“Established since 1999”
REGULATORY COMPLIANCE SERVICES
"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.
What is a CIU?
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:
Implementing the CIU
"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:
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.
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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guerra consulting group, inc. (GCGI)™
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san juan, P.r. 00919-3271
PHONE: (787) 283-1518
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