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
If you would like a quote or would like to ask questions, please contact us at one of our offices around the world.