Advanced Quality Management Systems for Pharmaceutical Manufacturers

The Life sciences manufacturing industry such as pharmaceutical, biotech and API manufacturers is under constant pressure to manage the increasing complexity of their operations with strict regulatory requirements and frequent changes. Now many manufacturers realized the need for enhancing the agility and flexibility of their Quality Management Systems (QMS) to meet market needs. But, this has to be done in a cost-effective way without any increase in the costs related to quality.

From the recent stats published by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the no of new pharma products developed is increasing worldwide in different parts of the world.

To cope up with the market requirements and competition, you need to have a lean and agile Quality Management Systems (QMS) for your quality management operations.

These systems must contain three important characteristics

• Capturing customer feedback and regulatory changes and to develop new processes and products rapidly.
• Managing both operational efficiency and compliance requirements even with the increase in business complexity with a streamlined process.
• Flexible to the introduction of different workflows and processes.

It is evident that there are a lot of advantages with these agile systems, but these Quality Management Systems (QMS) must be aligned with the company’s requirements. In the pharmaceutical industry, few misalignments can cause various compliance and quality issues in the pharmaceutical industry which involves huge remediation costs.

Significant implications for the Quality Management Systems (QMS)  based on recent industry trends

• There is an increase in the diversity of products due to the advancements in technology. Now the products may have lot of elements to manufacture. Traditional product lines are not so matured to handle this increased complexity. So these production lines must be updated with new workflows and processes to match the product requirements.

• When company acquisitions and merging of organisations take place, there is always a challenge exists of integrating the Quality systems of these different organisations.

• Regulators are using the latest technology and tools to access data to gain valuable insights. This enables the in-depth analysis of process and products. this is why sharing of data became very prominent giving data integrity great importance. Advanced analytics enables industries and regulatory agencies to derive new insights from the data.

Lean and Agile Quality Management Systems (QMS) model for the present market trend

Understanding the entire process and workflows in a large organisation operating in multiple locations is a very challenging and hard task.

Traditional QMS systems became very bulky due to the changes done in response to the quality issues and observations over time. This causes misalignment of the QMS system with company requirements.

Advancements in digital technology and an increase in the availability of data has changed the product design, development and innovation in the industry. The present-day organisations are looking to provide end-to-end solutions for their products from development to support.

The extensive usage of cloud-based systems helps to innovate new processes or workflows without any delay when there is any change in the system.

Different steps in the Implementation of Lean and Agile Quality Management Systems (QMS)

Capturing customer feedback for future improvements

According to the recent study pharma companies are lagging behind in collecting the customer feedback and incorporating it in their future designs. This is why many companies are struggling to meet the new regulatory guidelines.

Getting Customer feedback from customer complaints, product quality reports and service reports became an old method. Due to the increase in the no of communication channels, customer feedback can be found and captured for quality assessment. For examples, we can track customer feedbacks from different social platforms using advanced digital tools. Regulators attention to these platforms is increasing which may result in new developments in product validation and guidelines.

Distribution of feedback or insights obtained across the organisation

Once the issue has been identified and analysed, the CAPA and other governing systems in an organisation should effectively share the insights and lessons across the organisation to prevent the repetition of the same issue. This type of CAPA implementation method will not only prevent a repetition of issues but also helps all the processes in an organisation to work in harmony with each other.

Integrating QMS with development and operations

QMS integration with development process can speed up the process and allows the product to be introduced quickly into the market. Using common procedures and metrics as used in quality management, development can be done more effectively.

Effective usage of advanced analytics.

Advanced analytics will help to understand the critical processes and parameters during the commercial phase and to reduce the deviations and batch failures in the testing phase. These insights are very important to demonstrate the requirements of the market and to plan the design of the product.

Maintaining a high-quality culture.

As we know Feedback system plays a crucial role in the design and development phase of the product, we must ensure efficient handling of customer feedbacks by the employees by rewarding them for their work. This will motivate them to go the extra mile and collaborate across functions and proactively addressing quality issues.

Streamlining the QMS

There are three main difficulties in QMS to handle for the effective performance of the system

• Misalignment between core business system and QMS processes
• Complex SOPs that are difficult to read and understand
• Extensive documentation requirements that affect productivity

To limit the extent of documentation companies usually streamline their SOPs and design new document templates, but this will not have much effect on the QMS structure nor it helps in reviewing key elements thoroughly.

A misaligned QMS system with the core concept of the organisation can affect many processes. This mismatch can delay planning, lower operational effectiveness and slow down decision making. A recent study, it was revealed that this type of mismatch had reduced productivity and in turn increased pressure on production systems. As a result Quality of products will also get affected.

A lot of processes are almost the same for different product designs, this makes it easier to design and built a QMS system with minimum no of procedures. Many organizations in India have designed different types of quality systems for the same type of process. On average every organization have 30 to 40 per cent more change controls than needed. These can be reduced significantly as per the requirement.

Increasing the Flexibility of QMS

Universal

Some organisations prefer one QMS with the highest level of regulatory standards for all type of processes. However, this is effective as it ensures compliance of the entire organisation but will increase the cost of quality and reduce flexibility. This will halt the product from entering into the market quickly.

Modular.

Another type of quality system consists of Single EQMS with different quality modules. A module is selected based on the type of product. This type of modular QMS serves as fit for purpose quality system for each type of requirement. This type of qms will increase the flexibility and therefore increase the speed to market. Definite regulatory standards should be defined for each and every process to avoid extensive time consumption to assess each product.

Advanced

This type of QMS system is universally applicable to every type of product and also it enables flexibility by assigning to a particular team which understands the requirements of the product very well. In this approach lower levels of organization controls the compliance which reduces the oversight of the process to the management.

Process Specific

A fully separated QMS is assigned to each and every process to ensure compliance. This will promote a lean qms system within each unit covered by separate qms system. However, this model will increase duplication, administrative activity across different units and reduces speed to the market.

Based on the above discussion regarding the advantages and disadvantages of different qms systems, we cannot identify the perfect and agile EQMS system which suits for every application. We need to select the right qms system based on the context, product and quality requirements.

Integrating different QMS systems from multiple organizations

It is a very challenging and difficult task to integrate different EQMS systems implemented in various organizations when they are merged or acquired. This is similar to integrating separate QMS used for different business units.

There are few approaches for integrating different QMS system which includes full harmonization which consumes a lot of time and energy. You have to select the best approach which suits your requirements

Here are a few important considerations while choosing the right integration process

• QMS system and its objectives and company objectives should be clearly aligned with each other.
• QMS system should be clearly understandable and link its processes and policies to the lower level of organization for implementation.
• QMS should be flexible enough to incorporate business requirements and site-specific improvements for continuous development.
• Data obtained from different observations should be distributed across the organization for the harmonious workflow of the entire organization when there is any change.
• QMS system should be ready to adapt any type of regulatory changes and should have a proper change control system.
• A good QMS system should maintain a balance between compliance and business goals.
• It should not incur an unnecessary cost to the organization while maintaining compliance with regulatory guidelines.
• Any type of best practices followed outside the organization should be learned and adapted for the best possible outcomes. But, you have to understand your current QMS system to make any appropriate changes.
• A risk-based approach is very beneficial for a QMS. It should prioritize the key elements of the quality management process and to review those to avoid any high-level risks. A lean and targeted QMS works very effectively for a risk-based approach.
• QMS should be fully integrated to perform at its best. It should take all the audit requirements from the audit management regarding regulatory requirements and expertise for enhanced quality management. All the key modules of a QMS should work well together for effective quality management.

Conclusion

QMS should be examined periodically to identify the opportunities for simplification and modification. Although we should avoid unnecessary changes which leads to other changes in our qms system. The change in the fundamental design of the QMS system is very challenging though it is required in many cases

Technically sound and expertized system is not sufficient for the successful transformation of QMS system, top-level leadership of an organization should also support and put in the efforts. A long-lasting and successful QMS can only be built with the involvement of every part of the organization.

For a demo on AmpleLogic Electronic Quality Management System Software, write to us on info@amplelogic.com