Self-inspections (First-Party Audits)

The Importance of Self-Inspections, also referred to as ‘First Party Audits’

If you are a wholesale distributor of medicinal products, you need to comply with the Good Distribution Practice (GDP) guidelines issued by the European Commission and the Medicines and Healthcare products Regulatory Agency (MHRA).

These guidelines aim to ensure that the quality and integrity of medicines are maintained throughout the supply chain, from the manufacturer to the end user. In accordance with Chapter 8 of the EU GDP Guidelines, one of the key requirements of GDP is to conduct regular self-inspections and first-party audits of your own operations and processes.
(Information on Self-Inspection requirements are found in Chapter 8 of the EU GDP Guidelines. The link is shown at the foot of this page.)

What are self-inspections?

Self-inspections (or first party audits) are internal audits that you perform on your own site to check your implementation of and compliance with Good Distribution Practice (GDP) standards, and identify any deviations or potential areas for improvement or risk reduction. You should have a written procedure for planning, conducting, reporting and following up on self-inspections. Your Responsible Person (RP) or a suitably trained individual should oversee the self-inspection programme and ensure that any corrective and preventive actions (CAPAs) that may be needed are implemented effectively.

You should have a risk-based approach for your self-inspections, taking into account factors such as the complexity of the supply chain and the previous audit results.

Why are self-inspections (first-party audits) important?

Self-inspections or first-party audits are important tools for GDP compliance and continuous improvement. They can help you to:

• • Detect and prevent any errors, defects or falsifications that could compromise the quality and safety of medicines;
  • Assess the effectiveness and efficiency of your quality management system (QMS), standard operating procedures (SOPs), work instructions, logs and forms;
  • Evaluate the effectiveness of any recent change control or CAPA implementations.
  • Monitor the performance and competence of your staff and provide them with feedback and appropriate role-specific training;
  • Demonstrate your commitment to GDP compliance to the MHRA and other parties in your supply chain.

How often should you conduct self-inspections?

The frequency of self-inspections or first-party audits depends on several factors, such as the risk level of activities, the complexity of the business model, the changes within the business, any regulatory or Competent Authority updates and the results of previous inspections or audits.

However, as a general rule, you should conduct self-inspections at least once a year, covering all aspects of your GDP activities.
EU GDP Guidelines Chapter 8 dictates that:

“A self-inspection program should be implemented covering all aspects of GDP and compliance with regulations, guidelines and procedures within a defined timeframe.”

Therefore, you can perform one full self-inspection of your Quality Management System or you can split your self-inspections into smaller areas over the course of the year.  Just be sure to document this in your self-inspection programme and stick to the plan so no areas are missed. 

How can you conduct effective self-inspections (first-party audits)?

To conduct effective self-inspections or first-party audits, you should follow some best practices, such as guidance from ISO 9001 and other relevant standards or regulations:

• • Involve qualified and trained personnel and cover all areas and GDP activities and processes (note that ISO recommends that this is an individual who is independent to the area being audited);
  • Document the findings, observations and recommendations in a clear and concise report;
  • Assign responsibilities and deadlines for implementing CAPAs for any deviations discovered;
  • Verify the implementation and effectiveness of CAPAs;
  • Keep records of all self-inspections and first-party audits for at least five years.

Conclusion

Self-Inspections are a primary requirement to remain in GDP compliance.
Many discrepancies, even small ones, can go unnoticed and may only show up during an inspection by the MHRA or another company who may need to audit you. These discrepancies may become a catalyst for a deviation or non-conformance which if detected by an inspection, could be be costly; causing loss/interruption of business, until the issue is rectified. Any deviations or alteraration of procedure that seems to be not following the SOPs and could be against the grain of the QMS, must be reported to the RP straight away.

Training, Support and Advice

If you need guidance or assistance on how to conduct self-inspections or first-party audits, you can contact Paradigm Shift Consulting Ltd, an ISO 9001 accredited consultancy that provides training and quality management services to the pharmaceutical industry. Our team of experts who can help you with GDP training, SOP writing, mock MHRA inspections, contract RP services and more.

We offer free initial consultations, free IAG/CMT/MHRA letter reviews and free licence terminations.

You can also email your enquiry to info@paradigmshiftconsulting.co.uk.

 

A selection of associated topics and resources are shown here.

EU GDP Guidelines (2013/C 343/01)
Chapter 2.2 clause viii; Chapter 5 section 2 and 3; Chapter 7 sections 2 & 3; Chapter 8.

ISO9001
(1st, 2nd & 3rd party audits – the differences)

Why GDP Matters

Online GDP Webinar for RPs and Management

Inspections and Audits

Approving Suppliers & Customers in GDP

What is the MHRA?

External or Second Party Audits