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Qualification/Validation
Pharma Plant
CSV
Cleaning Validation
Packaging Plant
Logistics & Distribution
HLK
Data-Mapping

«High Quality Qualification/
Validation of your Processes
and Plant»

 
Validation and qualification
operations are classified according
to the approach employed as
prospective or retrospective. We
are able to provide versatile services
in this sector in accordance with
customer and regulatory authority
requirements.
 
We will provide qualified specialists
to support your qualification and
validation projects. We also offer
extensive company internal concepts
for qualification and validation.
 

Your objectives – our standards

 
    • qualification according to
prevailing regulations of the
FDA, EU, GxP and GAMP
    • assignment of regularly trained
staff
    • extensive experience, many
reference projects
    • global operations possible
 

Our Services

 
    • creation of regulations and SOPs
    • creation of master plans
    • creation of qualification plans for DQ, IQ, OQ and PQ
    • creation of risk analysis
    • creation of traceability matrix
    • coordination of local qualification activities
    • complilation of required documents for
approval, completeness testing
    • execution of IQ, OQ and PQ tests
    • creation of qualification reports for DQ, IQ, OQ and PQ
    • creation of final qualification reports
    • execution of delivery audits
 
Validation is establishing documented evidence that provides a high degree
of assurance that a specific process will consistently produce a product meeting
its predetermined specifications and quality attributes.
 
Qualification is the action of proving that any equipment or process works
correctly and consistently and produces the expected results. Qualification is
part of, but not limited to, a validation process, i.e. installation qualification (IQ),
operation qualification (OQ) and performance qualification (PQ).
 


Specialisation
 
In addition to qualification and validation
activities for pharmaceutical plant we also
specialise in the following sectors:
 
    •  Computer System Validation (CSV)
    •  Cleaning Validation
    •  Packing Plant
    •  Packaging Units (PU)
    •  Monitoring Systems
    •  Storage incl. Data Mapping
    •  Cold/deep freezer rooms incl. data mapping


Qualification/Validation
  Hohenrainstrasse 10 | CH-4133 Pratteln | Tel. +41 61 826 97 26 | Fax +41 61 826 97 27 | E-Mail info@pharmatronic.ch    PAG Intern