GMP Compliance Audits
GMP compliance audits are often referred to as ‘GMP Mock Audits’, ‘Pre-audit Audits’, ‘GMP Gap Analysis’ or ‘Pre-regulatory audits.’ A GMP Compliance Audit is an audit or an inspection conducted by someone external to your organisation with the purpose of discovering GMP deficiencies. A GMP Compliance Audit will allow you to avoid delays in bringing product to market due to not passing a GMP audit. The cost and time associated with regulatory re-audits if an audit outcome is not satisfactory can also be avoided or minimised.
PharmOut has several consultants who have years of experience as auditors for the Australian TGA. These consultants will conduct a GMP Compliance Audit as if they were doing so for a regulatory body, but coupled with friendly advice on how to fix your GMP problems. We can help you build a road map on how to remediate and enhance your facility and QMS/PQS to ensure compliance. We have pharmaceutical engineers and architects experienced in GMP related remediation projects to support our GMP / QA consultants in offering cost and timeline advice.
If you are exporting product to multiple countries that use different regulatory frameworks, we can help you achieve compliance in a practical way, rather than drowning yourself in paperwork.
PharmOut offers GMP Compliance Audits tailored for:
- Pharmaceutical manufacturers, sponsors and industry suppliers
- Complementary medicine manufacturers, sponsors and industry suppliers
- Medical Device manufacturers or sponsors
- Medical Devices Utilizing Animal Tissues
- Blood and Tissue organisations
- Research institutions – covering GCP and GLP.
Our GMP Compliance Audit Services
If you are soon to be audited by a GMP regulator, want to ensure you are still compliant after major change, or just had a tough regulatory audit and are facing a very difficult audit close out we offer two audit services that may assist you with ensuring GMP compliance:
1. Onsite GMP Audits
An on-site GMP audit is by far the best way to check if a company is GMP compliant and ready for an official regulatory audit (or not!). We will help you identify any GMP non-compliances through gap analyses and also recommend how they should be addressed. The length of the audit will depend on complexity of the manufacturing process, size of the company and history of compliance.
An on-site audit involves the following:
- Pre-audit discussion to determine the audit scope and plan.
- Audit preparation which includes a review of some of your key documents from your Standard Operating Procedures, the Site Master File, previous regulatory audit reports – deficiencies noted and responses provided.
- Performance of the audit and discussion of audit findings as well as coaching/training any of your staff involved in the audit.
- Compiling a report of audit findings and discussion with management – this will also include any recommendations on improvements if they are required.
2. Desktop GMP 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 GMP audit involves:
- Your company sending key documents e.g., validation master plan, batch release records, etc. 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 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 and discuss internally with your management.
PharmOut’s GMP 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 GMP 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.
Related services include GMP audits of suppliers and audit findings response development.
If you would like a quote or would like to ask questions, please contact us.
If you want to read more about regulatory matters and topics relating to PIC/S, the ICH, FDA, TGA, MHRA or EU and EMA, click on the relevant links.