JHS GMP Consulting
One-Stop Documentation and Testing Support for Aseptic Manufacturing Processes in Medical Devices and Pharmaceutical Products

In the evolving landscape of healthcare, the lines between the worlds of medical devices and pharmaceuticals are gradually blurring. A significant convergence is taking place between pharmaceuticals and medical device manufacturing processes, driven by the emergence of combined products.

Medical device manufacturers and pharma companies need to be prepared for this change, with proper product documentation and testing processes that adhere to regulatory standards. JHS GMP Consulting, a medical device consulting firm, stands ready to assist them in their preparation.

Leveraging its extensive expertise in the pharmaceutical and medical device industries, the firm offers holistic advice on aseptic manufacturing processes. It provides a tailored suite of services, including quality management systems (QMS) reviews, technical documentation support, in vitro diagnostic regulation (IVDR) implementation and project management for qualification and validation projects to effectively meet clients’ testing needs.

Through its consulting services, JHS GMP Consulting tackles emerging challenges and offers innovative solutions to clients in the pharmaceutical and medical device sectors.

“We help clients avoid unexpected compliance issues by ensuring their product documentation meets the required standards for medical devices and pharma products,” says Jochen Schneider, director of JHS GMP Consulting.

The company is geared towards bridging existing gaps in documentation and facilitating compliance with pharmaceutical industry standards, JHS GMP Consulting specialises in two essential services—comprehensive risk documentation and qualification process management.

During the preparation of product documentation for market launch, the company thoroughly analyses existing structures, identifies gaps and addresses them to meet pharmaceutical standards. This includes rectifying significant gaps original design documentation, covering software and hardware designs for technical processes.

A case in point showcases the effectiveness of JHS GMP Consulting in aligning documentation practices with industry standards. When confronted with challenges in fulfilling technical documentation requirements for medical devices and pharmaceuticals, a machinery company specialising in septic filling processes sought assistance. JHS GMP Consulting promptly intervened to optimise the documentation process in alignment with the required regulatory standards. This proactive approach ensured readiness for evolving regulations while minimising unforeseen risks.

Following the documentation, JHS GMP Consulting oversees the qualification process, transitioning from risk analysis to qualification testing. This process encompasses various technical tests, including Part 11 testing, filling tests and closing tests essential for liquid and powder filling processes that have minor technical distinctions. Through these offerings, it solves the issue of random and often unnecessary testing undertaken by medical devices and pharma companies, ensuring that every test conducted serves a clear purpose.

We help clients avoid unexpected compliance issues by ensuring their documentation meets the standards required for medical devices and pharma products

In engagements with clients, JHS GMP Consulting delves deeper into the rationale behind certain testing processes adopted by them. Posing thought-provoking questions about the implications of product touchpoints and the necessity of specific tests, Schneider and his team encourage clients to critically evaluate their existing practices and consider the potential benefits of implementing more rigorous documentation standards.

This act of shifting mindsets among clients represents a significant achievement for JHS GMP Consulting, signifying a departure from entrenched product testing practices towards more proactive and risk-aware processes.

Anticipating future alignment with pharmaceutical aseptic processes, JHS GMP Consulting has embarked on a long-term initiative to enhance documentation structures, ensuring compliance with evolving regulatory standards. The company is also expanding its services to encompass computerised system validation (CSV), recognising the growing demand for expertise in this area from an automation perspective.

In an industry characterised by constant innovation, JHS GMP Consulting serves as a trusted expert, navigating businesses through the complexities of pharmaceutical and medical device regulations. Focused on emerging trends and proactive solutions, it empowers clients to thrive amid regulatory changes and continue their march towards developing advanced products for healthcare uses.