Pharma companies these days have to comply with a number of standards as governed by Good Manufacturing Practice (GMP) and FDA regulations as well as social audits. Often audit checks result in non compliance that organisations are seldom even aware of. James Thomas, Country Manager, Kronos Incorporated explains ways and means by which companies can ensure compliance and audit securities
What mistakes have you seen that pharma companies typically make in the area of compliance and auditing?
The significance of regulatory bodies in compliance management for drug manufacturers was majorly introduced by international institutions like the US Food and Drug Administration (US FDA) and the European Medicines Agency (EMA). With CGMP and CF21 guidelines to processes in the pharmaceutical industry to be strictly followed, the sector has witnessed a serious compliance dimension to adherence, and audits. Internal and external audits are therefore becoming the order of the day, putting manufacturing plants through that, puts the entire organisation at risk of non-compliance as well as even becomes a reason for the shutting down of plants or entire operations itself.
In India especially, compliance challenges are more often looked at in the manufacturing processes related to material, machines and the running of the plants from a quality perspective. Often, the people dimension is not given as much importance, while the reality is that there is a human involved in some stage of most of these processes where machine and material interface in a continuous process, be it generics or formulations. Even in the drug discovery and clinical phases, in R&D, scientists have a key role to play in driving through key R&D investments to successful trials and subsequent roll out to manufacturing. Intentional and unintentional mistakes from workforce personnel or compliance deviations can lead to serious repercussions. We see this lack of visibility and traceability to employees on the shop floor, be it on-roll employees or contract workers that are deployed in an area where issues creep in. Added to this, there is also aspects related to employee fatigue, safety, secured access, etc. which are also gap areas which causes issues for the pharma sector in running a compliance driven process end to end, which is auditable, traceable, and has the data integrity seamlessly.
You say that compliance needs to be monitored more often and proactively so that audit checks happen smoothly. What role do mock inspections play in improving compliance?
Monitoring compliance and adhering to regulations is the most significant rule for any manufacturer to follow in this sector. Therefore, many companies have internal mock inspections that help them comply with the dictates of regulatory bodies. Mock inspections are mostly performed by an internal team using Food and Drug Administration’s (FDA) procedures. As it is a simulation of the actual audits conducted by FDA to assess clinical and manufacturing practices, it helps pharma companies prepare for actual audits, assess and corrects compliance issues if any, and gives an idea on what audit inspectors would be looking for. This helps in identifying gaps early and setting them right pro-actively.
An internal team of mock inspectors consists of qualified professionals with experience in regulatory compliance. Mock FDA audits are also employed by pharmaceutical companies to become certified in ISO and be qualified for a pre-approval inspection.
What is the role and benefits of a pharmacovigilance audit in this aspect?
Pharmacovigilance is known for drug safety related to the collection, detection, assessment, monitoring, and prevention of adverse effects of the drugs. It is formulated to focus on adverse drug reactions, therefore it is important that all pharma manufacturers go through pharmacovigilance audits, as it will review the quality management system currently used to collect, code and process data for case studies, and also assess compliance of the database with the current regulations. These measures are taken by manufacturers to monitor issues with medications more effectively and provide safer end products.
Do you think digital technologies can play a significant role in enhancing GMP and compliance? Can you name some technologies in this regard?
Digital technologies are definitely very important in ensuring compliance with GMP standards. In fact 21CFR part 11 itself is all about how digital records and electronic signatures can be used in place of handwritten signatures. Technology does play a very significant part in enabling traceability during the production process, which is one of the prime objectives of GMP. Initially the focus was around tracking the raw material and ingredients that went into a product, and over time, standards started developing around how the process itself was managed and the various controls around the process. One key area that most organisations these days focus is on the people element while tracking the whole activity. Who were the people on the production floor during the manufacturing process, when did they come in, who was authorised by whom, and similar such questions are being addressed by technologies like workforce management to enable a people traceability aspect to the entire process.
Speaking about digital technologies, data integrity and validation becomes extremely crucial right?
Digital technologies and validation have become pivotal for manufacturers to ensure compliance. Internal and external compliance validation of drug safety is critical for patient safety, as any defect in the proper functionality of the systems or non-compliance may have a direct impact on the safety of the patient. As many systems support regulated activities, compliance with local, state, national and international regulations are equally important.
Tell us about some essential exercises that the companies need to do on a regular basis.
While great strides have been taken to tighten the processes around quality management, we must agree that in the pharma space there is still largely a scope for human error and that can be very damaging. A shift must happen where organisations look at the most dynamic part of the business which is the people element. There are many aspects to the people dimension. For example, understanding and controlling how people move in and out of your production area, and which is the security and safety aspect especially when you work with a fluid workforce like contract labour. Another aspect is around understanding if you had the right person for the job at the right time, essentially doing a skill match right down to the shift level. This is important because an unskilled or untrained persons can be one of the factors that contribute to a defective batch or maybe even a recall. Also, a lot of errors on the production floor happen due to inattention which can largely be attributed to fatigue. Managing fatigue is something more and more organisations in India are looking at, something we must learn from our European counterparts.
How does Kronos’ technologies ensure compliance and audit securities to companies?
At Kronos, we believe in marrying people to processes, traceability, compliance and the framework around that. We are highly process-driven, and focus on recording, tracking and maintaining electronic data records on a regular basis. Keeping in mind the criticality of compliance and audit challenges in the pharma sector, we ensure visibility of operations in order to attain batch-to-batch accuracy. The idea here is to eliminate any gaps or vague areas in manufacturing in terms of the labour and value of labour involved. Adding to this, the CGMP and CFR 21 adherence is all about what we do – connecting people to processes and managing them in a regulatory framework. Kronos helps pharma manufacturers identify and address two key issues – the real time visibility on the workforce and their productivity in the production plant; and data traceability to gauge exact information (what, how and when) on the error that occurred in product or drug contamination. These measures by Kronos help companies to comply with the regulatory bodies and drive business outcomes.
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