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Process Analytical Technology (PAT) in Pharmaceuticals
Process analytical technology is really a method by which the pharmaceutical manufacturing process is designed, controlled and analyzed in order to ensure the product quality and the attributes of the recycleables used and manufacturing processes are ideal so that you can produce a final product of the best quality. That is achieved through the measurement of Critical Process Parameters (CPP) which will be the key variables affecting the pharmaceutical products' production process and have a direct impact on the merchandise perceived quality. Due to their nature, It is necessary to perform process analytical technology (PAT) in pharmaceuticals, to make certain the products are up to standard and so are safe for consumption and utilization.

Pharmaceutical products have an extremely significant role in the healthcare industry and healthcare in general especially when it comes to treating, managing and regulating various diseases and illnesses. This, therefore, requires the pharmaceutical manufacturer and regulatory processes and systems to have cutting edge scientific and impeccable engineering knowledge alongside the very best technology in quality evaluation and assurance to the challenges that arise from the advancement in pharmaceutical technology such are novel drugs and nanotechnology.

Factors that influence the PAT Framework:

Quality control may be accomplished by a thorough knowledge of the following:

1. Pharmacokinetic characteristics of the drug - this is one way the drug moves and interacts with your body with regards to absorption, distribution, metabolism and excretion.

2. Route of administration - most drugs are administered orally through tablets or liquids but there are many other routes which should be considered when it comes to quality control during manufacturing of the drug such routes are; injection routes, nasal routes, vaginal routes, oral routes, ocular routes and many more.

3. Toxicological characteristics - that is the most critical indicators that influence the PAT framework, it is basically the harmful effects that the pharmaceutical product may need to the user or consumer. The toxicological characteristics are very important with regards to determining the method of administration and the required dosage of a pharmaceutical product.

4. The chemical, physical and the biopharmaceutic characteristic - it has to do with the chemical composition of the drug, how it reacts to different environments such as for example humidity and temperature it also has to do with the physical type of the drug and as a result, it affects the packaging, distribution and delivery approach to the drug. All permitted by quality assurance and process analytical technology, therefore, creating a quality product and minimizing toxicology through the entire products shelf life.

PAT Principles:

The pharmaceutical products design and manufacturing processes usually involve a great deal of steps and some operations for the establishment of quality assurance. These steps are used order to regulate various properties of the recycleables found in the production of the products. In the modern times and as a result of overly aggressive advancement in science and technology, there's been many progress in terms of the analysis of chemical attributes and composition such as purity and identity. However some chemical attributes and composition haven't been well understood by the scientists, pharmacists and researchers which are involved in the production of certain pharmaceutical products and this may cause the variability and unpredictability of the raw materials to be offered to the ultimate products which might be harmful to the consumers in general.

Process analytical technology tools are used to help curb such difficulties in understanding the raw materials, they can result in the discovery of essential information with regards to physical, chemical and biological attributes of the raw materials and the pharmaceutical products.

more info :

a) Process Analyzers - Process analyzers have changed drastically during the past year or two, initial process analyzers predominantly made measurements such as pressure, temperature and pH. Nowadays there are process analyzers that do a lot more than that to the extent of being able to perform tests in physical, chemical and biological attributes. Process analyzers generally create large volumes of data that have become predominantly routine when it comes to quality assurance and regulatory decisions.

b) Multivariate Tools - They are useful for design, analysis and most importantly, data acquisition in the PAT process. The knowledge gained through this is fundamental in terms of the procedure design and the final product.

To conclude Process analytical technology ( PAT ) in pharmaceuticals, is an extremely important process and is essential in quality control assurance in fact it is an essential element in the continuing future of pharmaceuticals and the healthcare industry.

Ankur Choudhary is a professional pharmaceutical blogger and founder of Pharmaceutical Guidelines.
Website: https://pastelink.net/8wdc7yu4