Practical aspects of validation
"We are looking to establish a practical, standardised approach to validation," says David Woolley, who joined Brecon recently in the key post of Validation Manager.
"A great deal is written and spoken about this subject and to the uninitiated, it might seem to be one of enormous technical complexity. What we are aiming to do here at Brecon, however, is to demystify validation and approach the subject in a very down to earth fashion. By breaking it down into core disciplines such as cleaning, operation, maintenance and calibration, we are creating transparency for ourselves, our suppliers and for our customers."
In essence, validation is about verifying that equipment and associated software is capable of fulfilling its stated purpose. The process should therefore begin well before equipment is specified, with the first step being the compilation of a URS (User Requirement Specification) detailing exactly what the user – and, in many cases, its customers – want the equipment to do and how. At this stage the document represents an ideal scenario, a series of benchmarks against which the candidate equipment can be measured. The next step is to check off the items in the URS against the features of the various pieces of equipment under consideration and through this process of elimination, to identify which option most closely matches the specification. It would be a fortunate buyer indeed who was able to locate his ideal machine through this process but nevertheless, a leading contender should emerge.
Once the choice has been made, the URS will again be used as the basis for a second process – that of Design Qualification (DQ). This involves checking off the various aspects of the URS against the machine specification to identify positives and negatives and possibly giving the prospective vendor the opportunity to address the negatives.
Following order placement, the process moves to its practical stage with Factory Acceptance Tests (FATs). It is at this stage that the vendor must prove to the purchaser’s satisfaction that the equipment does indeed match up to its specification.
Once accepted at the equipment supplier’s site, the equipment is installed at the user’s site, at which point Operational Qualification (OQ) is carried out. The purpose of these tests is to confirm on site that the equipment is operating safely and correctly. Confirmation of calibration here is essential, as are cleaning, maintenance and training.
Further specific testing is performed during Performance qualifications (PQ’s). This process confirms the operation of the equipment in specific applications and is the major area of challenge as far as the customer is concerned.
"As a validation professional, it’s my job to convey to colleagues and customers that validation has clear practical advantages which can help us all," says David Woolley. "Initially it is about proving the equipment can do what it claims to do. However, PQ’s should not be seen to be the end of the process: validation should continue throughout the life of the machine to ensure that it continues to perform safely, securely and at optimum levels. This can be as simple as establishing and adhering to a routine for calibration of critical functions such as temperature and pressure, or as complex as software change control when a sophisticated system is upgraded."
"Well-maintained and validated equipment has benefits for all parties. For the user, it ensures that productivity is maximised. For the equipment supplier, it reduces the incidence of spurious breakdown callouts. And for the customer, it means that his product is packed to consistently high standards and that he can expect a reliable service. The establishment and maintenance of good practice in the area of validation, such as documented cleandown between batches, has a direct impact on the quality of the finished product and minimises the potential for reject packs.
First published in Packaging Today, August 2002
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