Documentation Guidance | Malcom Associates
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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.

The establishment of production Batch Record guidelines will:

 

  • Improve overall data integrity
  • Facilitate agreement and harmonization across departments
  • Along with Batch Record simplification, support compliance with ALCOA guidelines (attributable, legible, contemporaneous, original, accurate)
  • Define procedural elements and data that are essential to determining product quality
  • Ensure standard document format and uniform, consistent documentation content
  • Provide a rational for the examination of SOP references found in a Batch Record to confirm if the reference is valid for the task stated
  • Establish consistent documentation ‘best practices’
  • Outline cGMP requirements for documenting process(es)
  • Include internal company requirements and commitments
  • Provide consistent training on the rules and justification for documenting the process
  • Simplify the creation of new or revised documents
  • Simplify new product introduction, tech transfer and product transfer process, and implementation of EBR/MES
  • Support transparency between Operations and Quality units

And:

  • Can be used as a model for guidelines in other areas (labs, label issuance, Batch Record Release, etc.)
  • Is often used as a remediation tool to address regulatory commitments

When we develop your guidelines, the following are assessed:

Data

  • What production data is necessary? i.e., CMC requirements/specifications.
  • What data is required by CFR/cGMP?
  • What data is required by site and/or corporate SOP?
    • Can these ‘requirements’ be challenged?
    • Are they reasonable for the specific task or application?
  • Is data recorded, but no specification stated? i.e., how to handle For-Information-Only data?
    • Is there a validated specification?
    • Does the information belong in the batch record?
    • Should the data-gathering be the subject of a protocol or log?
    • Should the protocol or log have a defined end-date/life?
    • Should a report of the results of the data-gathered be required?
  • Equipment ID and calibration due dates:
    • Is calibration data already checked and documented in other documentation such as equipment logs?
    • Is equipment stationary and only allocated to one room?

Data Entry - Who, When, Where

  • Who records the data? (i.e., roles)
  • Where and when is the data recorded?
  • Where and when is the entry signed-off?
  • Is a verification of the entry to assure accuracy necessary?
  • Who performs the verification? (i.e., roles)
  • Where and when is the verification signed-off?

Data Entry - Mechanics of documenting data

  • How to record dates?
  • How to record ranges?
  • How many times must a single piece of data be recorded?
  • How to format/display formulas and calculations?
  • How to identify significant digits or specify decimal position requirements?

Second Checks

  • When are 2nd signatures required? (i.e., ‘verify Line Clearance’)
  • Does a verification of a past event require a 2nd signature? 
  • How are significant steps defined?
    • Does each action/step within a task need to be signed off?
    • Can steps be grouped into logical unit operations to minimize the numbers of signatures and/or system transactions?
  • Difference between verified and witnessed?

These guidelines will also:

  • Provide for a standard document format that ensures uniform and consistent content (i.e., a format that clearly identifies specification and signature requirements).
  • Provide a rational for the examination of SOP references found in a production batch record to confirm that the reference is valid for the task and meets cGMP and quality standards.
  • Establish Good Documentation Practices (GDP) ‘best practices’ if not defined in site SOPs.

To learn more about Batch Record Guidance and Good Documentation Practices Contact Us.