Top advice regarding qualification and validation

Top advice regarding qualification and validation

 With Rommelag Pharma Service (RPS), we offer those who purchase a bottelpack system a quick and economical complete concept for qualification and validation, which is recognized by the authorities. Due to our background with the Rommelag CMO facilities we know what matters and can support you to realize a cost-effective, successful and reliable validation approach for your Blow-Fill-Seal machine. It is, of course, entirely up to you as to whether we should only assist you in an advisory capacity, take on full project management, handle the entire validation service for you, or simply provide you with the blank documents.

You can also make use of Rommelag Pharma Service for systems which have already been installed and are already operational. The experience we have gathered at our production facilities puts us in a position to offer you comprehensive advice on efficient system usage and on optimizing the entire production process.

Rommelag Pharma Service experts will offer advice and plan your entire project together with you, from the greenfield stage to the complete production processes. We recommend that you incorporate Rommelag Pharma Service early on – it will be worth your while.

Rommelag Pharma Service packages for the validation of your bottelpack system

  • Qualification draft documents tailored individually for each machine
  • Takes OC / URS (if applicable) into consideration
  • Optional: Risk Analysis

  • Includes Silver Package
  • Workshop before FAT using draft documents
  • Consulting during FAT (Pre-IQ and Pre-OQ)
  • Consulting during IQ and OQ
  • Optional: Risk Analysis

  • Includes Silver Package
  • All test protocols (Pre-IQ / Pre-OQ, IQ / OQ) prepared by RPS and approved by the customer
  • All tests performed by RPS and approved by the customer
  • All reports prepared by RPS and approved by the customer
  • Optional:
    • Risk Analysis
    • SIP Validation
    • Air Flow Study and Particle Mapping
    • Cleaning Trial during FAT

RPS – FAST TRACK CONCEPT (only possible with Platinum Package)

Conservative approach:

  • FAT/commissioning tests are not used for qualification
  • Qualification starts once machine is ready for production


RPS Fast Track Concept:

  • Qualification documents are prepared in good time before FAT
  • Tests done during FAT are documented in GMP-compliant records and evaluated whether they can be used for qualification
  • Qualification-relevant FAT tests become Pre-IQ/Pre-OQ tests
  • Qualification-relevant commissioning tests become IQ/OQ tests

→ Fewer tests are left to be done during the official qualification phase!

Further RPS Services

  • Preparation of qualification documents
  • Execution of qualification tests
  • Consulting and support during validation
  • Possible range of applications:
    • HVAC
    • Water treatment
    • Pure steam
    • Autoclaves
    • Clean rooms
    • Secondary packaging

Re-qualifications are in order after any kind of modification that has a possible impact on the qualified status (e.g. CIS-modifications)

Following documents / activities can be provided:

  • Installation qualification
  • Operational qualification
  • Risk analysis

→ Offers are provided individually depending on the modification and kind of equipment

Based on over 40 years of own experience with the different Rommelag CMO facilities (as of today, 3 facilities in Germany and 2 facilities in Switzerland) and the experience with their customers, RPS has developed an “ideal workflow for a BFS-Facility”.

  • Layout provided by the customer is reviewed by RPS
  • Review of clean room classifications as well as man-, material- and waste-movement concepts resulting in a report with observations, comments and suggestions
  • Summary with comments/questions prepared by RPS
  • Conference call with RPS/sales/customer to discuss the issues raised
  • Preparation of process flow diagrams and calculation of human resources and material balance
  • Preparation of technical specifications (URS according to GMP standards) for downstream packaging equipment, including suggestions of suppliers and estimation of budget

Our Experts have gained experience from numerous successfully passed audits conducted by different authorities, such as

  • FDA
  • EU
  • PIC/S
  • WHO
  • country-specific authorities

We are offering:

  • Assistance in preparation and execution of pre-inspection workshops
  • Auditing of the customer’s equipment and facilities, e.g. after major changes of in-house management structures
  • GMP and process optimization (Estimated effort: 2 persons, 2-5 days)

RPS is able to provide customized solutions for training either at customer’s site, at a Rommelag site in Germany or in combination with our bTC - bottelpack training center.

Training topics can be:

  • Aseptic processing
  • Blow-Fill-Seal production
  • Qualification and validation
  • Risk management for Blow-Fill-Seal

Rommelag Pharma Service

Our Pharma Service Experts are happy to advise

Rommelag Pharma Service