GxP audits: How important are they and how are they conducted?
In the highly regulated pharmaceutical industry, audits are more than just a control mechanism – they are an indispensable tool for ensuring the quality and compliance of processes. Audits play a key role in ensuring that companies adhere to the strict requirements of Good Manufacturing Practice (GMP) and other GxP standards. The aim is not only to identify errors, but also to continuously improve processes and eliminate weaknesses before they lead to errors or quality problems. The role of audits in quality management can therefore not be overestimated. They help to meet regulatory requirements and at the same time strengthen the trust of customers and authorities in the company.
Below you will find out what a GxP audit is, why it is so important for companies in regulated industries and how it can be carried out optimally.
What is a GxP audit?
An audit is a systematic, independent and documented review that serves to determine whether activities and results meet the planned requirements. So much for the theory.
In the GxP area, audits are particularly important in practice, as they ensure that all processes actually meet the strict requirements of GMP, GLP and GCP standards. These audits not only check compliance with regulations, but also whether processes are used for continuous improvement and risk reduction and actually make this contribution.
Why are audits in the GxP area so important?
Audits fulfill a central function in the so-called Pharmaceutical Quality System (PQS) and offer many advantages that are important for the entire industry:
- Audits guarantee that companies comply with and implement the legal and regulatory requirements in such a way that the medicines produced are of truly impeccable quality and also safe.
- Audits make it possible to identify potential errors in operations and production at an early stage so that measures can be taken to minimize risks. This prevents critical errors or weaknesses in the production process from leading to serious problems and questionable medicines from reaching the market and patients.
- Audits offer the opportunity to evaluate existing processes and identify optimization potential. In this way, companies can increase their efficiency and improve quality at the same time.
- Regular audits strengthen the trust of customers, partners and regulatory authorities. A well-documented and executed audit shows that the company is able to critically scrutinize itself in order to reliably deliver high-quality products to the market.
The audit process: step by step
An audit in the GxP area follows a structured procedure that enables the auditor to thoroughly examine the processes in the company. Typically, an audit consists of six main phases:
- Planning: Audit preparation is crucial for success. The parties involved must ensure that all relevant people and documents are available. Thorough planning ensures a smooth process.
- The initial meeting: In this step, the auditors and the representatives of the company to be audited meet at the start of the audit. The audit plan or the audit agenda is discussed again. Questions are also clarified here and expectations are defined if they have not already been clearly understood before the audit.
- Conducting the audit: The auditor checks the company’s premises, machines, documents and processes. Interviews with employees also take place during this phase in order to assess the practical implementation of the processes.
- The final meeting: At the end of the audit, the results are summarized. This is where we discuss what worked well and where there is room for improvement.
- The audit report: The auditor prepares a detailed report documenting the results of the audit. This report also contains recommendations to help the company eliminate weaknesses and further improve processes.
- Follow-up of the audit results: After the audit, follow-up is essential to ensure that the recommended measures have been implemented. This includes documenting the corrections and, if necessary, rechecks to ensure the sustainability of the improvements.
Preparing the audited company for a GxP audit: how to succeed
Thorough preparation is the key to a successful audit. Companies should ensure that their documents are complete and up-to-date and that their employees are aware of the requirements of the audit. Employee training plays a central role here, as a well-prepared team helps to ensure that the audit runs smoothly and possible deficiencies can be identified at an early stage.
Tips for audit preparation:
- Review all important documents, including SOPs (standard operating procedures), batch documentation and qualification documents
- If possible, carry out internal mock audits in advance to identify weaknesses in advance
- Bring your team up to speed on regulatory requirements and audit expectations
Successful audit practice: the key to success
A successful audit requires careful preparation, a clear structure and detailed follow-up. Cooperation between the auditor and the audited company is of great importance in order to develop a common understanding of the requirements and expectations. This not only promotes compliance, but also the continuous improvement of processes. Companies that integrate regular audits into their business processes improve their quality assurance and reduce the risk of production errors or non-compliance with regulations.
Conclusion: Audits as the key to quality assurance
Audits are an indispensable part of quality management in the GxP sector. They not only help to ensure compliance with regulations, but also promote the quality and safety of products. Thorough preparation and the selection of experienced auditors are crucial to the success of an audit.
At Experts Institut, we not only offer training courses for auditors, but are also happy to support you in ensuring your compliance and continuously improving your processes. We can do “audits”. Contact us at info@expertsinstitut.de
Would you like to find out more?
Listen to our podcast episode “Audits in the pharmaceutical industry”, in which we examine the importance and challenges of audits in detail: https://podcasters.spotify.com/pod/show/experts-insights/episodes/Audits-in-der-Pharmaindustrie-e2of577
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Vita
- COO Experts Institut
- Senior Project Consultant
- Apotheker
- Langjährige internationale Projekttätigkeit in Europa, Nordamerika, Asien, Russland
- Sachkundige Person (D – AMG, AMWHV, CH – HMG, AMBV)
- Breite Compliance Expertise im Commercial (c)GMP- und Development GMP-Bereich (IMP-GMP)
- Langjähriger Third-Party GMP-Auditor (GMP- und Non-GMP)
- GMP/GDP-Trainer seit 2010
- Quality Culture Mediator
- Trained in cross-cultural aspects of communication, contextualization, and cultural anthropology as part of an MA.MIn and DIcs enrollment at Grace College&TS, US.
