GMP audit and inspections are pivotal in the drug development and manufacturing process for pharmaceutical industry suppliers and subcontractors. It is essential to have an experienced GMP auditor who can evaluate and monitor the Quality Management System (QMS) and supply chains, providing valuable insights that enable you to enhance control over quality. Regulatory agencies that establish standards for the pharmaceutical industry expect Good Manufacturing Practice compliance across production supply chains. Consequently, engaging with an increasingly complex supply chain, encompassing numerous suppliers, service providers, and subcontractors, becomes an obligation.
At Trilliyum Consulting, we boast a team of highly skilled senior GMP auditors with extensive experience in conducting pharmaceutical audits aligned with GMP. Our auditors possess in-depth knowledge of pharmaceutical regulatory standards, expectations, and procedures. We specialize in regulatory GxP audits in the pharmaceutical industry, adhering to applicable regulatory texts or standards such as Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP).Our commitment to maintaining the highest standards is reflected in our robust internal procedures, quality system, and auditor qualification process. These components are regularly audited by our clients, yielding positive outcomes that demonstrate the reliability and robustness of our services.
Our team comprises seasoned GMP auditors who possess a deep understanding of the pharmaceutical industry's intricacies. With their extensive experience, they bring valuable insights and a keen eye for identifying areas of improvement.
Compliance with regulatory standards is paramount in the pharmaceutical industry. Our auditors stay up-to-date with the latest regulations and guidelines to ensure that your organization meets all necessary compliance requirements.
In today's global pharmaceutical landscape, supply chains have become increasingly complex. Our auditors have the expertise to evaluate and monitor your supply chain, including suppliers and subcontractors, to identify any potential risks or non-compliance issues.
We conduct thorough audits that encompass all aspects of GMP compliance, including but not limited to production processes, quality control, documentation practices, and supplier management. Our audits leave no stone unturned, ensuring a comprehensive evaluation of your organization's adherence to GMP standards.
We understand that each organization is unique, with its own set of challenges and requirements. Our auditing approach is tailored to your specific needs, ensuring that our recommendations and corrective actions align with your organizational goals and objectives.
Our auditing services not only focus on identifying areas of non-compliance but also aim to drive continuous improvement within your organization. We provide actionable recommendations to enhance your quality management systems, streamline processes, and optimize overall efficiency.