Glossary
Batch Packaging Record (BPR)
What is Batch Packaging Record (BPR)?
Batch Packaging Record is a document that specifically provides detailed overview of the packaging process of certain product batches. This includes details such as the equipment to be used, the packaging instructions and materials, quality control checks, deviations and so on.
How can it streamline the packaging task?
A batch packaging record system can streamline the packaging of product batches by providing clear instructions and guidelines. This standardizes the process and helps in regulatory compliance. By recording the packaging regulations, error free operations can be executed.
What regulations BPR needs to comply with?
Batch Packaging Record should follow US FDA & EMA regulations, Good Manufacturing Practices (GMP) and GAMP guidelines, etc. These ensure that BPRs are up to the mark for retaining proper product quality, safety and packaging.
What are its alternatives?
Alternatives of Batch Packaging Record System are Electronic Batch Records (EBR), Paper Batch Records and Manufacturing Execution System (MES).
