The pharmaceutical sector is a very highly regulated industry. There are international and national regulations that multiple organizations manage, such as the US Food and Drug Administration (FDA), World Health Organization (WHO), the European Union (EU), and the Medicines and Healthcare products Regulatory Agency (MHRA), which regularly issue updates. These organizations publish industry-specific standards such as GxPs (good practice guidelines), EU Annex 11, FDA 21, and CFR part 11, but the most important is ISPE GAMP 5 from the International Society for Pharmaceutical Engineering. Given this volatile and complex regulatory landscape, there is a growing need for ALM software in pharma applications. In this PTC Talk, Kálmán Keresztesi, Manager, Controsys Control Engineering, discusses the practical implementation of a fully digital ALM solution in GAMP-compliant pharma lifecycle management.
What is the regulatory landscape for pharmaceutical manufacturers?
GAMP (good automation manufacturing practice) aims to deliver a cost-effective framework of good practice to ensure that computerized systems are effective and of high quality, fit for intended use, and compliant with applicable regulations. The latest release updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. It highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate procedures. It has a very strong life lifecycle approach within the quality management system. The target is to comply with GxP regulations fully, so all pharmaceutical developments based on computer systems must follow this guideline. The overall concept of the system is quality by design.
The lifecycle of a computer system consists of four phases - concept, project, operation, and finally, retirement. The validation starts with a short concept phase, where the system is defined before it is commissioned and verified in the project phase. It is then handed over to the user for operations, lasting as long as 15 years. During the operation cycle, the end user can make technical changes or extend the system. These changes must be controlled in the same manner as in the project phase. The retirement of those systems is regulated as they contain 15 years of information; this cannot be discarded once the system is decommissioned, it must be stored so that data can be retrieved if required.
What challenges does the pharmaceutical industry face in lifecycle management?
To meet compliance, computer system validation (CSV) traditionally follows the waterfall model. The waterfall model breaks project activities into linear sequential phases, passing them down onto each other. Each phase depends on the deliverables of the previous one and corresponds to a specialization of tasks.
The quality assurance (QA) department at pharmaceutical manufacturers is responsible for preparing, storing, and maintaining all the documents and reports that validate the system's compliance. This content must be available for inspection, which can be scheduled or unscheduled. Nowadays, most systems are documented and reported in two ways, either on a paper-based system or most manufacturers have already implemented electronic document-based systems where electronic records are stored in a document store. Both are document based.
What are the expectations of a digital lifecycle management system?
A digital lifecycle management system ensures GxP compliance and simplifies inspections while reducing validation risks and costs and accelerating cycle times. In the past, inspections could take four days. Before the inspection, the manufacturer would need about a week to prepare; collecting the documents and locating the necessary reports is difficult. With digital lifecycle management, the validation risks and costs can be reduced as all this information is readily available.
In today's complex environment, it must support efficient and guided collaboration and support multiple methodologies such as agile, waterfall, and hybrid. The main advantage of using digital ALM is streamlining the validation process.
How can Codebeamer ALM assist pharmaceutical manufacturers?
Codebeamer ALM is designed for safety-critical development. It is a holistically integrated collaborative application lifecycle management (ALM) platform with capabilities that cover the entire development lifecycle. Codebeamer can cover the entire lifecycle of operations from requirements management and software development, through Q&A and testing, DevOps and risk management, to variants management.
Getting started with Codebeamer could not be simpler. First, you buy and install it on premise either in a Linux, Docker, or Windows platform. Alternatively, you can take advantage of software as a service (SaaS). As software running on a computer from a pharmaceutical point of view, it has to be validated, but Controsys have developed templates to satisfy these requirements and enable the system to be quickly up and running. The most important thing is that compared to a document-based system, Codebeamer is item based. That means each individual requirement is part of the system as an individual item. Those items go through different workflows, which are fully configurable in the system.
Codebeamer can manage multiple areas inside the same server, including the validation and maintenance of CSV, manufacturing execution systems (MES), and laboratory information management systems (LIMS). It also facilitates change and corrective and preventative action (CAPA) management, risk assessment, and failure mode and effects analysis (FMEA).
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