In the world of pharmaceutical development, the journey of the drug product to commercialisation is largely defined by a single word: quality.
A key point that’s clear in the revised Annex 1 is the expectation that the entirety of the sterile product manufacturing process be based and consistently revised upon sound principles of Quality Risk Management (QRM) to minimise contamination risks and ultimately ensure the quality of the drug product.
In the world of pharmaceutical development, the journey of the drug product to commercialisation is largely defined by a single word: quality
Annex 1 formalised expectations that had long been held throughout the industry and by other regulatory presences: that the design and execution of manufacturing operations and facilities should be designed around the scope of the product, and not the product around the facility.
Regulatorily strong, sustainable drug manufacturing now requires a deep understanding of the overall drug product, quality attributes, and the processing measures necessary to achieve consistent, high-quality production throughout the product lifecycle.
Quality: What is it, and why is it important?
Throughout my career, I’ve seen the gradual progress towards product-centred design firsthand.
The pharmaceutical industry has seen profound advancements in treatment modalities, including the emergence of patient-centred medicine through high-yield, highly targeted products.
No longer tenable—and, in many cases, no longer compliant—is a facilities-first approach that attempts to constrain product needs to the limitations and capabilities inherent in whatever equipment and premises may be available.
Best practices now dictate a proactive, product-first approach in the strategy, design, and implementation of a drug manufacturing operation.
Annex 1 formalised expectations that had long been held throughout the industry and by other regulatory presences
Here, the concept of quality comes into focus; the more clearly and concisely product quality is defined and all the risks that could adversely affect that quality are understood, the more effectively the processes, equipment, and facilities can be designed to support the realisation of a product.
So, what exactly are we talking about when we discuss quality? Simply put, Quality is how appropriate and effective a drug is for its intended use and definitionally includes attributes like purity and strength (ICH Q8).
Once identified, a process and strategy can be developed that supports and controls the product’s critical quality attributes (CQA) and critical process parameters (CPP), and considers the full scope of the operation and all its potential variables related to quality and repeatability of production.
The end goal is to ensure that sterile products are effective, safe, and available to patients.
Best practices now dictate a proactive, product-first approach
Since quality is the priority, it’s necessary to understand how to assess these variables in relation to potential harm to the product and the associated risks.
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