Project Synopsis

Provide on-site process engineering commissioning and qualification support of an FDA regulated consumer health product manufacturing process.

Project Summary


The client, a world-wide leading supplier of consumer health and personal care products, was re-starting a batch mixing process at a northeastern U.S. FDA-regulated facility. Process Engineering Associates, LLC (PROCESS) was contracted to provide on-site engineering support as well as executing commissioning and qualification activities.  The following project tasks were executed:

  • Provided on-site review of the unqualified batch mixing process. Worked with client’s Engineering group to help ensure all the equipment, instrumentation, and control loops were specified and shown accurately on the Piping and Instrumentation Diagrams (P&IDs).
  • Completed the following activities for the batch mixing process as well as the supporting Clean Compressed Air (CCA) and United States Pharmacopeia – Purified Water (USP-PW) systems:
    • Developed User Requirement Specifications (URS) including Critical Quality Attributes (CQA), Critical Process Parameters (CPP), and General User Requirements.
      • Working with a cross-functional team, completed Critical Aspects Risk Assessment (CARA) and a Critical Aspects Design Review (CADR).
      • Updated a System Test Matrix (STM) to help ensure all applicable user requirements and critical aspects are tested against appropriate acceptance criteria.
      • Developed a Project Qualification Plan (PQP) to implement and integrate a risk-based approach to the specification, design, commissioning and qualification (C&Q), as well as acceptance and release phases of the batch mixing process.
      • Developed and executed the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) testing protocols. These protocols provide documented evidence that the system was installed in accordance with all established specifications, parameters, and applicable Standard Operating Procedures (SOP).
      • Generated a final PQP report summarizing results, documenting any deviations, and declaring the batch mixing process as successfully qualified and fit for intended use.

Industry Type

  • Personal Care Products Manufacturing

Utilized Skills

  • FDA process qualification engineering
  • Process commissioning support

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