In our GMP News from 19 December 2007 we addressed a Guideline of the former American Society of Testing and Materials (ASTM) that deals with modern qualification (ASTM E2500). In a further GMP News from 21 March 2012 we presented the ISPE (International Society for Engineering) Good Practice Guide "Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment" (FSE Guide). It facilitates the implementation of the ASTM Guide E2500.
The ISPE Baseline Guide Volume 5 "Commissioning and Qualification" (C&G) has been available since 2001. Now an ISPE mapping document explains the relationship between the ISPE Baseline Guide Volume 5 and the ISPE Guide (Applied Risk Management Guide) which has the function of a "bridge" between these two documents.
It is pleasing that the document is rather short, containing 4 pages. It starts with the explanation that the document establishes the relationship between ISPE Baseline Guide Volume 5 (C&G), FSE Guide and the Applied Risk Management Guide. In the overview the contents of the Guides mentioned above are shortly summarised. It states that the ISPE Baseline does not contain the newest concepts regarding "Quality by Design" and risk-based concepts as concerns qualification. This is the great difference to the FSE Guide, which emphasises especially these aspects, based on "fitness for intended use" concerning facilities, systems and equipment. The FSE Guide's focus is put on the risk-based product quality and patient safety. It is "compatible" with ICH Guidelines Q8(R2), Q9 and Q10 as well as with ASTM Standard E2500.
The Applied Risk Management Guide describes the application of Quality Risk Management to traditional C&Q approaches as used in Baseline Guide Volume 5. It describes how organisations can move from established qualification practices according to ISPE Baseline Guide Volume 5 (C&Q) to a science- and risk-based approach according to ISPE FSE Guide, ICH Q9 and ASTM E2500. It almost has the function of a bridge between ISPE Baseline Guide Volume 5 (C&Q) and ISPE FSE Guide. This relationship is shown in a graphic.
According to the document, an advantage of a science- and risk-based approach is the reassessment of the terminology, practices, and roles and responsibilities (Quality Assurance (QA) and Subject Matter Experts) with a focus on the suitability of facilities, systems and equipment for their intended use with regard to patient safety and product quality. This increased focus is supposed to lead to an improvement in design, to lower costs of inspections and testing and thereby to a concentration of resources and a better conformance to GxP regulations.
The ISPE Applied Risk Management Guide aims to help reach this science- and risk-based approach by providing a roadmap showing potential transitional solutions. For this reason a transitional strategy is described in the Guide. It is explicitly mentioned that the new approach may not be immediately achievable in all organisations. According to the FSE Guide, prerequisites have to be put in place for a complete implementation of a science- and risk-based approach. Traditional terminology and concepts are often embedded in Quality Management Systems and therefore the change must be carried out carefully, in order to ensure continued compliance with GMP. Primary concern is a long term benefit to be reached by adopting a science- and risk-based approach. Interestingly, the document states that the adoption of Quality Risk Management Approaches will increasingly lead to traditional qualification approaches becoming non-compliant as well as non-competitive.
Once again, the ISPE Baseline Guide Volume 5, the Applied Risk Management Guide and the FSE Guide are represented in a table as concerns terminology, adoption, organisation, risk assessment and regulatory aspects.
A further table explains approaches for an immediate adoption of FSE-Guides or of a transitional solution.
One of the next GMP News will be dedicated to the ISPE Applied Risk Management Guide. Its content will be examined in detail.
You can find the Mapping Dokument on the ISPE Website.
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