The Components Of Validation

In principle, there are either seven or eight components to a validation exercise (the eighth only applying when a complete process is being validated). The first of these is a planning document, the second two are design documents, and the remainder are qualification activities. They are:

• The Validation Master Plan (VMP) This is the over-arching document that defines the scope of the validation and its requirements, and specifies the relationship between the various documents and activities.

• The User Requirement Specification (URS) This document defines what the end-user requires of a system, and in most cases is the document against which proposed suppliers will submit tenders.

• The Functional Specification (FS) This is the response of the (proposed) supplier to the URS. It addresses the details of the way in which the supplier intends to fulfil the requirements set out in the URS.

• Design Qualification (DQ) This activity ensures that what has been asked for by the end-user is what the supplier has actually specified.

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URS.

Figure 15.1 V-diagram of the interrelationship between validation activities for individual systems (SC = system construction; for other abbreviations, see text).

• Installation Qualification (IQ) This activity ensures that the system has been installed to the correct specifications.

• Operational Qualification (OQ) This activity ensures that, once the equipment is installed, it 'does what it says on the can', i.e. OQ tests the operation of the system against predetermined acceptance criteria.

• Performance Qualification (PQ) This activity ensures that, using relevant starting materials, the system can reliably and reproducibly perform as intended in its final operating environment/conditions.

• Process Validation (PV) This establishes that when all the separate systems (validated individually by the steps above) are brought together to turn starting materials into a finished product, the overall process will consistently produce a product meeting its predetermined specifications and quality attributes. The process must be clearly defined.

Each of these components will be dealt with individually below, but by considering the descriptions above it can be seen that, excluding PV, they relate to one another in a notional V-shape, with construction (of the system to be validated) at its point. This is shown in Figure 15.1. The bold diagonal arrows show the chronological order in which each component is generated or carried out, and the horizontal arrows show how these relate to one another. Thus the earliest stage, the URS, is checked out at the last formal qualification stage, PQ. The detailed FS for the system is checked during the OQ and the design and construction of the system is checked during the IQ. These relationships hold good in general, but in some projects the interrelationships may be rather more complex.

From the above, it can be seen that Qualification is part of Validation, but that the individual qualification steps alone do not constitute validation.

The very first step in validation planning is to define the boundary of the system to be validated. With a simple piece of equipment this boundary may be very obvious, but as the item gets more complex, so do the decisions defining the boundary. A system is defined in the ISPE baseline guide (ISPE 2001a) as 'An organization of engineering components that has a defined operational function (e.g. piping, instrumentation, equipment, facilities, computer hardware, computer software, etc.)' System boundary is defined as 'a limit drawn around a system logically to define what is and is not included in the system.' So, for example, if validating a system for cleaning vessels in-place, one must decide whether to include the water supply pipework and the cleaning solution pipework within the system boundary.

Once the system boundary has been defined, an impact assessment can be carried out. This evaluates the impact of a system on product quality, and identifies the critical components within the

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