THE SHORTEST WAY
FROM ENGINEERING TO QUALIFICATION.

Think. Work. Integrate.

SPECIAL KNOW HOW

  ISOLATOR- AND FILLINGTECHNOLOGY


ISOLATOR- AND
FILLINGTECHNOLOGY

Our long experience in sterile filling technology with isolator technology gives our customers a high level of security. That is because we offer holistic support, in planning, design and implementation of regulation-compliant installations. If you wish, we will take over complete project management, leaving you to concentrate on other things, e.g., the development of new products.

Our services include:

    • Consultation in the procurement of new installations and machines for sterile filling processes
      and Fill & Finish appliances in sterile areas
    • Creation of tender documents
    • Evaluation of proposals
    • Conception of risk-analysis workshops
    • Mock-ups, which we conceive and implement either under own auspices or together with you

 

      HOMÖOPATHIE




    HOMEOPATHY

    In the field of homeopathy, it is not just the general requirements of the pharmaceutical industry that have to be fulfilled, but also those of the homeopathic drugs register (HAB). That makes it even more important that you can depend on outstanding knowledge of the sector: The Pitzek GMP Consulting experts have professional experience and projects experience in homeopathic companies. This means they are very familiar with Hahnemann’s homeopathic principles and take every care to ensure compliance with these requirements, always considering efficiency and cost-effectiveness. We combine the most up-to-date technology and methods with traditional homeopathic practice.


      MEDICINETECHNOLOGY


    MEDICINE
    TECHNOLOGY

    We are a problem solver, project manager, auditors as well as gmp-hands-on consultants. Further, we offer interim solutions and support. This is done for the quality management, development, manufacturing and supplier quality management for medical device manufacturer and his suppliers. Relevant norms/ regulations and laws ISO 9001, ISO 13485, 21 CFR part 820 (FDA) will be considered at all times.

    Our main focus covers:

          • Equipment and facility qualification, process validation, cleaning validation, computer system validation (CSV) and product validation
          • Deviation and complaint management
          • Document management incl. document reviews
          • Change management
          • Risk management
          • CAPA management
          • Audit management (audit preparation and follow up, conduct internal audits)
          • Supplier (quality) management that includes supplier selection, supplier qualification supplier audit and supplier
            monitoring (e.g. tool making, injection moulding, packaging, implants and surgical instruments manufacturing)