Why Have Standards?
Standards serve a very important purpose and are a part of our daily lives − in the lab where our samples are tested, in the equipment that we use at the gym, to the way we work and perform our jobs. We need them to help keep us safe, to make sure that there is consistency in how products are made, tested, and used by all, and sometimes the government may mandate compliance with a standard in lieu of government guidance. Standards benefit everyone too—industry, government, consumers, young professionals, and students.
A standard is an agreed-upon way of doing something. In this case, it is a written document that tells you how to do, make, test, or design something. A standard can set specific guidelines for the design, operation, manufacture, and use of is the product being produced. There are standards to protect human health, safety, and the environment, and standards to ensure that different products work compatibly.
PDA is recognized by industry professionals and regulators around the world who rely on PDA’s peer-reviewed technical documents for expert guidance and opinions on important scientific and regulatory topics. Therefore, the logical and natural progression was for PDA to expand this expertise into the world of creating standards that provide guidance to the industry on best practices for drug manufacturing for patient use.