20/09/2018
Data Integrity Assurance – Is it the only objective of a Remediation Plan?
Data Integrity issue in the pharma industry has become the buzz word during the last decade, thanks to the numerous warning letters and import alerts issued by FDA and citations by other regulatory agencies. Many pharma companies are now completely focused on building adequate controls on electronic data and upgrading their laboratory electronic instruments & automated systems and spending substantial resources as part of remediation. While such an industry focus and remediation exercise is absolutely essential and understandable, the question is, is focus on assuring integrity of data the final ‘Goal’ or just the ‘Beginning’? As widely pointed out by the regulators and industry thinkers in many industry forums and writings the answer seems obvious – It is just the beginning. The question remains, have we gone enough down the root cause analysis to determine what really causes data integrity issues in general?. While the ultimate root cause boils down to commitment by top management which is being addressed by regulators through actions of import alerts, the workable ones remain slightly higher in the root cause hierarchy which are essentially ‘systemic’ in nature. Assuming top management commitment, the main issues which need to be focused include:
o Poor process understanding & lack of robustness in the
manufacturing process.
o Inadequate method development/ validation and a robust
GLP.
o Poor implementation of quality management system.
o Inadequate employee empowerment and accountability.
These are the root causes for many of the serious citations by regulators such as repetitive failures, absence of root causes & poor CAPA, Method variability, unconfirmed OOSs, inadequate training at the grass root level and so on. It appears that many organisations are focused only on fixing data reliability issues as part of remediation exercises. Narrow focus on data integrity by means of building controls on electronic data, GAMP ..etc without addressing the above mentioned critical issues in a comprehensive manner will only lead to a situation where the reliable data reflects poor ‘quality metrics’. With assured data reliability and regulatory focus on ‘quality metrics’ in the coming years could as well lead to a situation where regulatory ‘time bomb’ is clicking for the unprepared organisations. Fixing data integrity issues is the beginning of building robust quality into the product. However, it is about time the organizations address quality in a more comprehensive manner in line with the principles laid down in guidance documents ICH Q8, Q9 & Q10 rather than narrowly focused on fixing data integrity issues alone.
