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News from the world of GMP

EU and FDA Readiness

The quality management system (QMS) used in the pharmaceutical, medical devices, cosmetics and food industries contributes to the product safety and quality of your products.

We can help you with everything from design and planning to preparing for audits and inspections. Our portfolio also includes adapting your documents to your changing environment.

Our diverse and practical expertise spans the traditional pharmaceutical, API, medical device, biotechnology, biomedical, food and cosmetic industries.

All pharmaceutical quality systems must be at a high level at all times. And the best way to do this is without extensive preparation for an FDA inspection. Although the aim is to achieve a consistently high level of GMP outside the USA, most pharmaceutical companies prepare individually for an FDA inspection. This is because inspections in Germany are announced, whereas in the USA they are regularly unannounced.

The targeted preparation for the inspection only begins after the announcement, often at great expense. This leads to enormous tension and stress for everyone involved.

That is why we take care of your QM standards in advance, as a prerequisite for your company’s successful market access. Let our experts show you how to organise your QM system so that you can meet all the different requirements and successfully pass audits and inspections.

In co-operation with you, we want to achieve or maintain a consistently high GMP level so that you are audit-ready at all times.

But when are you ready for an FDA inspection? There are many questions, such as

• • Have you identified and assessed all possible internal and external compliance risks?
  • Are you aware of current inspection trends and possible focal points that relate to your product?
  • Have you already involved customers, partners and service providers?
  • Have you prepared the employees involved? Are their roles clearly allocated?
  • Do you know how to make your documents available efficiently?

We will answer these and other questions for you, and with you, so that you will be more than ready for your audit.

YOUR USE

• We will look at your processes with a critical and unbiased eye, just as an auditor or inspector would do.
• Your company then fulfils the QM requirements
• Gain the tools to design your QM system to best meet the relevant requirements of standards/regulations
• You know how to successfully pass an audit/inspection

OUR ORDER

• Identifying, evaluating and managing potential internal and external compliance risks
• Wir formen die Struktur, sowie den Inhalt und die Dokumentations-anforderungen Ihres QM-Systems
• We integrate the QSR requirements into your company’s existing QM system
• We work together with you to prepare for auditing/inspection by

1. 1. Document review
   2. Practical tips and tricks
   3. Clarification of terms and their meaning in implementation

• We train correct behaviour during audits/inspections – formulating your answers
• We prepare you for the procedures of the auditors/inspectors
• We show you how to deal with deviations identified during audits/inspections
• We will inform you about deadlines and sanctions in the event of deviations

Further services for the introduction of a quality management system etc. can be found here QMS and Hygienic.

Questions? Contact us:
Head of QMS
Mail: bettina.ernst@pitzek-consulting.de
Mobil: +49 151 146 112 93