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Necessity of team training in Good Manufacturing Practices

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Guest user Created:   Jun 10, 2020 Last commented:   Jun 11, 2020

Necessity of team training in Good Manufacturing Practices

Is it essential to keep the entire team trained in Good Manufacturing Practices?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 11, 2020

According to the EudraLex, The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use; PArt 1 – Chapter personel in requirement 2.10 is stated that manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product, not necessarily the entire team.
 
For more information about Good manufacturing practice, please follow the link: https://ec.europa.eu/health/documents/eudralex/vol-4_en

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Jun 10, 2020

Jun 11, 2020