First, let’s establish that every process must follow normal scientific molding protocol. With pack and hold at zero, the shot should be 95 to 98% full. Temperatures and pressures should be kept as ...

Machine and process troubleshooting are the most important factors in controlling process and reducing defects. Poorly performing presses lead to process variance and uncontrollable scrap events, and ...

Market opportunities lie in enhancing risk-based V&V planning, focusing on DQ, IQ, OQ, and PQs to address cGMP deficiencies and regulatory expectations. By aligning with FDA, ICH, and ISO standards, ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Process validation plays a critical role in the success for a new biopharmaceutical on the path of commercialization, including the crucial process characterization. As a program advances towards ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

This is a preview. Log in through your library . Abstract Exhaust Gas Recirculation (EGR) is one of several technologies that are being investigated to deliver future legislative emissions targets for ...