Late Construction Phase Customizing test procedures as late as possible means waiting until a time when all change orders should be on the books and all requests for information should be answered.

Figure 1: Overview of the enhanced approach to analytical procedure development [Figure 1 is courtesy of the authors]. The analytical controls for a pharmaceutical product comprises ...

ICH Q14 Draft Guideline: Analytical Procedure Development In March 2022, the ICH Q14 draft guideline was published for public consultation aiming to describe science- and risk-based approaches for ...

Every lockout/tagout (LOTO) procedure is different from every other one. Why is this? Even if you have eight identical production machines, the ID numbers of the supply breakers will differ. The asset ...

As I described in my previous article about the protocol for clean room product development, there are often situations where a company has come into contact with IP that it cannot allow to spread ...

Early construction phase test procedure development provides plenty of time for project team members, in particular the contractors whose systems will be tested, to review, ask questions, and ...