AUDIT SERVICES
1.0 Mock Audits & Internal Audits
In the highly regulated pharmaceutical industry, maintaining compliance with stringent regulations, ensuring operational efficiency, and safeguarding product quality are critical to success. Our Mock Audit Services are tailored to help pharmaceutical companies navigate the complexities of regulatory requirements, minimize risks, and enhance operational effectiveness. With the expertise of our experienced auditors, we conduct comprehensive assessments to ensure your practices adhere to Good Manufacturing Practices (GMP), FDA, EMA, and other relevant industry standards.
Our Services Include:
GMP Compliance Audits
Good Manufacturing Practices (GMP) are vital for ensuring the safety, quality, and effectiveness of pharmaceutical products. Our GMP compliance audits evaluate your manufacturing facilities, production processes, equipment, documentation, and quality control systems. We identify potential gaps in compliance, provide actionable recommendations, and ensure your operations align with industry standards and regulatory expectations.
Regulatory Compliance Audits
Pharmaceutical companies must comply with a range of regulations from authorities such as the FDA, EMA, and other global agencies. Our regulatory compliance audits thoroughly examine your adherence to these requirements—from drug approval processes to post-market surveillance. Our experts ensure your products meet all applicable guidelines while aligning your processes with regulatory standards.
Quality Management System (QMS) Audits
A strong Quality Management System (QMS) is essential for the safety and efficacy of pharmaceutical products. We assess your QMS, focusing on key areas such as document control, change management, CAPA (Corrective and Preventive Actions), and risk management. Our audits highlight areas for improvement, helping you enhance your QMS and maintain consistent product quality and compliance.
Risk Management Audits
We conduct in-depth risk assessments to identify potential hazards in your processes, materials, and supply chain. Our audits evaluate your risk management practices, ensuring that you have effective systems in place for identifying, mitigating, and monitoring risks in accordance with regulatory standards.
Internal Audit Readiness Assessments
Preparing for official regulatory audits can be challenging. Our Mock Audit services simulate real audit conditions to assess your internal processes and readiness for external audits. This proactive approach helps identify any weaknesses in your documentation, processes, and compliance practices, giving you confidence before the actual audit.
2.0 Third Party Audits
In the pharmaceutical industry, ensuring the highest standards of quality, safety, and regulatory compliance requires more than just internal processes—it extends to your suppliers and vendors. Effective Supplier and Vendor Management is essential for maintaining product consistency, meeting regulatory requirements, and minimizing supply chain risks. Our Third Party Audit Services are designed to help you establish, sustain, and oversee strong compliance relationships with your suppliers and vendors, guaranteeing that all materials, components, and services meet the rigorous standards set by regulators and industry best practices.
We provide support in qualifying and evaluating your suppliers to confirm they adhere to the necessary regulatory, quality, and safety standards. Our approach involves assessing the supplier's manufacturing practices, quality assurance systems, and regulatory compliance to ensure alignment with your company's needs and industry requirements.
Vendor Audits and Compliance Checks
Conducting thorough audits of your suppliers and vendors to ensure they remain compliant with pharmaceutical regulations, including GMP, GDP (Good Distribution Practices), and other applicable standards.
Vendor Performance Monitoring
Performing regular audits to assess your vendors' performance based on key criteria such as quality, delivery timelines, and adherence to contractual agreements.