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BATCH PRODUCTION RECORDS

Possibly the most important facet of any GMP production operation is a robust and thorough batch production record system.  It is through batch production records that a company is ultimately able to control, document, trace, and guide the manufacturing process.

For a batch production record to meet GMP guidelines, several components must be incorporated at every step.  These include things such as good documentation practices, lot and batch traceability, equipment and calibration record, verification check points, and other regulatory requirements. 

Compliance Naturally uses user-friendly formats and critical control point analysis to ensure batch production records meet all requirements while simultaneously aiding production and maximizing throughput. 

It's through these batch records that each company is able to create repeatability and control in the manufacturing process in order to produce a consistent product. 

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bATCH PRODUCTION RECORD SERVICES INCLUDE:

  • RESEARCH DOCUMENTATION

  • DRAFTING AND CREATION

  • IMPLEMENTATION

  • OVERSIGHT

  • REVIEW AND ARCHIVAL

  • TRACEABILITY PROCEDURES

  • ETC.