Section Recommendation Evidence Impact/Notes 17.23 All language Remove section entirely. FDA Guidance No evidence that this improves quality and secondary - Sterile Drug engineering control smoke tests are not required by FDA or . Products CETA. No mention of SEC smoke tests in USP General Produced by Chapter <797>. Aseptic Processing – Current Good Manufacturing Practice. USP 797 A pharmacy shall conduct environmental Remove and replace with required to determine The language used in (g), (h), and (j) is extremely vague and “as monitoring of each primary and secondary the root cause of a contaminated CSP”. subjective, thereby providing no clarity of both the engineering control: expectations for compliance and the overall benefit to (g) in response to identified problems with staff public health. The recommended language would require technique; environmental monitoring to be conducted in order to (h)in response to actual or suspected defect or determine or rule out the controlled environment as a contaminant of a CSP or potential patient infection; possible cause of CSP contamination. (j) in response to a sudden or significant change in staffing or workload.
Section Recommendation Evidence Impact/Notes 17.23 All language Remove section entirely. . FDA Guidance - Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice. USP 797 No evidence that this improves quality and secondary engineering control smoke tests are not required by FDA or CETA. No mention of SEC smoke tests in USP General Chapter <797>. A pharmacy shall conduct environmental monitoring of each primary and secondary engineering control: (g) in response to identified problems with staff technique; (h)in response to actual or suspected defect or contaminant of a CSP or potential patient infection; (j) in response to a sudden or significant change in staffing or workload. Remove and replace with “as required to determine the root cause of a contaminated CSP”. The language used in (g), (h), and (j) is extremely vague and subjective, thereby providing no clarity of both the expectations for compliance and the overall benefit to public health. The recommended language would require environmental monitoring to be conducted in order to determine or rule out the controlled environment as a possible cause of CSP contamination.
intl-academy-compounding-pharmacists-247-17.docx