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FROM PLANNING TO IMPLEMENTATION.

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Competences

  GMP CONSULTING

GMP
CONSULTING/QMS




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.

QMS

We make you EU and FDA ready

The quality management system in the pharmaceutical industry helps to improve the product quality and minimize the risk of recall. We support you in planning and documentation, in preparations for audits and inspections, help with the adaptation to changing framework conditions and stand for your quality assurance.

Services:

  • Building of a QMS according to EU or FDA GMP Guideline and preparation of the QM manual
  • Exact verification of existing processes and production process
  • Internal and external compliance risks are identified and assessed
  • Identification and rectification of vulnerabilities and defects (gap analysis)
  • Documents are sensitively examined and supplemented
  • Processes and documentation are self-explanatory for all employees involved
  • Implementation of self-inspections and monitoring of official inspections


  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/PLANNING

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


  TECHNOLOGYTRANSFER


TECHNOLOGY
TRANSFER

A technology transfer is what happens when a pharmaceutical company wants to move from an existing production site to a new production site.
Technology transfer in the pharmaceutical industry means more than copy & paste! There are often reasons to move an existing product to another location or to build additional capacity. Most people talk about “copying the existing assets and processes”.
It sounds simple, but there’s more behind it. The manufacturing process is influenced by many factors. That’s why quality must be paramount in a tech transfer. Critical characteristics of the product must be known and taken into account in a technology transfer.

We assess

  • Manufacturer’s original information – Raw materials – Critical process parameters – Equipment and batch size in consideration of scale up and FDA guidelines
  • we check the transmission protocols in order to record the process correctly
  • Development of transfer tools and a thorough process – transition to validation

There are 4 key positions that also need to be challenged to ensure successful technology transfer:

  • Packaging line testing
  • Stability display methods
  • Cleaning validation
  • Health and safety review


  COMPUTERSYSTEMVALIDATION



COMPUTERSYSTEM
VALIDATION

Computer validation is the documented testing of software or a computer system. As a manufacturer of pharmaceutical products, it gives you documented proof that computer-controlled or automated systems perform consistently, in compliance with predetermined regulations.
With many years of experience, we offer you tailor-made computer system validation. We test your software for practicality and reliability. We will demonstrate together with you in a comprehensible manner that your computer system will function correctly after changes, modernization or even rescheduling and are suitable for the purpose used.
Automated systems are tested and validated in accordance with US and EU regulations. This gives you inspection security through documented measures and various tests.

Our Services

  • Risk analysis according to GAMP 5
  • Creating of quality project plan
  • Validation schedule and process validation
  • Creation of important engineering documents
  • Preparation of qualification documents
  • Creation of test plans
  • Execution and documentation of FAT and SAT tests
  • Creation of test logs
  • Execution of Design Qualification (DQ)
  • Execution of installation qualification (IQ) and functional qualification (OQ)