Our Good Laboratory Practice audits (GLP) are focused on research laboratories and organisations preparing non-clinical materials for studies conducted to assess the safety or efficacy of chemicals on living organisms and the environment. An on-site GLP audit will identify any non-compliance and MedicGLP Official recommend how they should be addressed. This is by far the best way to ensure that a company is GLP compliant and regulatory audit ready. The consultant will also include and discuss improvement recommendations if required. An onsite audit by a PharmOut consultant. The length of the audit will depend on complexity of the manufacturing or testing processes, MedicGLP Official the size of the company and history of compliance. Compiling a report of audit findings and discussion with management. The Desktop Audit format was developed by the Australian TGA, as described in "Guidance on The GMP Clearance Of Overseas Medicine Manufacturers". This format is now used by several other international regulatory authorities and is a more budget-friendly audit that doesn’t involve sending our consultants on-site.

Your company sending key GLP related documentation to the assigned auditor on our side. The auditor reviewing the documents for compliance. The auditor will then call you for clarification if required - this might involve requesting for and examining other GLP documents. Once all the issues have been discussed and a course of action agreed, the auditor will compile a final report that you can then provide to and discuss internally with your management. If you’ve had a difficult GLP audit and don’t know where to begin to address the issues, we can offer services to help you respond to the deficiencies as well as assist you with audit remediation programmes. In the realm of scientific research and development, ensuring compliance with Good Laboratory Practice (GLP) standards is vital for generating reliable and high-quality data. While internal audits play a crucial role in maintaining GLP compliance, the inclusion of external GLP audits brings a myriad of benefits to organizations seeking to enhance their laboratory practices and achieve regulatory excellence.

At PharmOut, we recognize the importance of rigorous GLP audits and offer comprehensive external auditing services. Independent Assessment: External GLP audits provide an objective and independent evaluation of your laboratory’s adherence to GLP principles and guidelines. An external auditor brings a fresh perspective, unclouded by internal biases or preconceived notions. This impartial assessment helps identify potential gaps, inconsistencies, or non-compliance issues that may have been overlooked during internal audits. The external auditor acts as a critical eye, ensuring that your laboratory operations align with the highest standards of GLP. Expertise and Industry Insights: External auditors specialized in GLP bring a wealth of knowledge and expertise to the auditing process. They possess a deep understanding of GLP regulations, industry best practices, and emerging trends. By engaging an external auditor, you gain access to their extensive experience and insights, enabling you to benchmark your laboratory against recognized standards and adopt industry-leading practices.

The auditor can also provide valuable recommendations and guidance for improving processes and procedures based on their in-depth knowledge of GLP requirements. Identification of Compliance Gaps: GLP regulations are complex and multifaceted, making it challenging to identify all compliance gaps internally. External GLP audits are designed to thoroughly examine all aspects of your laboratory operations, including documentation, standard operating procedures, data integrity, equipment calibration, personnel training, and more. Through meticulous evaluation, the auditor can pinpoint potential non-compliance issues or areas requiring improvement. This proactive approach allows you to address gaps before they escalate into significant regulatory concerns or impact the integrity of your research. Validation of Internal Auditing: Internal audits are an integral part of maintaining GLP compliance. However, external audits validate and provide an objective assessment of the effectiveness of your internal audit processes. An external auditor can evaluate the rigor, consistency, and thoroughness of your internal audit program, ensuring that it is robust and aligned with industry standards.