ICHQ中英文对照

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.

2.14 The persons authorized to release 门，同时履行质量保证(QA)和质量控制 (QC)的职责。依照组织机构的大小，可以是分开的QA和QC部门，或者只是一个人或小组。

2.14 应当指定授权发放中间体和原料药的人intermediates and APIs should be specified.

2.15 All quality-related activities should be recorded at the time they are performed.

2.16 Any deviation from established procedures should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented.

2.17 No materials should be released or used before the satisfactory completion of evaluation by the quality unit(s) unless there are appropriate systems in place to allow for such use (e.g., release under quarantine as described in Section 10 or the use of raw materials or intermediates pending completion of evaluation).

2.18 Procedures should exist for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g., quality-related complaints, recalls, and regulatory actions).

2.2 Responsibilities of the Quality Unit(s) 2.20 The quality unit(s) should be involved in all quality-related matters.

2.21 The quality unit(s) should review and approve all appropriate quality-related documents.

2.22 The main responsibilities of the independent quality unit(s) should not be

员。

2.15 所有有关质量的活动应当在其执行时就记录。

2.16 任何偏离既定规程的情况都应当有文字记录并加以解释。对于关键性偏差应当进行调查，并记录调查经过及其结果。

2.17 在质量部门对物料完成满意的评价之前，任何物料都不应当发放或使用，除非有合适的系统允许此类使用（如10.20条款所述的待检情况下的使用，或是原料或中间体在等待评价结束时的使用）。

2.18 应当有规程能确保公司的责任管理部门能及时得到有关药政检查、严重的GMP缺陷、产品缺陷及其相关活动（如质量投诉，召回，药政活动等）的通知。

2.2质量部门的责任

2.20 质量部门应当参与所有与质量有关的事物。

2.21 所有与质量有关的文件应当由质量部门审核批准。

2.22 独立的质量部门的主要职责不应当委派给他人。这些责任应当以文字形式加以说明，

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 company 2. Establishing a system to release or reject

raw materials, intermediates, packaging, and labeling materials

3. Reviewing completed batch production and

而且应当包括，但不限于： 1. 所有原料药的放行与否。用于生产商控制

范围以外的中间体的放行与否； 2. 建立一个放行与拒收原材料、中间体、包

装材料和标签的系统； 3. 在供销售的原料药放行前，审核已完成的

关键步骤的批生产记录和实验室检验记录；

4. 确保已对重大偏差进行了调查并已解决； 5. 批准所有的规格标准和主生产指令； laboratory control records of critical process steps before release of the API for distribution

4. Making sure that critical deviations are

investigated and resolved

5. Approving all specifications and master

production instructions

6. Approving all procedures affecting the

quality of intermediates or APIs

7. Making sure that internal audits

(self-inspections) are performed

8. Approving intermediate and API contract

manufacturers

9. Approving changes that potentially affect

intermediate or API quality

10. Reviewing and approving validation

protocols and reports

11. Making sure that quality-related complaints

are investigated and resolved

12. Making sure that effective systems are used

for maintaining and calibrating critical equipment

13. Making sure that materials are

appropriately tested and the results are reported

14. Making sure that there is stability data to

support retest or expiry dates and storage conditions on APIs and/or intermediates, where appropriate

15. Performing product quality reviews (as

defined in Section 2.5)

2.3 Responsibility for Production Activities The responsibility for production activities should be described in writing and should

6. 批准所有可能影响原料药和中间体质量

的规程；

7. 确保进行内部审计（自检）；

8. 批准中间体或原料药的委托生产商； 9. 批准可能影响到中间体或原料药质量的

变更；

10. 审核并批准验证方案和报告； 11. 确保调查并解决质量问题的投诉；

12. 确保用有效的体系来维护和校验关键设

备；

13. 确保物料都经过了适当的检验并报告结

果；

14. 确保有稳定性数据支持中间体或原料药

的复验期或有效期和储存条件； 15. 开展产品质量审核（详见2.5节）。

2.3生产作业的职责

生产作业的职责应当以文字形式加以说明，并应当包括，但不限于以下内容：

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 procedures

2. Producing APIs and, when appropriate,

intermediates according to pre-approved instructions

3. Reviewing all production batch records and

ensuring that these are completed and 1. 按书面程序起草、审核、批准和分发中间

体或原料药的生产指令；

2. 按照已批准的指令生产原料药或者中间

体；

3. 审核所有的批生产记录确保其完整并有

签名；

4. 确保所有的生产偏差都已报告、评价，对

关键的偏差已做了调查，并记录结论； 5. 确保生产设施的清洁，必要时要消毒； 6. 确保进行必要的校验，并有记录；

signed

4. Making sure that all production deviations

are reported and evaluated and that critical deviations are investigated and the conclusions are recorded

5. Making sure that production facilities are

clean and, when appropriate, disinfected 6. Making sure that the necessary calibrations

are performed and records kept

7. Making sure that the premises and

equipment are maintained and records kept 8. Making sure that validation protocols and

reports are reviewed and approved

9. Evaluating proposed changes in product,

process or equipment

10. Making sure that new and, when

appropriate, modified facilities and equipment are qualified

2.4 Internal Audits (Self Inspection)

2.40 To verify compliance with the principles of GMP for APIs, regular internal audits should be performed in accordance with an approved schedule.

2.41 Audit findings and corrective actions should be documented and brought to the attention of responsible management of the firm. Agreed corrective actions should be completed in a timely and effective manner.

2.5 Product Quality Review

2.50 Regular quality-reviews of APIs should be conducted with the objective of verifying the consistency of the process. Such reviews should

7. 确保对厂房和设备进行保养，并有记录； 8. 确保验证方案和报告的审核与批准； 9. 对产品、工艺或设备拟作的变更进行评

估；

10. 确保新的或已改进的生产设施和设备经

过了确认。

2.4内部审计（自检）

2.40 为确实符合原料药GMP原则，应当按照批准的计划进行定期的内部审计。

2.41 审计结果及整改措施应当形成文件，并引起公司责任管理人员的重视。获准的整改措施应当及时、有效地完成。

2.5产品质量审核

2.50 原料药的定期质量审核应当以证实工艺的一致性为目的来进行。此种审核通常应当每年进行一次，并记录，内容至少应当包括：

normally be conducted and documented annually and should include at least:

● A review of critical in-process control

and critical API test results ● A review of all batches that failed to

meet established specification(s) ● A review of all critical deviations or

nonconformances and related investigations ● A review of any changes carried out to

● 关键工艺控制以及原料药关键测试

结果的审核；

● 所有不符合既定质量标准的产品批

号的审核；

● 所有关键的偏差或违规行为及有关

调查的审核；

● 任何工艺或分析方法变动的审核； ● 稳定性监测的审核； ● 所有与质量有关的退货、投诉和召回

的审核；

the processes or analytical methods ● A review of results of the stability

monitoring program ● A review of all quality-related returns,

complaints and recalls ● A review of adequacy of corrective

actions

2.51 The results of this review should be evaluated and an assessment made of whether corrective action or any revalidation should be undertaken. Reasons for such corrective action should be documented. Agreed corrective actions should be completed in a timely and effective manner.

3. PERSONNEL

3.1 Personnel Qualifications

3.10 There should be an adequate number of personnel qualified by appropriate education, training, and/or experience to perform and supervise the manufacture of intermediates and APIs.

3.11 The responsibilities of all personnel engaged in the manufacture of intermediates and APIs should be specified in writing.

3.12 Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GMP as it relates to the employee’s functions. Records of training should be maintained. Training should be

● 整改措施的适当性的审核。

2.51 应当对质量审核结果进行评估，并做出是否需要整改或做任何再验证的评价。此类整改措施的理由应当文件化。获准的整改措施应当及时、有效地完成。

3. 人员

3.1员工的资质

3.10 应当有足够数量的员工具备从事和监管原料药和中间体生产的教育、培训和/或经历等资格。

3.11 参与原料药和中间体生产的所有人员的职责应当书面规定。

3.12 应当由有资格的人员定期进行培训，内容至少应当包括员工所从事的特定操作和与其职能有关的GMP。培训记录应当保存，并应当定期对培训进行评估。