The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To address this, GxP was established and its compliance is mandatory in the healthcare environment. The GxP is a generic term, where ‘G’ stands for Good, and ‘P’ stands for Practice. The ‘x’ is a variable that will change depending on the application. The most seen GxP include:
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- Good Distribution Practices (GDP)
- Good Clinical Practices (GCP)
- Good Pharmacovigilance Practice (GVP)
The GxP regulations must be followed. However, the guidance and standards such as GAMP, ISPE, PIC/S, WHO, ISO, among many others, provide the mechanism to demonstrate compliance in order to meet the regulatory expectations. These guidelines basically ensure that every action made by every personnel is clearly logged and documented, following three main pillars – accountability, traceability, and data integrity. The GxP represents the quality benchmark and none of the elements can be compromised.
Whilst the GxPs lay down the black-and-white of what to do and the required outcome, it provides flexibility on the ‘how’ to comply. There are many alternate ways to ensure GxP compliance and the 5 factors listed below are key controls in achieving GxP integrity.
1.People
‘Ideas are cheap, good ideas although are rarer, but still of little value in and of themselves in the end. It’s the execution that matters most.’ —Robin Bruce, Entrepreneur
The execution teams are the backbone of an organization. People are always one of the key factors in determining the success of a business, and in achieving compliance in any industry. In regulated GxP environments, it is essential that every member of the execution team is properly trained and most importantly, has the ‘quality’ mindset. A ‘quality’ mindset can mean drilling into the details of every process. It is not easy as it can be mundane and tedious like going down to the micro levels of spotting a missing reference number or a missing letter, among many others. Hence, putting the right talent at the right place is equally as important as giving adequate training. For instance, a talent of ISTJ in nature, who is often described as detail-oriented and like keeping their environment well-regulated, will thrive better than an ESFP talent who is immensely creative and often enjoys the spotlight, in a computerised system validation project (The Myers & Briggs Foundation, 2021) (search for Myers-Briggs Type Indicator if interested to find out your personality). Empower your talent, employ their inner nature and it will amplify the desired outcome.
2. Set the Standards and Be Consistent
‘A leader leads by examples, not by force.’ – Sun Tzu
The word ‘standards’ is abstract. It can be subjective and open to interpretation. Therefore, defining ‘standards’ and ‘quality’ should always come at the top of priorities. Not only that, practicing ‘standards’ and the culture of quality should also be emphasized. ‘Quality’ and ‘standards’ are just policies; they mean nothing if are not upheld (Pedersen, 2021). This is also the main reason for failure in audits despite the clear guidelines and policies in place. Breed a culture that everyone ‘lives’ quality in all their actions. Set the bar, practice it, and be a ‘quality cop’ for each other. Consistency is the key to achieving GXP compliance.
3. Communication
‘Communication – the human connection – is the key to personal and career success’ —Paul J. Meyer
Effective communication is a foundation to success in all aspects of work. The commonly seen communication flows such as downward, upward, or horizontal communication, be it in a written or verbal form, all serve one purpose which is to ensure smooth execution and problem-solving in day-to-day work (Lumen Principles of Management, 2021). Downward communication is undeniably important to align goals and visions, but effective upward communication is even more important in an organization. This is because the front liners are always dealing with first-hand challenges that the top may not be aware of. While in most of the organizations there is a policy that encourages employees to speak up, the question remains, is this policy well practised? Is the top management listening well? Does the culture provide a free-of-judgement and safe environment for everyone to voice out concerns or even to admit their mistake? This is especially important in GxP environments because a tiny mistake that is not rectified immediately may put a large community at risk. Until a truly open environment is implemented, there will always be hiccups in project execution in the GxP environments.
Effective communication also means successful message delivery across to the receiver(s) in the least amount of time. Everyone is multitasking at work and probably handle a few projects at one time. Spending long hours in ‘communication’ can be energy consuming and will directly impede task progression. Develop an effective communication plan that incorporates a lean and agile mindset, this helps to drive complex messages and will ensure the delivery of clear and effective information in any setting.
4. Continuous improvement
‘Even if you’re on the right track, you’ll get run over if you just sit there.’ —Will Rogers
Survival of the fittest is the stark reality of competitive markets in the business world. The markets are never stagnant, in fact, a dynamic business process is a necessity for the advancement of human civilisation. Similarly, the GxP regulations are also constantly scrutinized and improved to warrant safety for the community. Whilst we cannot control the changes in GxP regulations, what we can at least control best is our adaptability during the change.
The ability to adapt does not come overnight, it is through the cumulative effort of persistent learning and improving in all aspects. Learning all the fundamental knowledge and updates, for instance, the black-and-white of GxP, is the basic to understand ‘what has changed. By just learning the ‘what’ does not guarantee improvement. The main challenge lies within the ‘how’ and the mindset to continue to look for ways to perform better. This can mean stepping out of the comfort zone. However, please be reminded that the morphosis is going to be worthwhile as this upskills your adaptability and allows you to always be a step ahead in any challenges, including risk management during GxP practices.
5. Tools
‘Give me six hours to chop down a tree and I will spend the first four sharpening the axe.’ – Abraham Lincoln
Do you have the right tool and system that allow verifying the traceability of the documentation and data? GxP is complex, it is even more difficult to synchronize its practice especially in cross-functional and cross-regional settings. Using the right tools and establish a system that suits your needs will ensure a lean process in controlling all aspects of GxP. This may seem to incur extra cost on a short-term basis, but do not forget that one of the best approaches in cost reduction over the long run is to optimize systems and processes. Always allocate time to revise and re-evaluate the sustainability of the existing systems and tools, especially their capacity in bracing through crisis, like the Covid-19 pandemic.
Conclusion
GxP is not rocket science. It is important to understand the regulations, this, coupled with proper planning and controls can help in the success of GxP audits. Or better still, engage a subject matter expert to evaluate the existing practice. This encourages knowledge exchange and perhaps may spark some ideas on improving the existing system.
Author: KVALITO Consulting
KVALITO is a strategic partner and global quality and compliance services and network for regulated industries. Our specialized consultants can support you to successfully navigate the regulatory environment applying to the Medical Device and Life Science industry as a whole. To learn more about our services, feel free to send us an email at contact@kvalito.ch
References
- Lumen Principles of Management. (2021). Typical Communication Flows. Retrieved from https://courses.lumenlearning.com/wm-principlesofmanagement/chapter/reading-barriers-to-effective-communication/
- Pedersen, B. (2021). 6 Ways Quality Managers Can Build A Culture of Quality. Retrieved from Mastercontrol Learning Centre: https://www.mastercontrol.com/gxp-lifeline/6-ways-quality-managers-can-build-a-culture-of-quality/
- The Myers & Briggs Foundation. (2021). MBTI Basics. Retrieved from The Myers & Briggs Foundation: https://www.myersbriggs.org/my-mbti-personality-type/mbti-basics/
