Audit Management
In the pharmaceutical industry, ensuring compliance with Good Manufacturing Practices (GMP) and Active Pharmaceutical Ingredient (API) regulations is critical to guarantee product safety, quality, and efficacy. Our expert team provides comprehensive API and GMP auditing services tailored to your business needs, ensuring that your operations meet the stringent requirements of global regulatory authorities.
Our Services
1. API Auditing
Our API auditing service helps manufacturers and suppliers ensure compliance with industry regulations and standards, including ICH Q7 guidelines. Our audits focus on key areas such as:
• Raw Material Sourcing: Assessing the quality and traceability of API sources.
• Manufacturing Processes: Ensuring all API production stages comply with regulatory and safety standards.
• Quality Control & Documentation: Reviewing testing protocols, documentation practices, and validation processes.
• Supplier Audits: Auditing your third-party API suppliers to guarantee consistency and compliance.
2. GMP Auditing
We offer comprehensive GMP auditing to ensure that your manufacturing practices adhere to global regulatory requirements, including EU GMP, and MHRA guidelines. Our GMP audits cover:
• Facility Inspections: Reviewing the layout, cleanliness, and suitability of production facilities.
• Process Validation: Ensuring all production processes are validated, and risks are mitigated.
• Documentation & Record Keeping: Assessing the adequacy and accuracy of batch records, deviation reports, and quality management documentation.
• Personnel Training: Reviewing training programs and compliance of staff to ensure they are well-versed in GMP procedures.
• Risk Management: Evaluating your risk assessment protocols, including CAPAs (Corrective and Preventive Actions).
Why Choose Us?
• Experienced Auditors: Our team consists of seasoned professionals, Qualified persons, and Lead Auditors with deep expertise in regulatory requirements and industry standards.
• Comprehensive Reports: Post-audit, we provide detailed reports with actionable recommendations to help you address any gaps in compliance.
• Global Reach: We conduct audits across the globe, ensuring you meet both local and international regulations.
• Tailored Solutions: Whether you need a single audit or ongoing compliance support, we provide tailored solutions to meet your business goals.
• Confidential & Reliable: We maintain the highest standards of confidentiality and integrity, ensuring your sensitive information is secure.
