QUALITY & COMPLIANCE
- GxP audit & inspection readiness
- Quality Management Systems design, implementation, & support
- Quality Risk Management strategy & implementation
- GAMP compliance & data integrity
- CAPA strategy & implementation
- GxP documentation development, review & support
- GMP batch release, investigations, complaints & product recall support
- Regulatory strategy & response support
For further information regarding our Quality & Compliance offerings
Please contact:
Ronay LeBlanc, MA
[email protected]
CASE STUDY – GMP Quality Remediation after Consent Decree
Situation
A pharmaceutical company received numerous FDA 483’s and/or a Warning Letter(s) related to continual non-conformance of the company’s quality management systems with respect to current Good Manufacturing Practices (cGMP). Continued nonconformance and/or unsatisfactory responses could have resulted in the company entering into a Consent Decree with the FDA resulting in significant financial risk to the company.
Solution
Our Principal led an extensive audit of the company’s quality management systems and assisted with development and implementation of appropriate corrective and preventative actions (CAPA’s)
Impact
All FDA 483 and/or Warning Letter observations and deficiencies were satisfactorily addressed.
The potential for further regulatory action was mitigated.
A robust, cGMP compliant quality management system was put in place.
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