GMP Compliance Audits

CiPharma consultants have years of experience as TGA and PIC/S auditors having previously been regulatory auditors themselves. They have in-depth knowledge of the relevant guides and codes used by the regulators to assess GMP compliance as well as knowledge in interpreting requirements in order to practically apply them. Clients also benefit from their knowledge of regulator expectations and their GMP priorities.

Exporting to multiple countries

Where clients export products to multiple countries that use different regulatory frameworks, we can achieve compliance in a practical way that utilizes streamlined documentation processes.

Avoiding product release delays and extra audit costs

GMP Compliance Audits will allow you to avoid delays in bringing product to market faster by proactively working to comply with GMP audit requirements. Costs and delays associated with regulatory re-audits if an audit outcome is not satisfactory can be avoided or minimized.

Our GMP Audit Services

If your company:

  • are soon to be audited by a GMP regulator,
  • want to ensure you are still compliant after major change, or
  • just faced a challenging regulatory audit and face an arduous audit close out,

CiPharma offer two types of audit service 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 involve 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
  • An onsite audit by a¬†CiPharma 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.

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

Desktop GMP Audits

Depending on your organization’s circumstances a more cost effective option can be a desktop audit. Our Consultants use the Desktop Audit format which is now used by several other international regulatory authorities.

Desktop GMP Audits involve:

  • Sending of key documents e.g. validation master plan, batch release records etc to the auditor.
  • Auditor review of the documents for compliance.
  • Clarification to the auditor on anything they find which may involve provision of further documentation.
  • Once all the issues have been discussed and a course of action agreed, auditors will compile a final report that can be provided to your management.

The benefits

CiPharma’s GMP compliance audit will allow you to:

  • gain greater knowledge of the quality issues affecting your organization
  • develop increased awareness of regulatory expectations
  • recognize commonly seen GMP deficiencies and learn how to reduce them in your organization
  • understand the inspection process and how you can prepare for it
  • identify quality-critical areas in your own organization 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.