MTP4Pharma® - QPRI - Transparency for Project Efficiency

MTP4Pharma^®

Intrinsic compliance minimizes GxP compliance risks and increases efficiency at the same time

For operators of modular plants in a GxP-regulated environment:

As a Senior Management Consultant, I support you, your organization and your employees in the regulatory compliant design, implementation and operation of MTP-based modular plants in green- and brownfield environments.

As an external consultant or interim QA Manager, Computerised Systems Validation or Technical Compliance Manager, I support quality and technical compliance organisations in implementing MTP-based solutions to take full advantage of MTP-based modular plant concepts in GxP environments:

The achievable benefits include

reducing engineering effort by up to 70% by accelerating the development process and transition to industrial production;

increasing expandability and reusability of modular units/equipment by up to 80%;

reducing time to market and commissioning by up to 50%;

Elimination of redundant tests by systematically identifying and tagging quality-related and non-quality-related requirements and related verification measures into:

GEP: Verification measures regarding non-quality-relevant requirements are carried out under Engineering-Oversight. This means that tests are carried out in accordance with demonstrably established Good Engineering Practices (GEP) and the results are documented in accordance with Good Documentation Practices (GEP);

GMP: Verification measures regarding quality-related requirements, qualification and validation measures are carried out under QA-Oversight. This means that tests are carried out in accordance with Good Manufacturing Practices (GMP) and documented in accordance with Good Documentation Practices (GEP).

The systematic structuring of quality-related and non-quality-related requirements, as well as the division of the associated tests into verification measures in accordance with GEP procedures and validation and qualification measures in accordance with GMP procedures, allows the risk based determination of an appropriate overall test scope. This test scope serves to confirm suitability for the intended purpose. Under certain conditions, GEP-verification-measures carried out under engineering oversight can be referenced (‘leveraged’) as part of the validation and qualification measures carried out under QA oversight. This approach allows to eliminate repeat testing and allows the validation and qualification measures to focus on the critical quality-relevant requirements.

My support focuses on the implementation of integrated Good Engineering Practice processes supporting intrinsic compliance as the initial origin of the modular plant life cycle. This is of crucial importance to ensure the flexibility of validated modular plants (computerized systems) over the entire plant life cycle. The following phases build on these foundations: construction/FAT, manufacturing/verification, commissioning, qualification/validation, operation, change management and maintenance. The plant documentation created during the integrated database-driven engineering process is enriched with properties/data structures that enable the classification and verification of requirements and subsequent design decisions and technical specifications without significant additional effort to demonstrate suitability for the intended purpose. This applies to the entire plant life cycle of MTP-based modular plants.

For machine and plant manufacturers:

As a senior management consultant, I support you, your organization and your employees in efficiently implementing the requirements that apply to the delivery of modular systems and system components in a GxP-regulated environment. I pay particular attention to ensuring that relevant legal GxP requirements are identified and demonstrably taken into account.

Global standardization in the GxP environment

Based on the experience gained in recent years, I have initiated the Global ISPE^® GAMP^® Special Interest Group for the qualification/validation of MTP-based modular systems. The aim is to standardize concepts and efficient procedures in the GxP environment internationally.

Contact me

2025 ISPE Europe Annual Conference

I am looking forward to meeting you at the 2025 ISPE Europe Annual Conference, which will take place in London from Monday 12 May to Wednesday 14 May 2025.

Qualification and
Validation of
Modular Plants

What does the statement ‘intrinsic compliance minimizes GxP compliance risks’ mean?

Intrinsic: ‘coming from within’, ‘from within, due to inherent characteristics’, ‘intrinsic properties belong to the object itself and make it what it is’.

Antonym extrinsic: ‘originating from outside (stimuli), not occurring on its own initiative’.

Conformity: conformity is confirmed by means of a declaration of conformity. This declaration is a written confirmation at the end of a conformity assessment, with which the responsible parties (e.g. manufacturer, dealer, operator, entrepreneur, independent service provider) for a product, the provision of a service or an organisation (e.g. manufacturer, testing laboratory, operator of a quality management system) bindingly declare and confirm that an object to be tested (e.g. product, service, body, QMS) has the properties specified in the declaration. Conformity assessment is defined as ‘demonstrating that specific requirements related to a product, process, system, person or body have been met’.

Minimization: ‘in the consideration of risk and effort, reducing possible effects to the smallest possible, still acceptable extent’.

GxP: Good x Practices: e.g. Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), Good Documentation Practices (GDP).

GxP compliance: Means meeting the rules set out by the relevant authorities for pharmaceutical and related life science products and processes.

Risk: the effect of uncertainty on objectives.