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SCORECARD: PhRMA Comments on: Draft FDA Guidance “Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice” [Docket No. 2003D–0382] September 2003 Total Number of Changes Suggested: 118 Section Guidance Line Comment Rationale General There are some aspects of this draft guidance document that appear to improve global harmonization, for example, approach to aseptic processing vs. Terminal Sterilization and approach to environmental monitoring at rest in operation (dynamic condition). However, several opportunities for this FDA guidance to be harmonized with European GMP requirements, as included in Annex 1, appeared to have been missed. The creation of a unified global aseptic standard is both feasible and necessary, and should be considered. The following topics in the guidance appear to be in direct conflict with EU requirements and should be re-visited: Area classification (e.g. US Class 100/ISO 5 vs. EU Grade A) Introduction of a class 1000 area Static/dynamic testing (static required in EU, dynamic in the US) Five micron particle requirement (5 micron particle monitoring required in EU but not in US) Cubic meter measurement (Volume requirement explicit in EU, but not in US) Requirements for unidirectional flow (Difference in philosophy regarding provision of unidirectional flow) Isolator background requirement (EU: Grade D, US Class 100,000 – Grade C equivalent in dynamic condition) Blow/fill/seal background and critical zone monitoring requirement (EU background Grade C, US background Class 10,000 – Grade B equivalent in dynamic condition. Dynamic viable monitoring only in critical area: US – both viable and non-viable.) Area grading for component preparation (EU: Grade D, US Class 100,000 – Grade C equivalent in dynamic condition) Averaging of microbiological results Sterilizer load pattern record location (Validation documents in EU, batch record in US) General The guidance includes various terminologi