THE FASTEST WAY
FROM PLANNING TO IMPLEMENTATION.

Think. Work. Integrate.

Competences

  GMP ENGINEERING


GMP
ENGINEERING / CONCEPTION

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.


  GMP QUALIFICATION / VALIDATION



GMP
QUALIFICATION / VALIDATION

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



QUALIFICATION

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

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.).



  QUALITYMANAGEMENTSYSTEM



QUALITY
MANAGEMENT SYSTEM

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.



SERVICES IN GENERAL

  • Non-conformities – development/adaptation of QMS to meet current requirements, QM manual preparation
  • Support for cross-site process harmonisation
  • Identification/remediation of QMS weaknesses and deficiencies
    (gap analysis)
  • Review of PDCA cycle – critical review of processes and production flow, identification/assessment of risks, supplier evaluation/li>
  • Comprehensible technical preparation of processes/documentation for involved employees for traceability incl. file archiving
  • Preparation/delivery of training courses (GMP/quality assurance system) at all levels
  • Audit preparation: self-audit support, official audit support, complaint handling

SERVICES HYGIENE

  • Development and revision of hygiene concepts for your company
  • Technical support for the conceptual pre-planning of your cleanrooms and determination of requirements for all ISO/GMP classes
  • Consulting on your internal cleanroom cleaning or outsourcing the service, as well as controlling external cleaning service providers
  • Creation and implementation of cleanroom/hygiene training for your employees at all levels incl. dressing procedures
  • Consulting regarding the implementation of Pest Control requirements
  • Preparation for service provider qualification audits



  TECHNOLOGY­TRANSFER


TECHNOLOGY­
TRANSFER

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


  COMPUTER­SYSTEM­VALIDATION / AUTOMATION­TECHNOLOGY




COMPUTER­SYSTEM­VALIDATION
AUTOMATION­TECHNOLOGY

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)


AUTOMATION TECHNOLOGY

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.



EXCERPT PERFORMANCE HARDWARE

  • 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

EXCERPT PERFORMANCE SOFTWARE

  • 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