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Sep 04, 2020 The US Food and Drug Administration has issued a warning letter to Mylan Laboratories Limited's plant in Telangana for significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). USFDA in their letter dated…
Lean manufacturing is a methodology to reduce waste in a manufacturing system without sacrificing productivity. Lean manufacturing’s main goal is to eliminate waste. The waste can be categorized into three categories- Mura, Muri and Muda which are commonly known as…
Pharmacopoeia is the word derived from the ancient Greek φαρμακοποιΐα (pharmakopoiia), from φαρμακο- (pharmako-) ″drug″, followed by the verb-stem ποι- (poi-) ″make″ and finally the abstract noun ending -ια (-ia). These three elements together can be rendered as ″drug-mak-ing″ or…
GxP are quality standards and regulations which are to be followed in specific fields. GxP is a concept of good practices where G stands for ‘Good’, x is an acronym which stands for particular field like ‘Manufacturing/Laboratory/Clinical, etc.’ and P…
Principles of Quality Risk Management found their application in our day to day life, apart from their application in the industry, production, regulations etc. In pharmaceutical industries principles of QRM found their application for both manufacturers as well as reviewers/…