MTP4Pharma® Intrinsic Plug & Operate Compliance

info@mtp4pharma.eu

expertise.

we were the first. since 2020, we have been shaping the regulatory-compliant implementation of Plug & Operate (Plug & Produce, Plug & Play) approaches for MTP-based modular systems and plants.

consulting.

we help GxP regulated companies, smart module manufacturers, general contractors and service providers with clients in the pharmaceutical industry to adapt and optimise existing quality and engineering management systems to implement MTP-based solutions GMP compliant and efficient.

training.

our interdisciplinary training curricula provide the basis for successful implementation and operation of MTP-based solutions in GxP-regulated environments.

implementation.​

together with MTP-technology focussed industry partners and universities we are currently the only organization on the planet able to provide MTP-based end-2-end solutions for the GxP-regulated pharmaceutical industry.

partner.

Clients.

Forward Thinking Clients.

Committees.

Forward Thinking communities & expert groups.

Provide external expert support to the current Plug & Play Working Group during the update of the Plug & Play Computerised Systems Validation Strategy, originally published in 2021.

Initiation and management of the Global ISPE® GAMP® Special Interest Group (SIG) “MTP in Pharma – Modular Plant Validation and Qualification”.
See Communities of Practice – GAMP® Module Type Package Special Interest Group:
Thomas Makait | ISPE | International Society for Pharmaceutical Engineering

Provided external expert support to the joint NAMUR working groups 2.4.1 “Process Orchestration” and 2.3.1 “Batch Control” in the preparation of NE 185 “Requirements for the qualification of the process control technology (PCT) of modular plants in the GMP environment”, published in 2022.

As a PNO member, we provide expert support for the current update from MTP 1.0 to MTP 2.0.

Active member and contributor to the VDI/VDE Automation Methods Committee since 2005.

Provision of training courses for the professional preparation of requirements specifications and documents for automated manufacturing systems:
Lasten- und Pflichtenhefte für Automatisierungssysteme erstellen

About Us.

Curious About Our Culture?

For over 13 years, we have been at the forefront of technology. We work closely with universities, expert groups, communities of practice and standardisation organisations to bring the latest technology to the pharmaceutical industry in a compliant and efficient way!

managing director.

Thomas makait.

+26 years of experience in the pharmaceutical industry.
Lead of the ISPE® GAMP® SIG Special Interest Group ‘MTP in Pharma’. Active in BioPhorum®, GAMP®, GAMP® D-A-CH, ISPE®, NAMUR, PROFIBUS, VDI.

HEAD of innovation, research and development.

simon makait.


University of Applied Sciences.
B.Eng. Electrical Engineering and Information Technology.

Apprenticeship.
Electronics technician in automation.

Don’t Be Shy, ask us.​

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