Tag: Batch production and control record

According to Good Manufacturing Practices (GMP), every batch of a drug product must have a comprehensive record. This critical document, known as the **Batch Production and Control Record (BPCR)**, ensures product quality, safety, and regulatory compliance throughout the manufacturing process.

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.