FDA-oRIENTED
“Established since 1999”
GUERRA
consultinggroup,inc.™
REGULATORY COMPLIANCE SERVICES
GCGI's Compliance Investigation Unit (CIU) ™
resources
"The implementation of the unit resulted in zero FDA-483 objectionable observations during subsequent FDA inspections".
GCGI develops the organizational structure around which a Compliance Investigation Unit (CIU) is organized. This framework describes how members are accepted, how leadership is chosen and how decisions are made.
This branch will be responsible for consistent and thorough documentation of failure investigations and quality events in all cGMP activities.
GCGI will provide advice for timely resolution of investigation reports emphasizing on effective Corrective and Preventive Action Plans (CAPAs).
A Compliance Investigation Unit (CIU) allows a company to improve manufacturing process understanding and knowledge transfer during the resolution of failure investigations and quality events.
Company names, their logos and all their products, are registered trademarks of the corresponding company or its subsidiaries in the United States and other countries.
FACT
GCGI's Compliance Investigation Unit (CIU)™ has been implemented at:
What is a CIU?
Compliance
Investigation Unit
As the first step, GCGI will perform an evaluation of firm’s failure investigations and quality event system. Based on audit findings, recommendations will be provided how to best fit the Compliance Investigation Unit to the organization.
The second step involves the CIU implementation plan. The plan addresses the following topics:
guidelines
Implementing the CIU
Join the companies that have implemented GCGI's Compliance Investigation Unit (CIU)™.
"Dear Johnny:"
"I am writing this letter to thank you for your outstanding work in helping us succeed after receiving the FDA Warning Letter. You helped us at a very busy and critical time. Your regulatory and technical expertise and attention to detail were tremendously valuable resulting in zero (0) FDA-483 objectionable observations during the FDA follow-up inspection.
The implementation of GCGI’s THREE-TIER PROGRAM in FAILURE INVESTIGATIONS, GCGI’s Human Error Program and the development and implementation of a QA Compliance Investigation Unit (CIU) at our site really made a difference by changing our previous mindset into quality-oriented generating value and increased product revenues.
GCGI will provide clear guidelines for how the Compliance Investigation Unit (CIU) will proceed. The branch will have a structure matching its values to Company’s value.
GCGI will be involved in the following tasks:
- Advice on personnel selection providing identity to the people who will join the Unit, as well as to the group itself.
- Advice on work responsibilities and job descriptions for selected scientists, engineers and leaders.
organizational structure
Developed in 2009, GCGI's Compliance Investigation Unit (CIU)™ is a branch of the Quality Assurance Department responsible for ensuring the thorough and scientifically sound documentation of all cGMP manufacturing/ laboratory Failure Investigations and Quality Events. The Unit also gets involved in Process Excellence activities evaluating processes and systems in terms of how effectively and efficiently they create value to the company.
- How to compile information prior to the development of the investigation report.
- How to perform investigative activities including a thorough documentation of all events.
- How to effectively conduct personnel interviews within the scope of activities and functions of Human Resources and management.
- How to work with area approvers and/or reviewers to resolve questions and cGMP issues identified.
- How to identify and document scientific and technical data sources to be used in the investigation report.
- How to identify and document issues with raw data.
- How to determine data integrity issues when reviewing raw data.
- How to document investigation reports involving complex manufacturing and technical laboratory issues.
- How to document the investigation report complying with cGMP regulations and FDA guidance documents.
- How to thoroughly investigate all aspects of a Failure Investigation and/or Quality Event ensuring the proper identification and resolution of the root cause for both, main and side issues.
- How to make an assessment of product impact including recommendations of the implications of a quality event to upper management.
- How to identify and document Corrective and Preventive Actions (CAPAs).
- How to ensure CAPA effectiveness through tracking and trending investigation reports.
- How to perform quality metrics related to investigations, complaints and company’s quality and performance indicators from all cGMP areas.
- How to effectively interact the Unit with Process Excellence and Lean Six Sigma activities to improve process controls and to create value to the company.
Once scientists, engineers and leaders have been selected, GCGI recommends the implementation of the following programs in Failure Investigations, Quality Events and Human Error for optimum unit performance.
The quality of your work has been recognized and appreciated locally and by other functional team members worldwide. With your assistance, we extended the CIU concept to include sister companies dealing with product suppliers and equipment vendors. A complete success too!
Again, I would like to express my sincere thanks for your contributions to the successful implementation of a Quality Event and Failure Investigations Program at our site. I look forward to the opportunity to work together again."
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