Packaging validation trends in the pharmaceutical industry (middle)
"we respect the fact that some end users are indeed difficult to provide good user requirements specifications (URS)," Schuh said. "In order to help them, we have developed corresponding templates, which contain relevant information describing the functional specifications of basic equipment."The Jett (joint equipment transition team) alliance is also developing such a template. It is a special interest group under the International Pharmaceutical Engineering Association, which was founded to simplify the cGMP process. The goal of Jett is to improve the communication between users and suppliers of automatic production and processing equipment, so as to meet the requirements of verification more effectively. The alliance provides many documents and templates for different validation processes
"Jett is studying documents such as design requirements, and developing templates with validation lists and the like on the basis of cGMP," whittenton said. "For example, you can find templates about a bottle capping machine."
"as a supplier, we invest to be consistent with customers in terms of validation standards, and also interact and cooperate with customers and suppliers like Jett in the validation process," Schuh said. "End users and suppliers can work together to study how to interact and develop an efficient workflow."
"we have seen a lot of user requirements specifications, and now the trend is to reassess how to write a user requirements specification and how to improve the quality of user requirements specifications," whittenton said. "The whole industry needs to do better in this regard."
but not every supplier is very enthusiastic about this kind of document
"if some suppliers are not willing to provide such documents, as integrators, we may not really carry forward the use of body glass materials. It really belongs to iPhone 4 - choose them to build a production line in the style of matching the side metal binding," Leary said. "Some companies have a standard machine, which is what they sell, and other activities are a burden for them."
in other cases, customers are willing to pay extra to create these documents. However, the machine manufacturer may not find a qualified person to create these documents. Packaging companies have only begun to recognize this requirement in the past decade or so, Leary said
"when manufacturers are doing their own work, they will design all of them, so the details of the specification document will become theirs." Leary said
companies in the industry use process analytical technology (PAT) to respond to cGMP reports. Pat is a system that designs, analyzes and controls the manufacturing and packaging process by regularly measuring key quality and performance indicators. By assuming that quality control cannot be carried out until the product is produced, it should be considered at the machine design stage. The goal of pat is to understand and control the whole processThe overall goal of pat is to ensure the product quality at the end of the production process by implementing the principle of "design to ensure quality" in order to reduce the iron content in the molten aluminum from the source, so as to improve efficiency and reduce the risk of quality reduction. The measurement and control system will shorten the production cycle, prevent defective products and waste materials, and improve the safety of operators and the overall production efficiency. FDA has already set up several subsidiary committees to provide advice on how to use pat in the pharmaceutical industry
"pat fundamentally allows you to release your products without any additional testing," Chatterjee explained, "The current practice is that you have to take samples first, send them to the laboratory, test them in the experiment, and then leave the factory. Pat believes that if you can prove that you are controlling and monitoring the key attributes related to the processing process, such as the number of bags, the verification of the number, the correct label, the correct country, the legal printing, etc., and the packaging equipment can also ensure that its products can meet your quality standards, then this is the ultimate goal Quality assurance. "Pat is slowly starting - it requires users and suppliers to carry out a high-level cooperation in the design and R & D stage of equipment. It also requires "intelligent" machines and sensors not only to transmit the state of the processing process, but also to feed back the state of the sensor. This led to the birth of a new generation of integrated control system
in the past, the equipment simply controlled its own functions. Three or four other systems either tracked the feeding of the machine, measured the downtime, or tracked the performance of the machine. But now this machine 2. The stabilizer "knows" when it is a good machine and when it is not
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