FOCUS CHEMICALS & PHARMACEUTICALS
PAPERLESS SOLUTIONS FOR pilot manufacturing of drugs
In pharmaceutical manufacturing the materials produced are often used in early clinical studies (given to subjects) so quality is critical, writes Paul Denny-Gouldson of IDBS
A
ny organisation that manufactures a product whether pharmaceutical,
nutraceutical, food or a mechanical device is focused on quality. The organisation needs to be confident that every unit produced has the desired quality. However, there are a number of factors that can impact these standards, all of which are controllable if understood and managed effectively. Pilot manufacturing is put under the
same rigour as this is where all the rough edges in a production process are smoothed. In the case of pharmaceutical production the materials produced here are often used in early clinical studies ie given to subjects, so the importance of quality is obviously critical. In pharmaceutical manufacturing a large majority of quality systems still run on paper whether that be record-keeping or laboratory test results capture and reporting. The paper systems in use are well designed to catch issues but rely on human intervention and someone noticing/searching for elements and results that are out of specification. This is the domain of the QA groups who are tasked with finding issues when they arise and then putting in remedial action, stopping production, failing a batch etc. Paper systems are designed to help catch issues as they arise and typically use dual scientist data entry to reduce errors. One scientist is responsible for entering a piece of data, a pH or weight form a balance for instance, while the other is responsible for ensuring and witnessing that the first user has entered the correct measurement. You might think this is not too bad but when you consider the amount of data captured in
a large complex process and the nature of ‘transcription’ it has the potential to lead to errors. Furthermore, the QA group have to look through all the paper results at each individual element and decide if the data is good and the results are in spec. When an error is identified: the pH or weight is not within the specified range either by the scientist or QA group, then an escalation process is initiated. This can take time especially if the error
is at the end of a long process and only identified by the QA group. There are many potential areas of risk all of which can be addressed by applying technology and process changes. The first level of technology change is where the data is captured in an electronic form.
PAPER ON GLASS The simplest is direct replacement of the paper form with an electronic one - paper on glass. However, in the QA/QC manufacturing domain the business benefits of doing this are marginal at best as there is no additional reduction of the risk of errors and QA still have to go through all the data, check for errors and initiate remedial actions when required. The next level of automation in an
electronic system is the direct linking of instruments to the data capture environment. As highlighted earlier, one area for potential errors is the data transcription. Currently, this is typically managed by adding an extra person to the process to witness the data transcription but this is not an efficient and cost-effective process when alternatives now exist. The data is transferred in a secure and tamper-proof manner from the instrument to the
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electronic system. A further level of QA is that this data is non editable once entered into the system and any changes or edits are done in a separate field. The idea of witnessing this data capture is then redundant as the computer system acts as the data entry witness and audit logs/data locking can show no changes have occurred. This needs to be flexible and easily defined, particularly in the pilot manufacturing area.
BUILT-IN BUSINESS LOGIC The final level of automation and QA support is where the electronic system has built-in business logic about the data value specifications and has a method of highlighting them to the scientist or engineer in a visual manner. This can be taken a step further with capabilities to stop the workflow if an out of spec value is entered until an intervention is conducted ie QA group is then notified and looks at the consequences of the out of spec value. This QA notification can be automated which then limits the amount of time between exception and intervention further. These electronic and process augmentation approaches are a series of steps that a manufacturing organisation can undertake to improve QA and QC and therefore product quality control and assurance. It is important to note that an organisation does not have to implement all the steps and changes to their current process at the same time; this may introduce risk to production due to the large business process change and introduce the very thing that is trying to be reduced – product QA issues. It is important when considering the
implementation of such a system that the technology chosen has all the capabilities: it can grow with the demands of the QA and QC systems as they evolve from paper and deliver the full data capture and QA issue notification automation and resolution capabilities that the business will eventually want to get to.
IDBS T: 01483 595 000
www.idbs.com/en
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