Think. Work. Integrate.




We will guide you through the entire project planning process, from conception to implementation, from tendering to contract award, including basic and detail engineering. We tailor our solutions to your needs and requirements, and together we enable a structured qualification and validation approach from the outset. Our specialists will draw up the URS for you, the complete specification, handle enquiries with machine suppliers and evaluate quotations from both a technical and commercial perspective. We always keep an eye on budget, quality and deadlines.



Pitzek GMP Consulting takes on the complete implementation of GMP-compliant qualification and validation projects, whether in the production of pharmaceuticals, active ingredients, cosmetics or food and feed. In this way, our experts help you to bring your products to market even faster.

Our services include:

        • Creation of a Master Plan
        • Preparation of technical documentation (e.g. User Requirement Specification)
        • Preparation of specifications and requirements


Quality assurance at the highest level is our top priority. Because deviations have a direct impact on consumer health. Through our services
our experts ensure the proper functioning of systems, product quality and compliance.lung aller verbindlichen Auflagen
der Gesundheitsbehörden sicher.


Validation is the process by which our specialists establish a sound basis for bringing the final product to market. This confirms that the systems/devices are qualified and deliver safe, reproducible results. Processes, cleaning systems and IT can be validated. This is based on a professional risk assessment, which we carry out according to a validation plan in accordance with precise regulatory requirements (EU GMP guidelines, FDA, PIC/S, etc.).



We make you EU and FDA ready

The Quality Management System (QMS) used in the pharmaceutical, medical device and cosmetics industries contributes to the 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 the adaptation of your documents to changing conditions.

We have a wide range of practical expertise in the areas of classical pharmaceuticals, active pharmaceutical ingredients, medical devices, biotechnology, biomedicine and cosmetics.


  • Establishment of QMS in accordance with current requirements, including preparation of the QM manual
  • Support with cross-site process harmonisation
  • Identification and elimination of QMS weaknesses and deficiencies (gap analysis)
  • Critical review of existing processes and production flow – identification and assessment of risks
  • Comprehensible technical preparation of your processes and associated documentation for all staff involved
  • Provide and deliver GMP and QMS training to your staff at all levels of the organisation
  • Support in the performance of self-inspections and accompaniment during official inspections


  • Development and revision of hygiene concepts for your company
  • FTechnical support in the conceptual pre-planning of your cleanrooms and determination of requirements for all ISO/GMP classes
  • Advice on your in-house cleanroom cleaning or outsourcing the service
  • Preparation and delivery of cleanroom/hygiene training for your staff at all hierarchical levels, including gowning procedures/li>
  • Advice on the implementation of Pest Control requirements
  • Preparation for service provider qualification audits



EA technology transfer is what happens when a pharmaceutical company wants to move from an existing production site to a new production site. Tech transfer in the pharmaceutical industry means more than copy & paste! Often there are reasons to move an existing product to another location or to build up additional capacities. Most people then speak of “copying the existing facilities and processes”.
This sounds simple, but there is more to it. Many factors influence the manufacturing process. That is why quality must be the main focus of a tech transfer. Critical properties of the product must be known and taken into account.

DWe thereby evaluate

  • The original manufacturer’s information, raw materials, critical process parameters, equipment and batch size, taking into account scale-up and FDA guidelines.
  • Preview transfer protocols to properly capture the process
  • Development of transfer tools and a thorough process – transition to validation.

To this end, there are 4 key positions that also need to be challenged to ensure successful technology transfer:

  • Ppackaging line trials
  • Stability display methods
  • Cleaning validation
  • Health and safety check



COMPUTERSYSTEM                                                                          VALIDATION

Computer validation is the documented testing of software or a computer system and provides you, as a pharmaceutical manufacturer, with documented evidence that computer-controlled or automated systems consistently perform in accordance with specified regulations.

We test your software for practicality and reliability. We will work with you to demonstrate that your computer system, whether modified, upgraded or redesigned, will function properly and be suitable for its intended use. We test and validate automated systems in accordance with US and EU regulations. This gives you inspection security through documented measures and various tests with a 100% life science focus.

Our services include:

        • Risk analysis according to GAMP 5
        • Preparation of a quality project plan
        • Validation schedule and process validation
        • Preparation of engineering documents (FS, SDS, HDS, …)
        • Preparation of qualification documents and the test plans
        • Execution of FAT and SAT tests and documentation
        • Creation of test protocols
        • Carrying out the design qualification (DQ), the installation qualification (IQ) and the functional qualification (OQ)
        • Electronic signature and all types of electronic records according to FDA (21CFR Part11)


With our many years of experience, we can offer you customised planning and execution of your automation projects. Automation increases your process efficiency and plant availability and improves both quality and safety.

A seamless, digitally recorded and legally compliant workflow is perfect for traceability and anti-counterfeiting. The error rate is significantly reduced by automatically recording your production data. Your relevant production data and resources are available at the right time. Even the smallest deviations are detected, ensuring early, controlled intervention by operators.

In addition, we can use the collected data to perform performance checks on various equipment and identify and implement potential improvements. By optimising process automation, we are able to provide predictive maintenance. It is very important for us to look at the entire lifecycle of your plant and provide solution-oriented recommendations.


  • Infrastructure concepts for energy plants, undersupply, production networks IT and OT
  • Planning of electrical distributions, I/O signals and exchange between system manufacturers, interface communications
  • Coordination with renowned system integrators


  • Computer system validation (see excerpt services)
  • Concepts for data integrity in third-party systems, such as MES, LIMS, ERP, SAP, etc.
  • eQMS (electronic quality management system)
  • GAP analyses according to valid regulations also FDA
  • Coordination and support of system migrations