培養(yǎng)基灌裝驗證ppt課件-資料下載頁
2025-04-28 22:59本頁面
【正文】 e production simulations – “media fills” conducted to validate your capability to aseptically produce small volume parenteral (SVP) were found to be inadequate. The media fills for this line did not represent actual operations used in the aseptic production of ampoules and vials. For instance, the media fill performed by your firm in October 2022 failed to simulate the interventions performed in actual, routine production. For example, a routine production of a (b)(4) Injection vials lot would take approximately (b)(4) hours to be filled. Your written procedures (reflected in production protocols and batch record forms) for routine production require that an intervention take place every (b)(4) minutes for fillweight verification measurements. Our review found, however, written procedures for the media fill simulation (reflected in media fill protocol), require performance of this fillweight verification measurement only (b)(4) times throughout the media fill process. ? In your response to this letter, provide the finalized protocol and the summary report including all data generated during the execution of this media fill. 57 Warning Letter 3： Italy工廠 （ 2022） ? 1. Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 . 167。 (b)]. ? For example, the process simulations (media fill) do not represent actual production operations for your sterile API. The process simulation performed by your firm in July 2022 failed to include simulation of the routine interventions performed in a typical campaign of 13 batches. ? Placebo mediums should be evaluated for their ability to support growth. Their placebo used in the process simulation is sodium phosphate in different forms (solution and anhydrous) and sodium chloride solution (l %). ? Placebo mediums should be evaluated for their inhibitory effect on microanisms. Your response does not indicate that your firm uses betalactamase to inhibit the effect of antibiotic residue in the production line during process simulation. ? Gases used during process simulation should be evaluated for their inhibitory effect on microanisms. Your response states that the nitrogen used in the process simulation is removed by the test membrane during filtration. 58 問題和回答 59 謝謝！
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