The validation of the plants and systems that govern the production processes in the Pharmaceutical World is a decisive phase in commissioning as it is expressly required by GMP and, therefore, a necessary condition for obtaining authorization from the regulatory bodies.
iFix and Simplicity by GE Digital are SCADA platforms widely used in this sector and as a distributor on the Italian market we felt that (in order to better support our customers, whether they are End Users or System Integrators) we had to update ourselves and review these topics: to do this we selected the course "SUPERVISION OF THE SCADA PLANT AND ITS VALIDATION” provided by Quality System (consultants in the GxP field).
These are the objectives of the course:
- Understand the architecture of control systems
- Approach SCADA validation
- Identify the tests to be performed and the best practices for drafting the technical documentation
The checks and analyzes that the FDA and other institutions carry out before granting the "green light" are thorough, punctual and scientifically standardized: in practice we can already know what they are going to check (or at least have a fairly precise idea of it...).
Certainly they may not go into the smallest details on some aspects but (also to avoid costly surprises) it is still good to be in the best condition, i.e. being able to demonstrate that systems design and implementation were carry on holding always account of regulations and best practices.
Especially on fundamental issues (data integrity, alarm and event management, etc…) have ready the whole documentation ed have performed previously all possible test by the supplier (internal tests, SAT and FAT) can facilitate the liability validation process of the pharma company.
With particular reference to SCADA systems here then some advice on “where to look” (before someone else looks at it…).
Let's start from the basics: the GAMPs define 5 categories of software and the SCADA (as well as, typically, DCS, ERP and LIMS) falls into category 4, i.e. the one that brings together the SW platforms that can be configured but which do not have customizations or functions developed ad hoc.
In the case of implementations of the latter type (e.g. for some types of PLC) category 5 is "exceeded", with consequent additional required documents. The category to which it belongs defines in fact first the list of necessary technical documents: diagrams and technical specifications HW and SW are only a part of these. The FAT documents (Factory Acceptance Test) and SAT (Site Acceptance Test) must be provided by the technology supplier to document the checks carried out both at the supplier's premises and "on site": these checks concern drawings and technical diagrams, but also functions and alarms.
How do they affect validation? They can "lighten it up". For example, testing and reporting complete alarms to the SAT may result in fewer tests (always on alarms) to be performed in the formal validation phase.
Among other necessary qualification documents we can mention the User Requirements Specification, Design Qualification, Installation Qualification, Operational Qualification e Performance Qualification: where mechanical components, wiring diagrams and hardware components are involved, it leaves the area of competence of Annex 11 and 21 CFR part 11 to go beyond Annex 15.
However regarding the Control System are only the first two (Annex 11 and 21 CFR) to lay down the law, and the tests to be performed are divided into IQ (concerning the correspondence between electrical and architectural projects and their realization) e OQ (which instead focus on Operations, i.e. how the plant works and which parameters/alarms are involved in the various operating sequences); for category 5 SW, source code verification must also be performed. Over all possible tests that will come performed in the validation phase (and especially on the most probable) one cannot be caught unprepared: for each of the items mentioned above there are lists of checks that we can carry out in the preliminary phase so as not to leave room for chance.
Experience in this sector is essential: having witnessed (albeit "behind the scenes") 30 years of validation of machines and systems has always given us a good competitive advantage, also taking into account that the platforms distributed by ServiTecno boast thousands of installations in Pharma both in Italy and in the rest of the world: GE Digital technologies have always been designed for highly regulated environments, just think that General Electric has created an international working group for Pharma & Lifescience (in which we participate directly) for the verification of existing functions in relation to current regulations and the inclusion of new tools and functions in the design of future releases.
To learn more about which tests and how to perform them, you will find specific information in the courses ServiTecno for the use of SCADA in Pharma&Lifescience: to save time and money it is advisable to be assisted in these phases by professionals with experience in the sector.
