The health ministry of Indonesia has temporarily banned the sale of all syrup and liquid medicines, citing the risks to children (according to a BBC news report). In a statement, the ministry explained that acute kidney injury (AKI) has been linked to syrup medicines. The government cited a sharp increase in AKI cases among children, most of them under five years of age. However, the number of acute kidney failure cases could be much higher than reported.
 
Higher than accepted levels of diethylene glycol and ethylene glycol were found to be present in the products recovered from patient’s homes. Children suffering from AKI had allegedly been using syrups that contained diethylene glycol and ethylene glycol in very small amounts. Currently, there are 206 confirmed cases of AKI in Indonesia, of which 99 were fatal. However, the true number is likely to be higher.
 
As per the BBC news report the Indonesian authorities have so far not disclosed the brands or types of syrup medicines linked to sick children; instead, just temporarily banned the sale and prescription of all syrup and liquid medicines.
 
Earlier this month, cough syrup-linked child deaths were reported from African country The Gambia. The reason then was higher than accepted levels of diethylene glycol and ethylene glycol in syrups. ( A report in India's one of the leading newspaper Economic Times stated that the Medicines Control Agency MCA, has not yet found definitive links between the deaths and the cough syrup).

Unfortunately, we have been witnessing such tragedies since 1937, when the first elixir tragedy was reported in the United States.
 
Further to that, compliance procedures and regulations were strengthened, and for a few decades, it has helped bigtime in curbing such fatalities.
 
Over the years, pharma operations have graduated from ‘quality control’ to ‘quality assurance’ and now ‘quality-by-design’. One of the fundamental principles of quality-by-design (QbD) while formulating drug products is that safety is built-into the product by design. But then a quick question that pops up in my mind is- Are syrups safe?
 
In my view and I'm sure you will agree with me, there can be no justification to such tragedies. As an operational excellence leader, I believe that in addition to ensuring cGMP and quality compliance while manufacturing drug products, it is probably the need of the hour to re-think formulation strategies for syrup medications.
 
Go for syrups sans propylene glycol!
 
This is surely a challenge for pharma formulation development scientists, but it will be efforts worthwhile. Firstly, it will stop such potential tragedies and secondly, syrups shall truly become patient-friendly!

​
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It takes time, commitment, persistence and investment to truly embed operational excellence (OpEx) in healthcare organizations; it is indeed a long-term project. The healthcare industry is ripe for Six Sigma and Lean efforts.

The industry shares many of the same challenges as a for-profit company, with the addition of culture and hierarchy barriers. There have been 12 reform attempts by the U.S. government since the onset of the healthcare crisis in the early 20th century. Using these methods can improve operational efficiency and increase patient satisfaction. An example of operational excellence in the healthcare industry is the referral to listing process for heart transplant patients. Most patients seeking a heart transplant are suffering from severe heart failure, heart disease, or other environment-related conditions.

To implement a successful OpEx strategy, organizations should begin by assessing their current status. The goals must be SMART (specific, measurable, achievable, relevant, and time-bound). They should include broad objectives as well as specific KPIs. This will make it easier to implement the strategy. As with any change initiative, operational excellence programs require resources and education from all employees. Once everyone is on board, the next step is implementing the program.

One example of a healthcare company's use of Lean Six Sigma processes is the implementation of a safety checklist. These checklists help to reduce the number of hospital-acquired bloodstream infections by more than 80%, resulting in a lower cost per infection. Other examples of operational excellence include SickKids Hospital in Toronto Canada, which has created a culture that empowers departments to act on problems.

Organizational excellence programs need to be implemented by empowering team members. These teams need to be empowered and encouraged to come up with ideas and bring suggestions to management. By empowering employees, you can improve the customer experience and the overall knowledge of your team. Ultimately, operational excellence is a journey, and your organization will always improve. Therefore it is crucial to invest in a robust training program for your employees.

Metrics for operational excellence are vital to measuring progress and providing meaningful information to employees. They help them focus on their work and help them determine where they need to make more effort. Metrics should be specific, measurable, and timely, so that the team can make changes as they see fit. The company should measure customer satisfaction and the overall patient experience to ensure operational excellence. The results of the metrics can be used to prioritize priorities and improve operations.

Surgical services are a major source of revenue in many hospitals and health systems. However, many healthcare systems do not use their key assets in the most efficient way possible. For example, when it comes to data migration, a lot of employees are not willing to switch to new methods. Therefore, the implementation of an OpEx program should be supported by a serious commitment from top-level management. The results should be visible in a matter of months.

To know more about how to bring a culture of operational excellence at your organization, checkout- Top Ten Strategic Decision-Making Tools for Operational Excellence

​Implementing Lean methodology is a great way to increase your chances of success. The Lean methodology offers proven solutions that are based on gathered facts and work in the real world. Additionally, Lean solutions can be transferred to other facilities, which will result in continuous improvement. Many modern healthcare organizations face the challenge of staff utilization. By improving staff management processes, Lean healthcare organizations will be able to use their resources more efficiently and boost patient safety.

Related Reading:​

1. Kaizen for pharmaceutical, medical device and biotech industries
2. How to cut costs strategically using Kaizen
3. Streamline processes and workflows with Gemba Walk.
4. Top Ten Strategic Decision-Making Tools for Operational Excellence

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Dozens of child deaths have been reported recently in African country The Gambia. The deaths are allegedly linked to cough syrups containing unacceptable levels of diethylene glycol and ethylene glycol.
 
Diethylene glycol and ethylene glycol are known toxic items and are ‘source-related’ impurities of the solvent used in the cough formulation. At the outset, for those new to this topic, let me briefly explain what is meant by ‘source- related’ impurities- There are broadly two types of impurities in drug products- (1) Source-related impurity and (2) Impurities arising as a result of product manufacturing and/or generated during the shelf-life of a product. These impurities are referred to as degradation products.
 
The source-related impurities are traces of substances in the raw material in lieu of its manufacturing. These source-related impurities cannot be totally avoided but must be controlled and must be within permissible limits mandated in the pharmacopoeia. Further, these source-related impurities must be within acceptable limits in the finished formulation (whenever that raw material is used) at all times until after the expiration of that finished formulation.
 
Same goes for the degradation products, they too (if present) must be within limits stated in the product monograph. If the impurity levels get higher than accepted limits, it can cause minor to critical safety concerns.
 
Coming back to this unfortunate incident…

​Deaths linked to diethylene glycol from cough syrup was first reported in the year 1937 in the United States, the ill-famous ‘Elixir Tragedy’.
 
Since that incident, regulators and pharma companies worldwide have put in stringent cGMP (current good manufacturing practices) criteria in drug product development thru manufacturing as well as post-marketing surveillance. The fundamental objective of cGMP is to ensure quality, efficacy and safety in drug product at all times until after its expiration. An incident such as this one, prima facie means a break-off from the norms i.e. non-compliance to the cGMP process.
 
Also, cGMP does not mean ‘best practices’ implemented only during manufacturing. cGMP is a wide-spectrum best practice and is applicable to all upstream and downstream processes of a product’s lifecycle. Non-compliance in adhering to these ‘best practices’ at any stage of the upstream and/or downstream processes can lead to mishaps, even fatalities.
 
So, what happened in this case? Why so many people died after taking a cough syrup? Why did the syrups have unacceptable quantities of diethylene glycol in them? As a member of the pharma fraternity such questions came my way (from friends and acquaintances) for the past few days. Since this matter is under investigation by competent authorities, we'll know in the coming days. But our objective as responsible pharma professionals, is not to just find out what happened in this unfortunate case, but also proactively ensure that such situations do not happen in the future.
 
In fact, I shall say- selling a safe product to the consumer is the seller’s prime responsibility, no two ways about it. Hence, not just drug products, but all products must have the desired quality attributes and must be safe in the hands of the user.  But how can companies ensure this?
 
There are several ways to achieve this. But the surest and fastest route is to- Start implementing QbD (quality-by-design) in the product’s value chain, and mistake-proof all processes in the product’s supply chain.
 
Mistake-proofing means you don’t leave any scope for errors to happen while working the process. For example, try putting a two-pin or a three-pin plug into a socket. It won’t fit-in unless inserted the right way. Another example of process mistake-proofing is a washing machine. If you were to flip open a washer’s door while it was running its cycle, the machine immediately stops. But the moment you shut back the door it re-starts! Such mistake-proofing with a plug's or washer's design and operation is to prevent accidents i.e. consumer safety.
 
Pharma companies must couple cGMP with mistake-proofing; that is, apply appropriate error-proofing measures to all its technical and business processes.
 
Some of the promising and time-tested error-proofing tools are Poka Yoke, FMEA, Visual Management, CAPA etc. I’ve separate posts on Poka Yoke and Visual Management, do check them out …

1. Improve Process Efficiency with Visual Management
2. Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke
3. Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls?
4. Valsartan, Irbesartan, Losartan Product Recalls- What are the Lessons for Pharmaceutical Industry?

News update- Subsequently, a report in India's one of the leading newspaper Economic Times stated that the Medicines Control Agency MCA and The Gambian drug regulatory authorities have not yet found definitive links between the deaths and the cough syrup, and that the cause of child deaths is still unknown.

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Are you thinking of investing in upgrading your regulatory infrastructure and workflows, then this post is for you.

Regulatory information management (RIM) is an important part of the quality compliance management process for life sciences companies. Today, RIM can help life sciences companies modernize their immediate function globally, deepen strategic partnerships, and streamline regulatory pathways. These initiatives help companies expedite the approval of new products in all markets and ensure that existing products are compliant. By modernizing RIM, companies can harness this vital asset as an enterprise asset.

Complexity of life sciences regulatory information management

Today's life sciences organizations face an increasing complexity of managing regulatory information and documents. The research, development and regulatory processes can generate hundreds of thousands of documents, which must be managed securely. Furthermore, organizations must adhere to regional and country-specific regulatory requirements. In addition, they must handle multiple stakeholders, partner organizations, and many types of information.

With the growing complexity and evolution of life sciences business processes, a streamlined approach to regulatory information management (RIM) can provide long-term business benefits for life sciences companies. This approach allows for improved data management, more informed decisions, and greater time savings. Life sciences companies must make sure they have a comprehensive RIM solution in place to meet all of their regulatory requirements.

As costs continue to rise, regulatory information management becomes an increasingly complex challenge for life sciences companies. This complexity is exacerbated by the fragmented nature of data, which is stored in multiple systems and supported by inefficient software applications. This complexity leads to increased risks and increased cost. For instance, bringing a new drug to market costs upwards of $800 million to a billion dollars. In addition, a single successful clinical trial could mean the difference between winning or losing a drug to a competitor.

Today, life sciences organizations have a need to optimize their processes and lower overheads. However, despite the high volume of data generated, most companies lack visibility and accuracy. The lack of visibility and accuracy in data can lead to bottlenecks and unnecessary cost.

Impact of updated CSA guidelines on quality compliance management

A few days back i.e. on September 13th, USFDA issued draft guidelines on CSA (Computer Software Assurance) for Production and Quality Software. You may review the guidance document here.

CSA guidelines are intended to improve regulatory information management in life sciences organizations. They focus on critical thinking, streamlined-validation processes, data integrity, and operational efficiency. As a result, they are designed to help organizations save time, money, and resources. They also provide measurable Key Quality Attributes for compliance.

The new guidelines also aim to improve software development and testing efficiencies. The goal is to reduce error-prone manual processes and increase quality through sophisticated information technology and data solutions. CSA also aims to improve risk-based assurance by implementing critical thinking early in the development process and leveraging vendor documentation during validation. This process results in a reduction of software development and validation costs, documentation and testing time.

While CSA is not a new concept, it does require organizations to update their processes in order to keep pace with the CSA's evolving regulatory information management requirements. For example, CSA is designed to simplify the use of non-product software systems while maximizing testing efforts and minimizing documentation. It has a focus on testing for higher confidence in system performance. While CSA is intended to be guidance, the CSA principles apply to 21 CFR Part 11. The key to compliance is understanding the level of risk for each system.

Organizations must create a change management plan to help people adapt to the new guidelines. By the way, I have a separate post touching upon transition from CSV to CSA. You may check it out here. This change management plan should include a training and communication program to ensure all team members understand the new concepts. These concepts include critical thinking, risk-based thinking, data integrity, and value-add activities.

Related Reading:

1. Challenges in Modernizing Life Sciences Regulatory Information Management Systems 
2. USFDA Guidance on Life Sciences Regulatory Information Management
3. Economic Impact of Life Sciences Regulatory Information Management
4. What are the drawbacks if Regulatory Information Management (RIM) of life sciences organizations is not modernized?
5. Modernize regulatory information management to improve operational excellence in life science organizations 
6. How to Overcome Challenges in Life Sciences Regulatory Information Management 
7. Benefits of modernizing life sciences Regulatory Information Management
8. Transitioning from Computer Software Validation (CSV) to Computer Software Assurance (CSA)

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Supply chains in all industry sectors are strained; but the situation can be successfully squashed to a large extent with business process re-engineering. 

I was watching this news video about world’s largest chemical producer staring a shutdown in the face. Not just this news, but there are several not-so-big supplier units facing hard times. Such incidents reiterate my opinion (and I've been sharing this view for the past 2-3 years) that life science organizations globally must revisit their supply chain processes! 

It's true that life science companies have been addressing supply chain issues since the break of coronavirus pandemic further aggravated by port closures in several parts of the world. However, most companies are fire-fighting the issue thus bleeding their bottom line severely. Therefore I say, that, there is a dire need for supply chain process re-engineering in life science organizations. But then, how to go about it?
 
In this post, I shall touch upon ways to overcome challenges of supply chain management within the life science sector.
 
Life sciences supply chains are a unique ecosystem, filled with complex regulatory requirements, varying geographical landscapes, and multiple stakeholders. These factors can lead to significant challenges for organizations. These headwinds can lead to high lead times, high production cost, wastages, delays in product launch, increased remediation costs etc. As a result, enterprises must establish safeguards and shore-up their delicately balanced supply chains to avoid such pitfalls. Furthermore, include supply chain related factors in your QBD protocol while developing the products.
 
In addition to regulatory requirements, life sciences companies face significant risk when it comes to transportation. For example, delays or damaged shipments may result in thousands of dollars in labor costs. In addition, damaged goods must be disposed off according to legal requirements. As a result, life sciences companies need to be more efficient in addressing these risks. Digital tools and analytics are helpful in overcoming such challenges.

Digital tools and analytics help companies better predict customer demand, analyze supply chain complexities, and link automated production units to real-time demand. These tools and technologies also improve the transparency of the supply chain, which can boost trust and reduce cost-to-serve. Further, emerging technologies such as innovative Enterprise Resource Management (ERM) solutions can also help address such challenges.
 
A global shortage of talent in supply chain management with expertise in life sciences, is another challenge for life sciences organizations. According to a recently published survey, firms in the life sciences sector are worried about their ability to find the right talent to fill their positions. With labor costs rising, the competition for skilled professionals is fierce. Dedicated teams who could handle the organization’s supply chain led by an operational excellence expert is thus the need of the hour.
 
Additionally, shipping life science products is often a delicate process. Although drug-products are developed complying to the ICH norms of stability, a delay or deviation in the supply chain can lead to product expiration or render the entire shipment useless.
 
In addition to delivering products on-time, companies must balance consumer demand with the safety of their products. Sometimes, even the slightest change in temperature can ruin a product. Real-time tracking helps companies and logistics providers react quickly to potential delays. It also gives them a 360-degrees view of the entire supply chain, allowing them to respond before problems occur.
 
In addition to ensuring the safety and quality of life science products, companies must also meet regulatory standards. The life sciences industry is one among the most regulated industries in the world, and regulatory requirements vary widely from country to country. It is imperative for life sciences firms to follow international guidelines and standards. Many of these regulations are complex, and non-compliance with these regulations can result in stiff financial penalties, brand damage, and even litigation.
 
Another challenge in life sciences supply chain management is finding the right logistics provider. The selection process is not simple and often involves numerous variables and factors. It is imperative to choose the right delivery partner. If something goes wrong, the right supplier can help the business bounce back. In the life sciences industry, overcoming challenges and finding the right logistics provider is vital. Hence, business processes underlying vendor selection must be reset regularly.
 
Yet another parameter of improving supply chain is use of artificial intelligence (AI) in transforming mobility. Fully automated driving vehicles equipped with self-learning navigation systems are expected to boost supply chain logistics efficiency to the summit.
 
Logistics industry presently, still relies on human involvement to varying degrees; perhaps because our human race is diligent and wants to solve all problems ourselves. But the times are changing …
 
We have passed thru the steam age and the electronics age, are in the current information age, but the future shall be the age of artificial intelligence. 

You may say we are using smartphones or have robots doing the cleaning or handling warehouses or machines with CIP (clean-in-place) automation or even robots leading businesses as a CEO. But it is only the tip of the iceberg. In the future, AI technology will come alongside with us and change the world. 

So, what world will be the next world we live in? 

My answer is- Drug delivery techniques are already undergoing a profound change. Combined with fully automated logistics in the life sciences sector, we'll welcome a brand-new world …

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​In a world of ever-changing demand, labor shortages, raw materials scarcity, and spiraling costs, the cargo industry needs to take action to remain competitive.

If not, inaction will stifle future growth and negatively impact productivity. One way to combat these challenges is to improve operational excellence (OpEx). In this post, I'll examine some strategies for making your logistical network more efficient. Listed below are some of the most important principles to improve operational excellence in the logistics industry.

Continued improvement- Continuous improvement will increase efficiency. Without continuous improvement, your management team will have little time for top-line activities and innovation. As a result, the changes may not produce growth or save your company. In order to achieve continuous improvement, everyone within your company must know their contribution to the overall business process and follow a standard methodology for implementing changes. Note that, continuous progress is crucial for any business; but it's not enough, you must also have good strategic goals in place.

Set clear goals- Establish your vision and KPIs (key performance indicators) so that everyone can align their efforts. Clearly define the process and goals of your OpEx process. Educate your employees about the strategy. Then, empower them to participate in the process. By involving them, you'll improve employee knowledge and customer satisfaction. A well-designed OpEx strategy is an ongoing process that requires time, effort, and resources.

Clearly define the goals of your organization. Your goals should be SMART-defined i.e. specific, measurable, achievable, relevant, and time-bound. Your goals should be measurable and include broad goals as well as specific KPIs. This will help your organization improve in terms of performance and culture, resulting in long-term sustainable growth. If your organization can accomplish this, you'll be on your way to sustainable growth.

Operational excellence is a critical component of the logistics industry, because it increases efficiency, eliminates costly errors, and promotes a consistent work culture. Besides having stringent quality standards, operational excellence also requires training and empowerment of employees. For instance, in Bollore Logistics, a comprehensive training program helped its employees become more effective, more efficient, and more productive; read the full report here. And this in turn benefited the company's customers and suppliers.

Communication- In addition to SMART strategies, it's also important to improve communication. A well-communicated company culture will enable employees to focus on their tasks and work towards the same goal. Providing feedback and rewards for outstanding performance will encourage employees to continue their efforts, and ultimately, contribute to operational excellence.

The key to improving operational excellence is continuous improvement, effective communication, and a workforce-centric culture. The logistics industry requires all these things to succeed.

High energy costs and disruption of raw materials are just some of the challenges organizations face in today's volatile economy. With these challenges, firms must constantly improve their processes and operations to remain competitive.

​In addition to improving productivity and efficiency, they must also improve cost and quality. That's where operational excellence comes in. Ultimately, it's all about executing a winning business strategy. More on operational excellence, checkout Top Ten Strategic Decision-Making Tools for Operational Excellence

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As a supplier, you must consider your bottom line as a part of your strategic decision-making process. ​Profitability is the lifeblood of any organization; it keeps you in business and serves your customers.

In this post, I'll discuss the importance of rational decision-making in supply chain management. I'll also explore the impact of rational decision-making on asset utilization. You'll see how this type of strategic decision-making will benefit your bottom line.

Importance of rational decision-making in supply chain management
A key component of successful supply chain management is the ability to make rational decisions. While perfect economic rationality leads to the highest profit, it does not consider sustainability, reputation, or other factors. Many companies consider these factors in their decision-making process, and they often compromise between these three values to ensure that their supply chains are as efficient and cost-effective as possible. Despite these difficulties, it is important to note that supply chains can still be sustainable and ethical if managers use the right principles to guide them.

One of the key skills required to be an effective supply chain manager is the ability to make quick decisions. Quick decisions are often crucial in order to avoid costly interruptions. Moreover, supply chain management careers are dynamic and unpredictable, which makes quick decisions an essential trait. By making quick decisions, you will be able to effectively use staff and protect the goals of your organization. So, what are some other important skills required to be a successful supply chain leader?

A study results revealed that different factors affect decisionmaker's behavior in different ways. For example, the extent of bullwhip effect variation and the tendency of service level are different for different decisionmakers. (Tip: The Bullwhip effect refers to the phenomenon where order variability increases as the orders move upstream in the supply chain). The authors (of the study) also developed a system dynamics model of a supply chain that conforms to modern supply chain characteristics. They added two adjustment parameters and simulated the results. Based on the results, they concluded that behavioral adjustments with varying extents have different effects on supply chain performance.

Impact of rational decision-making on bottom line
Rationality is the ability to come to an informed decision. Rational decision-making models are logical and sequential and focus on listing various courses of action and evaluating the best one. They typically list all of the options, including their pros and cons, in order of importance. They begin by identifying a problem or opportunity, and then assess all options. Finally, they assign values to each option.

Applied to a supply chain management case study, researchers at the University of Lund applied a model of rational decision-making to the system. In this model, a problem is identified, a number of solutions are identified, and data is gathered to analyze the alternatives. The decisionmakers then choose the best solution and implement it. The process may also involve identifying trade-offs that affect the bottom line of supply chain management.

The downside of intuitive decision-making is that it's difficult to justify decisions after the fact. Because the decision-making process relies on accumulated knowledge, it is prone to cognitive biases. In contrast, systematic decision-making models use data analytics software and prescribed steps to arrive at optimal decisions. They can also help managers analyze multiple alternatives, which may reveal more than one advantage. So, how does rational decision-making affect the bottom line of supply chain management?

Impact of rational decision-making on asset utilization
Regulatory reforms and other disruptive events are often more detrimental than unforeseen ones. However, leaders can minimize the damage by minimizing the impacts of disruptive events by improving process flow and early identification. As a result, supply chains that have higher levels of operational slack have fewer disruptive events and greater flexibility. This may have a positive impact on a firm's ability to handle these events.

An article pool presents a thorough review of the advances in the field, and then provides managerial insights and ideas for further research. The authors also discuss the effects of supply chain disruptions and ripple effects, as well as analysis of current literature and comparisons. The article pool concludes with a list of research ideas that can be used to improve the effectiveness of supply chains. However, it is important to note that research on the topic of ripple effects is still in its early stages.
​
With mounting customer demands and the need for growth, supply chain leaders are tasked with optimizing the overall performance of the company's supply chain. However, while traditional goals such as working capital and profit margins remain important, a focus on revenue growth targets may be more effective. Initiatives aimed at cutting costs have had little success in structuring sustainable relationships. Thus, focusing on revenue growth is an important strategy for achieving profitable growth.

​Checkout- Top Ten Strategic Decision-Making Tools for Operational Excellence

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