GMP Compliance Audits – Pharmaceuticals

Auditing by ex-regulatory auditors

PharmOut is lucky to have several consultants who have years of experience as TGA and PIC/S auditors. They have in-depth knowledge of the relevant guides and codes used by the regulators to assess GMP compliance as well as knowing how to interpret the requirements in order to practically apply them. You will also benefit from their knowledge of what regulators expect and what their GMP priorities are.

Do you export to multiple countries?

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.

Avoid product release delays and extra audit costs

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.

Our GMP 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.

Onsite GMP Audits

An on-site GMP audit will identify any GMP non-compliance (gap analysis) and recommend how they should be addressed. This is by far the best way to ensure that a company is GMP compliant and regulatory audit ready.

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 Standard Operating Procedures, Site Master File, previous regulatory audit reports, deficiencies noted and responses provided
  • Discussion of audit findings and coaching/training your staff involved in the audit
  • Compiling a report of audit findings and discussion with management.
  • The length of the audit will depend on complexity of the manufacturing process, size of the company and history of compliance.

The consultant will also include and discuss improvement recommendations if required.

Desktop GMP Audits

A cheaper option is a desktop audit. Our Consultants use the Desktop Audit format 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.

A Desktop GMP Audit involves:

  • You sending key documents e.g. validation master plan, batch release records etc to the auditor.
  • The auditor reviewing the documents for compliance.
  • The auditor will then call you for clarification on anything they find. This might involve requesting 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 to your management.

The Benefits

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.

More information

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