Malcom Associates | Documentation Guidance
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Batch Record Guidance and Good Documentation Practices

Malcom’s Guidance for Good Documentation Practices and Master Batch Record Design ensures compliance with Batch Record documentation activities.  This structure for consistent batch record design improves overall data integrity, and reduces operator errors, exceptions, discrepancies, and investigations.

This Guidance document is used to develop, streamline, simplify and align the Master Batch Records and associated documentation.  The records addressed include all major manufacturing equipment and processes, industry ‘best’ good documentation practices, and facilitates compliance with cGMPs and other mandated requirements.

When the Guidance document concepts have been tested through the initial redesigned Master Batch Record(s), the document becomes the basis for redesigning and maintaining all manufacturing Batch Records within an organization.

Guidance for Good Documentation Practices and Master Batch Record Design

  • Defines procedural elements and data that are essential to determining product quality
  • Provides a standard document format
  • Provides a rational for the examination of SOP references found in a Batch Record to confirm that the reference is valid for the task and meets cGMP and quality standards
  • Ensures uniform and consistent documentation content
  • Establishes consistent documentation ‘best practices’
  • Outlines cGMP requirements for documenting process(es)
  • Includes internal company requirements and commitments
  • Simplifies the creation of new or revised documents
  • Simplifies new product introduction, tech transfer and product transfer process, and implementation of EBR/MES
  • Is often used as a remediation tool to address regulatory commitments