MTP4Pharma®
Valuable insights.
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simplification through standardised smartification.
with our support it’s easy and straightforward.
First, it would be best to be clear on your organisations current digitisation maturity and objectives, before you start an mtp-based modular plant project:
Updating, upgrading or migrating existing automated manufacturing systems to current technologies, product / application versions.
typically manufacturing processes and ways of workig remain the same.
a more advanced approach is to modernise systems and to optimize manufacturing process and ways of working overlapping and concurrently. in parallel the engineering and the pharmaceutical quality management systems are analysed and adopted to allow for efficient and compliant digitisation.
while modernization and optimization take place manufacturing processes and ways of working are continually challenged and iteratively adapted to fully utilize efficiency gains enabled by digitalisation.
plug & operate in modular plants:
Intrinsic compliance minimizes GxP compliance risks and increases efficiency at the same time.
• intrinsic compliance.
• quality by Design (QbD) and Good Engineering Practices (GEP).rward.
just follow a standardised triad approach.
ththe standardized plug & operate in modular plants.
this unheard level of standardization allows regulated companies and smart module manufacturers to minimize GxP compliance and commercial risks at the same time while boosting efficiency.
unbelievable?
try out our consulting approach to assist regulated companies and smart module manufacturers.
Advantages of modular plants
based on the Module Type Package (MTP) Standard
Reducing engineering effort by up to 70%
through the acceleration of the development and engineering effort and transition to industrial production. (source PNO)
increasing flexibility by up to 80%
by designing easily adaptable and qualifiable modular production platforms built from smart modules. (source PNO)
reducing time to market by up to 50 %
through the procurement of standard off-the-shelf modules. (source PNO)
Reducing on-site testing by up to 60 %1) 2)
for pre-qualified automated manufacturing equipment (smart modules):
– computerised system validation (CSV)
– equipment qualification (EQ)
note 1: for quality relevant verification activities executed by smart module vendors, QA-oversight of the GxP-regulated company must be ensured.
note 2: smart module qualification must be completed by the GxP-regulated company at the location of use.
insights for
ensuring QA-oversight on external verification activities.
how QA-oversight can be ensured efficiently in a standardized manner, is part of our consulting services. this approach helps to minimze regulated companies review activities when leveraging vendor documentation.
insights for
standardized plug & operate of modular plants.
flexible and efficient plug & operate in modular plants is based on intrinsically compliant design, implementation and qualification. for each critical element of a modular plant.
insights for
intrinsic compliance.
intrinsically compliant design, implementation and qualification for each critical element of a modular plant are based on Quality by Design (QbD) and Good Engineering Practices (GEP). for regulated companies as well as for smart module manufacturers.
insights for
quality by Design (qbD) and Good Engineering Practices (GEP).
QbD and GEPs foundation are seamless data driven process, equipment and automation engineering utilizing the MTP-standards capabilities for semantic modelling. allowing regulated companies to leverage smart module manufacturers design, engineering, verification and documentation in a standardized approach.
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