With the ability to directly influence the quality of life, the pharmaceutical domain gains importance, ahead of other sectors. Regulatory compliance agencies such as the US FDA, MHRA in UK, PMDA in Japan, Health Canada, MCC in South Africa, TGA in Australia, ANVISA in Brazil and others continuously strive to ensure pharmaceutical product safety, by conducting regular inspection of manufacturing sites, and approving drugs for distribution in these countries.
Traditionally, product quality was determined only by testing the product and determining that it complied with established specifications. However, regulatory agencies emphasize that quality should be built and integrated into the product. Therefore quality must be ensured at each step – right from drug development to product manufacturing and sale.
To pass these stringent tests, pharmaceutical companies must convincingly demonstrate regulatory compliance, and adopt standards such as Good Clinical Practices (GCPs), Good Documentation Practices (GDPs), Computer Systems Validation (CSV), Sarbanes Oxley (SOX), and others. Specifically, this entails:
- Describing actions taken towards ensuring compliance
- Maintaining test records, detailing the testing approach, and justifying scenarios for testing
- Performing impact assessment
- Creating and updating requirements documentation, and validating requirements
- Ensuring project execution, and testing in line with requirements
- Producing evidence for all of the above!
The above asks, by all means, are beyond the realm of traditional testing, which ensures mere compliance with established specifications and requirements. Companies must shift from such reactive testing, to a more pro-active approach, where quality is built and integrated into products and processes not just during the testing phase, but at the outset from drug development to finished product manufacturing and sale. Simply put, in the pharmaceutical domain, Right First Time (RFT) is the mantra for success.
Its about doing it right the first time, every time, even when no ones watching
In a recent case, a Life Sciences organization exposed itself to financial implications, compliance penalties, and loss of reputation, due to schedule slippage of an ERP implementation. The projects functional consultants veered away from RFT, and introduced code and configuration changes mid-way. The result production defects unveiled just two weeks before go-live, compromised functionality, and post deployment downtime. While the modified code passed unit testing, the team missed out on two important quality assurance (QA) checks – change control and impact assessment. The modified configuration and code not only impacted key business processes, but also introduced significant business risks, making the solution not fit for purpose. Last minute firefighting, team ramp-up, stringent quality checks, and extraordinary team work saved the situation. But a pro-active (not reactive!) RFT approach could have altogether prevented the rework, risk, time, money, frustration, stress, and chaos. In most organizations, such situations, sadly, continue to be a norm rather than an exception.
Here are some key Good Quality Practices (GQPs) to start with, for your business to imbibe the RFT culture:
- Deploy uniform practices across geographically dispersed departments, through enterprise-wide standards and procedures
- Drive defect prevention by defining clear roles, responsibilities, and accountability, for all stakeholders across the value chain
- Maintain process rigor through Good Documentation Practices (GDP) such as internal and external reviews of GxP and non-GxP deliverables
- Avoid compliance risks by maintaining quality standards. Never compromise on quality checks or rejections, even if it means slipped schedules or a missed milestone
- Ensure transparency in all lifecycle activities, to avoid surprises during the QA cycle
- Define and track an RFT metrics portfolio – and strive to achieve its measures and goals
These controls are applicable not just to drug discovery and related processes, but also to the widely adopted, popular digital technology initiatives, aimed at improving customer experience. With QA straddling the pharmaceutical value chain, strong, active, responsive and good QA practices, are high-return assets for pharmaceutical organizations. But a system is only as good as its processes and people. For the asset to deliver returns, departments must work as a team, and top management must provide support and demonstrate commitment.
As the age old saying goes Quality is never an accident. Its a habit and a way of life. Its about doing it right (right first time and right every time) even when no ones watching. After all, GCP and GDP are not enough. Your pharmaceutical business also needs GQP.