Audits & Inspektionen

pass optimally

Competent 360° support
Many years of experience
Global supplier qualification

Your advantages as a partner of Experts Institut

Ihre Audits & Inspektionen:
Gründlich vorbereitet, professionell organisiert, effektiv durchgeführt

Competent support
You can rely on consultants with many years of experience – for internal and external audits in the GMP and ISO areas.
Experienced - in all areas
To ensure that your inspections and audits are successful and efficient, we are always at your side: from preparation to support and follow-up.
Supplier qualification
If required, use the support of our experienced consultants for your company in supplier qualification at home and abroad – including in India and China.
National & international tätig
Benefit worldwide from conscientious and careful support during audits and inspections in the GMP and ISO environment.

Internal and external audits and inspections are required by law in both the GMP and ISO areas.

They are also an integral part of every company’s quality management system.

It is crucial to prepare them thoroughly and organize them professionally.

Then they can be carried out effectively.

There is often a lack of internal manpower, know-how or the time required for conscientious and careful preparation.

WE ARE

Uncomplicated and solution-oriented
Sustainable and empathetic
digital and agile
working where and for what we are needed

WE WILL

Building excellence and passing it on to our customers
Deliver high-level results
Achieving compliance and efficiency

WE DELIVER

personal integrity
Customized and feasible solutions
Meeting at eye level

Know-how

Meet legal requirements

Holistic

Internal and external audits in the GMP and ISO area

International

Deploy experienced consultants worldwide

incl. Suppliers

Globale Qualifizierung von Lieferanten
(inkl. Indien & China)

GMP audit services

At Experts Institut, we offer comprehensive GMP audits and inspections to ensure that your pharmaceutical manufacturing processes meet the highest quality and compliance standards. Our services in the area of GMP audits and inspections include

1. on-site inspections: Our experts carry out on-site inspections at your production facilities to ensure that all GMP requirements are met. During these inspections, we check your systems, processes and documentation.

2. compliance report: After completion of the inspection, we prepare a detailed compliance report. This report contains a summary of the findings, identification of GMP non-compliances and recommendations for remediation.

3. gap analysis: Our experts carry out gap analyses to identify potential violations of GMP guidelines. Based on these analyses, we develop customized solutions to eliminate deficiencies and ensure compliance.

4. regulatory support: We offer support in regulatory matters in connection with GMP audits and inspections. Our experts are on hand to help you meet regulatory requirements and ensure successful audits.

5. follow-up and training: Once the inspection is complete, we support you in implementing corrective actions and training your team to ensure GMP compliance.

Our GMP audits and inspections aim to ensure that your pharmaceutical manufacturing processes meet the highest quality and compliance standards and help you maintain an excellent quality management system.

Auditor training

We have been successfully training auditors in the national and international pharmaceutical and active ingredients industry for many years. We first teach the theoretical tools and then assist with the practical implementation.

Auditor training is also particularly efficient if you have your suppliers qualified – by us.

Supplier qualification / third-party audits

On the one hand, globalization means that there are always new and economically attractive sources for covering GMP-relevant raw material and service requirements. On the other hand, the requirements for supplier qualification have also increased significantly in recent years. If you want to develop a concept for efficient and GMP-compliant supplier qualification, we will be happy to advise and support you. Experts Institut takes over the complete audit planning, including scheduling and audit administration in preparation for an audit Of course, we also audit your contract manufacturers and suppliers worldwide. This gives you a deep insight into these companies and a sound basis on which you can continue to work with suppliers or service providers. We create the audit report just for you and exactly according to your specifications. We do not reuse audit reports, as is usual with other providers.

Inspektionsvorbereitung & Inspektionsbegleitung

Sie wollen Behördeninspektionen (EU, FDA, Swissmedic, ANVISA/Brasilien, PMDA/Japan) und Kundenaudits souverän bestehen? Wir beraten und begleiten Unternehmen seit Jahren erfolgreich in allen Phasen solcher Inspektionen und Audits.

Zunächst identifizieren wir in Mock-Audits Schwachstellen in Ihrer GMP-Compliance oder bewerten mit Ihnen zusammen vorhandene Inspektionsberichte. Anschließend stehen wir Ihnen bei der Vorbereitung von Audit oder Inspektion Ihrer Firma in allen Fragen zur Seite. Wichtig kann zum Beispiel auch ein Training Ihrer Mitarbeiter sein, um sie auf Details und Stolpersteine vorzubereiten. So können sie sich während Audit oder Inspektion selbstbewusst und professionell verhalten.
Häufig ist es auch sinnvoll, dass wir Ihre Inspektion begleiten. Nach unserer Erfahrung wird das bei Behörden gerne gesehen.

Weitere Vorteile für Sie:
▪ Wir überarbeiten Qualitätssicherungssysteme wie zum Beispiel CAPA, PQR, Abweichungen.
▪ Wir führen Risikoanalysen durch.
▪ Auf Wunsch nehmen wir Kontakt mit Behörden auf, um diese in den Upgrade-Prozess einzubinden.

Mock audits

Preparation is everything: Mock audits help you to prepare effectively for upcoming inspections by authorities and customer audits. Mock audits are not only used to confirm internal quality levels. They also uncover possible GMP deficits and weaknesses in your quality management system at an early stage. This allows continuous improvement measures to be introduced – over and above self-inspection.

We support you by
▪ Check the documents in advance,
▪ Train your employees for the inspection,
▪ Simulate the inspection.

Benefit from our many years of auditing experience in an international environment.

Inspection follow-up

Good follow-up is also important. Of course, a successful inspection requires more than just conscientious preparation and professional behavior during the inspection.

The follow-up begins with an adequate response to the inspection report and extends to the implementation of the defined measures, whether corrective or preventive.

For example, our experienced consultants will work with you to draw up a schedule for implementing the defined measures and will also monitor this schedule. We also support you with appropriate self-inspections.

Request

Send us an inquiry with your requirements for audits and inspections in the GMP or ISO environment.

Material

You will receive non-binding initial information and get in touch with your personal contact person.

Conversation

We will discuss your needs together in a personal meeting. You will then receive a concrete offer.

Support

You benefit from our support in the area of audits and inspections.

Get in touch with us!

Claudia Teupe

Claudia Teupe

Head of Administration

Your personal contact for everything to do with auditions

Neustadt

Experts Institut Beratungs GmbH
Kirchwiesenstrasse 5

D-67434 Neustadt a. d. Weinstraße

Phone: +49 (0)6321 969210
E-mail: info@expertsinstitut.de

Fax: +49 (0)6321 9692199

Bamberg

Experts Institut Beratungs GmbH
Untere Sandstraße 53

D-96047 Bamberg

Phone: +49 (0)951 51939330
E-mail: info@expertsinstitut.de

Freiburg

Experts Institut Beratungs GmbH
Habsburgerstrasse 101a

D-79104 Freiburg im Breisgau

Phone: +49 (0)6321 9692120
E-mail: info@expertsinstitut.de

St. Gilgen (Austria)

Experts Institut Beratungs GmbH
Helenenstrasse 16

A-5340 St. Gilgen, Austria

Tel.: +43 (0)6227 21068
E-mail: info@expertsinstitut.de

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