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Many small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must incorporate.
A quality management system (QMS) should describe how an organisation conducts business and manages quality in the fullest sense. Although this is a very simple concept, many small organisations fail to grasp it and tie themselves in knots trying to run their business in one manner while their QMS is set up to run the business in another. This results in an organisation that is not correctly aligned, and the tensions between the QMS and the business then cause conflicts, inefficiencies and risks that, if not addressed, can endanger the future of the business. To describe this as a headache is certainly a severe understatement.
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Many small organisations do not understand what a QMS should be designed to do and, as a result, they struggle to operate the system in an effective and efficient manner, and within regulatory standards. More importantly, they fail to gain the true benefits from a business perspective.
So, why do many small organisations not adopt a QMS wholeheartedly and, hence, fail to realise the benefits? One of the primary reasons is that such organisations do not have a clear idea of how to develop and set up a QMS. Additionally, being typically R&D-lead organisations, they do not usually have the expertise or the culture to drive QMS introduction. These factors can cause organisations to make the wrong decisions on how to develop and introduce a QMS. Subsequently, when the QMS does not meet expectations, the QMS itself is blamed, and the chances of convincing the management team to go back and re-deploy a new QMS are slim.
Documents within the QMS need to effectively describe the key processes being used by the organisation, but this should be done in a non-bureaucratic manner — the application of common sense goes a long way to ensure that documents and associated systems are well-designed and effective in their application. It is recommended that the organisation develops a hierarchy of documents starting with policies at the top, which then establish the necessary procedures within the QMS. There also needs to be a solid and disciplined approach to prevent the number of documents increasing as the business develops. Some additional documents may be necessary, but these need to be carefully considered to prevent the QMS from becoming unwieldy and disorganised.
QMS development should be accompanied by a proactive training strategy and the organisation will also need to consider whether there is a need for a cultural change (the time taken to do this should not be underestimated). The key to a successful QMS is the people who operate it; hence, culture, training and organisational structure must embody the best approach to gaining people's engagement and alignment to the business strategy.
The introduction of an effective and efficient QMS requires the backing of the organisation's entire management team; otherwise the system will not be aligned to the core aims of the business.
ICH Q10, which has been accepted globally by regulators as the best top-level design for a QMS in the pharmaceutical/biopharmaceutical sectors, provides an excellent description of the responsibilities of the management team in the QMS:
If these elements are built into the QMS from the start, it will allow a business to fully alight all strategies embodied in the QMS, which will allow the organisation to meet the three main objectives of having a QMS — compliance, risk management and productivity. The management team also needs to consider how best to ensure that the QMS is embedded within the organisation, and how the quality function should be organised and deployed to ensure the QMS remains effective and compliant. It is essential that the management team truly own the QMS and does not merely speak about its objectives and aims, while leaving the work and worry to the quality manager and/or their team.
Regulatory requirements can lead to some confusion over what is actually required in a QMS. We believe that the requirements are best defined in the FDA's Quality System Inspection Technique (QSIT) approach, which defines six key systems:
Each of these systems and the elements required is described in further detail within the QSIT guidance. The organisation can then assess which elements are necessary for their business operations. If an element is not necessary, a statement should be made within the documentation of the QMS. This will ensure that all necessary areas are considered and that the QMS stays aligned to the business as the organisation develops.
The organisation also needs to consider whether any specific elements in what they do that are not described in the QSIT documentation. Again, use of ICH guidance will help; ICH Q8 describes the R&D process in broad terms. In addition, the authors would need to add the EU driven requirements for clear Quality (Technical) Agreements between the company and its suppliers and customers. These agreement documents should describe the responsibilities of each company in the relationship from a quality assurance and regulatory perspective.
The most effective way of allowing the QMS to develop as the business grows (and its needs change and develop) is to select appropriate elements from a well-designed and compliant e-system. In an ideal world, this e-system would be populated with well-written generic documents that could be individually tailored as required to meet the needs of the organisation. Again in an ideal world, regular updates would be made to the generic documents and be made available to users of the e-system to assure compliance with changing regulations, as well as the incorporation of best practices into the QMS.
Although regulatory compliance is a driver for pharmaceutical/biopharmaceutical companies to implement a QMS, there are also other important business drivers. A well-designed QMS can (and should be) an integral part of a business's risk management policy. In small organisations — particularly those that outsource significant elements of their business — risk management is not an optional add-on that is just 'nice to have'; it is a key tool for running the business that ensures not only the company's survival, but also its growth during the early days. It is also now an expectation of regulators that organisations will quantify and manage risks in their supply chains – this is well described in ICH Q9. The importance of a QMS is also highlighted by the way in which regulators themselves use risk management processes to ensure the overall compliance of the organisations within their regulatory control.
In addition, a well-designed QMS will ensure that the business model is correctly aligned throughout the organisation, ensuring that everyone involved in businesses processes understands and delivers what is expected of them. If these processes are well-designed and linked via a compliant electronic QMS, small companies can maximise the benefits of having such a system.
Pharmaceutical/biopharmaceutical companies that possess an inefficient and ineffective QMS face significant cost and business risks, and the absence of a system altogether may lead to business failure.
A simple, well-designed QMS is an important asset because it can ensure an organisation remains productive and effective as it grows and develops. The metrics from the QMS will also ensure that the business has data to make the correct decisions over how to improve the way the business operates within a regulatory framework. Establishing a QMS, however, requires commitment from the top of the organisation and the management team needs to view the system as a key strategy for the business; the QMS will probably be a dismal failure if only the quality manager is left to act upon the data provided by the system.
For a small organisation, the most effective way that this can be done is via a compliant e-system, which should contain the essential elements described earlier. This allows the QMS to be efficiently managed and provides management data that move the organisation forward and enable it to become more productive and effective, while remaining compliant — an essential consideration for pharmaceutical/biopharmaceutical companies.
If this approach is taken and implemented fully across the entire company, it becomes a significant business asset that provides a framework of processes, sub-systems and metrics, ensuring that business issues are alleviated and resolved in a proactive and efficient manner.
Graham Clapperton is Managing Director at QP Vision Ltd.
Michael Gamlen is Managing Director at Pharmaceutical Development Services Ltd. email@example.com