Quality Practice: A summary
26th February 2018, in the journal club meeting the topic, “Quality Practice: A summary'', was discussed. The pharmaceutical industry is one of the most regulated activity sectors. The regulation includes specific quality systems such as good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP). The principles of GLP mainly cover the formal quality aspects of the procedures and do not evaluate the technical aspects in depth. On the other hand, EN 45001 accreditation covers technical performance and is not suitable for pharmaceutical research and development (R &D) as it is almost impossible to comply with the requirements of the European standard in the pharmaceutical environment. The challenge to the pharmaceutical industry is therefore to develop quality systems, compatible with GLP principles, that not only cover formal quality items but also ensure good scientific and technical performance.
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