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Process qualification is the qualification of manufacturing and production processes to confirm they are able to operate at a certain standard during sustained commercial manufacturing. Data covering critical process parameters must be recorded and analyzed to ensure critical quality attributes can be guaranteed throughout production. [ 1 ]
Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. [ 1 ]
Manufacturing process management (MPM) is a collection of technologies and methods used to define how products are to be manufactured. MPM differs from ERP/MRP which is used to plan the ordering of materials and other resources, set manufacturing schedules, and compile cost data.
Manufacturing engineers develop and create physical artifacts, production processes, and technology. It is a very broad area which includes the design and development of products. Manufacturing engineering is considered to be a sub-discipline of industrial engineering/systems engineering and has very strong overlaps with mechanical engineering ...
Margins can be narrowed through various process upgrades (i.e. equipment upgrades, enhanced control methods, etc.). Once margins are narrowed, an economic analysis can be done on the process to determine how the set point target is to be shifted. Less conservative process set points lead to increased economic efficiency. [11]
ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2]
Measuring OEE is a manufacturing best practice. By measuring OEE and the underlying losses, important insights can be gained on how to systematically improve the manufacturing process. OEE is an effective metric for identifying losses, bench-marking progress, and improving the productivity of manufacturing equipment (i.e., eliminating waste).