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Workshop QRM and QbD

Progress-PME also offers the ‘Introduction to QbD and QRM’ workshop for managers in the (bio)pharmaceutical industry. Click here for more information.

Quality legislation and regulations
The ICH regulations ICH Q8, Q9 and Q10 and the recently enforced Q11 describe what QRM and QbD entail and how companies can apply these methods. The US Food and Drug Administration (FDA) included all these regulations in its ‘Guidance for Industry Process Validation: General Principles and Practices’, which has been in force since 2011. Draft Annex 15 of the European regulations (EMA) was brought in line with the FDA regulations in 2014 and ICH Q8-Q11 are expected to come into force in 2015.

Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)
CQA, a product’s critical quality attributes, are a set of quantitative product requirements that guarantee the safety of the patient and the efficacy of the product for those products whose manufacture meet the specifications. QbD involves structurally and efficiently developing a robust and upscalable process that meets the specifications set by the CQA.

QRM is a tool for using risk methods to determine which process parameters might influence the Critical Quality Attributes (CQA). This then shows what the potential critical process parameters (CPP) are. Knowledge regarding the process and the CPP will grow throughout the product’s lifecycle, from development to commercial phase up to the end of the lifecycle. Good QRM allows the new knowledge to be relayed back to the organisation and the documentation and process to be adapted to it. Continuous process improvement guarantees a safe and effective product combined with the highest process yield.                                                                                        
 ‘Begin with the end in mind.’

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