The manufacturing and distribution of pharmaceutical products is underpinned by incredibly high standards of quality, safety, ethics, and transparency. Indeed, the pharmaceutical industry must ensure compliance with applicable regulations at all levels – from international to national and local.
This complex set of standards are each designed to support the production of safe and efficacious formulations that are also cost-effective. As a result, the pharmaceutical industry is one of the most heavily regulated in the world.
Compliance with the labyrinth of rules is non-negotiable for any company looking to sell its products safely and efficiently. In order to navigate these complex regulations and the challenges that arise from them, it’s important for companies to understand their specific regulatory requirements and be prepared to face and overcome challenges along the way.
Lack of clearly defined procedures and SOPs
We often forget the importance of a well written and informative Standard Operating Procedure (SOP) and as such, these important documents can become neglected. An SOP is a series of step-by-step written instructions detailing a process that must be followed in order to complete a routine task the same way every time. Following SOPs the same way each time is essential to enabling the processes required to maintain compliance with industry standards and regulations. While they may sound trivial, SOPs ultimately improve the performance of an organisation and form a vital part of an organisations’ compliance toolkit. While regulatory bodies do not mandate the style or content, they require that an SOP be in place.
Organisations are expected to be compliant with their commitments in order to avoid any legal ramification. Indeed, the majority of negative audit findings can be ascribed to a company’s own lack of compliance within its own self-defined procedures. During audits it is often the case that the SOP details the correct process, but it becomes clear that this has not been followed. Lack of training, and awareness, as well as the SOP being out of date are a few of the many reasons why this may be the case.
There are many areas in which SOPs can fail, consequently, there can be substantial penalties involved. Such as:
- Poorly written SOPs – Following written procedures may appear straightforward, but without concise and regularly updated procedures, deviations in how things are practiced can occur.
- Lack of SOP maintenance – Linking to the previous point, procedures develop and evolve with time and experience. However, many companies neglect to formally document these procedural changes in the latest edition of their SOPs. In all processes, it is crucial to document the processes for revising existing SOPs, creating new ones, and training, retraining, and authorizing staff.
- Lack of extensive SOP training – Training staff on the content of SOPs is as important as well-written SOPs. Compliance teams should ensure that all concerned personnel are aware of the SOPs for which they are responsible. As well as reviewing training records, auditors will gauge employee understanding of processes by asking them to explain what is in the standard operating procedure and demonstrate how it is implemented.
If not handled beforehand, any issues with the clarity of SOPs and their understanding can cause serious issues during a compliance audit.
The lack of standardised safety and acceptance of risk
There are significant differences among regulations and policies across the globe. These differences in regulatory frameworks have considerable effects on pharmaceutical manufacturing and represent significant challenges to any multinational company. Increasing standardization has the potential to reduce error, remove unnecessary variation and reduce uncertainty in clinical interactions. Despite the increasing use of guidelines and other types of standardised practices in healthcare, a wide range of everyday objects, patient pathways, workflows, and tools of work remain highly localised and unique to each setting.
Occasionally, variability is not problematic, but sometimes it introduces risks and inefficiencies that are better resolved through standardisation and harmonisation. Standardisation is rarely a straightforward process – challenges might arise because standards themselves are defined and implemented through complex processes involving people, routines, protocols, and technologies requiring multi-types of purposeful efforts during development, implementation and maintenance stages. Understanding the existing system into which new or revised standards are introduced is crucial for their success, as is whether stakeholders adopt the changes to these new standards. It is vital that pharmaceutical compliance teams have a firm grasp on the regulatory landscape affecting their business.
Cybersecurity
According to Statista Research Department, data breaches cost the healthcare industry upwards of $10 million a year, leading to regulatory penalties, litigation, and loss of customer confidence. Adding to the woes of healthcare organizations is the rising threat of pharmaceutical cybercrime in the United Kingdom and across the world. For bad-actors, healthcare institutions represent the ‘motherlode’ due to the high level of Personally Identifiable Information (PII) they store and process. As important as it is to prevent data theft or ransom, it’s even more important to ensure that data isn’t tampered with, lost, or stolen. Any of these will lead to significant compliance issues for a pharmaceutical organisation.
Now more than ever, companies are having to be more cautious – as the amount of data that is created grows, the stakes get ever higher to ensure it is protected.
There are many complex challenges facing pharmaceutical compliance today. Pharmaceutical companies need to navigate the labyrinth of regulations effectively in order to remain compliant with various laws and regulations. In an ever-changing industry, these regulations evolve constantly, and it is vital that these companies stay up to date in order to avoid legal action or reputational damage.
Having a clear understanding of the regulations in each geography is vital for those working in pharmaceutical compliance. At SCM, we are experts in pharmaceutical compliance, with decades of boots-on-the ground experience. Our compliance services enable successful innovative compliance outcomes with business goals at the heart of our approach. To talk about your compliance needs, reach out to us, below.