Life within an API manufacturer can be characterized as dynamic, fluid and fast paced.  Projects may include large capital projects for the installation of new equipment or remodeling/repurposing of existing equipment and spaces.  Alternatively, projects may consist of minor piping changes, equipment additions, decommissioning, repairs, pump replacements, solvent additions, pack-out equipment, and facility upgrades.   Examples of the types of project Performance Validation has supported within the API Space at one manufacturer include:

  • 354 Small Upgrade, Repair, and Product/Process Enabling Projects (<$250K).
  • 29 Large Capital Projects (>$250K).
  • 113 Utility Improvement Projects.
  • 54 Tank and Pressure Filter (SDNF) Replacements Projects.
  • 48 Instrument and Controls Upgrade Projects.
  • 45 Solvent Recovery Division Projects.
  • 31 Safety Improvement Projects.
  • 17 Milling and Micronizing Projects.

In many cases project needs are identified, approved, executed, and completed in a comparatively short time frame.  Projects have to be accurately estimated for both scope and effort and need to be completed with minimal downtime to reduce the impact to production.  Additionally, the facility needs to remain “audit-ready” at all times, no matter the number of on-going projects or the states of completion of those projects.

The Solution

To address these challenges, Performance Validation provides an embedded team of highly-skilled, well-trained Engineers and Specialists focused on supporting our API clients with continuous, one-stop Verification support for the entire API production area.  By providing a dedicated embedded team, Performance Validation not only understands the client’s policies and procedures used to perform the verification work but can institutionalize our intrinsic knowledge and experience gained from execution of these projects.  This combination allows the team to complete the 100+ API Verification projects performed each year on-time and under-budget.

The Results

Performance Validation is continuously completing fast-paced and complex API capital projects on-time and within budget.  The API facilities are frequently subjected to audits: FDA, international regulatory agencies, and internal audits.  These audits have been completed with no major findings related to PVs work.  PV was instrumental in assisting the client with implementation of the ASTM E2500 Verification process and templates. With PV’s assistance the client is able to improve and expand their capabilities and capacities and remain competitive in the international API market.

The Benefits

Managing this volume of projects requires dedicated and specialized professionals.  PV’s support gives our API client “peace of mind” that work will be completed and documented correctly.  PV is able to be the sole source provider for all API projects, regardless of the size, duration, or scope.  This allows our client to benefit from a consistency of project management and deliverable quality.  In addition to performing high-quality project work for our client, PV has built a relationship with our client that facilitates communication and collaboration. One such collaboration is the ongoing development of stream-lined, cost-effective services while still focusing on adding value and on preserving the product’s Strength, Identity, Safety, Purity, and Quality (SISPQ).

For additional information, please schedule a call with one of our subject matter experts.

John Underwood

Vice President, Michigan Division Director
Performance Validation, LLC

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