THE FASTEST WAY
FROM PLANNING TO IMPLEMENTATION.

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Competences

  GMP CONSULTING


GMP
CONSULTING

Our experts advise companies in all the relevant areas of GMP, always with the consideration of commercial aspects. We will support you in quality control, quality assurance, production and with technical service. Our work is based on well-founded knowledge of all international regulations, official requirements and detailed insight into the processes within your sector. High-quality, GMP-compliant concepts are built on this foundation – and you save valuable time in marketing your products.


  GMP ENGINEERING


GMP
ENGINEERING

We will support you in your entire project planning, from the awarding process up to order placement including Basic and Detail Engineering. Our specialists will produce the URS and the entire specification for you, deal with enquiries from machine suppliers and evaluate the tenders from a technical and commercial point of view. We always keep focus on budget, quality and deadlines.


  GMP QUALIFICATION / VALIDATION



GMP
QUALIFICATION / VALIDATION

Pitzek GMP Consulting will carry out the complete implementation of GMP-compliant qualification and validation projects, whether that is in the production of pharmaceuticals, active substances, cosmetics or foodstuffs and animal feeds. In this way, our experts contribute to you being able to market your products even faster.

Our services include:

    • Creation of a Master Plan
    • Preparation of technical documentation (e.g. User Requirement Specification)
    • Creation of Specifications and lists of Requirements



QUALIFICATION

The highest level of quality assurance is the highest priority to us as any deviation have a direct influence on the health of the consumer. Through our services in comprehensive qualification, our experts will ensure fault-free functioning of installations, product quality and the fulfilment of all binding official requirements of the health authorities.

VALIDATION

Within the process of validation, our specialists will create a firm foundation for bringing the final product to the market. This includes confirmation that the technical installations have been qualified and deliver safe reproduceable results. Processes, cleaning systems and IT can be validated. An expert risk assessment forms a basis on which we can carry out a validation plan pursuant to precise regulatory stipulations, (EU-GMP-guidelines, FDA, PIC/S etc.).



  PROJECT MANAGEMENT


PROJECT
MANAGEMENT

If you entrust your project management to the experts of Pitzek GMP Consulting, you are guaranteed smooth, simple processes. We have been planning industrial installations in the fields of pharmacology, chemistry and food. We can thus support you in all project phases, from project definition to successful conclusion. Every single one of our consultants has completed an engineering degree – skills that you can rely upon. For you that means comprehensive freeing up of your own resources and high adherence to schedules.

Our services include:

        • Definition of project aims
        • Setting up project structures
        • Definition of milestones
        • Resources, schedule and budget planning
        • Projectmeetings
        • Award of Contract
        • Supporting and final documentation
        • Management of partial projects
        • Management of external suppliers and providers