Click the blue text to follow us This article is based on the paper “Research on Key GMP Inspection Points in the Production of Antibody-Drug Conjugates” (Author: Ma Yansong, et al.; National Medical Products Administration Center for Food and Drug Review) published in 2025, systematically outlining the entire GMP regulatory chain of ADC drugs from … Read more
Thank you for your continued support. Let’s start learning now To do things well, one must do good things, and to do good things, one must do them well. Q6661 What are the main risks in ADC segmented production?The main risks in ADC segmented production are concentrated in the transportation and handover of intermediate products. … Read more
Guidelines for Quality Management of Surgical Robot Production in Beijing Inspection Guidelines (2025 Edition) Release Date: April 3, 2025 The surgical robot, which refers to the auxiliary surgical equipment utilizing robotic technology, is a highly integrated medical device whose safety, effectiveness, and reliability are directly related to the life and health of patients. To strengthen … Read more
The assembly of semiconductors has extremely high requirements for the dimensional fit of parts. The micron-level fit of precision fixtures and functional components on the assembly line directly determines the yield rate and subsequent maintenance frequency. PEEK material, due to its high temperature resistance, wear resistance, and mechanical stability, is widely used in clamping parts, … Read more
Implementation of ‘Dual Responsibilities’ Report Over the past six months, I have diligently implemented the spirit of the relevant documents on party conduct and integrity, strictly adhered to the regulations of the responsibility system for party conduct and integrity, and acted in accordance with the party’s organizational principles and discipline. I have maintained self-respect, self-reflection, … Read more
Free Download | Quality Management PPT Materials Origin of the Zero Defect Concept: Philip B. Crosby, known as the “father of zero defects” and “global quality management guru,” introduced the concept of “zero defects” in the early 1960s and promoted the zero defects movement in the United States. Later, the idea of zero defects spread … Read more
Management of Outsourced PCBA Processing Inspections Introduction: For companies that have their PCBA manufactured by outsourced SMT factories, it is not sufficient to simply hand over the manufacturing requirements and expect good quality without oversight. Discovering issues only at the end of the process is too late for effective remediation. A crucial aspect is that … Read more
Author Author Steve Williams is the President of The Right Approach Consulting. He is also an independent certified coach, trainer, and speaker for the John Maxwell team. The ISO 9001 international quality standard is revised every 5 to 7 years, but it has far exceeded this regular cycle. The latest revision is expected to be … Read more
Today, Xinyan Electronics, a one-stop PCBA processing manufacturer, will discuss the role of SPI inspection in SMT processing and its significance. 1. How SPI Becomes the “Eye of Fire” on SMT Production Lines SPI (Solder Paste Inspection) solder paste inspection machines, which may seem like ordinary metal enclosures, house a precision optical system. Unlike traditional … Read more
1. PCBA Production Process OverviewPCBA (Printed Circuit Board Assembly) production process encompasses multiple stages from design to finished product assembly, with the core steps as follows:1. Design and Material Preparation o Circuit Design: Use software such as Altium Designer and Cadence to complete schematic design, determine component parameters, layout, and signal integrity requirements. o PCB … Read more