Quality by Design (QbD) is the latest paradigm shift that pharmaceutical producers must achieve. Richard Lucas, Product Manager, Bioquell UK, argues that HPV technology offers a QbD approach to risk management in cleanrooms.
Quality cannot be tested into products; it should be built in by design. These wise words are used to support a range of manufacturing processes and are echoed in the ICH Guidelines for Pharmaceutical Development,1 where they set out a clear message that for the manufacture of medicinal products – quality can be planned. The principle of the Quality by Design (QbD) approach is that quality can be built into a production process through a clear knowledge of the process requirements, the risks involved and how these can be mitigated.
One of the most important challenges for quality control during pharmaceutical manufacturing is the risk of biological contamination. It is critical that medicinal products are manufactured within a sterile environment, both to ensure patient safety and to maintain production efficiency. Investigating the causes of incidents of biological contamination is a time-consuming and costly process. Root-cause analysis tests need to be carried out, alongside microbiological identification, and corrective and preventative action has to follow. The controlled destruction of contaminated batches of product will also be required.
The careful design and planning of effective decontamination and sterile procedures is an imperative step, therefore, in any pharmaceutical manufacturing process, particularly as changing trends in drug development and regulatory enforcement drive the search for new sterilisation solutions.
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Cleanroom Technology.
Subscribe now Already a subscriber? Sign in here.