Qualification / validation of your processes / systems / equipment in the highest quality

Your processes and equipment in high quality

We provide a variety of qualification / validation services based on customer and authority specific requirements.
We provide you with our qualified specialist staff for support in qualification and validation projects. In addition, we advise you comprehensively with regard to in-house concepts for the qualification or validation.

Your goals – our standards

  • Qualification / validation according to the current regulations of the FDA, EU, GxP, GAMP
  • Deployment of regularly trained employees
  • Extensive experience gained through numerous reference projects

Our Services

  • Creation of rules and SOPs
  • Creation of the master plan
  • Creation of training plans for DQ, IQ, OQ, and PQ
  • Creation of plans for the process, cleaning and method validation
  • Creation of risk analyses
  • Creation of the traceability matrix
  • Coordination of on-site qualification and validation activities
  • Collection and checking of the required documents with regard to approval and completeness
  • Performance of IQ, OQ and PQ tests
  • Creation of qualification reports
  • Creation of the final qualification report
  • Conducting supplier audits

Specialisation

  • In addition to the qualification and validation activities for general pharmaceutical plants, we specialise in the following areas: computer system validation (CSV)
  • Cleaning validation
  • Logistics systems – track & trace
  • Package units (PU)
  • Monitoring systems
  • Warehousing incl. data mapping
  • Cooling and freezing cells incl. data mapping

Pharmaceutical plants are subject to strict conditions imposed by national and international authorities. These must be adhered to, in order to ensure that products are produced according to the appropriate specifications.

Pharmaceutical plants are subject to strict conditions imposed by national and international authorities. These must be adhered to, in order to ensure that products are produced according to the appropriate specifications.

We accompany you through your qualification projects from the design phase to full-swing operation.

You benefit from:

  • decades of experience with regulations
  •  our employees’ profound knowledge and expertise
  • our interdisciplinary teams made up of process, machine, automation, IT, quality and pharmaceutical engineers

If GxP-relevant processes are supported by a computer system and GxP-relevant data is collected or processed, then your system must be validated.

With our integrated and pragmatic approach to software validation, we can validate the software in one run and define and implement the operational IT service processes to maintain the validated state.

We cover the following areas:

  • Process automation
  • Laboratory systems
  • Monitoring systems
  • MES
  • ERP

When it comes to cleaning validation, we operate in a complex environment where our experts are very knowledgeable.

Do you ask yourself the following questions?

  • Which cleaning methods have to be used in the process?
  • Which components have to be used in the cleaning process?
  • Which cleaning agents have to be used?

…Then we’re the perfect partner for you!

Whether it’s about qualification or optimization, when it comes to logistics systems, we’re always the right contact person:

  • Tube filling
  • Cartoning machine
  • Bubble wrap
  • Vials
  • Track & trace

…We conscientiously qualify and validate your investment.

When it comes to the risk analysis, the following important aspects are scrutinised among others:

  • Contamination
  • Capacity
  • Mix-ups
  • False labelling
  • Error regarding batch numbers or expiration dates
  • Missing or incorrect leaflets

With our knowledge and experience, we help you to prevent and to eliminate such risks!

Good Distribution Practice (GDP)

The GDP guideline is not only relevant for wholesalers in the pharmaceutical sector, but also for drug manufacturers. Thus the drug manufacturer must comply with the GDP rules and implement them. The GDP guideline is particularly important to all service providers involved in the supply chain who perform the following activities:

  • Procurement
  • Storage
  • Delivery
  • Export
  • Transport
  • Tracking

As a specialist company, we are always up-to-date and will gladly advise you, so that your company can handle the products in the logistics area competently and pass future audits with flying colours.

As a service provider, we undertake all calibration, validation and qualification activities, while your company can fully concentrate on your core business.

Our Services:

  • Reviewing and updating of your quality management (QM) system / quality assurance (QA) system
  • Conducting risk analyses (RA)
  • Execution according to the CAPA system for correction and prevention of deviations
  • Data mapping
  • Calibration of all measurement instruments used in the pharmaceutical logistics sector, e.g. temperature and humidity sensors
  • Internal and external audits
  • Consulting for GMP and GDP related issues

We are well equipped for the qualification of the ventilation and monitoring systems. From the design of the sensors to complete commissioning, we can support you in your projects.

We use our climatic chamber to calibrate the measuring instruments, so that humidity and temperature can be qualified in accordance with the required specifications.

The following physical parameters are qualified in the monitoring area:

  • Humidity
  • Temperature
  • Differential pressure
    • Particle measuring
    • Hepa filter monitoring
    • Room classifications

Thanks to our many years of experience, we are able to identify problem areas in your warehouses and cold storage cells and to confirm them in the context of data mapping. After evaluating the collected data, we can analyse the trends and define promising measures.

We have data loggers that can be used in normal or ex-rooms.

Our Services:

  • Analysis of environmental conditions
  • Creation of mapping plans
  • Design of the data loggers
  • Evaluation of the data loggers
  • Definition of hot spots
  • Written reports including definition of measures

Personnel on request

Are you looking for employees to assist with peak order periods, to bridge staff shortages, or in the long term from an outsourcing partner? Pharmatronic AG offers tailored solution for small, medium and large companies from our extensive portfolio.