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Manufacturers should conduct inspection feasibilitystudies for visible particulate detectability, unit inspection duration,illumination, and fatigue time frame. These studies should be scientificallybased and analyzed using appropriate statistical methodology. Depending on thestudy results, manufacturers may need to adjustparticulate standards or inspection processes or, in some cases, changeequipment to improve accuracy and reduce patient risk.

制造商應(yīng)進(jìn)行可見顆粒可檢測性、單位檢查持續(xù)時間、照明和疲勞時間框架的檢查可行性研究。這些研究應(yīng)以科學(xué)為基礎(chǔ)，并使用適當(dāng)?shù)慕y(tǒng)計方法進(jìn)行分析。根據(jù)研究結(jié)果，制造商可能需要調(diào)整顆粒標(biāo)準(zhǔn)或檢查過程，或者在某些情況下更換設(shè)備以提高準(zhǔn)確性并降低患者風(fēng)險。

Manufacturers must implement written procedures forproduction and process controls (§ 211.100), which should cover each aspect ofthe visual inspection process. Such procedures should cover handling of theunits (e.g., swirling, inversion, distance from light), maximum length of theinspection period without a rest break, and disposition and documentation ofproducts that were rejected based on the results of the visual inspection.

制造商必須實(shí)施書面的生產(chǎn)和過程控制程序（§ 211.100），其中應(yīng)涵蓋目視檢查過程的各個方面。這些程序應(yīng)包括對被檢查單元的處理（例如，旋轉(zhuǎn)、反轉(zhuǎn)、與光的距離）、無休息不間斷檢查的最長時長，以及根據(jù)目視檢查結(jié)果對被拒絕的產(chǎn)品進(jìn)行處置和記錄。

Only certified inspectors and qualifiedequipment should be used to inspect injectable products for visible particulates.Personnel conducting inspections (100% inspection and AQL inspection) must beadequately trained (including, as appropriate, periodic retraining or requalification)(§§ 211.25 and 600.10(b)).

只有經(jīng)認(rèn)證的檢查人員和已確認(rèn)的設(shè)備才能用于檢查注射產(chǎn)品的可見顆粒。進(jìn)行檢查（100%檢查和AQL檢查）的人員必須經(jīng)過充分的培訓(xùn)（包括適當(dāng)?shù)亩ㄆ谠倥嘤?xùn)或再確認(rèn)）（§§ 211.25和600.10（b））。

Formalized training and qualificationprograms promote consistent performance by individual inspectors or automatedinspection machines and help minimize variability among different inspectors ormachines (Melchore 2011). The program can include a combination of trainingmaterials, standard operating procedures (SOPs), on-the-job training, andtesting. Inspector candidates should be trained in the relevant CGMPrequirements and should have normal near visual acuity (with or without the useof corrective lenses) and no impairment of color vision (Ricci et al. 1998).

正式的培訓(xùn)和確認(rèn)程序促進(jìn)了檢查人員或自動檢查機(jī)的一致性能，并有助于最大限度地減少不同檢查人員或機(jī)器之間的可變性（Melchore 2011）。培訓(xùn)的程序可以包括培訓(xùn)材料，標(biāo)準(zhǔn)操作程序（SOP），崗位培訓(xùn)和測試的組合。準(zhǔn)檢查人員應(yīng)接受相關(guān)CGMP要求的培訓(xùn)，并且應(yīng)具有正常的近距視敏度（無論是否使用矯正鏡片）并且沒有色覺障礙。

Regarding inspection equipment:

關(guān)于檢查設(shè)備：

The specific backdrop and light intensity selected for manual inspection stations should be qualified.

為人工檢查站選擇的特定的背景和光強(qiáng)應(yīng)進(jìn)行確認(rèn)。

Semi-automated inspection equipment shouldbe properly calibrated and qualified at a specific vial-spin and belt speed.Lighting should also be qualified to allow for accurate human detection ofdefective products.

半自動檢查設(shè)備應(yīng)在特定的瓶子旋轉(zhuǎn)速度和傳送帶速度下進(jìn)行適當(dāng)校準(zhǔn)和確認(rèn)。照明應(yīng)進(jìn)行確認(rèn)以對缺陷產(chǎn)品進(jìn)行準(zhǔn)確的人工檢測。

Automated inspection machines should bevalidated to meet or surpass human inspection capabilities and can be qualifiedusing training standards or artificial intelligence technology.

自動檢查設(shè)備應(yīng)經(jīng)過驗(yàn)證，以達(dá)到或超過人工檢測能力，并可以使用培訓(xùn)標(biāo)準(zhǔn)或人工智能技術(shù)進(jìn)行確認(rèn)。

For personnel qualification and automatedinspection systems validation, a mixture of good injectable product units anddefective units containing visible particulates should be used (Melchore 2011).This test set should be prepared and approved by quality assurance staff.Manufacturers should develop libraries of defective units from samplescollected throughout the product life cycle, samples created to simulateproduction defects, or samples purchased to be representative of the types ofparticulates likely to occur for the drug product and its manufacturingprocess. Quality assurance staff should review the library of defective samples and compare the samples to established standards for proper classification. Thelibrary should contain examples from the lower limits of visual detectiondetermined in the threshold studies. If a new particulate matter defect isidentified, it should be analyzed to determine its source and added to thetraining library.

對于人員確認(rèn)和自動檢查系統(tǒng)的驗(yàn)證，應(yīng)使用合格的注射產(chǎn)品單元和含有可見顆粒的缺陷單元的混合作為測試集（Melchore 2011）。該測試集應(yīng)由質(zhì)量保證人員準(zhǔn)備和批準(zhǔn)。制造商應(yīng)從整個產(chǎn)品生命周期中收集的缺陷樣品、為模擬生產(chǎn)缺陷而創(chuàng)建的樣品或?yàn)榇硭幤芳捌渲圃爝^程中可能發(fā)生的顆粒類型而購買的樣品中開發(fā)缺陷庫。QA人員應(yīng)審核缺陷樣品庫，并將樣品與已建立的標(biāo)準(zhǔn)進(jìn)行比較，以便進(jìn)行適當(dāng)?shù)姆诸悺Ｔ撊毕輲鞈?yīng)包含閾值研究中確定的視覺檢測下限的示例。如果發(fā)現(xiàn)新的顆粒缺陷類型，應(yīng)對其進(jìn)行分析以確定其來源并將其添加到培訓(xùn)庫中。

Typically, the percentage of defectiveunits in a test set should not exceed 10–20 percent, and the test set quantitiesshould be sufficient to provide an adequate degree of confidence in the test results.Trained inspectors should review defective units before they are included inthe test set to determine if the visible particulates in them can be detectedunder normal conditions, and the identity of defective units should be maskedto test subjects. The quality unit should control the test sets to ensure thatqualification tests are not manipulated or biased.

通常，測試集中缺陷單元的百分比不應(yīng)超過10–20%，并且測試集數(shù)量應(yīng)足以在測試結(jié)果中提供足夠的置信度。經(jīng)培訓(xùn)的檢查人員應(yīng)在缺陷單元納入測試集之前對其進(jìn)行檢查，以確定在正常條件下是否可以檢測到其中的可見顆粒，并且應(yīng)向測試對象掩蓋缺陷單元的身份。質(zhì)量部門應(yīng)控制測試集，以確保確認(rèn)測試不受操縱或偏頗。

The quality unit should also establish andapprove qualification protocols that identify the sample test sets, testduration, grading method for test results, documentation of test results,acceptance criteria for certification, and actions to be taken for testfailures. The protocols should also specify requalification testing methods andfrequency.

質(zhì)量部門還應(yīng)建立和批準(zhǔn)確認(rèn)方案，以確定樣品測試集，測試持續(xù)時間，測試結(jié)果的分級方法，測試結(jié)果的文件，認(rèn)證的接受標(biāo)準(zhǔn)以及測試失敗應(yīng)采取的行動。方案還應(yīng)規(guī)定再確認(rèn)測試的方法和頻率。