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近日，F(xiàn)DA發(fā)布了Apitoria Pharma Private Limited的483報告，其中提及有變更控制的“計劃性偏差”，該公司最終因為變更評估不當(dāng)導(dǎo)致批次不合格，但FDA引用的缺陷落點則是“未能制定并遵循書面程序來調(diào)查關(guān)鍵偏差或中間體及API批次不符合標(biāo)準(zhǔn)的情況”：

Failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API batches to meet specifications. Specifically,

未能制定并遵循書面程序來調(diào)查關(guān)鍵偏差或中間體及API批次不符合標(biāo)準(zhǔn)的情況。具體而言：

Your firm’s change control request is inadequate and does not include risk evaluation and risk mitigation strategy. XX batch XX was manufactured following a planned deviation under Change Control Request CRF-UII-000286 (No. DE-UII-000018) for reduced batch size of approximately XX due to terminal batch of the campaign. Despite the reduced batch size, the process parameters and general process of established and validated for XX batch size were utilized that resulted in OOS for particle size. The change control request neglected the fact that the manufacturing process for batch size of XX had been previously validated which was more suitable for the subject batch.

貴公司的變更控制申請不充分，未包含風(fēng)險評估和風(fēng)險緩解策略。 批次XX按照變更控制申請 CRF-UII-000286下的計劃性偏差（編號 DE-UII-000018）生產(chǎn)，因該批次為生產(chǎn)階段的最后一批而按計劃性偏差進行生產(chǎn)，批量約為XX 。盡管批量減小，但仍采用已驗證批量的既定工藝參數(shù)和常規(guī)工藝，導(dǎo)致粒度不合格（OOS）。該變更控制申請忽略XX批量的生產(chǎn)工藝此前已驗證且更適用于該批次的生產(chǎn)。

此外，該公司還涉及變更批次的批記錄審核不完整，且未就此啟動偏差調(diào)查的缺陷：

Failure of your quality unit to review and approve all appropriate quality - related documents. Specifically,

貴公司質(zhì)量部門未能審核和批準(zhǔn)所有質(zhì)量相關(guān)文件。具體而言：

XX API (Lot# XX) has a change control (ID #CRF - UII - 000693) due the size reduction of this batch from reduced batch size XX instead of standard batch size xx and was approved on 16 July 2024. BPCR review check list for this batch was reviewed and verified by manufacturing andquality assurance on 27 July 2024. However, manufacturing and quality assurance personnel has signed the BPCR check list stating that any changed controls document was not initiated for this XX API (Lot# XX) and have attached to the final batch records. No quality assurance related deviation or investigation was initiated for not adequately reviewing quality documents.

某原料藥（批號XX）有一項變更控制（編號 CRF - UII - 000693）：批量從標(biāo)準(zhǔn)批量縮小為XX，并于 2024 年 7 月 16 日獲得批準(zhǔn)。該批次的批生產(chǎn)控制記錄（BPCR）審核檢查表由生產(chǎn)部門和QA于2024年 7 月 27 日進行了審核和確認(rèn)。然而，生產(chǎn)和質(zhì)量保證人員在批生產(chǎn)控制記錄（BPCR）檢查表上簽字，表明該原料藥（批號XX）沒有任何變更，然后隨附在最終批記錄中。對于未充分審核質(zhì)量文件的情況，未啟動與質(zhì)量保證相關(guān)的偏差處理或調(diào)查。