Managing Highly Challenging GMP Processes

Interview with Thomas Pitzek, CEO of Pitzek GMP Consulting

  • Managing Highly Challenging GMP Processes (c) Dmitry Kalinovsky/ShutterstockManaging Highly Challenging GMP Processes (c) Dmitry Kalinovsky/Shutterstock
  • Managing Highly Challenging GMP Processes (c) Dmitry Kalinovsky/Shutterstock
  • Thomas Pitzek, CEO, Pitzek GMP Consulting

The German service provider Pitzek GMP Consulting, based in Neustadt/Weinstraße, has nearly 30 years of consultancy experience in GMP processing for pharmaceutical and life science product. In Germany, a team of almost 30 experts in biochemistry, process engineering, bioprocess engineering, pharmaceutical engineering and biology is active. After continuously expanding its presence in Germany, the company recently opened an office in Singapore. CHEManager asked founder and CEO Thomas Pitzek about the reasons for the expansion into the Asian market and his strategy for the further development of the company.

CHEManager: Mr. Pitzek, which services does Pitzek GMP Consulting offer and in which areas do you focus your activities?

Thomas Pitzek: Pitzek GMP Consulting stands for nearly 30 years of GMP processing for pharmaceutical and life science products, high competence in GMP consulting, qualification / validation, GMP engineering and project management. What makes Pitzek GMP Consulting special - short ways through an actively cooperating management. As a GMP expert, Pitzek GMP Consulting offers the highest quality in compliance issues, from consulting through conception to the implementation of new production lines. Due to decades of experience, we have specialized in isolator technology

In which geographical markets is your company active?

T. Pitzek: Our location on the wine route allows us to operate throughout Germany and beyond. In addition, we are currently developing our subsidiary in Singapore.

What is the typical course of a project that your company is entrusted with?

T. Pitzek: We advise in advance on the alignment, take care of the right machine builder if necessary, take care of customize equipment and document everything strictly according to GMP guidelines, always under the aspect of the highest quality standards and cost-efficient.

What were the reasons for the decision to open a branch office in Singapore?

T. Pitzek: The new subsidiary is located in the heart of downtown Singapore, which is now considered the international hub for the pharmaceutical industry and the medical technology in Southeast Asia (SEA).

There are also numerous known pharmaceutical and medical technology businesses as well as customers of the German business established. Now with the established representation in Asia, our consulting firm wants to support its globally operating pharmaceutical customers with even more targeted consultancy, qualification and validation, as well as engineering and additional GMP consulting.

Do your clients tend to be large companies or are small and medium-sized companies among them?

T. Pitzek: We work with small, medium and large sized companies equally. The company size of the customer doesn´t matter, we always deliver the best quality. That is the claim on ourselves.

You recently started a cooperation with GAT - Gesellschaft für Automatisierungstechnik. What are the benefits of this partnership for your customers?

T. Pitzek: In the context of Industry 4.0 and the comprehensive digitization of industrial production, we can better prepare ourselves for the future and handle projects along the entire value chain, including automation technology.

You are also involved in/heading the regional Community of Practice (CoP) Aseptic Processing of the International Society for Pharmaceutical Engineering (ISPE). What are the objectives of this group?

T. Pitzek: The aim of CoP Aseptic Processing is to offer operators, planners, manufacturers and interested parties who are dealing with the technology of aseptic manufacturing in their professional lives a discussion platform for specialist topics and the exchange of experiences. This objective is supported by annual expert discussions on aseptic processing topics. It is a particular aim to include in the expert discussions the dialogue with representatives of the authorities. In addition, an exchange with the CoPs of other affiliates takes place regularly.

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