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. 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.)
Self-inspections 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.
First-party audits are external audits that you perform on your suppliers or service providers, such as manufacturers, importers, transporters, consultants or storage facilities, to verify their expertise or compliance with GDP standards and to put appropriate contractual requirements in place.
You should have a risk-based approach for selecting and auditing your suppliers or service providers, taking into account factors such as the type of product, the volume of transactions, any deviations, the frequency of MHRA inspections, the complexity of the supply chain and the previous audit results.
Self-inspections and first-party audits are important tools for GDP compliance and continuous improvement. They can help you to:
The frequency of self-inspections and 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. You should also conduct first-party audits at least once every three years for each supplier or service provider, unless the site is carrying out high risk activities or has struggled with non-compliance, otherwise beyond this three year period it should be justified by a risk assessment.
To conduct effective self-inspections and first-party audits, you should follow some best practices, such as guidance from ISO 9001 and other relevant standards or regulations:
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.
Your first-party audits are also critical to ensuring that any new incoming and outgoing lines of the supply chain are in compliance with GDP. A first-party audit is recommended to be carried out upon potential new customers, transport companies and suppliers. This can be supported with positive confirmation of GDP Certificates and a presence of the potential new supplier or customer on the required database registries, such as the GPhC for Pharmacies, and the registry of licensed businesses within the MHRA at Gov.uk.
If you need guidance or assistance on how to conduct self-inspections or first-party audits, we can offer a free over-the-phone initial consultation on 0330 133 0920 or you can email us on info@ukgdpassociation.co.uk.
Alternatively, use the contact form at the top right of this screen.
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 Management Reviews Are Important
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