Understanding the Role of Batch Production and Control Records: What is BPCR in Pharma?
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4 min read
Under Title 21 of the Code of Federal Regulations (CFR), pharmaceutical manufacturers must maintain meticulous records for every drug batch produced [1.3.2, 1.3.3]. Central to this is understanding: **what is BPCR in pharma?** It stands for the Batch Production and Control Record, a cornerstone of quality and regulatory adherence.