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batch record review

A Batch Record flow chart.

Alliance Quality Consulting will review batch records in a compliant and efficient manner including all documents that recorded all of the steps involved in the manufacturing, testing, and packaging of a batch of a pharmaceutical product. Batch records are essential for ensuring the quality and safety of pharmaceutical products, and they are subject to close regulatory scrutiny. 


Let us assist in:

 

  • Developing and implementing a batch record review procedure
  • Reviewing batch records for accuracy, completeness, and compliance
  • Identifying and addressing any discrepancies or omissions in batch records
  • Reporting batch record review findings to the regulatory authorities

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