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Modern Architecture

New site preparation for FDA Pre Approval Inspection (PAI) 

Experienced - Qualified - Supportive

Magnifying glass, compass and pencil on

A European/Asian based injectable manufacturing company with production sites in Europe/Asia wanted to market their product in the United States.  There had never been a company in that country approved by the US FDA before.  Several competitive manufacturers applied but were unsuccessful in getting US FDA approval. The firm had eight injectable ANDAs in development and wanted to obtain approval for the US marketplace.


The design of the site and movement of material, personnel, product, and waste was not in compliance with the respective regulations. The QA and operation team lacked ample experience and knowledge to remediate and  manage the challenges presented for the task. 


The QMS was severely fragmented.  The manufacturing processes, equipment and operational aspects were not in compliance with the applicable regulations.


An ICS Maven Senior Associate was assigned the task of identifying , managing , remediating the issues, and supporting the firm in attaining the approvals both for the site and the products.


The preparation and execution of the project was planned and executed as following steps:


  • A detailed baseline assessment was performed by the Associate.

  • Evaluated the sites design, configuration of facilities, equipment, and utilities installation, structures and qualification.

  • Investigated the manufacturing processes and assessed the raw material suppliers.

  • Presented the finding to the site and corporate management along with an overall remediation plan that included step by step list of corrective actions.



  • For each task we identified a lead from our associates along with the company counterpart to be accountable for organizing and supporting the activities as per our plan. 

  • Identified the interdependencies for every aspect of the project, and synchronized the timing to assure uninterrupted forward movement without any delay and minimal compromise.

  • Prepared a project schedule, a respective dashboard, and identified an internal project administrator.

  • Scheduled weekly update for both the site and corporate executives.

  • Established a firm process on how to deal with unanticipated hinderances and delays.

  • Trained every individual who worked within the project on their respective tasks.



  • Evaluated qualification packages (IQ, OQ, PQ and CSVs)

  • Drafted a new VMP for Facilities, equipment, and Utilities (FEU), the computerized systems, and  the QC laboratories.

  • Augmented and/or reissued all qualification protocols, executed them accordingly and prepared new reports.

  • Redesign the plant material, personnel, product, and waste movement throughout the site. Prepare the respective procedures, flow diagrams and dispensed the necessary training.

  • Advised and worked with the process engineers to redesign the manufacturing processes.

  • Audited the raw materials suppliers, assisted the companies to requalify the equipment, processes as deemed necessary, selected backup suppliers and qualified them accordingly. 

  • Designed a comprehensive Quality Management System for the corporation and implemented it at the site.

  • Prepared and upgraded all procedures specifically in relation to manufacturing QA, QC, Maintenance, Engineering, and Warehouse management, including those Quality Events (Deviation, OOS, Change Control, Complaints CAPA, etc.)

  • Prepared new process validation protocols and successfully validated the manufacturing processes.

  • Performed a comprehensive data Integrity assessment of the development data and QC documentation.

  • Assess the cold chain management, redesign/ requalified the processes, the shipping containers, and shipping routes.

  • Reviewed the filling dossier, cleaned up the BLAs.

  • Accompanied the RA and company executives during meetings with the FDA. Presented the sites, the newly implemented QMS and manufacturing processes.

  • Answered all FDA questions related to our activities.

  • Implemented an environmental monitoring system.

  • Redesigned the calibration program; applied it to all instruments, equipment and gauges throughout the site.

  • Implemented a formal companywide training program and applied it to each employee on tasks relevant to his/her position and role.



  • Hosted the FDA PAI inspection.

  • Successfully passed the inspection with four small observations.

  • All four observations were remediated prior to the inspector’s departure and the site was approved.


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