9 Tips to Build an Effective Post Market Supplier Strategy for Combination Products

Supplier Performance Management Software Systems

With the evolution of the combination products developed by medical device manufacturers and pharmaceutical companies in partnership, the need for a robust quality management system is accelerated.

In an effort to improve health and safety for the patients, the healthcare industry has introduced combination products. The objective is to create and deliver safe products that can fulfill customer needs for quality healthcare. Many new therapies are researched and tested for a range of diseases, which are further administered in many new ways.

These new ways are about combining drugs, biological product/devices, and medical devices for minimizing the adverse events while making a significant improvement in treatments and user experiences.

What are the Combination Products?

Combination products are the newly introduced therapeutics that include a combination of two or more products. The combination could be of biologics/device, drug/device, drugs/biologics, or drug/device/biologics, in a regulated manner and marketed as a single unit.

There are many examples of combination products like drug-inlayed implantable devices, drugs contained in delivery devices especially in medical kits, and drugs and devices that are packaged separately but are meant to be used together.

Need for Combination Products

Combination products are proven drug-delivery approaches for the pharmaceutical and medical device companies in an equally effective manner. In fact, both these units of the healthcare industry have found that the combination products are more effective in patients care than that of a single component working alone.

Considering the success of combination products since their inception and the potential waiting to be unleashed, it will be of no big surprise that combination products will mark an expeditious growth in the coming years. Furthermore, the next decade is going to witness many more combination product solutions that will be covering medical devices, biologics, drug-delivery systems, along with the electronics and nanotechnology.

Critical Factors to Consider While Building Supply Chain for Combination Products

The organizational success depends on its ability to control different variables required for the development of the combination products, which relies on the selection of the right manufacturing partner or device supplier. Additionally, you need to maintain a balance of the development support and manufacturing services.

It is often a common scenario to witness project delays and complications due to collaboration among different organizations. There could be a lot of factors that may result in confusions. For example – a product development starts with the design. On the basis of what, you decide on the components’ requirements from the suppliers. When you handle design and manufacturing yourself, you need to ensure knowledge transfer to your teams about the quality of components required and the quality checks they need to perform before moving ahead with the manufacturing. However, you have advanced supplier management software to help you with the critical phases from the selection of a supplier to tracking their performance on a regular basis.

It won’t be wrong to say having a good supply chain process is necessary to meet the targeted key deliverables and the product launch dates.

Roles of Quality Systems Management

When you will have the right vendor to help you with the combination product development efforts – their necessary capabilities will enhance the experience through quality systems management. And, this is important because the drug and device regulations overlap each other. For the majority of the times, the overlap of the regulations is evident.

For example, both the regulations are applicable for management, personnel, and organization. Also, both of them need electronic documentation and record-keeping.

In fact, both the regulations are considered similar by the U.S. Food and Drug Administration (FDA) since they are meant for attaining the same goals. Nevertheless, each regulation is different in terms of characteristics of the product-types they are tailored for.

The manufacturer for the combination product chooses needs to assess the possibilities where they can comply with both the sets of regulations for processing and executing the product development while being considerate about the requirements of the cGMPs (Current Good Manufacturing Practices), Quality Systems (QS), and other regulations.

9 Tips to Build an Effective Post-Market Supplier Strategy for Combination Products

It becomes difficult to manage CAPAs especially when you have multiple suppliers for distribution of combination products. The best way to manage CAPAs that includes multiple suppliers is through purchase controls. There should be proper processes for validation and verification of the CAPAs already executed. You can leverage quality metrics to track suppliers for the continuous improvement and verification of the CAPA. Here are some tips that will help you in building an effective post-market supplier strategy for combination products;

  • Establish a Post-market risk assessment process for suppliers wherein they can receive, investigate and mitigate CAPAs and Complaints.
  • Connect all the quality system indicators including nonconformances, audit findings, customer complaints, product failures, etc. to the CAPA system of product owner’s for appropriate risk management of the major and critical quality issues.
  • Highlight all the important guidelines for suppliers in the Quality Technical Agreement and Planning Document.
  • Make sure every CAPA for the combination products is verified and validated for effectiveness. You can refer to 483s combination product sites for the requirements specified by the FDA.
  • Be sure to deploy the right people for the determination of the root cause since ineffective root cause analysis may result in repetitive quality issues in the market.
  • Make sure you add all the potential nonconformances in a document that you identified in the development phase – be it in software, product design, or product residual as they need to be monitored for the overall improvement and productivity.
  • Be specific about the identification of complaint receivers so that the right suppliers receive the complaints and process it appropriately within time. The root cause identification will help you determine the right supplier agency to notify.
  • Familiarize the Complaints management team with the latest FDA Guidance on Post-market Safety Reporting for Combination Products.
  • Always keep in mind that the Product Owner should notify the FDA for safety reporting, not the Supplier.

Therefore, we can say that it is very important to develop a robust post-market strategy for combination products to demonstrate the relationship between the suppliers in regard to commercial operations. However, the product owner may have different suppliers for the development phase.

Having a proper strategy for managing post-market product complaints will benefit organizations during routine inspections from FDA.

To Summarize:

If you want to manage the post-market surveillance activities for the combination products that are under multiple suppliers, you need the right supplier quality management system provided that being product owner you know exactly what is required. Also, the experienced quality professionals must be in place to ensure product maintenance throughout the product lifetime.

Go with the guidelines and tips shared above to manage your way to a successful compliance state with the support of a powerful supplier quality management system.

Change Management: It’s All About Managing Change in Subtle Manner

Change Control Management Software Systems

The ever-growing and evolving business world, an organization needs to cope with the technological advancements and changes to be successful. More you will be your adaptability; higher will be the chances of success. Hence, change management system has become quite necessary to understand and implement in every organization.

What is Change Management?

Change Management broadly covers the approaches made by organizations to prepare, assist, and support their employees, teams, and even management for making a change – in policies, workflows, processes, etc.
Continue reading

Electronic Signatures: New Protocol of Verification of Quality Records and Documents

QMS Software with Digital Signature Feature

As organizations are going paperless with the adoption of electronic document management systems and record-keeping, the next natural evolution for them is electronic signatures. The norm of digital signatures has offered companies a secure way to verify the authenticity of the electronic records and critical documents.

Let’s start with the fundamentals by going through the definition of the term “Electronic Signatures” and how is it different from the term digital signatures, which people often find confusing.
Continue reading

Major Challenges Medical Device Industries face to Manage their Device Records

QMS for Medical Devices

The medical device industry has witnessed tremendous growth in the past 10-20 years – in terms of revenues as well as the technical complexities of the product. There have been technological evolutions too in the medical device industry, but healthcare professionals still face many obstacles in meeting their goal of delivering quality care within an affordable range of the patients.

The major reason behind the obstacles is inappropriate management of information and device records. It’s high time for healthcare professionals to realize the need for an electronic document management system for maintaining Device Master Record (DMR).
Continue reading

7 Reasons: It’s Time for Cloud-Driven QMS

cloud-based QMS Software

Organizations need effective EQMS to manage their quality management processes efficiently while mitigating compliance and operative risks. A quality management solution ensures you have streamlined processes to maintain a balanced structure and achieve organizational efficacy. But, the advantages of cloud-driven QMS are still dominating.

However, having an EQMS doesn’t necessarily ensure that you will become a quality-focused organization. Because not all EQMS solutions help establish agile quality processes in your organization that are straightforward, easy-to-use, and scalable. If you will choose the wrong solution or implement the right solution in the wrong way, you may end up complicating your quality processes even more.

And, agile quality management solution is very significant for highly regulated industries including pharmaceuticals, biomedicals, and life sciences that have to evolve with ever-changing conditions in their marketplace i.e. new regulatory standards, and customer requirements.
Continue reading

Quality Management Vs Quality Control

Quality Management vs Quality Control

Quality is, indeed, a broader aspect to understand than what it sounds. Quality Assurance, Quality Control, and Quality Management are commonly used terminologies by organizations with respect to the quality of their products and services. However, implementing a quality management software simplifies the quality operations for every industry.

But what’s the difference between the terminologies?

This post will help you understand each of them in detail. Let’s quickly start with their definitions:

Quality Assurance

It basically refers to the section of quality management that ensures the quality requirements are fulfilled – in compliance with regulatory standards as well as customer expectations. Alternatively, we can define quality assurance as a planned and systematic implementation of certain activities required to fulfil quality requirements, building trust for the brand among the potential as well as existing customers without fail.
Continue reading

Know How Quality Management and Risk Management Inter-related

Know how quality management risk management interrelated

The organizations today are taking steps for continuous improvement of quality in their products and services to meet customer requirements and compliance standards simultaneously. The focus on continual improvement helps them to drive operational excellence while mitigating risks.

Making a holistic approach towards the organization’s operational excellence requires two aspects in the first place: Quality Management and Risk Management. Both aspects play a significant role for businesses to attain their quality goals. You can bring them together for a successful implementation of the quality management system in your organization.

In fact, quality management and risk management are often referred to as the two sides of the same coin. Let’s quickly have the definitions of Quality Management and Risk Management before further discussion:

Continue reading

Proactive Vs Reactive : Which Approach is Better to Attain Quality

Building a culture of quality depends on reactive and proactive functions, processes, and workflows in the organization. However, the best approach to attain quality has always been debatable. In this post, we will look at the pros and cons of both reactive and proactive approach towards the quality issues to identify which one is better for quality management.

Though most of the companies today are equipped with advanced quality management systems; still only some of them are striving with excellence while others are still struggling for effective management of their quality issues. The only difference is their approach – some of them are leaning ahead with proactive approach while others are still relying on the reactive one.

Before any further arguments, let’s just understand both the approaches in depth. It will help you have a clear choice of approach you should take your business ahead with.
Continue reading

Drive Continuous Improvement by Analyzing Audit Findings

Internal Audit Management and Tracking Software
Creating an environment of continuous improvement requires a management-driven mindset and detailed analysis of audit findings that should be conveyed at all the levels in the organization. Thanks to the advanced audit management software, it has become easier to manage audit-related activities.

The continuously changing landscape of quality standards and customer requirements has made it important for organizations to have improved, effective, and efficient auditing structure that can help them attain quality as well as operational excellence. However, the audit process should be presented as one of the tools to drive continuous improvement.
Continue reading

Industry 4.0: A Quick Brief on Benefits and Challenges

Quality Management Software Industry 4.0

Industry 4.0 indicates the start of a new industrial revolution to enhance communication, analysis, and utilization of the resources in the manufacturing companies by bringing together two powerful components: advanced techniques of manufacturing and internet of things.

Also referred as the fourth industrial revolution, Industry 4.0 is the digitization of industrial marketing keeping the smart manufacturing operations at the forefront. Though the term Industry 4.0 was introduced in the context of manufacturing initially, it has now covered every industry thanks to technological advancement. It is considered as a leap in quality management system driven by IoT.

Industry 4.0 comprises advanced analytics, Robotics & Automation, Big Data, Internet of Things (IoT), Artificial Intelligence, and Process Digitization across the business supply and value chain.
Continue reading