Formulation quality

Speeifieation teehniques whieh aid produet developers in formulating quality objeetives and speeifieations Q... 

Level 1 changes are those that are unlikely to have any detectable impact on formulation quality and performance. 

Level 3 changes are those that are likely to have a significant impact on formulation quality and performance. Tests and filing documentation vary depending on the following three factors therapeutic range, solubility, and permeability. For example ... 

Sarah Adams. Swallowing a bitter pill. Pharmaceutical Formulation Quality. Dec/Jan 2003. 

Nash, R. A., Making the Paper Match the Work, Pharmaceutical Formulation Quality (Oct/Nov 2000). 

Level 2 changes that could have a significant impact on the formulation quality and performance... 

C. H. Dubin, Scale-up technology transfer, from the laboratory to commercial production, P/zarm. Formulation Quality Oct/Nov (2003), 19-21. 

Level 1 Deletion or partial deletion of an ingredient to affect the color or flavor of the drug product Level 1 changes are those that are unlikely to have any detectable impact on formulation quality and performance... 

Magazines Pharmaceutical Technology Contract Pharma Pharmaceutical Processing Formulation Quality Drug Discovery Development Biopharm. 

Ever-Flex Thermoplastic elastomers, TPO formulations Quality Service Technology... 

CampaneUa, P. and Robinson, M. Patient safety and peak performance. Pharmaceutical Formulation Quality, 2006. 

Analysis or Sample-Orientation. The formulation of requirements for Craitent Uniformity (CU) however is chosen the other way around. The pharmacopoeia has formulated in every detail, how the sampling plan has to be performed and what outcome will lead to rejection or approval of the batch investigated. These requirements are formulated analysis or sample-oriented. The requirements and the influence oti consumer s risks (the chance that the consumer gets a safe product) as well as on producer s risk (the chance that a batch is incorrectly rejected) can be derived from the procedure and laid down in the Operations Characteristic (OC). The chances of acceptance are of course dependent on quality characteristics of the investigated batch such as mean content, standard deviation of the assay and percentage outliers. The OC does not formulate quality specifications, but is only a listing of chances, either to reject or to accept, as a function of a quality characteristic. 

A change in scale invariably impacts on process conditions and, consequently, on the product quality. For pharmaceutical industries, the Food and Drug Administration (FDA) ranks the impacts on the drug product arising from changes of process conditions including production scales into three levels as shown in Table 1 (1). Level 1 is reserved for changes that are unlikely to have any detectable impact on the formulation quality and performance (2). For all practical purposes, scale-up should aim to achieve an impact equivalent to or less than Level 1. 

---