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 to be able to produce a final product of the highest quality. This is achieved through the measurement of Critical Process Parameters (CPP) which are the key variables affecting the pharmaceutical products' production process and have a direct impact on the products perceived quality. Due to their nature, It is necessary to execute process analytical technology (PAT) in pharmaceuticals, to ensure that the products are around standard and 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 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 can be achieved by a thorough knowledge of the following:

1. Pharmacokinetic characteristics of the drug - this is how the drug moves and interacts with the body with regard to 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 with regards to quality control during manufacturing of the drug such routes are; injection routes, nasal routes, vaginal routes, oral routes, ocular routes and many others.

3. Toxicological characteristics - that is the most important factors that influence the PAT framework, it really is basically the harmful effects that the pharmaceutical product may need to an individual or consumer. The toxicological characteristics are very important when it comes to determining the technique of administration and the mandatory dosage of a pharmaceutical product.

4. The chemical, physical and the biopharmaceutic characteristic - it 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 is due to the physical type 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 a lot of steps and a series of operations for the establishment of quality assurance. These steps are taken in order to regulate various properties of the recycleables used in the production of the products. In the modern times and as a result of overly aggressive advancement in science and technology, there has been plenty of progress with regards to 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 which could cause the variability and unpredictability of the raw materials to be offered to the ultimate 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 recycleables and the pharmaceutical products.

PAT Tools:

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

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

In conclusion Process analytical technology ( PAT ) in pharmaceuticals, is a very 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.