Synopsisof1987AsepticProcessingGuidanceRevision.pptVIP

Synopsis of 1987 Aseptic Processing Guidance Revision;Updating the Aseptic Processing Guidance;Updating the Aseptic Processing Guidance;Updating the Aseptic Processing Guidance ;Updating the Aseptic Processing Guidance ;Risk-Based Approach Sterile Drugs ;Updating the Aseptic Processing Guidance ;Updating the Aseptic Processing Guidance ;Risk-Based Approach  Critical Control Points;Updating the Aseptic Processing Guidance ;ADVISORY COMMITTEE MEETING COMMENTS;ADVISORY COMMITTEE MEETING COMMENTS;PQRI Aseptic Processing Workgroup;PQRI Aseptic Processing Working Group;Working Group Members;Working Group Goals;Basis of Recommendations to FDA;Project Timeline (actual); Clarifications;Clarifications #1;Clarifications #5;Clarifications #7; Recommendations;Recommendation #1 ;Recommendation #1 ;Recommendation #2;Recommendation #3;When filling more than 10,000 units 1 contaminated unit requires an investigation 2 contaminated units are considered cause for revalidation following investigation. Recurring incidents of contaminated units from media fills for an individual line, regardless of the set acceptance criteria, should be a signal that action should be taken. ;Recommendation #4 ;Recommendation #4(cont’d) ;Recommendation #5 ;Recommendation #6;Recommendation #6;The section needs to recognize, up front, that there are two major ‘types’ of isolators; open and closed. The term “Unidirectional” in 1369 should be split out for open isolators. Within a closed isolator turbulent flow is normally acceptable. The terms open isolator and closed isolators should be better defined. Recommend that the definitions be based on those contained in PDA Technical Report No. 34. ;Recommendation #8 ;Recommendation #9;Recommendation #9;Recommendation #10;PQRI Working Group Summary;Status of Guidance Revision