Process Analytical Technologies |
What is PAT ?
Process Analytical Technology (PAT) is a system for designing, analyzing, and controlling manufacturing processes based on an understanding of the scientific and engineering principals involved and identification of the variables which affect product quality. The PAT initiative is consistent with the current FDA belief that quality cannot be tested into products, but should be built-in or by design. Then, the goal of PAT is to enhance understanding and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.
According to the FDA guidance, the desired state of pharmaceutical manufacturing is that :
- Product quality and performance are ensured
through the design of effective and efficient manufacturing processes
- Product and process specifications are based on a mechanistic understanding of how formulation and process factors affect product performance
- Continuous real time quality assurance
- Relevant regulatory policies and procedures are tailored to accommodate the most current level of scientific knowledge :
- Risk-based regulatory approaches recognize the level of scientific understanding of how formulation and manufacturing process factors affect product quality and performance
- the capability of process control strategies to prevent or mitigate the risk of producing a poor quality product
PAT Tools
PAT tools can be categorized according to the following :
• Multivariate tools for design, data acquisition and analysis
• Process analyzers
• Process control tools
• Continuous improvement and knowledge management tools
An appropriate combination of some, or all, of these tools may
be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance. MIVADO GP can provide you with and implement PAT tools in your site during the product development phase. Partners and our experienced team can assist and advise when PAT tools are implementing. For one or other tools, MIVADO GP can also carry out the complete validation of your tools according to 21
CFR Part 11.
MIVADO GP can also assist clients at the first time inspection of
Regulatory agencies.
Building quality into products
Effective PAT implementation is founded on detailed, science-based understanding of the chemical and mechanical properties of all elements of the proposed drug product. In order to design a process that provides consistent product, the chemical, physical, and biopharmaceutical characteristics of the drug and other components of the drug product must be determined. Although the science of analyzing for chemical attributes such as identity and purity is mature, certain physical attributes such as solid form, particle size, and particle shape are more difficult to analyze and control.
PAT tools implementation can involve the following considerations :
- Process understanding through advanced solid-
stateresearch
- Identification of critical control variables using multivariate techniques
- Development and validation of appropriate analytical methods for measuring critical control variables
- Transfer of analytical methods to on-, in-, or at-line use
- Consultation and assistance in method validation and use after transfer
MIVADO GP can assist clients in all aspects of PAT
implementation and contact us today for the conformity and
innovation of your manufacturing processes. For all information
related to PAT tools and their implementation, Contact us as of
today.
