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Home Uncategorized GMP requires that the records of all raw materials and packaging materials should be kept for at least a few years after the shelf life of the batch

GMP requires that the records of all raw materials and packaging materials should be kept for at least a few years after the shelf life of the batch

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GMP provisions stipulate that each batch of drugs shall have batch records, including batch production records, batch packaging records, batch inspection records, drug release audit records and other records related to this batch of products. Batch records shall be managed by the quality management department and kept for at least one year after the expiration date of the drug. Other important documents such as quality standards, process procedures, operating procedures, stability investigation, confirmation, verification and change shall be kept for a long time
therefore, it is the safest way to keep general records consistent with batch records. Generally, prosecutors will not ask questions in this regard, so it is OK to keep them until they are valid for one year. The usual domestic practice is the same.

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