Process Analytical Technology PAT in Pharmaceuticals

Process analytical technology is a method through which the pharmaceutical manufacturing process was created, controlled and analyzed in order to ensure the quality and the attributes of the raw materials used and manufacturing processes are ideal so that you can produce a final product of the highest quality. This 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 products perceived quality. Due to their nature, It's important to perform process analytical technology (PAT) in pharmaceuticals, to ensure that 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 generally especially when it involves treating, managing and regulating various diseases and illnesses. This, therefore, requires the pharmaceutical manufacturer and regulatory processes and systems to have leading 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 how the drug moves and interacts with your body in terms of absorption, distribution, metabolism and excretion.

2. Route of administration - most drugs are administered orally through tablets or liquids but there are lots of other routes that ought to 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 - this is just about the most critical indicators that influence the PAT framework, it really 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 technique of administration and the mandatory dosage of a pharmaceutical product.

4. The chemical, physical and the biopharmaceutic characteristic - this has related to the chemical composition of the drug, how it reacts to different environments such as for example humidity and temperature in addition, it has to do with the physical form of the drug and for that reason, it affects the packaging, distribution and delivery approach to the drug. All made possible by quality assurance and process analytical technology, therefore, creating a quality product and minimizing toxicology throughout the products shelf life.

PAT Principles:

The pharmaceutical products design and manufacturing processes usually involve plenty of steps and some operations for the establishment of quality assurance. These steps are taken in order to modify various properties of the raw materials found in the production of the merchandise. In read more and because of the overly aggressive advancement in science and technology, there has been lots of progress with regards to the analysis of chemical attributes and composition such as purity and identity. However some chemical attributes and composition have not been well understood by the scientists, pharmacists and researchers that are involved in the production of certain pharmaceutical products and this could cause the variability and unpredictability of the raw materials to be offered to the final products which might be bad for the consumers generally.

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

PAT Tools:

a) Process Analyzers - Process analyzers have changed drastically in the past couple of years, initial process analyzers predominantly made measurements such as pressure, temperature and pH. These days you can find process analyzers that a lot more than that to the extent of being able to carry out tests in physical, chemical and biological attributes. Process analyzers generally create large volumes of data which have become predominantly routine with regards to quality assurance and regulatory decisions.

b) Multivariate Tools - They're used for design, analysis & most importantly, data acquisition in the PAT process. The knowledge gained through that is fundamental when it comes to the procedure design and the final product.

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

Ankur Choudhary is really a professional pharmaceutical blogger and founder of Pharmaceutical Guidelines.