RPS Packages

RPS Packages Qualification and Validation at a Glance

With our three modular packages, you can choose the level of qualification and validation support that best fits your specific needs—from providing templates to complete management.

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Silver

  • Provision of customized templates for the qualification of your bottelpack system
    • Installation Qualification (IQ)
    • Operational Qualification (OQ)
  • Consideration of available system specifications (URS, FS, etc.)
  • Optional: Risk Analysis

Free
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Gold

  • Includes all the benefits of the Silver package
  • Workshop prior to Factory Acceptance Test (FAT) to explain the purpose and recommended execution of qualification activities based on the templates
  • Support during FAT for Pre-IQ and Pre-OQ
  • Support for IQ and OQ
  • Optional: Risk Analysis

Free
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Platinum

  • Includes all the benefits of the Gold package
  • Provision of all test protocols (Pre-IQ, Pre-OQ, IQ, and OQ) for the qualification of your bottelpack system
  • All tests are conducted by us
  • All reports for each qualification stage are prepared by us

  • Optional:

    • Risk Analysis
    • SIP Validation
    • Airflow study and particle mapping
    • Cleaning procedures during FAT
Free
including RPS Fast Track Concept

RPS Fast Track Concept

Time Advantage: The RPS Fast Track Concept

With the RPS Fast-Track Concept, we are able to reduce the duration of the qualification process by up to 40% compared to conservative approaches.

With RPS Fast Track Concept

  • Qualification documents are prepared in time before FAT.
  • Tests conducted during FAT are documented in GMP-compliant records and evaluated for their suitability for qualification.
  • FAT tests relevant for qualification become Pre-IQ or Pre-OQ tests
  • Commissioning tests relevant for qualification become IQ or OQ tests
  • Fewer tests are required during the official qualification phase

Conservative Approach

  • FAT/commissioning tests are not used for qualification
  • Qualification begins once the system is ready for production

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Qualification

Qualification of Other Systems and Equipment

Neben der Qualifizierung von bottelpack Anlagen bieten wir Ihnen ebenfalls Unterstützung bei der Qualifizierung von sonstigen Anlagen und Betriebsmitteln. Für die Qualifizierung bieten wir Ihnen gerne die Erstellung aller erforderlichen Dokumente und die Durchführung der Tests an. Ebenso beraten und unterstützen wir Sie bei der Validierung. Zum Beispiel bei diesen Anwendungen:

In addition to the qualification of bottelpack systems, we also offer support for the qualification of other systems and equipment. We are happy to create all necessary documentation and perform the required tests for qualification. We also advise and support you in validation—for example, in these applications:

  • Ventilation technology/HVAC
  • Cleanrooms
  • Purified media
  • Batch preparation
  • Autoclaving
  • In-process control
  • Secondary packaging
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Requalification
Requalification after Modification
Quality assurance always has top priority. Therefore, system modifications that potentially affect the qualified status require re-examination and approval. We support you in qualification and risk analysis.
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Optimize your qualification and validation process

Contact Rommelag Pharma Service and find out which of our RPS packages best suits your situation. We will be happy to advise you