(providing strong guidance) outlining a scientific and risk-based approach to AIQ, but it does not define the acceptance criteria for specific instrument types, stating6: "Detailed instrument operating parameters to be qualified are found in the respective general chapters for specific instrument types...
Therefore, it is essential to establish “fitness for intended use” before the analytical procedure is performed. The main resource for instrument and system requirements are the specific monographs and general chapters in the pharmacopeias. In particular, United States Pharmacopeia (USP) has a uniqu...
Those are general opportunities; now let’s turn to see how this is working in the specific sector of authoring and publishing. Instead of being forced to take the traditional route of the legacy gatekeepers (publishing houses), there is a flourishing new set of alternatives evolving: Assisted,...
USP 661.2 includes a chemical suitability/safety assessment using comprehensive extractable and leachable testing. USP 661.2 is not intended to replace ISO 1663 and 1664 standards that address these testing methodologies. Instead, USP 661.2: References the ISO chapters and provides guidance that informs ...
In the US, FDA has not yet set implementation dates for drug applications. However the USP has announced an implementation date of January 1, 2018 for General Chapters <232>,Elemental Impurities—Limitsand <2232>,Elemental Contaminants in Dietary Supplements,in order to align with ICH Q3D....
The instrument performance that needs to be satisfied is defined in the infrared general chapters of the relevant pharmacopoeias. Unfortunately for infrared users, the general chapters are not harmonized, and this is frustrating, as well as being potentially confusing. For example, although there is...
This is because most poetry lists are pretty small. Poetry is not in general given much space in bookshops and it is difficult to achieve any sales for first collections. Self-publishing offers a good approach and the live poetry scene is much livelier than it used to be. Getting your ...
And they can be also due to the government agencies or the general business environment in Brazil. In this case, they are conflicting norms, an exaggerated demand of documents and certificates, poor communication, and red tape. Universities also lack clear rules on intellectual property and ...
“What Time Is It? Where are We Going?”Chekhov’scherryorchard:The story of a Verb1As before, so now during rehearsals ofThe Cherry Orchard,one almost had to use pliers to drag out of Anton Pavlovichany comments and advice on his play. His answers resembledriddles, and one had figure ...
2.2. Genetic Mechanisms of PV There are three genetic mechanisms of PV which shall be discussed in the follow- ing chapters: Variation in length of DNA Short Sequence Repeats (SSRs) [35–37], DNA inversion [38], and DNA recombination [39,40]. 2.2.1. Variation in Length of DNA Short ...