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483 Database inspector profile report Joel Hustedt 201907
| 频率
| 缺陷
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| 4
| [原] Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
[译] 确保无菌、防止药品微生物污染的操作规程未建立，编写和遵循。
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| 3
| [原] Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process．
[译] 确保无菌、防止药品微生物污染的操作规程未包括灭菌过程的验证。
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| 3
| [原] Equipment used in the manufacture, processing packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
[译] 用于制造，加工，包装或保存药品的设备的设计不合适，不便于其使用、清洁和维护操作。
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| 2
| [原] Written production and process control procedures are not followed in the execution of production and process control functions.
[译] 在执行生产和工艺控制功能时未遵循SOP和工艺控制规程。
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| 2
| [原] Reprocessing was performed without the review of the quality control unit.
[译] 在质量控制部门未审查的情况下进行返工处理。
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| 2
| [原] There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
[译] 没有关于生产和工艺控制的书面规程，以确保药品具有其所称或表明拥有的成分，规格， 质量和纯度。
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| 2
| [原] The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
[译] 未制订并遵守适用于质量控制部门的书面的职责与操作规程。
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| 2
| [原] Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
[译] 没有建立控制规程来验证那些可能导致中间体和药品特性变化的生产工艺。
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| 2
| [原] Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
[译] 对一批或其任一原辅料未能满足其质量标准进行调查的书面记录，存在未包括结论和后续行 动的情况。
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| 2
| [原] Deviations from written specifications are not justified.
[译] 与书面规程存在不合理偏差。
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| 2
| [原] Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
[译] 设备和器具没有按适当时间间隔进行维护，以防止改变药品的安全性，成分，规格，质 量或纯度的污染。
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| 2
| [原] Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
[译] 用于生产，加工，包装或保存药品的设备（包括器具）的清洁和维护，没有遵循书面规程。
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| 2
| [原] Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
[译] 用于药品放行的检测未包含恰当的、确定其满足最终质量标准的实验结果，就进行放行。
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| 2
| [原] Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
[译] 对一批或其任一原辅料未能满足其质量标准的，没有继续调查同一药品的其他批次。
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