Case Study | Led the FDA inspection readiness project for a European client
OSICS NETWORK, a renowned corporate consulting firm, undertook a transformative project for a European client that sought to register its product in the highly regulated US market. The client faced a challenging situation characterized by limited audit experience at their site, primarily consisting of Polish Health Authorities inspections.
This had led to recurring human errors and deviations, a weak preventive maintenance program, and unclear responsibilities within the Quality team. Furthermore, the client was experiencing rapid production volume growth, necessitating a robust compliance strategy. OSICS NETWORK’s comprehensive approach was instrumental in addressing these critical issues.
SITUATION
When our European client decided to register a product in the highly regulated US market, they were confronted with several formidable challenges:
- Limited Audit Experience: The client’s facility had only been subjected to inspections by Polish Health Authorities, leaving them with limited exposure to the rigorous standards set by the FDA.
- Recurring Deviations: The site suffered from recurring human error deviations, which posed a significant obstacle to compliance.
- Weak Preventive Maintenance: A lackluster preventive maintenance program left the facility vulnerable to operational disruptions.
- Ambiguous Responsibilities: There was a lack of clarity in the Quality team regarding responsibilities and accountabilities.
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Rapid Production Growth: The client experienced a meteoric rise in production volume, from 3.5 billion tablets to an impressive 5 billion tablets annually. This exponential growth magnified the importance of compliance and quality.
APPROACH
OSICS NETWORK embarked on a comprehensive approach to address these challenges and bolster the client’s FDA inspection readiness:
- Streamlined Teams: The core team was structured into six distinct streams, aligning with a systematic, system-based inspection approach.
- Expertise Allocation: Each team included subject matter experts from various areas, complemented by dedicated quality specialists responsible for their respective domains.
- Internal Audits: Rigorous internal assessment audits were conducted across all Good Manufacturing Practice (GMP) areas to identify and rectify compliance gaps.
- Learning from FDA: OSICS NETWORK closely studied FDA warning letters and observations, conducting a thorough gap assessment to preempt potential issues.
- Process Mapping: A Value Stream Mapping (VSM) approach was employed to map and streamline processes for efficiency and compliance.
- CAPA Plan Review: The core team, along with management, reviewed and monitored the implementation status of Corrective and Preventive Action (CAPA) plans.
- Staff Training: A specialized “Face to Face with Inspector” training program was conducted for the entire staff to prepare them for FDA inspections.
- Presentation Preparation: Customized presentations were meticulously prepared to ensure clarity and transparency during inspector interactions.
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Cultivating Quality Culture: Efforts were made to strengthen the quality culture within the organization, instilling a sense of ownership and responsibility at all levels.
IMPACT
The profound impact of OSICS NETWORK’s partnership with the European client became evident:
- Successful Mock Inspection: Following 1.5 years of dedicated effort, a rigorous two-week mock inspection was conducted by two global auditors and two ex-FDA inspectors from Parexel. The result was overwhelmingly positive, with no critical observations and only five major observations (three of which pertained to investigations of OOS’s, complaints, and deviations), accompanied by minor observations.
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Strengthened Ownership and Quality Culture: The project left an enduring legacy by strengthening the sense of ownership and nurturing a pervasive quality culture across all teams within the client’s organization.
In conclusion, OSICS NETWORK’s strategic intervention not only fortified the European client’s FDA inspection readiness but also sowed the seeds for a sustained commitment to quality and compliance.
This case study underscores the invaluable role of expertise, meticulous planning, and a relentless pursuit of excellence in ensuring success in the highly regulated pharmaceutical industry. OSICS NETWORK continues to be a beacon of excellence in the realm of regulatory compliance and quality management.