The quality of drug products is critical and integral for many Pharma manufacturers. It is the basis on which the relevant pharma controls, resources, activities, and growth are defined. The required quality level in the pharmaceutical industry distinguishes this industry from other manufacturing industries, such as food, beverages, and chemicals.
In the pharma industry, quality is employed for several reasons, such as regulatory regulations, market reputation and customer tests, to name a few. However, the main reason for caring is the extent to which the pharma drug product comes into contact with humans, which is more sensitive than other products. All of those mentioned above are critical for ensuring quality in pharma organizations.
What is the quality system?
A quality system represents an organization's plan, outlines, departmental objectives, and resources to achieve customer satisfaction by fulfilling the customer's expectations with a particular product. Its primary aim is to provide detailed business models, processes, and people approaches to bringing quality to the end product. One integral part of the quality system is the self-assessment and system improvement to enable continuous improvement, detect any problems, and effectively remove them.
The quality system is increasingly being used as a tool to market itself as a symbol of perfectness, monitoring, robustness and customer satisfactory across various industries such as Aviation, Software development , Industrial engineering, in addition to Life Sciences
What is a pharma quality system?
A Pharma quality system is a set of rules and practices applied across different areas and sections of a pharmaceutical organization to achieve quality in their final product. It focuses on using quality in the initial and individual stages of pharmaceutical drug manufacturing rather than just focusing on the final stage or product.
A robust quality system enables
Desired quality in the product
Industrial process performance is up to date
Proper accountability in all stages
Continuous improvement
The organization's capacity to ensure quality continuously grows.
How is the quality system implemented in the pharmaceutical industry?
To implement a quality system in the pharmaceutical industry, one must follow a framework that fulfils all the quality-related features. However, since the pharma industry is highly regulated, regulatory bodies should approve the framework, and one such framework is ICH Q10.
The ICH Q10 and Pharmaceutical quality system
The ICH Q10 is a harmonized quality system that can be used in addition to regional GMP regulations. Note that implementing ICH Q10 does not complement the regional GMP guidelines or provide an alternative. Let's briefly discuss ICH q 10.
What type of pharmaceutical industry takes advantage of this framework?
Before we go and discuss briefly the ICH Q10 pharma quality system, first discuss what kind of life science industry benefits from
Pharmaceutical development
These pharmaceutical companies involved in pharmaceutical development are not engaged in large-scale production. It includes developing new drugs, improving existing drug products, experimenting with a new chemical API or drug and method development. This type of company is involved in repeated testing until the desired results are obtained.
ICH Q10 for these organizations helps devise a system that increases testing procedure efficiency and enhances the results' authenticity. It utilizes a model-based approach to invest quality in all parts of the testing process.
Technology transfer
Technology transfer means transferring knowledge from one entity to another, and it can take many forms. It can be from drug development organizations to commercial manufacturing or from existing product exceptional cases such as mergers or sales to another group or owner.
ICH Q10 ensures quality in this domain by preserving the integrity of the technology transfer through documentary systems and approved mechanisms because data and methods are essential in technology transfer. The ICH Q10 enables the preservation of data and processes.
Commercial manufacturing
In commercial manufacturing, the methods, requirements, resources and skills are predefined with a defined success rate. These organization methods and processes are only used to preserve and repeat the results and the desired product constituents.
PQS in commercial manufacturing helps to achieve repeatable processes, desired product characteristics, required production capacity and product quality. PQS focuses on documentation, training and monitoring in every drug manufacturing process to achieve the desired results.
Some areas where PQS can be implemented include facilities, equipment, packaging, labelling, quality department, and release and storage.
Product discontinuation
Product discontinuation means a pharma organization has decided to stop manufacturing a product for many reasons, such as low performance or replacement by a more effective product.
PQS is used to enhance performance by implementing various processes that could help retain the records and integrity of the product.
How to implement ICH q 10 in the Pharma industry
ICH provides helpful information for implementing PQS in the pharma industry. This article offers some brief points of the ICH quality system, as mentioned below.
According to official guidelines, the ICH is implemented by the following
Management responsibility
Continual improvement of product performance and product quality
Continual improvement of the Pharmaceutical quality system
Management responsibility
This section focuses on management's commitment to implementing and maintaining quality; It identifies management as a key decision-maker. Some of the roles for which the management is responsible include the following.
Commitment
Management is responsible for designing, implementing and monitoring quality systems.
Support quality systems throughout the organization by any means.
Raise quality issues to the appropriate level through effective communication and escalation processes.
Define roles and responsibilities, i.e., duties of individuals at all levels, and at the same time, communicate these to appropriate levels.
Conduct a review of the process, product and Quality System.
Advocate for continual improvement at all levels.
Support those mentioned above and other quality principles by providing adequate and required resources at all levels when required.
Quality policy
Management is responsible for devising a quality policy, providing the current thinking of an organization towards quality procedures. It must include the intention to follow regulatory requirements and facilitate continuous improvement.
The quality policy must be communicated to personnel of all levels of all relevant departments and should be revised periodically.
Quality planning
Senior management must arrange to implement quality policy about company straorganizationlity policy across the entire organization. It is also responsible for providing training and observing quality in all organizational functions. The management should also introduce and implement performance indicators to measure the progress of quality objectives, monitoring, regular communication and how to act upon
Resource Management
Management is also responsible for arranging human resources, finance, facilities, and equipment to implement and maintain quality systems. It is also responsible for setting resources to implement quality in a specific product or process when required.
Internal communication
Management should establish adequate mediums to facilitate appropriate communication between all levels. The management must also provide the escalation of product quality and quality system issues.
Management review
Management is responsible for checking the suitability and effectiveness by implementing management review. It should assess the conclusion of process performance and product quality.
Management of outsourced activities and purchase of materials
This emphasizes the importance of management's supervision to ensure quality in outsourcing activities and purchasing material. It is enabled by
Assessing suitability and completeness of outsourced party in carrying out the services or providing materials
It defines the communication and responsibilities of involved parties. For outsourcing parties, it should be in a written agreement.
Monitoring review of contractors' performance
Monitoring the incoming material to verify their source
Management of change in product ownership
This is related to management's responsibility in product ownership in case a change occurs and ensures
Continual improvement of process performance and product qualities
It focuses on different stages of the process life cycle that enhance the effectiveness of regional GMP guidelines.
The goals that it intends to achieve are
Life cycle stage goals which focus on Pharma development, technology transfer, commercial manufacturing, product and documentation
Pharma quality system elements
The primary purpose of the ICH quality system element is to enhance the quality system because these elements are fully or partially required under GMP regulations.
There are four elements, and are mentioned below
Process performance and product quality monitoring system
Corrective action and preventive action - CAPA
Change management system
Management review of process performance and product quality
Continual improvement of Pharmaceutical Quality System
This section describes the activities for managing and improving the PQS and focuses on
Management review of PQS by having a formal process for reviewing the existing current state of the quality system and include
Measurement of achievement of objectives
Assessment of performance indicators that indicate the effectiveness of process within the PQS, and includes complaint deviation, feedback on outsource activities, self-assessment processes and external evaluations.
Monitoring of internal and external factors impacting the PQS by monitoring factors such as emerging regulations, guidance and quality issues
Innovations in the Pharma industry
Changes, business environment and product ownership
Outcomes of Management review and monitoring
The outcome of Management review and monitoring can include
Improvements in pharmaceutical quality system
Allocation of more resources
Revising quality policy and objectives
Documentation and timely communication of the results of Management review, including escalation of critical matters to the senior management for prompt action
About the Author:
Muhammad Asim Niazi
Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.
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Pharma Sources Insight January 2025
