物料效期管理

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只有经质量管理部门批准放行并在有效期或复验期内的物料方可使用。
物料要按照有效期或复验期贮存，贮存期内发现对质量有不良影响的特殊情况出现时应当及时复验。       

Only the materials approved and released by the quality management department and within the validity period or re-inspection period can be used.
The materials should be stored according to the validity period or the re-inspection period, and the re-inspection should be timely in case of any special circumstances found to have an adverse effect on the quality during the storage period.

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有效期：物料有效期是指物料被批准的使用期限，表示该物料在规定的贮存条件下能够保证质量的期限。
复验期：物料复验期是指物料贮存一定时间后，为确保其仍适用于预定用途，由企业确定的需重新检验的日期。

Validity period: The material validity period refers to the approved use period of the material, indicating the period during which the material can guarantee the quality under the specified storage conditions.
Re-inspection period: The material re-inspection period refers to the date when the material needs to be re-inspected to ensure that it is still suitable for the intended use after the material has been stored for a certain period of time.

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无有效期的物料，应根据物料性质及历史数据分析或稳定性实验结果确定复验期。
超过有效期的物料不可继续使用；超过复验期的物料，按规定复验合格后可继续使用。
物料不可无限制地复验，复验次数原则上不得超过2次。
严格按规定条件贮存的物料，在有效期内可以不进行复验。
包装材料可以根据物料的特性、贮存条件、物料关键质量属性的影响因素或稳定性试验数据确定复验期。内包材的复验期管理参照原辅料管理，外包材的复验期管理以不影响使用为原则。

For materials with no validity period, the re-inspection period should be determined according to the material properties and historical data analysis or stability test results.
Materials that exceed the validity period cannot be used continuously; materials that exceed the re-inspection period can continue to be used after passing the re-inspection according to regulations.
Materials cannot be re-inspected unlimitedly, and the number of re-inspections shall not exceed 2 times in principle.
Materials stored in strict accordance with the specified conditions may not be re-inspected within the validity period.
For packaging materials, the re-inspection period can be determined according to the characteristics of the material, storage conditions, factors affecting the key quality attributes of the material, or stability test data. The management of the re-inspection period of the inner packaging material shall refer to the management of the raw and auxiliary materials, and the management of the re-inspection period of the outer packaging material shall be based on the principle of not affecting the use.

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有效期及复验期确定：
有效期：执行物料生产企业标签标示有效期（即法定有效期）。
复验期：
（1）有有效期的物料：在有效期内确定复验期，复验期不得超过有效期。
（2）无有效期的物料：可根据科学数据，必要时结合稳定性研究的结果来确定物料的复验期。
（3）通常情况物料复验期以该物料有效期届满前3个月内为宜。

The validity period and re-inspection period are determined:
Validity period: Execute the material production enterprise label to indicate the validity period (that is, the legal validity period).
Retest period:
(1) Materials with an expiration date: The re-inspection period is determined within the expiry date, and the re-inspection period shall not exceed the expiry date.
(2) Materials with no validity period: The re-inspection period of materials can be determined based on scientific data and, if necessary, the results of stability studies.
(3) Usually, the material re-inspection period is within 3 months before the expiration date of the material.

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处理程序
经检验合格进库的物料，在规定的贮存条件下，有效期（或复验期）内，按规定复验期申请复验，由质检部负责检验工作，复验合格后方可继续发放使用。
易变质、易受微生物污染的原辅料以及超过规定复验期限的原辅料，在领用前必须抽样复验合格后方可发放。
超过有效期的物料，不得继续使用，须按《不合格品管理规程》处理。
由于意外事故，如受潮、光照、外包装破损质量受影响的物料，低温贮存的物料发生意外情况，如断电、冷藏设备损坏等，应及时申请复验。若复验合格应尽快使用，若不能及时使用的应由仓库提出妥善保管措施，并由质量管理部门决定限期使用及范围，否则按《不合格品管理规程》处理。
对尚在有效期（或复验期）内，但已怀疑有质量问题的物料，使用前应复验，合格后方可使用。
在库原辅料、包装材料须按规定妥善保管，仓库保管员要做到先进先出、近期选出，尽量避免物料的积压。
复验合格的物料，应立即使用。
复验不合格的原辅料和包装材料，按《不合格品管理规程》处理。复验合格的物料应填报物料复验记录，并做好相应标示。
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The materials that have passed the inspection and entered the warehouse, under the specified storage conditions and within the validity period (or re-inspection period), apply for re-inspection according to the specified re-inspection period, and the quality inspection department is responsible for the inspection work, and can continue to be released and used after the re-inspection is passed.
The raw and auxiliary materials that are susceptible to deterioration and microbial contamination, as well as the raw and auxiliary materials that exceed the prescribed re-inspection period, must be sampled and re-inspected before they are used before they are released.
Materials beyond the validity period shall not continue to be used, and shall be handled in accordance with the "Management Regulations for Nonconforming Products".
Due to accidents, such as moisture, light, damaged outer packaging, materials whose quality has been affected, and materials stored at low temperature have accidents, such as power failure, damage to refrigeration equipment, etc., you should apply for re-inspection in time. If the re-inspection is qualified, it should be used as soon as possible. If it cannot be used in time, the warehouse should propose proper storage measures, and the quality management department will determine the use and scope within a time limit.
For materials that are still within the validity period (or re-inspection period), but have suspected quality problems, they should be re-inspected before use, and can only be used after passing the test.
The raw and auxiliary materials and packaging materials in the warehouse must be properly stored according to the regulations.
Materials that pass the re-inspection should be used immediately.
Unqualified raw and auxiliary materials and packaging materials shall be dealt with in accordance with the "Management Regulations for Unqualified Products". Materials that pass the re-inspection shall fill in the material re-inspection record and make corresponding labels.

njywps

学习了，谢谢分享

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njywps 发表于 2022-9-3 20:13
学习了，谢谢分享

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