RPS Packages

RPS Packages for 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

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

FAQs

Silver provides customized templates for Installation Qualification (IQ) and Operational Qualification (OQ) that the customer's own team executes; Gold adds a pre-FAT workshop and hands-on support during FAT, IQ, and OQ; Platinum includes complete test protocols with Rommelag conducting all tests and preparing all reports itself, plus the RPS Fast Track Concept. Rommelag structures the three tiers around how much of the qualification work a customer's own team wants to run: an experienced in-house team can execute independently using Silver's templates, while a team without that capacity can hand the entire process to Rommelag through Platinum. The templates and protocols behind all three packages are the same ones Rommelag uses to qualify its own bottelpack lines in its CDMO production, not a separate framework developed only for customers.

The RPS Fast Track Concept is included as part of the Platinum package. In a conservative approach, Factory Acceptance Test (FAT) and commissioning tests aren't used for qualification, and the qualification phase only starts once the system is ready for production. Rommelag's Fast Track Concept instead documents FAT and commissioning tests in GMP-compliant records as they happen, so tests relevant for qualification become Pre-IQ, Pre-OQ, IQ, or OQ tests directly, which means fewer tests have to be repeated during the official qualification phase.

Beyond the bottelpack system itself, Rommelag also supports qualification and validation for connected systems and equipment, including HVAC/ventilation technology, cleanrooms, purified media, batch preparation, autoclaving, in-process control, and secondary packaging. That matters because a bottelpack line rarely operates in isolation, and a qualification gap in a connected system such as HVAC or purified media can hold up approval of the whole production line even if the bottelpack machine itself is fully qualified.

Any modification to a qualified bottelpack system requires re-examination before it can be considered qualified again, since the original qualification only covers the system as it was tested. Rommelag supports this requalification process together with the required risk analysis, which determines the actual scope of re-examination needed for the specific modification — the qualification responsibility itself stays with the pharmaceutical manufacturer, as it does throughout the qualification process.