Cliniserve can reduce your workload to plan and perform your GMP audit and have detailed and product specific audit reports based on current guidelines in a timely manner.
Corrective and Preventative Action Plan Development
- Auditors of Cliniserve support to implement, maintain and monitor a GMP-compliant quality management system.
- We give assistance to develop corrective and preventative action (CAPA) plan to address GMP violations. After developing the CAPA plan, we review and assess the implementation and effectiveness of improvements.
In 2019, FDA investigators reported around 800 Form 483s to drug manufacturing facilities. Experienced auditors could have identified those issues before the regulatory inspector. Inadequate audit program leave you vulnerable to regulatory enforcement action.
You don’t have to risk your business or your status with regulatory bodies. We can help you to avoid worry that you are unknowingly out of compliance with CGMP regulations.
Our team is having thorough knowledge of ICH Topic Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients, EudraLex, Volume 4, The Rules Governing Medicinal Products in the European Union, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use etc.
During audit, below listed key points are covered
- Quality Management System
- Buildings and Facilities
- Process Equipment
- Documentation and Records
- Materials Management
- Production and In-Process Controls
- Packaging and Identification Labeling of APIs and Intermediates
- Storage and Distribution
- Laboratory Controls
- Change Control
- Rejection and Re-Use of Materials
- Complaints and Recalls
- Environmental Control
- Good Documentation Practice
- Computer System Validation
- Data Integrity Compliance