GMP & Validation

GMP and Validation

This is an area that Pharmaceutical and Life Sciences business must comply with to ensure any new systems or processes can be fully validated in accordance with regulatory requirements.

RB Plant have helped clients in this sector not only writing and executing validation protocols but also freeing up their time to focus on their core activities and producing protocols that the client inherits into their internal procedures for future projects.

We carry out:

  • 100% coverage of all protocols to achieve regulatory compliance.
    • Protocol and procedures documentation.
    • Design Qualification and GMP reviews.
    • Installation Qualification (IQ).
    • Operational Qualification (OQ).
    • Performance Qualification (PQ).
  • Validation master planning.
  • Process validation.
  • Prospective, retrospective and routine validation studies.
  • Software validation to GAMP 5
  • Construction auditing.
  • Wet and dry commissioning.
  • Validation training.
  • Factory and site acceptance test witnessing.

GAP Analysis

Businesses can sometimes find their projects stalling for several reasons. This may be due to lack of in-house resources but can also be the result of engaging external consultancies who may not be able to provide 100% of the required expertise to bring the project to a successful conclusion.

Understandably, having invested much time and money in a project, businesses are keen to salvage as much value from any work already carried out rather than start again from a blank canvas. This can often be the case after several months of work has been completed with negligible progress.

RB Plant have provided a GAP analysis for clients who are in such a position and need to achieve progression to the next stage gate. Some examples are:

  • Concept design that may not fulfil all safety, technical and environmental criteria.
  • CAPEX sanctioning case not robust enough to win over client executive teams.
  • Design for new process complete but no coherent plan as to how to interface with existing plant.

We have often worked constructively with incumbent designers to identify which aspects of any pre-work can be taken forward and where there are shortfalls which could prevent progression to the next stage. This helps the client not only take their project to the next level but also recover value from any money invested prior to RB Plant’s involvement.