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
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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
- 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
- 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.