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Mass spectrometry is an extremely sensitive method for the detection and identification of traces of gaseous substances. The technique can quantify atoms or molecules and provide chemical and structural information (functional groups and side chains) on the compounds analysed...
Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing...
It is important to realise early in your project that if you are validating a computerised system, you do not just concentrate on the computer hardware and software. Validation encompasses more, as will be discussed within this handbook...
Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein...
For quantitative results, the curves obtained from the measurement instrument have to be properly evaluated. Often, several different procedures are available for calculating numerical results from the curves...
Pharmaceutical tablets are coated for a variety of reasons, such as to enhance the appearance, taste, chemical stability, or swallowability of the tablet or to create a particular release profile for the active pharmaceutical ingredient (API)...
For the study of a pharmaceutical drug product, particle characteristics (count, size and chemistry) and compound distributions (size and spatial) are among key parameters that strongly determine the quality of the product...
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing...
For certain product types, there is a requirement for testing to determine the absence of certain microorganisms...
Plastic packaging systems for pharmaceutical use include, but are not limited to bags, bottles, vials, ampoules, cartridges, dry powder and metered dose inhalers, syringes, blisters, pouches and their associated closures and secondary components like labels and printing overpouches...
The measurement and quantification of crystallinity in pharmaceuticals is of vital importance, as this has a direct influence on the solubility and stability of the final drug product, affecting both efficacy and expiration...
Confocal Raman imaging is a non-destructive microscopy technique that can identify the molecules in a sample and visualise their distribution in three dimensions...
The development of powerful, modern browsers and the proliferation of mobile platforms has altered the way in which programs run and where data is stored...
Various sources estimate that more than 125 million people worldwide wear contact lenses – their popularity having grown appreciably as lenses have become safer and more effective...
Drug analysis needs to be cost effective without compromising on accuracy...
