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.
Our Good Laboratory Practice Audit Services
If you have an upcoming audit scheduled and want to ensure you are prepared well in advance, or have just had a tough regulatory audit and are facing a very difficult audit close-out we can offer the following GLP audit services:
1. On-site Good Laboratory Practice Audits
An on-site GLP audit will identify any non-compliance and 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 on-site GLP audit involves the following:
- Pre-audit discussion to determine the audit scope and plan
- Audit preparation: review of some of your key documents well as previous regulatory audit reports, deficiencies noted, and responses provided
- An onsite audit by a PharmOut consultant. The length of the audit will depend on complexity of the manufacturing or testing processes, the size of the company and history of compliance.
- Examination of your laboratories for GLP compliance (whether it’s processing human samples, involves bioanalysis, etc.)
- Discussion of audit findings and coaching/training your staff involved in the audit
- Compiling a report of audit findings and discussion with management.
2. Desktop Good Laboratory Practice Audits
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.
A Desktop GLP Audit involves:
- 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.
3. Remediation Services:
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.
PharmOut’s GLP compliance audit will allow you to:
- gain greater knowledge of any quality issues affecting your organisation (before an official auditor gets there!)
- develop increased awareness of regulatory expectations
- recognise commonly seen GLP deficiencies and learn how to reduce them in your organisation
- understand the official inspection process and how you can prepare for it
- identify quality-critical areas in your own organisation e.g. technical agreements, training, record keeping, delegation
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. Here are the key advantages of conducting external GLP audits:
- 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. This validation strengthens confidence in your laboratory’s compliance efforts and provides assurance to regulatory bodies, sponsors, and stakeholders.
- Continuous Improvement: External GLP audits are not merely focused on identifying non-compliance; they also provide opportunities for continuous improvement. By leveraging the expertise and recommendations of the external auditor, you can implement corrective actions and preventive measures to enhance your laboratory’s performance. The auditor’s insights and suggestions for optimizing processes, enhancing data integrity, and streamlining workflows can contribute to the overall efficiency and effectiveness of your laboratory operations. External audits facilitate a culture of continuous improvement and ensure your laboratory remains at the forefront of GLP compliance.
PharmOut is dedicated to supporting organizations in achieving and maintaining GLP compliance through our comprehensive external auditing services. Our experienced auditors possess a deep understanding of GLP regulations and industry requirements. They conduct thorough evaluations, provide actionable recommendations, and collaborate with you to enhance your laboratory practices. With PharmOut as your external auditing partner, you can trust that your laboratory will operate at the highest level of GLP compliance, inspiring confidence in your research outcomes.
Unlock the advantages of external GLP audits with PharmOut and strengthen your laboratory’s commitment to regulatory excellence. Contact us today to learn more about our auditing services and embark on a path of continuous improvement and quality assurance.
If you would like a quote or would like to ask questions, please contact us at one of our offices around the world.