Case Studies

In addition to the specific deliverables of the project at hand, for every engagement we strive to deliver two overriding benefits to our clients:

Meet Regulatory Directives

  • Encourage early adoption of technical advances by the pharmaceutical industry
  • Implementation of risk based approaches that focus on industry and agency attention to critical areas
  • Ensure that regulatory review, compliance and inspection policies are based on state-of-the-art pharmaceutical science

Meet Business Needs

  • Maintain profitability by facilitating the efficient and effective introduction and operation of facilities, processes and equipment

Here are a few examples of our work.

Case studies

Project: Start-up of a 240,000 square foot manufacturing plant, one 368,000 square foot manufacturing plant and a 56,000 square foot central utilities building for a biologics manufacturer.

Scope of work: Qualification (IQ, OQ, CIP PQ and SIP PQ) of various pieces of clean utility equipment and manufacturing systems such as WFI, clean steam, process air, CO2, N2, O2, USPW, clean compressed air, autoclaves, glass/parts washers, temperature control units (freezers and refrigerators), HVAC, buffer preparation and hold tanks, media preparation and hold tanks, production and seed bioreactors, UF/DF harvest system, and purification (chromatography skids, UF/DF skids).

ICQ contribution: Consulting, guidance, planning, scheduling and generation and execution of integrated C&Q and validation protocols and plans. ICQ adhered to the client’s site-specific company procedures and policies, while defining a portfolio of projects, necessary resources, critical dependencies and timeline to achieve future state vision.
Project: Write and/or revise all site Engineering Procedures; full site C&Q Program, employing industry standards to help remediate consent decree initiatives.

Scope of work: Manage the development and generation of the client’s engineering project; program standard operating procedures (SOPs), detailing the project lifecycle from basis of design to detailed design, through commissioning and qualification.

ICQ contribution: ICQ delivered SOP documents and a detailed outline for an integrated commissioning and qualification approach. These SOPs are at various stages of approval and with the help of ICQ, the client has begun to implement the approach across the organization. ICQ defined a portfolio of projects, necessary resources, critical dependencies and timeline to achieve future state vision.
Project: Project management and individual contributor resources for client’s Facility Expansion Project.

Scope of work: The project scope included both upstream and downstream equipment and processes validation.

ICQ contribution: Consulting, guidance, planning, scheduling and generation and execution of integrated C&Q and validation protocols and plans—including the Process Validation plan. ICQ adhered to the client’s site-specific company procedures and policies, and defined a portfolio of projects, necessary resources, critical dependencies and timeline to achieve future state vision.
Project: $20MM project to install, start-up, commission and qualify a new process train and utility improvements in an existing 59,000 square foot cell culture facility.

Scope of work: Commissioning and qualification of: sterile media feed, seed reactor, bioreactor, harvest vessel, and base addition vessel; microfiltration skid, chromatography column, chromatography skid, eluate vessel, and cold room; 2,500 square foot new Grade D clean room for solvent handling, multiple buffer prep/hold vessels, cold room, column master mover, qualification skid, slurry packing skid and slurry vessel; RODI distribution, HWFI distribution, AWFI distribution, process waste system, two CIP skids and distribution changes to facilitate improved cleaning, mixed gases redundancy, two CIP skids and distribution, RODI generation skid; process waste lift system, mixed gases system, utility sampling improvements.

ICQ contribution: Installation and startup was completed in seven weeks, with qualification completed through final report closures four weeks later. 237 protocols were written, approved, executed, post-approved and closed during this time frame with 72 protocols completed in a single month. Total project qualification effort was completed significantly ahead of target, resulting in a savings to the client of nearly $20 million—a recovery of about two-thirds the total project capital cost!
Project: Project execution and support of a biologics facility start-up.

Scope of work: Commissioning and qualification of manufacturing suites and associated equipment for solution preparation, formulation, cryopelletization, lyophilization, and filling/packaging of a bulk pharmaceutical product; also included clean and dirty utilities, warehouse, lab, office and mechanical space.

ICQ contribution: Guidance, planning, scheduling and generation and execution of integrated C&Q and validation protocols and plans—including the Process Validation plan. ICQ adhered to the client’s site-specific company procedures and policies, and defined a portfolio of projects, necessary resources, critical dependencies, and timeline to achieve future state vision.