Shire (Now Takeda) Case Study

Expertise and the Staff to Implement

Shire (Now Takeda) Case Study

Expertise and the Staff to Implement

Shire (case study heading image)

Shire Project Highlights

  • Biotech Manufacturing Facility
  • Lexington, MA
  • 2014: Comprehensively assessed and redeveloped AIQ and CQV programs to address audit shortcomings without interrupting ongoing production schedules
  • Achieved compliance and greater efficiencies with a consistent, methodical approach
  • Generated comprehensive Validation Master Plans for each manufacturing facility
Shire Case Study - Expertise and the Staff to Implement
Shire (case study heading image)

Shire Project Highlights

  • Biotech Manufacturing Facility
  • Lexington, MA
  • 2014: Comprehensively assessed and redeveloped AIQ and CQV programs to address audit shortcomings without interrupting ongoing production schedules
  • Achieved compliance and greater efficiencies with a consistent, methodical approach
  • Generated comprehensive Validation Master Plans for each manufacturing facility

Success can create its own set of challenges. Through in-house R&D and strategic acquisitions, this client became a global force, commercializing a series of transformative biologics for rare diseases that simultaneously saved lives, fueled corporate growth, and strained some of the company’s manufacturing procedures.

At their Massachusetts facility, the validation and quality teams do outstanding work. So they understood the magnitude of the challenges they faced after a regulatory audit illuminated several areas that needed attention.

To assist, the company engaged ICQ to provide the expertise and resources needed to ensure compliance and improve procedures, all while working in real time, with live product in production.

“ICQ was instrumental in the development of our CQV and AIQ programs, from providing leadership and guidance of the high-level principles and procedures, to the actual generation of standard operating procedures.”

Former Senior Director of Validation, Shire

“These programs and procedures provided compliance and efficiencies as well as a consistent approach and methodology. Additionally, ICQ generated comprehensive site Validation Master Plans which outlined our CQV strategy and documentation for each of our manufacturing facilities.”

Former Senior Director of Validation, Shire

“These programs and procedures provided compliance and efficiencies as well as a consistent approach and methodology. Additionally, ICQ generated comprehensive site Validation Master Plans which outlined our CQV strategy and documentation for each of our manufacturing facilities.”

Former Senior Director of Validation, Shire

A multi-year project ensued, led by ICQ Principal Michael Gatta, focused on a comprehensive assessment and redevelopment of the company’s Analytical Instrument Qualification (AIQ) and Commissioning, Qualification, and Validation (CQV) programs. Multidisciplinary teams from ICQ worked on the rolling engagement, first assessing the operating status quo, then crafting new plans and writing the myriad of standard operating procedures (SOPs) needed.

As many as 25 people from ICQ were stationed at the company for months at a time to provide the extra hands on deck needed to finalize and implement the new programs. Over time, all the audit findings were satisfactorily addressed and improved programs created without interrupting any production schedules.

“It’s all about developing the right plans and procedures, classifying and assessing systems properly, then getting everyone working to those plans. You want to be able to show that you are better today than you were yesterday, and you have a sustainable program in place that is tied to the relevant regulations.”

Michael Gatta, Principal, ICQ