Process Design is the first of three stages during the procedure of Process Validation. The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Process Design describes the commercial production process based on planned master production and control records in order to ensure consistent delivery of a product according to defined quality attributes.
Current Good Manufacturing Practice (CGMP)
According to FDA the CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have.
CGMP conditions need not necessarily be followed in early process design steps. Accordance to scientific methods and documentation is however useful. For commercially distributed goods which are manufactured in stage 2 (Process Qualification) or stage 3 (Continued Process Verification) CGMP conditions are necessary according to ICH Q10. Continuous control, improvement and documentation help to establish and preserve a satisfying lifecycle of process and product. The PANDA system allows integrating, analyzing and displaying collected data from different sources in order to support development of feasible processes. Laboratory or pilot-scale models at least allow estimations and extrapolation concerning the following commercial process. DoE-studies can help to establish process knowledge like incoming ranges of component quality, equipment parameters and in-process material quality attributes.
The PANDA system can route collected and prepared data into automatically generated reports. Documentation and differentiation is a key-capability for a reasonable and clear representation and understanding of collected data. Process knowledge and understanding is the basis for establishing an approach to process control overall and in detail. Process control is quality control.
Process analytical technology (PAT)
FDA expects both examination of material quality and equipment monitoring. PAT can be involved into those processes and control loops allow adjusting process conditions so that the output remains constant within defined operational limits. Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA). The PANDA system supports in a comprehensive way the display of all relevant information.
Process Design supported with PANDA
PANDA is a flexible system to support the process design phase. CPP data of experimental processes can be captured in different systems like OSI PI or GECCO. Also CQA data can be already available via LIMS systems, via Excel or GECCO. In the process design phase, PANDA supports the responsible users in research and engineering with analysis reports which bring together the influencing process parameters and the resulting product properties. With PANDA system in this stage Critical Process Parameters (CPP) und Critical Quality Attributes (CQA) can be defined and continuously monitored over the whole product lifecycle. Deviations from the design space are easily detected.