The study on quality assurance (QA) stems from a related project we conducted for a client in 2008/2009 on QA organization in pharmaceutical companies, which raised questions regarding QA. The study, conducted earlier this year, aimed to understand pharmaceutical employees' thoughts relating to QA and to highlight some of their key concerns with respect to implementing QA processes and techniques. We intend to conduct the study again at a later date to obtain further information on upcoming trends.
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We surveyed one or two persons (mainly heads of corporate QA) from 14 pharmaceutical companies (10 of which are in the top 20 worldwide pharmaceutical companies) — representing more than $300 billion net sales in 2008. Once we understood some of the key issues relating to QA implementation amongst our survey respondents, we were able to provide some recommendations that would allow pharmaceutical companies to adhere to good QA practice.
Four key areas of concern relating to the implementation of QA techniques in the pharmaceutical industry were highlighted at the study's conclusion:
- Respondents were not convinced that a high standard of quality could be guaranteed in a production network comprising own plants, contract manufacturers and suppliers.
- With the increasing importance of integrated risk-based concepts in quality management (e.g., risk-based auditing integrating most GxP topics, stricter use of preventive risk management tools and introducing comprehensive riskbased key performance indicators (KPI) reporting), regulations harmonization and the rising pressure to reduce costs, respondents were uncertain how each of these concepts could be enforced whilst still maintaining high standards of quality.
- Respondents emphasized the need for a unified approach to QA throughout the industry — allowing manufacturers to make a seamless transition from classical processes to a modern control strategy — in particular as the Quality by (QbD) Design concept becomes more widespread.
- Driven by ICH Q10,1 which demonstrates industry and regulatory authorities' support of an effective pharmaceutical quality system, the idea of continuous improvement and of pharmaceutical product lifecycle management globally is gaining importance. Respondents highlighted that this drive towards excellence will require a shift in communication methods across corporations. The exchange of expertise and knowledge of new processes will also be essential. Thus, it is believed that the shift towards quality and excellence will require more of employees; however, the overall notion is that this will eventually lead to more stable and cost-effective processes, rather than a more costly enterprise in the long run.
In summary, based on the results of the study and, in particular, the four key areas highlighted above, we recommend five key actions that should be taken by management to ease the transition to QA excellence:
- Adjust the corporatewide QA organization on all tiers to be well prepared for virtual networks and to encourage better crossfunctional integration.
- Develop and install business processes that are necessary for a comprehensive thirdparty quality management with regard to outsourced and insourced products, APIs, packaging materials and excipients.
- Foster integrated riskbased concepts, QbD concepts and continuous improvement ideas in the entire QA organization.
- Design and implement a robust enhanced QA related IT system architecture (eQA) that is costefficient and flexible enough to fulfil future requirements.
- Communicate to management that the outlined actions will lead to more transparent, robust and controlled processes contributing to a costefficient production.
To adhere to these recommendations, the QA units at corporate level (CQA) will have to play a leading role; each recommendation has strategic importance and will have a corporatewide impact.