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What is a Pharmaceutical Quality system anyway?

Understanding the expectations of the regulators for your Pharmaceutical Quality System (PQS) can be challenging, have you ever been confused by the number of acronyms and technical terminology.  A QMS can be a series of documents hundreds of pages long, the Quality Management System (QMS) can refer to the processes that are used to control your operations, including the likes of  CA/PA and Change control. And that is just the terminology, creating clarity in the ambiguity to effectively manage your manufacturing processes is the real challenge.

We have often felt that just to understand terminology is difficult enough. Fortunately there is guidance out there from the FDA and other governing bodies that helps us to understand it. What we have found is that the next step for us in working with customers new to the requirements of the GMP’s (Good Manufacturing Practices)  is working together to understand the role of the electronic Quality Management System (eQMS) is in achieving the objectives of your PQS.

What Objectives?

Referring to the guidance from the Food and Drug Administration (FDA) in the United States, they help to refine the requirements from the International conference on Harmonisation (ICH)  Q10 model for the effective implementation and operation of a PQS. ICH Q10 brings together (harmonises) the best practices from the ISO and cGMP practices around the world. It is intended to provide clear understanding of the best practice to “enhance the quality and availability of medicines world wide in the interest of public health.”

There are clearly define objectives in ICH Q10:

  • Achieve product realisation (1.5.1)
    • To establish, implement, and maintain a system that allows the delivery of products with the quality attributes appropriate to meet the needs of patients, health care professionals, regulatory authorities (including compliance with approved regulatory filings) and other internal and external customers.
  • Establish and Maintain a State of control (1.5.2)
    • To develop and use effective monitoring and control systems for process performance and product quality, thereby providing assurance of continued suitability and capability of processes. Quality risk management can be useful in identifying the monitoring and control systems.
  • Facilitate Continual Improvement (1.5.3)
    • To identify and implement appropriate product quality improvements, process improvements, variability reduction, innovations, and pharmaceutical quality system enhancements, thereby increasing the ability to fulfil a pharmaceutical manufacturer’s own quality needs consistently. Quality risk management can be useful for identifying and prioritizing areas for continual improvement.

Enbalers of your PQS

These are enabled by effective Knowledge management (KM) (1.6.1)

  • Product and process knowledge should be managed from development through the commercial life of the product up to and including product discontinuation. For example, development activities using scientific approaches provide knowledge for product and process understanding. Knowledge management is a systematic approach to acquiring, analysing, storing, and disseminating information related to products, manufacturing processes, and components. Sources of knowledge include, but are not limited to, prior knowledge (public domain or internally documented); pharmaceutical development studies; technology transfer activities; process validation studies over the product lifecycle; manufacturing experience; innovation; continual improvement; and change management activities.

and by Quality Risk Management (QRM) (1.6.2)

  • Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating, and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. ICH Q9 provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

We have seen that the effective implementation of an eQMS like Ibiqs, can assist in achieving all of the objectives in bold text.

Our Journey with the Ibiqs ‘PQS’

In our development of Ibiqs the QikSolve eQMS built on Office 365, we have come to understand more and more that a Pharmaceutical Quality system is built on the processes to maintain a state of control. The most important difference between a paper based Quality management system and an electronic system is the fact that your eQMS is the most valuable form of Knowledge Management. It is the repository where all your mistakes and errors are logged fixed and decoded. It acts as a powerful database so that you can understand and realise your Product safely and effectively.

Within QikSolve we use the same eQMS that we deploy to customers. As we collect more information and data we are able to make better decisions our “Product Quality System” allows us to see the mistakes we are making. This lets us implement corrections over time.  Importantly, when a new employee starts, they can search through the records and quickly see how an incident has been dealt with in the past. Software development is a fast moving space. Our customers requirements are always evolving and we like to make to embrace technologies that improve our effectiveness.  To give our customers better value in their Pharmaceutical Quality Systems. This means we are always exposing ourselves to new risks and potential errors. Without a good eQMS and it’s powerful Knowledge management aspects we are vulnerable to disappointing our customers and not living up to our own high expectations.

Learn more

If you would like to know more about how Ibiqs can help you. Not just Establish and Maintain a state of Control and Facilitate Continual Improvement, please contact us at info@qiksolve.com