Good Clinical Practice Audits – Drugs / Devices / IVDS

Our Good Clinical Practice audits (GCP) are is focused on research laboratories and organisations preparing clinical trial materials or early stage commercial product at the transition of first-in-human trials.

Our Good Clinical Practice Audit Services

If you are soon to be audited by a regulator, want to ensure you are still compliant after major change, or just had a tough GCP audit and are facing a very difficult close out, we offer the following audit services that may assist you with ensuring GCP compliance for your facility:

1. Onsite Good Clinical Practice Audits

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An on-site GCP audit will identify any non-compliance (using gap analysis) and recommend how they should be addressed. This is by far the best way to ensure that a company is GCP compliant and regulatory audit ready. The consultant will also include and discuss improvement recommendations if required.

An on-site audit involves the following:

  • Pre-audit discussion to determine the audit scope and plan.
  • Audit preparation: review of some of your key documents such as Policies, Standard Operating Procedures, 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 process, size of the company and history of compliance.
  • 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 Clinical 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 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 GCP audit involves the following:

  • Your company sending key GCP documents 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 GCP-related 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 discuss internally with your management.

 

3. Remediation  Services:

If you’ve had a difficult GCP audit and don’t know where to begin to address the issues, we can also offer services to help you respond to the deficiencies as well as assist you with audit remediation programmes.

 

The Benefits:

PharmOut’s GCP compliance audit will allow you to:

  • gain greater knowledge of the quality issues affecting your organisation
  • develop increased awareness of regulatory expectations
  • recognise commonly seen GCP deficiencies and learn how to reduce them in your organisation
  • understand the 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
  • receive guidance on changing legislation and increasing complexity in the manufacturing and distribution chain for medicinal products.

 

More Information

If you would like a quote or would like to ask questions, please contact us.