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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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28. October 2024/by Dr. rer. nat. Dietmar Gross

Business Solutions

Information security – a must for modern companies

In today’s digital world, information security is more than just a technical concern: it is a business-critical necessity. Companies must protect sensitive data and at the same time meet legal requirements. This article highlights the most important aspects of information security with a focus on the implementation of an ISMS according to ISO 27001 and the new EU NIS2 directive, which comes into force in 2024.

Why is information security important?

Information security ensures the confidentiality, integrity and availability of data and IT systems. It not only protects against cyber attacks, but also ensures the continuity of business processes. An effective information security management system (ISMS) helps companies to identify and minimize risks.

Implementation of an ISMS through ISO 27001

ISO 27001 is an internationally recognized standard that helps companies to develop and implement an ISMS. It offers a systematic approach to protecting information and minimizing risks.

Why is ISO 27001 important?

By complying with ISO 27001, companies can strengthen the trust of their customers and partners
Many industries require compliance with certain security standards, ISO 27001 helps to meet these requirements
The standard provides a clear framework for identifying and managing security risks

Steps for implementation

A project team is set up to take responsibility for implementing the ISMS
Clear roles and responsibilities are defined to ensure smooth implementation
A delta audit and an inventory are carried out to identify vulnerabilities and the current security status
All employees involved are sensitized and qualified through targeted training courses
Departments receive weekly task packages that cover various chapters of ISO 27001
A comprehensive, digitalized ISMS is created to ensure sustainable information security
Internal auditors are trained to carry out regular audits in the company
Regular internal audits ensure that all measures are properly complied with
A gap analysis is used to identify weaknesses, which are then remedied with a concrete action plan
The action plan is implemented by implementing the planned measures in a targeted manner
The certification process is continuously monitored until successful completion of ISO 27001 certification

NIS2 and the connection to ISO 27001

The NIS2 Directive, which comes into force in October 2024, tightens information security requirements, especially for operators of critical infrastructure (KRITIS), and affects around 21,600 new companies in Europe. The aim of the directive is to strengthen protection against cyberattacks and resilience.

ISO 27001 and NIS2 both pursue the goal of information security, but differ in scope. While ISO 27001 provides a flexible framework for implementing an ISMS, NIS2 adds additional requirements specifically aimed at KRITIS operators and critical facilities. Companies that are ISO 27001 compliant have already met many of the NIS2 requirements.

NIS2 introduces the following obligations for companies:

Companies need to further enhance their security standards and conduct regular audits to ensure both cyber security and physical resilience
Security incidents must be reported within 24 hours as there are stricter reporting requirements
Violations may result in penalties in the form of fines of up to 10 million euros or 2% of global turnover

Conclusion: Why information security is essential for companies

The importance of information security in the modern business world cannot be overemphasized. With increasing connectivity and the steady rise of cyber threats, it is becoming imperative for companies to develop robust security strategies and comply with regulatory requirements such as the NIS2 directive. By implementing an effective information security management system in accordance with ISO 27001, companies can not only minimize their risk, but also strengthen the trust of their customers and partners. Given the new challenges that come with NIS2, it is crucial that companies act proactively to adapt to the increased information security requirements and avoid potential sanctions.

How we as Experts Institut can help

As Experts Institut, we offer comprehensive consulting services for the implementation and optimization of ISMS in accordance with ISO 27001. We also support companies in implementing the new requirements of the NIS2 directive. Our focus is on supporting customers in complying with IT compliance requirements and strengthening their information security.

Are you considering optimizing the security measures in your company? Get ahead and in touch with us – info@expertsinstitut.de

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9. October 2024/by Carsten Pickel

Business Solutions

ISO 9001 certification: Step by step to a successful QMS

ISO 9001 certification is an internationally recognized standard in quality management. It stands for trust, efficiency and reliability – qualities that customers and business partners value. However, the certification process can seem challenging. In this guide, you will learn how to successfully implement certification and how we can support you step by step.

Why ISO 9001 certification?

ISO 9001 certification offers many advantages: more efficient processes, better risk management and greater trust from customers and partners. It can also open up new business opportunities, as many tenders and contracts require ISO certification.

1. initial consultation and analysis: the start

The first step towards ISO 9001 certification is a comprehensive analysis of your existing structures and processes. This will determine how well your quality management system (QMS) already meets the requirements of the standard and where improvements are needed.

Why is this important? Many companies already unconsciously fulfill parts of the ISO 9001 standards. A professional analysis uncovers these strengths and identifies specific weaknesses in order to make the process efficient and time-saving.

2. planning the implementation: tailored to your requirements

Following the analysis, a customized implementation plan is drawn up that defines all the steps required for full compliance with ISO 9001 standards.

What makes this step so important? Thoughtful planning ensures that the standard requirements are implemented without disrupting your day-to-day operations. This maximizes the benefits of certification and minimizes disruption.

3. implementation of the quality management system (QMS)

Now it is a matter of either implementing the QMS from scratch or optimizing existing processes. This ensures that all requirements of the ISO 9001 standard are met.

Why is this important? An optimized QMS not only improves the quality of your products and services, but also increases efficiency. Clear processes, reduced errors and motivated employees contribute to successful certification.

4. internal audits and training: Preparation is everything

Internal audits and the training of your employees are essential components before the official certification audit begins. They identify weak points and ensure that the QMS is implemented correctly. At the same time, employees are prepared for the new processes.

Why this step? Training ensures that employees understand the new processes and use the QMS efficiently. The internal audits ensure that your company is ready for official certification.

5th certification audit: The decisive step

During the certification audit, an external auditor checks whether your company meets the ISO 9001 requirements. This is the last step before receiving the certificate.

Our support: We accompany you through the entire audit process and are on hand to answer any questions or challenges you may have. Our aim is to make the audit as smooth as possible and ensure successful certification.

6. receipt of the certificate: Your seal of quality

After the successful audit, you will receive the ISO 9001 certificate, which is valid for three years and confirms that your company meets the highest quality standards.

What comes next? Regular internal audits and continuous improvements are crucial in order to maintain certification in the long term and to be successful in the recertification process.

Conclusion: Your partner for successful ISO 9001 certification

ISO 9001 certification requires careful planning and specialist knowledge. With our advice at your side, the process will be smooth and efficient. Contact us to find out more about our customized consulting services and make your certification a success. Get ahead and in touch with us – info@expertsinstitut.de

Read our entire blog: https://experts-institut.de/newsroom/

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25. September 2024/by Viola Cussmann