessment for Compressed Air Page 4 of 15The execution and documentation of specific measures are traced and controlled via test specifications, list of critical sensors, preventive maintenanceplans, and/or open item lists.Document titles and revision should be documented in column “Test Documentation / Traceability / Reference” under the corres ponding point (DQ, IQ,…). In case of to many documents or title of document to long it is possible to include a reference (e.g. a reference to a Test Specification overview)in the column.The execution completion should be documented with initials and date in the column “Action / Responsible Due Date”.Step 6 – Measures completedAfter documented execution of all specific measures and tests to mitigate risks, the completion and closure is checked and confirmed in the last cellof each row.Step 7 – Risk Assessment CompletionAfter all measures of the entire analyses are completed (step 6 for all rows) the Risk Assessment will be finally approved on the cover page (section“Final Assessment Completion”).GMP and Functional Risk Assessment for Compressed Air Page 5 of 15GMP and Functional Risk Assessment for Compressed Air Page 6 of 15GMP and Functional Risk Assessment for Compressed Air Page 7 of 15GMP and Functional Risk Assessment for Compressed Air Page 8 of 15GMP and Functional Risk Assessment for Compressed Air Page 9 of 15GMP and Functional Risk Assessment for Compressed Air Page 10 of 15GMP and Functional Risk Assessment for Compressed Air Page 11 of 15GMP and Functional Risk Assessment for Compressed Air Page 12 of 15GMP and Functional Risk Assessment for Compressed Air Page 13 of 15GMP and Functional Risk Assessment for Compressed Air Page 14 of 15GMP and Functional Risk Assessment for Compressed Air Page 15 of 15。