http://www.manostaxx.com Military Standards Can be downloaded free of charge using the website: http://assist.daps.dla.mil/quicksearch/. MIL-STD-1916 (1996) – DOD Preferred Methods for Acceptance of Product To download…
Category: Gestão da Qualidade
http://www.manostaxx.com Random Sampling ¤ 100% inspection can be time-consuming, or destructive. ¤ How many samples to check? ¤ Follow statistics rather than a fixed percentage…
http://www.manostaxx.com Table of contents About this document 1. Purpose 2. Scope 3. Introduction Checklist – GMP regulations by activity About quality management 4. Pharmaceutical quality…
http://www.manostaxx.com Key Differences in the Regulatory Framework (EU vs US) Key Differences between US and EU – Focus GMP/GDP Process Key Differences between Annex 1…
http://www.manostaxx.com Introduction These guidelines are primarily intended for use by governmental organizations, such as drug regulatory authorities (including inspectorates), quality control laboratories and customs and…
http://www.manostaxx.com As we noted in our last blog, the USP has fully promulgated the regulations for testing for elemental impurities in drug products, effective January…
http://www.manostaxx.com On January 1, 2018, new guidelines regarding elemental impurities in brand and generic drug products went into effect. Elemental impurities, such as arsenic and…
http://www.manostaxx.com Those new to the field of quality risk management (QRM) should be familiar with the history of risk management for pharmaceutical and biopharmaceutical products…
http://www.manostaxx.com The definition of quality of a pharmaceutical product means the product is fit for its intended use, is free from defects, and meets or…
http://www.manostaxx.com 2017 was a challenging year for quality. Many manufacturers had to evolve their quality management system due to changes in standards and compliance requirements,…