Vaccine Manufacturer - Malcom Associates
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Vaccine Manufacturer


Vaccine Manufacturer

Batch Record Redesign & Simplification

Client Situation

  • High percentage of Batch Record errors and missing entries contributing to extended Product Release times.
  • Extended manufacturing and product release cycle times negatively impacting supply chain and profitability.
  • Client attempted internal effort for over 9 months with limited success, needed direction and guidance.
  • Needed a redesigned Batch Record to prepare for migration to Electronic Batch Record.

Key Issues and Internal Barriers

  • Past efforts to streamline and simplify Batch Records have not produced the expected and necessary results.
  • Resource, workload, time constraints, and priorities of other initiatives.
  • Lack of methodology and inability to get agreement between QA and manufacturing on what constituted ‘good documentation practices’.
  • Difficulty training new personnel quickly on documentation.

Client Strategic Objectives

  • Improve content, clarify work instructions, reduce Batch Record errors, make the documents user friendly, increase ‘right first time’ quality, and reduce Batch Record review and Product Release cycle times.
  • Develop and implement consistent documentation rules and industry best practices.

Key Program Components

  • Develop Guidance document to define documentation rules, best practices, and eliminate barriers between QA and manufacturing.
  • Redesign a Batch Record that ‘fits’ the actual process.
  • Reduce procedural errors and potential for errors.
  • Eliminate redundant and unnecessary data requirements, and forms.
  • Reduce Batch Record review and Product Release cycle times.
  • Reduce deviations and investigations.
  • Improve and reduce time to train new personnel.

Results and Improvements

  • Developed guidance and facilitated QA and manufacturing agreement to establish rules and consistent documentation practices across operations.
  • Reduced number of Batch Record pages by 15% and eliminated 40% of the redundant supplemental forms.
  • Reduced 22% of the data entries even after adding 10% additional data entries to address compliance issues.
  • Error rates and review cycle times reduced.
  • Eliminated redundant information, included clear, consistent identification of specifications to meet process requirements.

As a result of Malcom’s redesign initiative, the client expanded the new redesign and guidelines to the remaining business units and products.

Primary measurable results:

Client Quotes