Pharmaceuticals process validation properties

During a validation process, the products and processes are subjected to testing at extreme conditions of in-process limits and their performance is evaluated against the acceptance criteria. The parameters of different pharmaceutical operations are varied and product properties are recorded and evaluated (Figure 3). When it is found that adjustment is required, necessary actions are taken in consultation with R D personnel. Generally, validation data of three production scale batches are compared to generate a high level of quality assurance. 

A number of valid reasons have prompted the research-oriented chemical industry to invest substantial resources into the effort to dramatically increase the evaluation efficiency of new chemical entities. The objective is to optimize rapidity and cost in the early phases of the process, leading to the identification of compounds with promising properties for further development into commercial products (typically pharmaceuticals or agrochemicals). In drug discovery, the wealth of new molecular targets with therapeutic potential is bound to increase, due to the efforts to understand the mechanisms of diseases and due to the data retrieved from genomics [1, 2],... 

When a pharmacist regularly produces a specific preparation for an individual patient, a better substantiation of the design quality is necessary. Both literature and experimental research may provide extra information about the pharmacotherapy and about pharmaceutical properties such as homogeneity, stability microbiological quality, compatibility, tolerability, and taste. For this, the pharmacist may use data from other pharmacies as well. Furthermore, more specific in-process controls may be added to the preparation process. An end control (usually non-destructive) by the operator is required for every batch, as well as a more specific validation of the preparation method. 

---