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

As part of this, we support you from conception and planning to preparations for audits and inspections. Our portfolio also includes adapting your documents to your changed framework conditions.

Our diverse and practical expertise lies in the areas of traditional pharmaceuticals, APIs, medical devices, biotechnology, biomedicine, food and the cosmetics industry.

All pharmaceutical quality systems in the operating units must always be at a high level. And the best way to achieve this is without extensive preparation for an inspection by the FDA. Although the aim is to establish a consistently high level of GMP outside the USA, most companies in the pharmaceutical industry prepare individually for an FDA inspection. This is due to the fact that inspections are announced in Germany, whereas they regularly take place unannounced in the USA.

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.

We therefore take care of your QM standards in advance as a prerequisite for your company's successful market access. Find out from our experts how to design your QM system so that all the different requirements are met and you successfully pass audits and inspections.

In cooperation 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 tons of 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 assigned?
• Do you know how to make your documents available efficiently?

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

YOUR BENEFITS

• We check your processes with a critical and unbiased eye, just as the auditor/inspector would do
• Your company then fulfills the QM requirements
• You will acquire the tools to design your QM system so that you optimally meet the relevant requirements of the standards/regulations
• You know how to successfully pass an audit/inspection

OUR ENDEAVOR

• We work with you to identify potential internal and external compliance risks, assess them and address them together with you
• We shape the structure, content and documentation requirements of your QM system
• We integrate the QSR requirements into your company's existing QM system
• We make the preparations for an audit/inspection together with you by

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

• We train correct behavior 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 hygiene.

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