The pharmaceutical quality revolution
DOI:
https://doi.org/10.15587/2313-8416.2016.58866Ключевые слова:
Continual improvement, Critical Process Parameter (CPP), Critical Quality Attribute (CQA), Knowledge management, Lifecycle, Pharmaceutical Quality System (PQS), Quality by design (QbD), Quality risk management, Quality Target Product Profile (QTPP), SupplАннотация
Pharmaceutical products are patient-oriented. If they had a deficient quality they might put live at risk. Ensuring their quality is not, however, a straightforward task and this is why different approaches have been used along the way. This article analyzes them and shows how our present approach, if well implemented, is very effective in ensuring quality.
Methods. This article analyzes the current pharmaceutical quality system as described by international guidances in the light of practical experience gathered by the author as an international GMP-consultant.
Result. Nowadays we have come to understand that as quality is a global concept in terms of time and of requirements, it has to be assured in a global way too. This is why quality assurance is a permanent process that starts during the development of a product and goes on during its manufacturing life. Manufacturing should be performed within a pharmaceutical quality system which ensures GMP compliance. Decisions should be science and risk-based. Products and processes are monitored by means of critical variables.
Conclusions. The approach followed in the 21st century for ensuring quality is very effective and allows for a progressive reduction of the level of quality risk. However, this quality system is either comprehensive or there is no quality
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