Creating a culture of quality and compliance

Picture this scenario: You are an employee in a pharmaceutical company that manufactures drugs which are exported all around the world. As you report to work, you find out that there is a FDA inspector at your door, asking to see the GMP practices being observed at your organisation by walking through your facilities. If you were writing this story, how would the next lines read?

This scenario is no longer a hypothetical one, and if you have been following the news, or are in this industry in any capacity, or have been sick and trusted the efficacy of the medicine you have been prescribed, this applies to you closely.

Lately, Indian pharma companies have received large amount of critical global attention due to certain evasions, violations and avoidances during US FDA inspections, and the subsequent enforcement actions against individual Indian pharma companies are threatening the reputation of India’s $19 billion pharma sector

India is a global powerhouse in the production of generic drugs, being the second-largest supplier of pharmaceuticals to the US. Last year, pharma exports from India to the US rose 32 per cent to $4.2 billion. India accounts for about 40 per cent of generic and over-the-counter products and 10 per cent of finished dosages used in the US. Given those numbers, it is not surprising that India’s government and foreign regulatory agencies are emphasising the need to ensure consistent quality of the country’s drug products.

Dr Kavita Mehrotra	Scott Barnard	Ellen Leinfuss

There is a need for all of us to not give in to the easier interpretation of being targeted and use this attention to our advantage by enhancing ourselves and becoming a force to contend with in the global stage.

In a dubious way, the reassuring news is that India is not the only country facing drug quality problems or GMP non-compliance. Virtually every country, including the US, struggles to maintain the quality of medical products, whether they are imported or produced domestically. And there are no short cuts to excellence. There is a need to create a culture of quality and compliance in order to meet our highest commitment to patient safety, one pill at a time. And that is a commitment to embrace actionable steps to use information and learning as a tool for cultural change.

Business benefits of GMP

GMP compliance facilitates drug approvals and sales in multiple markets. Even though some countries may have slightly different GMP requirements, the FDA’s GMP standards are generally accepted by their regulatory counterparts, minimising the time needed for additional market entry. In addition, demonstrated GMP compliance is a requirement for ‘preferred supplier’ status with global customers. GMP compliance provides customers, confidence in the quality of a company’s products. Customers, patients and prescribers all rely on the company’s reputation for quality and compliance. At the same time, GMP compliance reduces the risk of quality failure, legal liability and reputational damage. GMP compliance promotes operational efficiency, workforce performance and cost effectiveness. Costs associated with product waste, operational inefficiency and poorly controlled ingredient use all contribute to unnecessary operational expenses. In addition, recalled products, repeat inspections and investigations, fines and penalties, remedial actions and legal liabilities all add up to the total cost of production.

The value of GMP compliance

GMPs are required for the manufacture of products regulated by the FDA and other regulatory agencies, but they also serve as a useful roadmap of quality assurance, operational efficiency and employee performance for all drug manufacturers. In an ideal scenario, a single manufacturing and product quality standard would apply globally, allowing for seamless movement of consistently high-quality products. Although harmonisation of GMPs globally has not yet been fully embraced, there is growing cooperation among national authorities on GMP standards, facility investigations and enforcement actions.

In fact, in the recent signing of the Statement of Intent between the US FDA Commissioner Dr Margaret Hamburg, and the Government of India represented by Keshav Desiraju, Secretary, Department of Health and Family Welfare, among other things, US FDA and Indian regulatory bodies agreed to:

1. Sharing of information relevant to lack of compliance with accepted current Good Manufacturing Practice, Good Clinical Practice, or Good Laboratory Practice, as appropriate, by manufactures and sponsors of medical products and manufacturers of cosmetics, in their respective countries, or any other information as mutually decided upon.
2. Engaging collaboratively as observers in medical and cosmetic product and inspections conducted by the other participant as per specific terms to be agreed and as time and resources allow.
3. Collaborating in relevant scientific meetings, symposia, seminars, and other appropriate venues that may be organised either in the US or in India.

All these go to show that all responsible regulators globally are willing and intent coming to a globally acceptable standard of GMP collaboratively and productively.

Achieving GMP compliance

Although an effective, comprehensive compliance programme involves multiple components, GMP violations frequently involve cases where policies and procedures are not written, comprehensible or complete or the individuals involved do not have the necessary knowledge to perform their job functions accurately and in compliance with written procedures or the required documentation is inadequate, non-existent or inaccurate.

Regulatory compliance is an ongoing activity and requires management support. Consistent GMP compliance requires the right people with the right knowledge to perform their jobs responsibilities, including validation and documentation. Creating an effective compliance programme doesn’t happen overnight. It requires commitment, resources, discipline and continuous improvement. Recent emphasis among regulators on risk-based action offers a rough roadmap of steps to pursue. Here are some of the most important steps.

Risk assessment: Companies should assess the risks they face based on their products, production processes, facility conditions and workforce. It is especially important to conduct an assessment of the knowledge required for job functions and the level of knowledge held by individuals charged with fulfilling those functions.

Adequate written procedures: Standard Operating Procedures (SOPs) are often found to be inadequate or inaccurate, leaving employees without clear knowledge or direction. Written procedures must be understandable, in the language used by workers, accurate and regularly updated to comply with changes in regulation, equipment, processes or workforces. It is essential to remember that SOPs must be regularly updated, distributed and available for reference.

Knowledge gaps: Employees should be assessed for their level of knowledge and whether it meets the requirements of their job responsibilities. Assessments must be made of both long-time employees and new-hires to determine knowledge gaps and develop appropriate tools to address those gaps.

Training: A guideline does not change the culture of the organisation, but learning and a shared understanding of priorities does. Learning can be used both as a tool for offering foundational training, as well as a vehicle for cultural change and change management.

Training and learning should be targeted to the job role of each employee. It should involve activities that are tracked and recorded and ready to present to an internal auditor or regulatory investigator. Importantly, the training activity must be effective, and trainers should perform an assessment or monitor a production employee to make sure the employee retained the knowledge.

To help foster a culture of quality, many companies expand job-role ‘training’ GMP topics to include the most recent regulatory expectations around corrective actions, complaints, documentation, and many other areas.

Documentation: Recent violations have centered on misrepresentations in documentation. While these violations appear to have been intentional, many companies fail to establish effective electronic record keeping that cannot be falsified. It is often said, “If it isn’t documented, it did not happen.”

With projected export figures of finished drug products from India to the US expected to grow by 40 per cent, Indian pharma companies are in dire need to achieve regulatory compliance to minimise organisational risk and improve quality and business performance through training on GMP compliance. The key factor to consider is that quality and compliance is not an event. It is a culture that is driven from management.

Quality metrics: When a company measures specific indicators such as product error rates, CAPA ( Corrective and preventive actions) initiations, complaint rate, etc, they can build a stronger quality culture by addressing these metrics over time. That is, establishing a continuous improvement programme that targets these specific performance issues. As a best practice, companies should make these quality metrics visible to both senior management and production personnel, to help them see positive trends and aim for a common goal.

Conclusion

The highest offering of information and knowledge is that is affords us the opportunity to change– a direction and a roadmap to where we can be with focus and relentless commitment. In this case, the stakes are the highest they can be: the commitment patient life, health and safety.

And then, one of the ways that the story we started writing together in the beginning, could end like this: The audit went well.

The manufacturing procedures are in place: The GMP training has been taken and implemented. Your company has a programme committed to training. The FDA inspector requests reports of topic covered, completions, and implementations of best practices, and the commitment to excellence is demonstrated it the only way it can: leading by example.