Understanding Validation and Qualification With Respect to Storage Mapping
There are numerous regulations that are at play in storage mapping today. That said, any business that manufactures or handles pharmaceuticals needs to ensure that they fully comply with the current GMP and GDP guidance.
In short, this means that the production, handling, and storage of all pharmaceutical products, as well as active pharmaceutical ingredients (APIs), must take place in validated facilities where qualified processes and equipment are in use.
Qualified processes mean providing proof that anything physically used in the manufacture, storage, or transportation of pharmaceuticals meets its design purpose fully.
This could be the room where a drug is produced, for example, or it could be the automated system that makes it. There again, qualification is needed to prove a storage facility or transportation container meets its intended usage criteria.
Only when a company has shown that each piece of physical equipment, including the facility where such equipment is used, is fit for purpose can it be said to be qualified.
To put it another way, when an item is used to produce, handle, or store a product made by a pharmaceutical company, a validation must be performed that demonstrates it functions within its design parameters. If just one element in the production, handling, storage, and delivery chain is not validated, then the process is not qualified.
Under GMP and GDP guidelines, validation relates to the entire process whereas qualification relates to every step within that process.
A simple way to think about the difference between validation and qualification is that anything physical that you could touch needs to be validated. The whole process, which consists of a well documented procedure resulting from these series of steps, is what needs to be qualified.