The hottest packaging verification trend in pharma

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."

"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."

extra payment

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 process

"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. "

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

this article comes from the Internet version. The right to overexertion belongs to the original author. It is only for everyone to share and learn. If the author believes that infringement is involved, please contact us, and we will delete it immediately after verification