【文章內(nèi)容簡介】 0。質(zhì)量管理體系應(yīng)當(dāng)包括組織機構(gòu)、規(guī)程、工藝和資源，以及確保原料藥會符合其預(yù)期的質(zhì)量與純度要求所必需的活動。所有涉及質(zhì)量管理的活動都應(yīng)當(dāng)明確規(guī)定，并使其文件化。 There should be a quality unit(s) that is independent of production and that fulfills both quality assurance (QA) and quality control (QC) responsibilities. The quality unit can be in the form of separate QA and QC units or a single individual or group, depending upon the size and structure of the organization. 應(yīng)當(dāng)設(shè)立一個獨立于生產(chǎn)部門的質(zhì)量部門，同時履行質(zhì)量保證(QA)和質(zhì)量控制 (QC)的職責(zé)。依照組織機構(gòu)的大小，可以是分開的QA和QC部門，或者只是一個人或小組。 The persons authorized to release intermediates and APIs should be specified. 應(yīng)當(dāng)指定授權(quán)發(fā)放中間體和原料藥的人員。 All qualityrelated activities should be recorded at the time they are performed. 所有有關(guān)質(zhì)量的活動應(yīng)當(dāng)在其執(zhí)行時就記錄。 Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented. 任何偏離既定規(guī)程的情況都應(yīng)當(dāng)有文字記錄并加以解釋。對于關(guān)鍵性偏差應(yīng)當(dāng)進(jìn)行調(diào)查，并記錄調(diào)查經(jīng)過及其結(jié)果。 No materials should be released or used before the satisfactory pletion of evaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (., release under quarantine as described in Section 10 or the use of raw materials or intermediates pending pletion of evaluation). 在質(zhì)量部門對物料完成滿意的評價之前，任何物料都不應(yīng)當(dāng)發(fā)放或使用，除非有合適的系統(tǒng)允許此類使用（，或是原料或中間體在等待評價結(jié)束時的使用）。 Procedures should exist for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (., qualityrelated plaints, recalls, and regulatory actions). 應(yīng)當(dāng)有規(guī)程能確保公司的責(zé)任管理部門能及時得到有關(guān)藥政檢查、嚴(yán)重的GMP缺陷、產(chǎn)品缺陷及其相關(guān)活動（如質(zhì)量投訴，召回，藥政活動等）的通知。 Responsibilities of the Quality Unit(s) The quality unit(s) should be involved in all qualityrelated matters. 質(zhì)量部門應(yīng)當(dāng)參與所有與質(zhì)量有關(guān)的事物。 The quality unit(s) should review and approve all appropriate qualityrelated documents. 所有與質(zhì)量有關(guān)的文件應(yīng)當(dāng)由質(zhì)量部門審核批準(zhǔn)。 The main responsibilities of the independent quality unit(s) should not be delegated. These responsibilities should be described in writing and should include, but not necessarily be limited to:1. Releasing or rejecting all APIs. Releasing or rejecting intermediates for use outside the control of the manufacturing pany2. Establishing a system to release or reject raw materials, intermediates, packaging, and labeling materials3. Reviewing pleted batch production and laboratory control records of critical process steps before release of the API for distribution4. Making sure that critical deviations are investigated and resolved5. Approving all specifications and master production instructions6. Approving all procedures affecting the quality of intermediates or APIs7. Making sure that internal audits (selfinspections) are performed8. Approving intermediate and API contract manufacturers9. Approving changes that potentially affect intermediate or API quality10. Reviewing and approving validation protocols and reports11. Making sure that qualityrelated plaints are investigated and resolved12. Making sure that effective systems are used for maintaining and calibrating critical equipment13. Making sure that materials are appropriately tested and the results are reported14. Making sure that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates, where appropriate15. Performing product quality reviews (as defined in Section ) 獨立的質(zhì)量部門的主要職責(zé)不應(yīng)當(dāng)委派給他人。這些責(zé)任應(yīng)當(dāng)以文字形式加以說明，而且應(yīng)當(dāng)包括，但不限于：1. 所有原料藥的放行與否。用于生產(chǎn)商控制范圍以外的中間體的放行與否；2. 建立一個放行與拒收原材料、中間體、包裝材料和標(biāo)簽的系統(tǒng)；3. 在供銷售的原料藥放行前，審核已完成的關(guān)鍵步驟的批生產(chǎn)記錄和實驗室檢驗記錄；4. 確保已對重大偏差進(jìn)行了調(diào)查并已解決；5. 批準(zhǔn)所有的規(guī)格標(biāo)準(zhǔn)和主生產(chǎn)指令；6. 批準(zhǔn)所有可能影響原料藥和中間體質(zhì)量的規(guī)程；7. 確保進(jìn)行內(nèi)部審計（自檢）；8. 批準(zhǔn)中間體或原料藥的委托生產(chǎn)商；9. 批準(zhǔn)可能影響到中間體或原料藥質(zhì)量的變更；10. 審核并批準(zhǔn)驗證方案和報告；11. 確保調(diào)查并解決質(zhì)量問題的投訴；12. 確保用有效的體系來維護(hù)和校驗關(guān)鍵設(shè)備；13. 確保物料都經(jīng)過了適當(dāng)?shù)臋z驗并報告結(jié)果；14. 確保有穩(wěn)定性數(shù)據(jù)支持中間體或原料藥的復(fù)驗期或有效期和儲存條件；15. 開展產(chǎn)品質(zhì)量審核（）。 Responsibility for Production Activities The responsibility for production activities should be described in writing and should include, but not necessarily be limited to:1. Preparing, reviewing, approving, and distributing the instructions for the production of intermediates or APIs according to written procedures2. Producing APIs and, when appropriate, intermediates according to preapproved instructions3. Reviewing all production batch records and ensuring that these are pleted and signed4. Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded5. Making sure that production facilities are clean and, when appropriate, disinfected6. Making sure that the necessary calibrations are performed and records kept7. Making sure that the premises and equipment are maintained and records kept8. Making sure that validation protocols and reports are reviewed and approved9. Evaluating proposed changes in product, process or equipment10. Making sure that new and, when appropriate, modified facilities and equipment are qualified 生產(chǎn)作業(yè)的職責(zé)應(yīng)當(dāng)以文字形式加以說明，并應(yīng)當(dāng)包括，但不限于以下內(nèi)容：1. 按書面程序起草、審核、批準(zhǔn)和分發(fā)中間體或原料藥的生產(chǎn)指令；2. 按照已批準(zhǔn)的指令生產(chǎn)原料藥或者中間體；3. 審核所有的批生產(chǎn)記錄確保其完整并有簽名；4. 確保所有的生產(chǎn)偏差都已報告、評價，對關(guān)鍵的偏差已做了調(diào)查，并記錄結(jié)論；5. 確保生產(chǎn)設(shè)施的清潔，必要時要消毒；6. 確保進(jìn)行必要的校驗，并有記錄；7. 確保對廠房和設(shè)備進(jìn)行保養(yǎng)，并有記錄；8. 確保驗證方案和報告的審核與批準(zhǔn)；9. 對產(chǎn)品、工藝或設(shè)備擬作的變更進(jìn)行評估；10. 確保新的或已改進(jìn)的生產(chǎn)設(shè)施和設(shè)備經(jīng)過了確認(rèn)。 Internal Audits (Self Inspection) （自檢） To verify pliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule. 為確實符合原料藥GMP原則，應(yīng)當(dāng)按照批準(zhǔn)的計劃進(jìn)行定期的內(nèi)部審計。 Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be pleted in a timely and effective manner. 審計結(jié)果及整改措施應(yīng)當(dāng)形成文件，并引起公司責(zé)任管理人員的重視。獲