Pharmaceutical Manufacturer - Malcom Associates
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Pharmaceutical Manufacturer


Pharmaceutical Manufacturer

Remediation – Regulatory Closure

Client Situation

  • Compliance expertise needed to address remediation commitments.
  • Customer complaints and product field recalls.
  • Equipment set-up procedures and Batch Records not sufficiently robust.
  • Lack of equipment set-up instructions, critical parameters, and tolerances.
  • Need to enhance equipment accept/reject challenges.
  • Need to develop yield specifications for all Batch Records.

Key Issues and Internal Barriers

  • Additional efforts to validate the equipment and associated product specifications extending overall remediation timeline.
  • Lack of methodology, resources, time constraints, and priorities of other initiatives.
  • Inability of Production and QA to agree on what constitutes effective procedures and documentation for line clearance and line release for filling/packaging.

Client Strategic Objectives

  • Redesign the equipment set-up SOPs and Work Instructions and enhance inspection criteria and increase the frequency of more robust checks.
  • Improve the overall work flow in Batch Records and SOPs, define and clarify operator responsibilities and inspection requirements.
  • Research and summarize yield data and include in all Batch Records the appropriate yield specifications for each product/presentation produced.
  • Meet remediation commitments ahead of scheduled timeline.

Key Program Components

  • Work with mechanics to modify and enhance the equipment set-up activities, sequence of activities, critical parameters, change parts requirements, and components used.
  • Organize and simplify the SOP with “step-by-step” instructions to improve the set-up process, lists applicable set-up points, specifications, tolerances, ranges, challenges and verification.
  • Perform Line Trials to confirm the set-up process and finalize the SOPs for change control.
  • Add the necessary set-up information and critical parameters to the applicable Batch Records.
  • Data mining to develop accurate yield specifications.

Results and Improvements

  • Project completed on time and FDA letter of closure for commitments achieved ahead of schedule.
  • Developed 45 equipment set-up SOPs and associated Work Instructions for set-up, change parts requirements (cleaning and use), components used, parameters, specifications, tolerances, ranges, challenges and verification checks.
  • Added relevant equipment setup information and critical parameters to applicable Packaging Batch to ensure the equipment and line setup conforms to the specifications.
  • Modified over 280 Packaging Batch Records that;
    • Enhanced inspection criteria and frequency covering fill weight control, container sealing, and lot number and expiration date legibility.
    • Added additional challenges to comply with §211.68 to confirm that the automated equipment properly performs the specified operation.
    • Defined and enhanced inspection Pass/Fail criteria and action to take if a criterion is not met.
    • Improved line release and line clearance procedures and provided training to line leads and QA personnel on how to effectively perform line clearances.

As a result of Malcom’s remediation program, the client now has the necessary equipment setup instructions and Batch Records to ensure that the equipment setup and the packaging line operation will produce a quality product that meets specifications and customer expectations.

Client Quotes