There are two broad categories of audit you are likely to come across in the pharmaceutical industry: internal audits and external audits. Each has the same goal of verifying compliance with jurisdictional, industry-based or project-specific standards in some way, but they are carried out in different ways and by different auditing agents.
In this article, we will look at the key types of audits in pharmaceutical sector.
Internal audit (first party audit)
An internal audit is carried out by one of your own organisation’s quality assurance or internal audit staff to evaluate compliance with Good Manufacturing Practices (GMP), regulatory standards, clinical best practices or internal procedures. Frequently, the main purpose of an internal audit is to identify areas for improvement before an external inspection. They can also be used to verify the effectiveness of your standard operating procedures (SOPs), proactively detect or mitigate risk, and ensure alignment with project-specific quality guidelines.
Many organisations carry out internal audits on an annual basis, although they may be needed more frequently for high-risk or complex projects.
Self-audits or self-inspections:
These are a subset of internal audits in which an organisation critically reviews specific aspects of its processes, facilities or systems, in order to identify issues at an early stage or to implement proactive improvement. Self-inspections are a good way of increasing accountability within an organisation, and also make the task of formal internal and external audits less onerous on internal stakeholders. To be effective, self-audits should be fully documented and include a series of checks and balances to ensure their independence and validity. Most self-audits include a variety of corrective and preventative actions, or CAPAs, to address any shortcomings revealed by the audit.
External audits (second or third-party audits)
External audits are conducted by a party outside of your organisation, such as a third-party independent auditor or a government regulatory agent. In the EU, for instance, an audit may be carried out by the EMA (European Medical Association), the Food and Drug Administration (FDA) in the USA or the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. Clients or sponsors may also sometimes request an independent external audit of their suppliers or their testing laboratories as part of their contractual obligations.
Regulatory external audits:
These audits are conducted by an official government regulatory body to assess compliance with best practices, approve new facilities or specific operations, or to investigate alleged non-compliance or quality issues. An external audit may be conducted on a routine basis (e.g. a three-year cycle), or be triggered by an event such as a product recall, consumer complaint, or regulatory submission.
Third-party audit:
These audits are conducted by an independent third party, usually at the request of a certification body (e.g. ISO) or a customer. The purpose is to validate that an organisation meets GMP standards, or the standards required by a certification such as ISO 9001 or ISO 27001. In terms of frequency, third-party audits are more ad hoc than regulatory external audits and are scheduled based on client-specific requirements or contractual needs.
Download your free Derouging guide
Derouging is an important part of quality control for pharmaceutical industry equipment, and can be used as part of self-inspections or internal audits to improve hygiene standards and boost compliance. To find out more, please download a free copy of our Derouging Guide by clicking here.