GAMP®5: COMPUTER SYSTEM VALIDATION IS UNDERGOING CHANGE
Version 5 of the GAMP® Guideline was published in March 2008. The changed procedures recommended in this guide require a changing of views especially in the quality control departments of the pharmaceutical companies. When well-established procedures are given up and replaced by new ones, at first uncertainty grows as to whether the new processes have been installed properly and whether they provide sufficient validation evidence as required by the authorities. So, the foremost question is how far the hitherto established processes can be streamlined. Besides, alternative software development procedures as well as the use of modern processing methods, such as "Service- Oriented Architecture (SOA)", Open-Source Software or "Cloud Computing", and the resulting consequences for computer system validation are increasingly discussed.
In the past years, both the regulations and viewpoints of the authorities, on the American as well as on the European side, and the validation methods used in the pharmaceutical industry have changed drastically. The detailed analysis of the product attributes, their criticality and their mapping to the corresponding parameters of the production and logistic processes have become much more significant. Here, the "Quality-by-Design (QBD)" approach, which is described in the ICH Guideline Q8, is the central principle ranging from the structured and science-based product development in the laboratory via the structured and model-based design of the production and logistic processes to the design of model-based automatic control systems which steer the process flow on-line. The QBD-approach shall ensure that the "design space" of the product, i.e. the multi-dimensional space constituted by the product attributes, is known and described in order to map the product attributes to the process parameters as far as possible by analytical methods. This allows to acquire and evaluate process parameters and product attributes on-line and to keep them within the preset parameter limits (design space) in case of variations of the starting materials attributes and varying process parameters due to outside influences by means of the specifically designed, automatically operating on-line control systems.
Especially the efficiency of this control is thus of utmost importance since, with its help, follow-up validation can be avoided in vast areas. It is obvious that the complexity of the control system strongly depends on the complexity of the process. However, higher complexity demands greater efforts in designing and implementing the control system. Therefore it is important to know the process in detail and to identify the parameters that substantially affect it by means of risk and criticality analysis in order to be able to design a less complex control structure. The GAMP® Guide has already suggested such principles for the validation of computer systems for many years (GAMP® 2 already described a method for risk management). Yet, the procedures had only been described partially and in different places, e.g. in the Good Practice Guides. In the current version 5 of the guide, these principles have now been assigned greater significance in accordance with the current state of the art. In GAMP® 5 it is said:
Recommendation
Berlin, Germany23 April 2024
Computerised System Validation: Introduction to Risk Management
"The purpose of this Guide is to provide a cost effective framework of good practice to ensure that the computerized systems are fit for intended use and compliant with applicable regulations. The framework aims to safeguard patient safety, product quality, and data integrity, while also delivering business benefit. This Guide also provides suppliers to the life science industry with guidance on the development and maintenance of systems by following good practice."
GAMP® 5 addresses the budget-friendly computer system validation as essential basic principle. This includes
- developing a detailed product and process understanding as the basis for the structured determination of the necessary validation activities and for designing computer controls.
- a science-based quality risk management for focussing the efforts on patient-critical aspects,
- a scaling (adapting) of all life cycle activities and the corresponding documentation dependent on the risk, the complexity and the novelty of a system,
- avoiding the duplication of activities (e.g. by fully integrating the engineering and computer system activities so that these only have to be carried out once) and clearly defining the roles of the experts and the quality assurance, as well as
- making efficient use of the supplier activities up to the biggest possible extent while simultaneously maintaining suitability for the intended purpose.
GAMP® 5 has been issued to address new innovative approaches which are available and useable now if the appropriate prerequisites are met, while still satisfying international GxP regulatory expectations. GAMP® 5 represents industry good practice at time of publication and is intended to encourage the adoption of such approaches. The guide aims to address the need to safeguard public health, product quality, and data integrity while at the same time enabling innovation and technological advance.
Recommendation
Berlin, Germany24-26 April 2024
Computerised System Validation: The GAMP 5 Approach
Author:
Prof Dr Hartmut Hensel
... is a leading member in various German speaking GAMP® -Committees. He also was member of the editing committee for the Guide on the Validation in the Prozessleittechnik. Prof Hensel translated GAMP®3, GAMP®4 and GAMP®5 into German.
