Process analytical technology is a method through which the pharmaceutical manufacturing process is designed, controlled and analyzed in order to ensure the quality and the attributes of the raw materials used and manufacturing processes are ideal in order 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 perform process analytical technology (PAT) in pharmaceuticals, to ensure that the products are up to standard and are safe for consumption and utilization.
Pharmaceutical products have an increasingly 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 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 understanding of the following:
1. Pharmacokinetic characteristics of the drug – this is how the drug moves and interacts with the 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 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 others.
3. Toxicological characteristics – this is one of the most important factors that influence the PAT framework, it is simply the harmful effects that the pharmaceutical product might have to the user or consumer. The toxicological characteristics are very important when it comes to determining the method of administration and the required dosage of a pharmaceutical product.
4. The chemical, physical and the biopharmaceutic characteristic – this has to do with the chemical composition of the drug, how it reacts to different environments such as humidity and temperature it also has to do with the physical form of the drug and as a result, it affects the packaging, distribution and delivery method of 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 raw materials used in the production of the products. In the recent years and due to the overly aggressive advancement in science and technology, there has been a lot of progress when it comes 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 may cause the variability and unpredictability of the raw materials to be passed on to the final products which may 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 lead to the discovery of very important 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 there are process analyzers that do way 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 that have become predominantly routine when it comes to quality assurance and regulatory decisions.
b) Multivariate Tools – They are used for design, analysis and most importantly, data acquisition in the PAT process. The knowledge gained through this 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 and it is an essential element in the future of pharmaceuticals and the healthcare industry.