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Requirements for Batch Production Records

BayBiotech.NET
Batch Production Record is an example of a GMP document and is designed to standardize the process and provides with lot-specific information.
GMP Requirements for Batch Records are defined under following FDA regulations:
 Master Batch Record 21 CFR 211.188
 21 CFR 211.194—Laboratory Records
 21 CFR 211.194—Review by the Quality Control Unit
A batch production record must be established every time a batch is manufactured and must include the following:
Requirements for Laboratory Operations

•Establish and follow written procedures for laboratory operations
•Use adequate laboratory facilities
•Requirements for Laboratory control processes
•Methods for testing and examination
Requirements for Manufacturing Operations
•Establish and follow written procedures for manufacturing operations
•Ensure product specifications are consistent
•Adequate sanitation principles
•Prevent contamination
•Appropriate disposition of rejected or unsuitable dietary supplements
•Requirements for repackaging and relabeling
•Packaged and labeled supplements rejected for distribution
•Record Keeping
•Establish and follow written procedures for holding and distributing operations
•Requirements to hold components, supplements, packaging and labels
•Requirements for in-process materials
•Requirements for reserve samples
•Distribution requirements to protect against contamination and deterioration

The content produced here are part of the QA/Regulatory training taken from Kriger Research Center.

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