Research organisations GLP Audits - Drugs / Devices / IVDS

Auditing by industry or ex-regulatory auditors

This service is focussed on research organisations preparing clinical trial materials or early stage commercial product at the transition of first-in-human trials. The GMP codes, (ICH Q11) now require a stronger link between the product development and the ongoing operations, with an essential link to the "3 golden batch validation" and the FDA's Three Stage Process Validation requirements.

PharmOut has consultants who have years of industry and/or regulatory experience, as HSA / TGA and PIC/S auditors, balanced with the knowledge of manufacturing, quality assurance, regulatory and engineering. They have indepth knowledge of the relevant GMP codes of GMP codes and other guidelines, like the WHO / ICH guidelines used by the regulators to assess GLP compliance as well as knowing how to interpret the requirements in order to practically apply them.

Our GLP 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 regulatory audit and are facing a very difficult audit close out,

we offer two audit services that may assist you with ensuring GLP compliance.

Onsite GLP Audits

An on-site GLP audit will identify any GLP non-compliance (gap analysis) 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.

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.

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

The benefits

PharmOut's GLP 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.